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and Doctoral Studies Collection 2019 Implementation of an E Implementation of an Evidence-Based

Diabetic F vidence-Based Diabetic Foot Car oot Care Protocol and Impact on Health Outcomes Tina
Marie Warfield Walden University Follow this and additional works at:
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[email protected]. Walden University College of Health Sciences This is to certify that the
doctoral study by Tina Warfield has been found to be complete and satisfactory in all respects, and
that any and all revisions required by the review committee have been made. Review Committee Dr.
Mattie Burton, Committee Chairperson, Nursing Faculty Dr. Rosaline Olade, Committee Member,
Nursing Faculty Dr. Mary Martin, University Reviewer, Nursing Faculty Chief Academic Officer and
Provost Sue Subocz, Ph.D. Walden University 2019 Abstract Implementation of an Evidence-Based
Diabetic Foot Care Protocol and Impact on Health Outcomes by Tina M. Warfield MSN, Walden
University, 2016 BSN, College of Notre Dame, 2009 Project Submitted in Partial Fulfillment of the
Requirements for the Degree of Doctor of Nursing Practice Walden University November, 2019
Abstract Diabetes is a condition that can lead to foot ulcers that often progress to amputation of a
limb. Providing patients with education about foot care is crucial because it can help to prevent or
minimize the incidence of foot ulcer development and amputation of a limb. Foot care education as
a strategy not only empowers patients with proper foot care knowledge and skill to support and
motivate self-care but can also enhance the partnership between the provider and patient. The
purpose of this quality improvement project was the implementation of a sustainable evidence-
based foot care program for adult patients with diabetes as a routine organizational protocol for
quality improvement in diabetic care in a primary care clinic. The question for this project was: How
does the implementation of an evidence-based diabetic foot care protocol impact the health
outcomes of diabetic patients in a primary care clinic? Orem’s self-care deficit nursing theory and
the logic model for evidence-based practice were used to guide this DNP project. The research
method for the quality improvement project was a review of the literature. The participants were
staff and adults with diabetes at the primary care clinic. The results of the chart review showed that
80% of the charts included documented foot assessments and patient education, which was an
improvement when compared to 40% pre-implementation of the foot care program. The program
has improved the foot health knowledge and skills of clinicians and people with diabetes and has
also helped to reduce the burden of healthcare costs related to the lower incidence of
hospitalization for the treatment of wounds and amputation associated with complications of
diabetes. Implementation of Evidence-Based Diabetic Foot Care Protocol and Impact on Health
Outcomes by Tina Marie Warfield MSN, Walden University, 2016 BSN, College of Notre Dame, 2009
Project Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Nursing
Practice Walden University November, 2019 Dedication I want to thank God for blessing me with the
ability to be humble and the health, strength, wisdom, and persistence needed to complete this
project. This DNP Project is dedicated to the best parents in the world Emma Geraldine Warfield and
Charles Franklin Warfield, my children James Walker Hawkins III and Chene’ Marie Christy, my
grandchildren Jalaysia Marie Hawkins, Jalizza Love Hawkins, Jade Emma Hawkins, James Walker
Hawkins IV, my brothers United States Army Vietnam Veteran CSM Melton L. Cooper and Stanley A.
Warfield, my sisters Cicely A. Warfield and Linda D. Warfield-Allison and to all my nephews and
great-nephews, nieces and great-nieces, aunts, uncles and cousins of the Warfield and Cooper family
and personal friends. And in loving memory of Charles “Frankie” Warfield III, James Oliver Warfield,
and Barbara Lee Warfield. Thanks for your support and encouragement. Acknowledgments I want to
thank Dr. Thomas Biondo, M.D. for making this opportunity possible. I would also like to thank
Sandra Gallion, Office Manager, Dr. Hi-Sup Sim, M.D., Erin Browne, PA, Melanie Blair, Melissa
Gardner, Heather Ely, Tracy Rogers, Caroline Gilley and Mr. Fred Cimo for your support and guidance
in making this experience a positive one. I will also include a very special “Thank You” to Jane Koch
AGNP-BC for her consistent support. And, I would also like to acknowledge Dr. Mattie Burton and Dr.
Rosaline Olade Committee Chair for providing constant support and guidance and Dr. Zin M. Htway
for helping to make this project possible. Table of Contents List of
Tables ...................................................................................................................... ii Section 1: Nature
of the Project...........................................................................................1 Section 2: Background and
Context ....................................................................................9 Section 3: Collection and Analysis of
Evidence................................................................23 Section 4: Findings and
Recommendations.......................................................................37 Section 5: Dissemination
Plan ...........................................................................................57
References..........................................................................................................................62 Appendix
A: Plan for a Diabetic Foot CareProtocol .........................................................69 Appendix B: Primary
Care Diabetic Chart Review Form……………………………….73 Appendix C: Annual Comprehensive
Diabetes Foot Exam Form……………………….74 Appendix D: Take Care of Your Feet for a
Lifetime…………………………………….75 i List of Tables Table 1. Quality Improvement Chart Review In
Primary Care…….................................40 Table 2. Quality Improvement Chart Review In Primary
Care…….................................42 ii 1 Section 1: Nature of the Project Introduction As a result of growth
in the number of people diagnosed with diabetes, health care providers foresee a critical surge in
problems associated with the disease. Diabetic foot ulcers are complications associated with
diabetes and often the ulcers progress to amputation of the lower extremity (Fitzgerald, 2012).
Management of diabetic foot complications can be challenging as well as result in high costs for both
individuals who suffer from lower extremity complications and society (Boutoille, Féraille, Maulaz, &
Krempf, 2008). This will have a negative impact on the quality of life of adults with diabetes as well
as the United States health care system related to extended hospital stays and the expenses
associated with amputation and wound management. Education can be used to promote the
prevention of foot ulcers because it can improve patient’s knowledge and can motivate them to self-
manage and perform interventions that will lower risk of injury and keep the cost for care minimal
(Hartley & Repede, 2011). The quality improvement project was conducted at a primary care clinic in
Harford County Maryland. As a member of a quality improvement team, I created this project to
develop a sustainable plan that provides evidence-based recommendations related to improved
diabetic care and quality healthcare delivery at a primary care organization. I created evidence-
based recommendations to expand the role of nurses to provide training for diabetic foot
assessments as well as routinely performing foot assessments and promoting patient awareness and
knowledge of strategies that can potentially help adults with diabetes prevent or significantly
minimize the incidence of 2 foot ulcers and amputation and reduce the rates of hospitalizations
related to amputation. This Doctor of Nursing Practice (DNP) project has the potential to contribute
to positive social change through improved quality of life for adult diabetics, enhanced the skills and
knowledge of nurses at a primary care clinic, and lowered the cost of health care for the health
population. Problem Statement Diabetes is a chronic condition in which blood glucose levels are
above normal or greater than or equal to 200 mg/dl (American Diabetes Association, 2016). Blood
glucose elevation occurs as a result of the pancreas not producing enough insulin or when the body
does not effectively use the insulin it provides (World Health Organization, 2016). Diabetes is a
condition that has a systemic impact and can potentially cause other complications that affect the
eyes, cardiovascular system, kidneys, and limbs as well as coexisting complications such as
osteoporosis and depression (Kent et al., 2013). Approximately 26 million Americans, or 8% of the
entire population in the United States is living with diabetes, and 1.6 million of the new cases are 20
years and older (Fitzgerald, 2012). It is expected that the number of people with diabetes will double
to approximately 48 million individuals by 2050 (Fitzgerald, 2012). Local primary care organizations
provide care to adult patients with diabetes including those with feet injury or limb amputation.
With the expected increase in the number of people who potentially will be diagnosed with
diabetes, local primary care organizations can facilitate prevention of feet and limb injuries
associated with the disease and can promote a positive social change by implementing diabetic foot
assessment training for staff nurses including foot 3 health education as a routine intervention when
caring for diabetic patients in their clinical practice. An identified problem in a local primary clinic
was the incidence of foot ulcers, amputation of toe, toes, or limb. In the clinic, there was an absence
of foot health education focused on the improvement of patient and staff understanding about the
importance of daily foot care and the association of foot ulcers and amputation of a foot or limb in
the diabetic population. The implementation of the quality improvement team recommendations for
an evidence-based foot care protocol to leadership at a local primary care clinic is significant to the
field of nursing. The diabetic foot care protocol is significant because the protocol provided a
strategy for health care providers that helped to prevent or minimize the incidence of injury or
amputation of a limb for people with diabetes and enhanced the quality of health care delivery, both
of which the quality improvement team intended as the outcomes of this DNP project. Purpose The
purpose of this quality improvement project was the implementation of a sustainable evidence-
based foot care program for adult patients with diabetes as a routine organizational protocol for
quality improvement in diabetic care in a primary care clinic. The question for this project was: How
does the implementation of an evidence-based diabetic foot care protocol impact the health
outcomes of diabetic patients in a primary care clinic? The project involved the quality improvement
team collaboration with staff nurses and leadership and empowered staff with knowledge and skills
to care for adults with diabetes at the organization about how to properly care for their feet to
prevent or 4 decrease the incidence of a foot injury and amputation of a limb. Increasing staff and
patient knowledge with regard to proper foot care techniques motivated individuals to perform self-
care activities or as Orem described as learned behaviors that help them to achieve the necessary
therapeutic self-care needs for maintenance of an individuals’ wellbeing (McEwin & Wills, 2014).
Studies have proven that interventions that improve selfefficacy improve self-management and
outcomes of chronic diseases (McCleary-Jones, 2011). Teaching patients about how to properly care
for their feet during routine visits with their doctor and documenting the encounter in the patient
health record allowed clinicians to understand what patients knew and reinforced what was learned,
as a result of self-care and foot care education. Maintaining an active partnership with patients with
diabetes was necessary to ensure that they adequately cared for their feet. Guidance with the
evaluation of foot health resulted in improved knowledge, prevention of foot injury or minimal foot
injury and decreased risk of amputation. Patients became empowered with the ability to understand
as well as perform selfcare when they received foot care education, feet assessments by trained
nurses and evaluation of their feet integrated and documented routinely into their visits with the
primary care clinic. Further implementation studies are necessary to determine the success of this
approach (Jonker, Comijs, Knipscheer, & Deeg, 2015). This project helped to close the gap in practice
as an additional program with evidence-based interventions focused on increasing knowledge and
skills of nurses, patient-centered education and proper foot care techniques. This approach was
expected to be more efficient and cost-effective and helped to prevent or minimize ulcers and
amputations that 5 often lead to poor quality of life and expensive health care cost. The evidence
revealed from the impact of the implementation provided information that can lead to the
development of more programs in other local primary care organizations. The evidencebased foot
care protocol was intended to improve the knowledge, skill, and role of staff nurses by training them
to perform diabetic foot assessments and to accurately document the results, increase patient
awareness, motivate patient self-care, decrease incidence of ulcers and prevent or minimize
hospitalizations related to amputation of a limb all of which contributed to social change in the
organization as well as the community. Nature of the Doctoral Project The purpose of this quality
improvement project was to provide evidence-based recommendations to be implemented by the
quality improvement team at a primary care clinic, and to evaluate the impact on how to
recommendations helped to prevent or minimize the development of foot ulcers or limb amputation
in the adult diabetic population. The sources of evidence to meet the purpose of this doctoral
project included literature from a peer-reviewed journal and national clinical guideline reviews, as
well as Evidence Generated for the Doctoral Project. The Centers for Disease Control and Prevention
(CDC), Agency for Healthcare Research and Quality (AHRQ), American Diabetes Association (ADA),
National Institute for Health and Care Excellence (NICE) Diabetic foot problems, prevention, and
management guidelines were reviewed. I obtained literature through the Walden University Library
database and included the CINAHL Database, ProQuest Database, MEDLINE Database, and Ovid
Database. I used the logic model as a framework and helped the quality improvement team organize
and 6 develop a quality improvement plan. The quality improvement initiative generated evidence
such as an increased number of nurses trained to teach and perform foot assessments, an increase
in the number of patients who have foot assessments, a higher number of patients who received
foot health education, a higher number of patients with foot ulcers referred for specialized wound
treatment or podiatry services and lower incidence of foot ulcers and amputations. Other evidence
generated from the implementation of this DNP project was staff improvement of documentation in
the health records of diabetic patients who received care at the clinic. It was expected that the
health records would have an increase in the number of charts that included documentation of
routine foot health including foot assessment and the results, patient education and referral for
podiatry or wound management when needed. Significance Stakeholders included patients and
caregivers of patients with a diagnosis of diabetes, the health team or nursing staff, health care
providers, diabetes educators, podiatrist, footwear retailers, wound care specialists, and
neurosurgeons. All stakeholders had an impact on quality improvement and the effectiveness of the
foot care program for prevention of foot ulcers by providing education or specialized services such
as proper fitting footwear, wound treatment and surgery if needed. The evidence-based foot care
program contributed education strategies for clinicians trained to perform diabetic feet assessments
that when applied into practice aided in helping patients prevent the incidence of foot ulcers,
promote independence in the management of foot health and routine documentation of foot ulcer
education. The significance of this DNP project was 7 that it promoted a positive social change
related to improved staff and patient awareness of daily diabetic foot care and its association with
lower incidence of injury to the feet and transferability of the evidence for future implementation in
other primary care organizations in the community. Summary This section included an overview of
the project problem, purpose, nature of the doctoral project and its significance to healthcare and
patient outcomes. Patients with diabetes often suffer from foot complications and prevention of
such complications requires foot care (Fujiwara et al., 2011). A critical strategy for prevention of foot
injury is ensuring patients are adequately educated about how to care for their feet (Clair, 2011).
Healthcare organizations were aware that there was a need to integrate evidence-based practices
into clinical practice for optimal outcomes and were achieved with interventions directed at patients
such as teaching adult patients with diabetes about caring for their feet. This changed their behavior,
contributed to the prevention of diabetic foot ulcer and amputation, and decreased economic
burden (Dorresteijn, Kriegsman, & Valk, 2010). Plans to narrow the gaps in practice by providing
strategies to decrease the incidence of foot ulcers and amputations in adult diabetics in healthcare
settings aligned with Healthy People 2020 objective of reducing the rate of lower extremity
amputations in persons with diagnosed diabetes (HealthyPeople.gov. 2017). Section 2 will include an
overview of the concepts, models, and theories as well as the relevance of this project development
to nursing practice, local background, and context. Section 2 will also include discussion of the role
of the DNP student and project 8 team, and the development of a plan for evidence-based diabetic
foot care protocol to address the gap in current practice. 9 Section 2: Background and Context
Introduction Diabetes is a serious health condition that when uncontrolled is associated with
complications. More 29 million Americans are living with the disease (Shiu, & Wong, 2011). The
complications of diabetes contribute to healthcare challenges that include foot injuries such as
blisters that may progress further to foot ulcers and potentially amputation of foot, toe, or leg
(Romero, 2016). In primary care, health education is one of the purposes of nurses’ work and
includes education for patients with diabetes mellitus and diabetic foot care (Porcelis Vargas, Souza
Lima, Loyze da Silva, Dornelles Schoeller, de Oliveira Vragas, & Rozza Lopes, 2017). Health care
clinicians can promote prevention of foot injury by using foot care education as a method to prevent
injury to their feet and will give diabetic patients knowledge that will guide them in performing daily
self-care rituals such as foot washing techniques, thorough inspection, toenail care, early
identification of changes, and the insight to know when their feet should be examined or treated by
a professional (McInnes et al., 2011). The question for this practice change project was: How does
the implementation of an evidence-based diabetic foot care protocol impact the health outcomes of
diabetic patients in a primary care clinic? In this section, I will discuss the concepts, models, theories,
relevance to nursing practice, local background and context, the role of the DNP student and the
role of the DNP Project team. 10 Concepts, Models, and Theories Orem’s self-care deficit nursing
theory was the theory I recommended for this evidence-based project for the promotion of quality
care. Health education programs are successful when theoretical foundation guides the application
and include the evidence of research and professional interpretation for the appropriate use
(Hodges & Videto, 2011). The implementation of Orem’s self-care deficit theory of nursing facilitated
the health team with guidelines that ensured improved patient knowledge and self-care. Self-care is
a deliberate therapeutic action performed by humans to maintain healthy development and function
that is consistent with life, health, and well-being. according to Hartweg and Pickens (2016, p. 5).
Orem’s self-care deficit theory contributed to organizational changes by assisting the health team
with developing as well as the implementation of a protocol that closed the gap between foot health
knowledge of clinicians and helping adult diabetics meet their own feet health needs. The health
team or organization provided a supportive-educative environment where resources were available
to interact with adult diabetics to help them improve their foot care knowledge and reach their
optimal ability (Grove, Burns, & Gray, 2013). Through observation, I identified the need to improve
care quality at the organizational level as well as a need to empower staff nurses and adult patients
with diabetes with strategies that encouraged independent foot care and aided in preventing or
lowering incidence of foot problems that lead to ulceration and amputation. I used Orem’s self-care
deficit nursing theory to guide the translation of evidence into practice for routine use such as
performance of foot assessments, foot care education, and 11 documentation of the results in the
health record when caring for patients with diabetes. The theory allowed for ongoing evaluation of
outcomes and protocol modification that achieved and maintained optimal outcomes for diabetic
patients as it related to foot health and improved health care delivery for the organization. The logic
model is a visual and useful tool that I used in the development of recommendations for this
evidence-based program. It was a helpful way to demonstrate to stakeholders or the healthcare
team about the relationship between the theoretical foundation and the activities that achieved the
expected outcomes of a program intended to improve patient awareness with regard to feet health,
promote self-care or change behavior, and improve the quality of healthcare delivery in a primary
care clinic (Hodges & Videto, 2011). For this project, I adapted the logic model framework from W.K.
Kellogg Foundation (2006) and I used the model as a visual tool for all stakeholders at the primary
care facility as a guide to achieve improved diabetic care. The components of the logic model
framework that I used for this quality improvement project were inputs, outputs, outcomes, and
impact. The components were useful for this program because each component can be efficiently
monitored or evaluated and lead to the implementation of any necessary adjustments to the
program plan that improved the foot health and quality of health care provided to adult patients
with diabetes a primary care clinic. In this project and as a member of a quality improvement team, I
aimed to develop and implement a sustainable plan that provided evidence-based strategies related
to improved diabetic care and quality healthcare delivery to diabetic patients at a primary care
organization. The plan was to develop a foot care protocol and then routinely 12 implement into
practice in a primary care clinic. The health team provided staff nurses with training to perform
diabetic foot assessments independently and educate adult diabetic patients about foot health
strategies that helped in preventing foot injury. Clinicians routinely performed foot assessments and
then documented the assessment findings in the health record. To motivate self-performance,
clinicians gave a foot health pamphlet to adult patients with diabetes to take home to reinforce
education received during their visit and for guidance at home on how to properly care for their feet.
The health team studied the diabetic foot care intervention and determined if future modifications
to the protocol were necessary. The health team developed questions that guided in determining
the need for adjustment of the foot health protocol. The health team performed an on-going
evaluation of organizational intervention. The health team wanted to know the following: • Did the
patient understand the foot health information provided by clinicians? • Was the information
brochure given to the patients’ readable and understood? • Was the patient performing the foot
care activities daily? If not; what was preventing the activity from occurring? • Were clinicians
performing follow-up feet assessments, comparing the new findings, and documenting the results in
the health record? • Were patients referred to a wound care specialist or podiatrist as needed? 13
The health team intended the quality improvement program to improve the foot care knowledge
and skills of clinicians who provided care to adult patients with diabetes and the knowledge and foot
health of adults with diabetes at a primary care organization including prevention of foot ulcer and
amputation. The health team acted or made changes to the foot health protocol if the answer was
“yes” to the outcome evaluation questions such as: Have any foot ulcers developed? Have any
amputations occurred? Relevance to Nursing Practice Adult patients with diabetes are affected by
the complications of the disease involving their feet, causing injuries that often have outcomes that
result in blisters, foot ulcers, and amputation of a limb. Knowledge about foot care empowers adult
patients with diabetes to prevent the occurrence of injury to their feet through the use of education
and performance of foot help strategies which include foot washing techniques, assessment, well-
fitting socks, and well-fitting shoes. It is estimated that in the United States, 15 billion dollars are
spent annually related to the burden of foot ulcers associated with diabetes, as well as 69 billion on
indirect medical cost involving premature death, disability and reduced productivity and 176 billion
on direct medical cost for a combined total cost of diabetes equal to 245 billion dollars in the United
States (American Podiatric Medical Association, 2017). Self-monitoring of foot health is vital in the
prevention of diabetes complications related to the foot, and it is important for providers to use a
patient-centered approach to self-selected behavioral goal setting as well as identify any self-
management deficits and collaborate with patients to develop strategies to overcome those deficits
(American 14 Diabetes Association, 2017). Uninformed patients regarding self-help behaviors for
diabetic foot care presents a barrier to prevention and make the lack of foot health knowledge a
cause in greater than 90% of foot ulcers that reoccur (Miller et al., 2014). When investigating the
literature, I discovered that patient education for prevention of foot ulcers is most effective when all
levels of the health team in healthcare organizations participate in the effort of educating patients in
regard to their foot health including selfcare at home (Miller et al., 2014). Previously patients with
diabetes were educated to avoid situations that placed them at risk for injury, including walking
around with no shoes and shoes that are too tight, small, or too big. They also received training to
substitute lack of sensation with other senses such as touch or sight; however, the effectiveness of
patient education programs in the body of knowledge were inconclusive (Morey-Vargas, & Smith,
2015). This quality improvement initiative advanced nursing practice by expanding the role of nurses
by participating in diabetic foot assessment training and once trained provided training to other
nurses about how to perform diabetic foot assessments routinely and accurately record the findings
in the health record. The nurses informed patients with strategies that aided in improved foot health
for diabetics at the organization and lowering the cost for care by minimizing injury to feet and
avoiding expensive wound treatment. Developing a partnership between health care providers and
adult patients with diabetes and foot health education helped to close the gap in practice with
improved health outcomes for diabetic patients at a primary care clinic. For prevention of diabetic
foot ulcers in diabetic patients or for patients at risk for diabetic foot ulcers the following 15
components were included in patient education: (a) awareness and understanding, (b) avoid injuries,
(c) daily foot inspections, (d) feet hygiene, (e) sock selection, (f) nail care, (g) footwear selection, (h)
footwear fitting, (i) and health provider support (MoreyVargas, & Smith, 2015). Local Background
and Context The Maryland Department of Mental Health and Hygiene has documented 8.7% of
Maryland’s population has a diagnosis of diabetes and, of those diagnosed, 4.7% live locally in
Harford County (Maryland Department of Health and Mental Hygiene, 2016). The quality
improvement project was conducted at a primary care clinic in Harford County Maryland. Diabetes
continues to be the most typical and crucial cause of lower limb amputation and minimizing the risk
of complications associated with the condition is possible with self- help behaviors aimed at
preventing or decreasing the development of diabetic foot ulcers (Kent et al., 2013). There is routine
nursing practice, such as diabetic foot assessments and education strategies, that when
implemented during patient encounters at a primary care organization, motivated individuals to
perform self- care to prevent injury to the lower extremity. Some interventions that aided in the
prevention of diabetic foot ulcer include foot care education with regard to foot washing techniques,
nail care, daily foot inspection for early detection of swelling, redness, pre-ulcerative lesions, blisters
as well as callus development, socks and shoes that fit well and other potential problem areas
(Fitzgerald, 2012). Other important interventions are the services of a multidisciplinary 16 health
care team and access to experienced vascular surgery all of which in many incidents can prevent
ulceration and amputation (Shaw, 2014). Role of the DNP Student In this project, I implemented a
foot care protocol for adult diabetic patients into the routine clinical practice of a primary care
organization in Harford County, Maryland. My role as a DNP student was my opportunity to apply
activities in the practicum setting that is expected of me as a DNP graduate. In the practicum setting,
I used skills that enabled me to successfully identify gaps or needs in clinical practice that minimized
the quality of health care delivery. Performing a literature search is a developing skill and working
tool used in my DNP role and was essential when in search of the latest evidence for solutions to
identified needs in the clinical practice setting. I used CINAHL, ProQuest, Medline, and Ovid
databases when investigating the literature for this project. My role required the ability to develop
professional partnerships with all members of the organization as well as specialists in the
community to recommend safe, attainable, and cost-efficient strategies based on research findings. I
used my knowledge as a DNP student to translate the new evidence into the clinical setting and then
used by health care providers for clinical decision-making that achieved the best clinical outcomes
for patients who received care in health organizations. I am the DNP student for this QI project, and I
was responsible for the ongoing assessment of the change in practice. I also was responsible for
analyzing the collected data, informing stakeholders of the evaluation results, and through
collaboration, determine if there was a need to adjust 17 implementation strategies intended to
improve outcomes to results that are considered to be the best. The motivation for this doctoral
project was the observation of adult patients with diabetes in need of treatment for diabetic wounds
to their feet including amputation of toe or toes and lower limb. The observation of adult patients
with diabetes living with consequences of complications of diabetes was a thought-provoking
experience that lead to a research inquiry and ultimately an evidence-based project using a foot care
protocol as a strategy for prevention of foot ulcers. A perspective that affected my choices about the
evidence-based foot care protocol was the empowerment the educational intervention provided for
staff nurses trained to perform diabetic foot assessments and for adult patients with diabetics.
Another aspect that affected my decision was the patient-clinician partnership enhanced
documentation, monitoring of foot health and developed partnerships in community settings should
the need for specialized services arise. The foot care protocol intervention was effective and
promoted a positive social change in improved quality of care, prevention of or minimal foot ulcers
and amputation, improved monitoring of feet conditions, documentation of assessment findings in
the health record and lower cost of health care services related to improved health and decreased
hospitalizations. I did not foresee any biases associated with this quality improvement initiative
intended to promote quality health care delivery, enhance the knowledge and skills of nurses, and
improve the feet health of adult diabetics’ at a primary care clinic. 18 Role of the Project Team The
purpose of this quality improvement project was to provide evidence-based recommendations of
the quality improvement team to the leadership at a primary care clinic that helped prevent or
minimize the development of foot ulcers or limb amputation in the adult population. There was a
need to bring awareness to members of the organization focused on quality health care delivery and
improved foot care for people with diabetes to achieve the goal of the quality improvement project.
Identifying members of the group who had an interest in improving diabetic foot care aided in
forming a quality improvement team that participated in developing a plan for implementation of a
diabetic foot care protocol at a primary care clinic. The quality improvement team included all who
provide service to people with diabetes’ at the primary care facility, are affected by the intervention
and are users of the evaluation results (Hodges, & Videto, 2011). At the organization the nurse
manager, physicians, registered nurses, medical assistants, and the administrative assistant were the
quality improvement team with expectations and roles that were clearly defined and promoted the
commitment of all members to the project (OToole, Cabral, Blumen, & Blake, 2011). The nurse
manager assumed the role as the champion leader and was responsible for ensuring communication
about the status of implementation of the diabetic foot care protocol occurring among all members
of the quality improvement team as well as informing non-team members of the project updates.
The nurse manager also provided support and positive feedback to all members of the quality
improvement team, motivated them to perform to the best of their ability, and contributed to the
achievement 19 of identified goals that lead to optimal foot health outcomes for the diabetic patient
(OToole, Cabral, Blumen, & Blake, 2011). The physician was assigned the role of team leader. The
team leader was responsible for clinical support and system leadership. The physician or team leader
also provided training and guidance to lead staff nurses in performing feet assessments and
evaluation of their skill to practice independently as well as their ability to train other nurses, offer
treatment orders and monitor the clinical progression or regression of wounds. The team leader also
worked collaboratively with specialists such as podiatry, wound care specialist, neurology, and
surgical services as needed to obtain the best and cost-effective treatment interventions for the
diabetic patient. Registered nurses received training to independently perform diabetic foot
assessments, provided foot health education, evaluated learning effectiveness and reeducated as
needed. The registered nurse also performed a routine and on-going assessment of the feet,
documented the status including new injury, improved wound healing, non-healing wounds, or
trauma that may require more extensive treatment such as the service of a specialist or podiatrist in
the community. Medical assistant’ role involved collecting and recording in the health record any
concerns, complaints of new injury or improvement or the resolution of past wounds as reported by
the patient. The medical assistant ensured that socks and shoes were removed during their patient
encounter. The medical assistant also performed and recorded foot care interventions as delegated
by the Registered Nurse. 20 The administrative assistant was responsible for the evaluation of charts
to confirm that people with diabetes at the organization have a foot health assessment and follow-
up assessment documentation included in the health record. Programming the electronic medical
record to integrate consistent foot assessment documentation was another responsibility of the
administrative assistant. The administrative assistant was also responsible for scheduling follow up
appointments as ordered by the physician and provided take away education materials for review at
home. The team shared responsibilities, performed high-quality teamwork and worked
collaboratively toward developing a plan that addressed the question: How does the
implementation of an evidence-based diabetic foot care protocol impact the health outcomes of
diabetic patients in a primary care clinic? The project team expected that implementing a diabetic
foot care protocol will have a positive impact on the knowledge and skills of staff nurses at the
primary care organization, and the healthcare outcomes for adult patients with diabetes will be
better foot care, lower the incidence of hospitalizations related to wound care or foot injury and
keeping the cost of healthcare low. I presented the project team members with background
information, evidence, and other forms of information related to diabetes, foot health, and
prevention of foot ulcers, hospitalizations associated with diabetic wounds or amputation and the
high cost of healthcare services for the treatment. The processes by which the information was
disseminated was through my presentation of evidence retrieved from electronic databases and
professional journals. I shared the evidence with the quality improvement 21 team for review. Then
in a group discussion, I provided feedback about how the information can be used to develop a plan
for a diabetic foot care protocol and then implement the protocol into daily or routine practice when
caring for adult patients with diabetes at the primary organization. Another strategy I used was the
presentation and dissemination of the Take Care of Your Feet for a Lifetime (n.d.) provider or patient
education pamphlet. The pamphlet is a free non-copyright education resource from the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) an institute within the National
Institutes of Health (NIH) which encourages that the foot care content is shared freely. I used the
presentation and dissemination of the pamphlet to share comprehensive foot care knowledge with
the quality improvement team and as an educational tool for adult patients’ with diabetes to
enhance the organization’s foot health initiative. The group discussion provided an opportunity for
dialogue among team members about suggestions, questions, and concerns regarding planning and
development of a foot health protocol as a quality improvement initiative for implementation at a
primary care clinic. All team members reviewed and provided feedback regarding the doctoral
project results. The nurse manager or champion leader provided daily review and feedback to
members of the quality improvement team throughout the workday. The physician or team leader,
the registered nurses, and the medical assistants all provided review and feedback every week. The
administrative assistant provided daily evaluation and feedback to all members of the health team
to ensure that all foot health documentation 22 was completed thoroughly and daily to achieve
optimal improvement in foot care for diabetics and health care services at the primary care clinic.
Summary As a result of the increasing number of adults with diabetes the incidence of foot ulcers
and amputations are occurring and can be prevented or lower the incidence of foot injury when
patients have the knowledge to use strategies that aid in the prevention of foot injury. When nursing
staff implemented evidence-based foot care education retrieved from reliable literature resources of
evidence into the health care encounter it filled the gap in practice with improved knowledge and
self-care in adult patients with diabetes at a primary care clinic for prevention of foot ulcers. For
health care providers the evidence-based project filled the gap through improved diabetic foot care
knowledge and foot assessment skills for staff nurses, implementation of routine foot assessments
for patients with diabetes, teaching, documentation, and collaboration with community resources
providers for specialized or extensive wound treatment as necessary. Section 2 provided an
overview of the concepts, models, and theories as well as an addition to the relevance of the
development of this project to nursing practice, local background, context, the role of the DNP
student and the Quality Improvement team. The models selected provided a framework and
guidance that contributed to the development, implementation, collection, and analysis of data that
supported the success of the development and implementation of an evidence-based diabetic foot
care protocol that addressed the gap in current practice. The outcomes included improved
knowledge for patients about proper foot care; patients were motivated to perform care 23
independently and are aware of the relationship between poor foot care, ulcers, and amputation.
Additionally, determined that evidence-based foot care when routinely implemented into practice
improved the foot health of adult diabetic patients. Evidence of quality improvement was supported
through documentation of teaching and assessment results in the patient health record. Section 3
will address the practice focused question, sources of evidence retrieved as a result of the
performance of literature search using electronic databases to address the practice question as well
as analysis and synthesis of post-implementation data. 24 Section 3: Collection and Analysis of
Evidence Introduction Diabetes is a disease that can cause chronic complications for individuals who
are diagnosed with the illness. Foot ulcers and amputation of a limb are often consequences
resulting from complications of diabetes. Foot ulcers and the loss of a toe or limb can possibly be
prevented or at least minimized when patients are involved in properly caring for their feet involving
daily washing, inspection, socks and shoes that fit properly and knowing when to contact a health
care provider when an injury may need to be evaluated by a professional. Improved care quality and
health care delivery and lower costs of health care were outcomes of an educational evidence-based
foot care program for adult patients with diabetes with self-care behaviors when foot health was
included into the routine care provided in the health care organization located in Harford County,
Maryland. This section will discuss the practice-focused question for this quality improvement
project, the sources of evidence used to support improvement in care delivery and enhanced foot
care for adult patients with diabetes at a primary care organization. I will also discuss the analysis
and synthesis used to answer the practicefocused question associated with this DNP Project.
Practice-focused Question In Maryland, diabetes affects 8.7% of the population with 4.7% of those
affected living locally in Harford County (Maryland Department of Health and Mental Hygiene,
2016). The practice focused question was: How does the implementation of an 25 evidence-based
diabetic foot care protocol impact the health outcomes of diabetic patients in a primary care clinic?
This evidence-based project filled the gap in practice related to patient knowledge regarding the
prevention of foot ulcers. For nursing staff, this evidence-based foot care education project filled the
gap in practice and quality improvement. The knowledge and skills improved for nurses who were
trained to perform diabetic foot assessments and routinely implement the intervention when
providing care to diabetics at the primary care clinic. Another approach used by the team to bridge
the gap in practice and quality improvement was teaching to encourage self-performance of foot
care, documentation of patient education and findings of foot assessments and collaboration with
community providers for specialized treatment as needed. The implementation of this evidence-
based project placed focus on improving the knowledge and skills of nurses through diabetic foot
assessment training and daily performance during patient encounters. The implementation of the
evidence-based project also aided in the prevention of diabetic foot ulcers and limb amputation in
adults with diabetes. Sources of Evidence The purpose of this quality improvement project was to
provide the in-depth knowledge needed to make evidence-based quality improvement changes
through the implementation of routine foot assessments for foot ulcer prevention in clinical practice
in a primary care health care organization (Grove, Burns, & Gray, 2013). The sources of evidence that
I relied upon to address the practice focused question for this evidenced- 26 based project included
prevention and management guidelines from the following national agencies: Agency for Healthcare
Research and Quality (AHRQ), American Diabetes Association (ADA), Centers for Disease Control and
Prevention, National Institute for Health and Care Excellence (NICE), as well as evidence generated
from the analysis of the post-implementation data from this doctoral project. Evidence from the
Literature I reviewed literature resources through CINAHL Database, ProQuest Database, MEDLINE
Database, and Ovid Database. The key terms I used in search of evidencebased literature included:
foot ulcers, and diabetic foot ulcers, prevention of foot ulcers, special shoes for diabetics, socks and
shoes for diabetics, shoes for diabetics, diabetic foot, and patient education. There is an economic
burden associated with diabetes involving foot ulcers and amputations of feet and lower extremities.
According to Hoogeveen (2015), clinical practice prevention strategies are best directed at both
health care providers and patients, as there is insufficient evidence that single preventive
interventions have been effective for prevention of foot ulcers. Dorresteijn (2010) contributed to
evidence-based practice by concluding that educating people with diabetes about the need to look
after their feet seems to improve people’s foot care knowledge and behavior in the short term and
that there is insufficient evidence that education alone, without additional preventive measures, will
effectively reduce the occurrence of ulcers as well as amputations. Lorenz (2010) contributed
evidence using a cohort study to show that proper socks are an integral part of comprehensive foot
health. The study also showed that socks 27 can make a difference between successful treatment
outcomes or management of further complications such as foot ulcers related to wrong socks which
can bunch, bind, break, trap in moisture, and create pressure points and hotspots. Shapiro (2016)
conducted a study and contributed evidence by concluding that education alone does not seem to
decrease the risk of ulcer and amputation and suggests that more research with strong methodology
is necessary. I obtained evidence for this DNP project from the review of literature, national clinical
guideline reviews, rating of existing evidence, and current policy review at the project facility. The
evidence I retrieved ensured that the knowledge used for the development of a diabetic foot care
protocol for staff nurses to implement into routine practice when caring for diabetic patients was
evidence that provided the best clinical outcomes. Keogh (2014) reported that the National
Confidential Enquiry into Patient Outcome and Death (NCEPOD) performed a study that involved 519
cases of lower limb amputation and patients with diabetes made up 55% of the cases. Twenty
percent of the cases were patients with poorly managed diabetes. The NCEPOD reported that
services of health providers are poorly coordinated and only 44% of study participants described
their treatment as good. The report encourages better coordination among primary care providers
because there is an increasing number of patients with diabetes and it is contributing to the higher
number of amputations. The NCEPOD suggested that there is a need for patient awareness about
what to look for when caring for their feet such as reduced sensation, redness and blistering as well
as access to specialized services for the treatment of wound complications (Keogh, 2014). 28
Bonner, Foster and Spears-Lanoix, (2016) performed a systematic review of literature and discussed
foot care practice interventions and foot care knowledge among patients with Type 2 diabetes. It
was determined that there is an association of lower incidence of complications to the lower
extremities for patients with Type 2 diabetes when foot care education is included during patient
encounters, and daily foot care is performed as a self-help strategy that aids in the prevention of
injury to the lower extremities. Foot health interventions promote an improved quality of life for
patients with diabetes, but there is a lack of studies focused on lowering the incidence of injury to
the lower extremity. There is a need for additional research to evaluate foot health strategies across
numerous geographic areas and populations (Bonner, Foster & SpearsLanoix, 2016). In the primary
care organization in Harford County, Maryland where the study was conducted it was expected by
the team that by implementing the evidencebased protocol it would aid in achieving outcomes of
the highest quality and low costs, such as improved documentation as it relates to teaching and foot
evaluation findings in the medical records, improvement in the knowledge of patients, performance
of self-care, and lower incidence of foot ulcers and amputation. Evidence Generated for the Doctoral
Project In a primary care clinic in Harford County, Maryland, I identified a problem, the occurrence of
foot ulcers and amputation of a toe, toes, or lower limb in people with diabetes. The relevance of
this data to the practice problem in this project is the lack of diabetic foot care education among
staff and diabetics at the facility. The implementation of this DNP Project or diabetic foot care
protocol by the quality improvement team as 29 standard practice when caring for patients with
diabetes at a primary care clinic provided data that improved the knowledge and skills of staff nurses
through diabetic foot assessment training and application of the expertise into routine practice
when caring for diabetics. People with diabetes had improved knowledge, skills, and foot health
related to foot health education and motivation to perform self-care to their feet daily. This DNP
project was implemented in a primary care clinic in Harford County, Maryland that has many thriving
health care facilities which provide health care services to a population estimated by the United
States census to be 13,576 (World Population Review, 2018). From the community population, the
primary care organization provides care to an average of 30 to 35 patients per day or 150 to 175
patients per week, and some of them have diabetes. Participants The participants for the
implementation of a foot care program were all members who provided care to patients with
diabetes at the health care clinic. The group included three primary care providers, two registered
nurses, one office manager, two medical assistants, and an administrative assistant. The participants
were relevant for the implementation of this project because they are the staffs who routinely
provide care to all patients who receive care at the organization. Care providers’ improved foot
health practice, new knowledge, and regular performance of patient teaching was enhanced by this
program and diabetic patients received quality health care services and better foot health outcomes.
30 Procedures To perform the chart review, the administrative assistant identified and flagged a
total of 30 charts or 10 charts monthly for 3 months of diabetic patients attending the clinic before
the implementation of the foot care protocol and then 30 charts 1 month after the program was
implemented. The project team collected relevant data associated with this scholarly project and
analyzed the data with statistical assistance. To collect data and to successfully guide this DNP
project, the team selected the Annual Diabetic Foot Assessment form, the Primary Care Diabetic
Chart Review Form I created for this initiative and the Take Care of Your Feet for a Lifetime (n.d.)
education pamphlet (Appendix B, C, D). These are tools the team used to lead the organization to a
primary care clinic that delivers quality health care services to people with diabetes that promoted
independent foot care and lower incidence of foot ulcers and amputation. The team selected the
Annual Diabetic Foot Assessment form recommended by the National Diabetes Education Program’s
Feet Can Last a Lifetime (NIDDK, n.d.) and the form as a tool to guide all clinicians when performing
foot assessments. This form was appropriate because the form aided all care providers in accurate
documentation in the health record and improved the foot health in people with diabetes who
receive care at the facility. Protections For this DNP project, I created a data form to include only
information from the patient chart needed for analysis to determine the effectiveness of the
proposed foot care program. I used the Microsoft Word program to create the form. I designed the
form and 31 the form aided in extracting information and to record efficiently only relevant
information needed for this DNP project. There was no identifiable patient information included on
the form titled Primary Care Diabetic Chart Review Form. There is an area to record the audit period
both at the beginning and end dates as well as reviewer initials. The other information the team
extracted from the chart review for data analysis was documented foot assessment, documented
foot health education, and documented referral for wound care or podiatry. Take Care of Your Feet
for a Lifetime (n.d.) was a foot health education resource used by the team for this quality
improvement initiative and was beneficial for both care providers and patients with diabetes. The
free noncopyright pamphlet is from the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) and served as a guide for health care providers when educating diabetic patients
during health visits and then disseminated to the diabetic patient as a take-home self-help resource.
Data collected from the chart review was stored by the champion leader in a locked file cabinet
throughout the data collection and analysis process. The data collection form had no identifiable
patient data and supported the chart reviewer with consistent patient confidentiality during the DNP
project in alignment with the Health Insurance Portability and Accountability Act (HIPPA) law.
Written approval was obtained from the Walden University Institutional Review Board before this
quality improvement initiative was implemented. 32 Analysis and Synthesis The project team
intended to develop and implement an evidence-based diabetic foot care protocol for routine use by
nurses at a primary care clinic and is aimed at reducing the incidence of foot ulcers in adult diabetic
patients in the clinical setting. The quality improvement team used Orem’s self -care deficit theory
and the logic model to develop a plan for implementation of an evidence-based foot care protocol
that meets the foot care needs of adult patients with diabetes. The approach placed focus on adult
patients with diabetes awareness of strategies that aided in the prevention of injury to their feet,
amputation of a toe, toes, or limb, promote self-performance of daily feet care, follow-up education
with stakeholders at the primary clinic. Electronic databases were accessed by the team and used for
retrieval of free resources for health care providers about foot care, socks, and shoes for providers
to give to diabetics to help guide their daily care at home. I used electronic databases to obtain
evidence to collaborate with team members to develop and implement an evidence-based protocol
that trained staff nurses to perform diabetic feet assessments, educate them to implement the
intervention into routine practice and guide them to document the findings accurately in the
medical record. The implementation of a diabetic foot care protocol in a primary care clinic required
the doctor or team champion to provide training to a primary nurse to accurately perform foot
assessments and document the findings in the medical record. The doctor determined the
effectiveness of the training when the primary nurse was evaluated or could demonstrate a foot
assessment and accurately record the findings in the patient chart. The primary nurse then assumed
the role of training and evaluating other staff 33 nurses to perform foot assessments on diabetic
patients at the primary care clinic and to accurately include the results of the evaluation in the
patient health record. Nurses adhered to the diabetic foot care protocol by routinely performing feet
assessments on adult diabetics, recording the results and referring to community resources such as
podiatry, wound consultants, neurology, and surgical for extensive treatment as needed to aid in the
achievement of optimal health outcomes for people with diabetes. The team used the patient health
record as the primary source for data to review existing as well as future data collected and
documented into the medical record related to this quality improvement initiative. Chart review was
a method that was reliable, easily accessible and organized data. The team used the chart review
method to analyze the effectiveness or outcomes of a program intended to improve the foot health
of diabetics and quality of health care delivery at a primary care organization. To assure the integrity
of the evidence, the health team selected an existing evidencebased foot assessment screening tool
available for free for clinicians to use in practice that guided the intervention for identification of the
current state of foot health for the diabetic patient. Accurate documentation of foot assessment
results into the health record occurred routinely when caring for diabetic patients at the primary
care clinic. A member of the health team regularly or weekly examined the patient chart to ensure
documentation of the foot assessment was performed; the patient received education, the result of
the evaluation as well as referral for further treatment was all included. The diabetic foot care
protocol included the use of a standard evidence-based foot assessment tool or template that aided
in accurate examination and documentation of foot 34 health data, patient education and proper
documentation in the health record. The foot assessment required the answer of yes or no to
questions associated with the right and left foot. Items included: • Is an ulcer present? • Is there
redness? • Is there swelling? • Is there pain? • Is a referral required for further treatment? The
quality improvement team documented data related to patient education in the medical record as
yes or no in response to questions such as: Did the patient receive foot care education? Did the
patient verbalize understanding of foot care education? Did the patient receive a take-home foot
health education packet Take Care of Your Feet for a Lifetime? To ensure the protocol was
implemented as the quality improvement team intended, I ensured the project team planned and
performed chart audits. The team determined if there was routine and accurate documentation of a
foot assessment, foot care education and referral for specialized wound management by performing
chart audits. The quality improvement team utilized the Primary Care Diabetic Chart Review Form a
self-developed checkoff list for recording data from chart review that included all components of the
diabetic protocol such as foot assessment, foot care education and refer for further treatment. The
chart audit responses were recorded on the form as yes or no if there was a documented foot
assessment, documented education, and documented referral to 35 community resources for
wound management found in the health record. Data were collected by the quality improvement
team from 30 randomly selected charts of people with diabetes’ who visited the primary care
organization one month before the initial implementation of the quality improvement initiative.
Documented foot assessments, documented patient education, and wound referral was the baseline
data collected and recorded for the audit. It was recommended by this Doctoral student or project
leader that three months, six months and nine months after implementation of the quality
improvement initiative data be collected and analyzed to determine the impact of the foot care
protocol at the primary care clinic. For this project, one month after implementation of the quality
improvement initiative the project team collected the initial data from chart review and recorded
the data on the Primary Care Diabetic Chart Review Form created by this DNP student for this quality
improvement initiative. The project leader or DNP student with assistance entered data from the
Primary Care Diabetic Chart Review Form into Microsoft Excel Descriptive Statistics for analysis of
the retrospective data and postimplementation data collected to evaluate the impact of
implementing a foot care protocol in the primary care clinic. Analysis of the data provided evidence
to answer the proposed practice question; How does the implementation of an evidence-based
diabetic foot care protocol impact the health outcomes of diabetic patients in a primary care clinic?
Summary The sought-after impact of this practice change project was for quality improvement in a
healthcare organization. The effectiveness of the evidence-based 36 practice change was identified
with nurses trained to independently and routinely perform diabetic foot assessments and
accurately document the results in the medical record. The patient education component of the
program promoted improved awareness about foot health for patients and clinicians enhanced
patient knowledge and motivated selfperformance of foot care. Additional expected outcomes of
the initiative were a reduction in the incidence of ulcers, an increase in referral for wound
management and podiatry and lower incidents of limb amputation, and hospitalizations related to
wound management. All staff at the primary care clinic had an improvement with routine
documentation of foot assessments and the results, foot care education, and evaluation of ongoing
knowledge in the patient medical record. Section 3 was an overview that included restatement of
the practice-focused question, purpose and goals, sources of evidence was used to guide the quality
improvement project of developing and implementing an evidence-based foot care protocol that
filled the gap in practice with patient knowledge for prevention of foot ulcers and decreasing the
incidence of amputation of a limb. For healthcare providers the evidence-based project filled the gap
through training staff nurses to perform diabetic foot assessments and routinely implement the
intervention into clinical practice when caring for diabetics in a primary care clinic. Also, teaching,
documentation, and collaboration with community resource providers for specialized or extensive
wound treatment as necessary, were part of the quality improvement for the organization. 37
Section 4: Findings and Recommendations Introduction Diabetes is a chronic disease and many
adults in the global population are living with the disease. A primary health concern of diabetes is
the associated complications such as diabetic foot ulcer and lower limb amputation. According to
Ahmed, Alsharif, Alsharif, and Abdin (2011), 15% of adult patients with diabetes can develop foot
ulcers, 14% to 24% of adult patients with diabetes have an amputation of the lower extremities.
They also reported that nontraumatic amputation of lower extremities is a common cause of
diabetes. Diabetic foot ulcer and amputation are health care problems that are associated with a
high mortality rate, often re-occur, and contribute to high health care costs and poor quality of life
(Jeffcoate, Vileikyte, Boyko, Armstrong, & Boulton, 2018). The problem I identified was in a primary
care clinic in Harford County, Maryland and was an absence of diabetic foot care education during
routine health care visits for diabetic patients who receive care at a primary care clinic. Additionally,
there was a lack of clinicians who were trained to perform diabetic foot assessments and accurately
document the findings in the medical record. The purpose of this quality improvement project was
to implement a sustainable evidencebased foot care program for adult patients with diabetes as a
routine protocol for quality improvement in diabetic care at a primary care organization. For this
doctoral project the practice-focused question I developed was: How does the implementation of an
evidence-based diabetic foot care protocol impact the health outcomes of diabetic patients in a
primary care clinic? 38 There were several sources of evidence that the quality improvement team
relied upon to address the practice focused question for this evidenced-based project. The sources
of evidence included prevention and management guidelines from the following national agencies:
American Diabetes Association (ADA), Agency for Healthcare Research and Quality (AHRQ), Centers
for Disease Control and Prevention, National Institute for Health and Care Excellence (NICE).
Additionally, evidence generated from the analysis of the postimplementation data from this
doctoral project. I reviewed literature resources reviewed through CINAHL Database, ProQuest
Database, MEDLINE Database, and Ovid Database. The key terms I used in search of evidence-based
literature included: diabetic foot ulcers, foot ulcers, prevention of foot ulcers, special shoes for
diabetics, shoes for diabetics, socks, diabetic foot, and patient education. Findings and Implications
The quality improvement team focused on the development and implementation of an evidence-
based sustainable diabetic foot care protocol for daily use in a primary care clinic to improve the foot
health outcomes of adult patients with diabetes and enhance the health care services of nursing
staff when caring for patients with diabetes. For this quality improvement project the team manually
collected data from 30 random charts of patients with diabetes who received services at the primary
care clinic one month before implementation of the foot care program and then from 30 random
charts of diabetic patients one month after application of the foot care program. All of the data for
analysis were deidentified data. The quality improvement team extracted data from the 39 chart
review and recorded on a Primary Care Diabetic Chart Review Form I created for this project. The
form included the beginning and end dates of the audit and specifically sought after information
related to foot care and documented information in the health record of diabetics at the primary
care clinic such as documented foot assessment, documented foot health education, documented
referral for wound care or podiatry or if none of the information is present in the medical record.
The pre-implementation and post-implementation data were extracted and were coded as Yes
documentation and No documentation and the variables were coded as; A- Documented foot
assessments, BDocumented Education, C-Documented referral to specialist/podiatry. With statistical
assistance, the recorded data from the Primary Care Diabetic Chart Review Forms were transferred
into Statistical Package for the Social Sciences (SPSS) Version 25 for data analysis. The data output
showed in a frequency table and bar chart. From that output, the results were evaluated and a table
was developed to display and then compare the percentage results for two groups of seven variables
or data for pre-implementation of the foot care protocol for December 2018 and the post-
implementation data of a diabetic foot care protocol for February 2019. 40 Table 1. Quality
Improvement Chart Review in Primary Care
______________________________________________________________________________
Single variables Pre implementation Post implementation N=30 N % N %
______________________________________________________________________________ A 3
10.0 0 0 Foot Assessment B 5 16.7 2 6.7 Patient Education C 0 0.0 0 0.0 Referral to
Podiatry/Specialist
______________________________________________________________________________
Note. A-Documented Foot Assessment B-Documented Patient Education C- Documented Referral to
Podiatry/Specialist. With statistical assistance, I evaluated the data for December 2018 and for
February 2019 and used the data to measure the change in daily practice at a primary care clinic in
Harford County, Maryland when providing foot care services to people with diabetes. Documented
Foot Assessment There were 10% of 30 charts that showed documentation of only a foot
assessment in the health record before implementation of the foot care program. When compared
to the post-implementation data the results showed an improvement. Of 30 charts 0% of them
included only documentation for foot assessment. Documented Patient Education 41 There were
6.7% of 30 charts examined post-implementation that had only patient education documented and
included a takeaway foot health pamphlet. The postimplementation result is lower when compared
to 16.7% of the medical records before implementation. Documented Podiatry Referral Examination
of medical records pre- and post-implementation revealed that there were no files that had only
referral to podiatry documented in the health record. Table 2. Quality Improvement Chart Review in
Primary Care Joint Variables Pre implementation Post implementation N=30 N % N %
______________________________________________________________________________ AB
12 40.0 24 80.0 Foot Assessment and Patient Education AC 0 0.0 2 6.7 Foot Assessment and Referral
to Podiatry Specialist BC 0 0.0 0 0.0 Patient Education and Referral to Podiatry Specialist ABC 7 23.3 2
6.7 Foot Assessment, Patient Education and Referral to Podiatry Specialist
______________________________________________________________________________
Note. A-Documented Foot Assessment B-Documented Patient Education C- Documented Referral to
Podiatry/Specialist. Documented Foot Assessment and Patient Education 42 After the
implementation of the diabetic foot care protocol, evaluation of the results showed that of 30 charts
reviewed, 80% of the records included documentation of the performance of foot assessments and
patient education which included a take-home pamphlet. The percentage is an improvement when
compared to 40% of the charts reviewed before implementing the program. Documented Foot
Assessment and Podiatry Referral Of 30 charts reviewed pre-implementation there were no health
records that contained only documented foot assessment and a referral to podiatry.
Postimplementation 6.7% of 30 charts reviewed had both foot assessment and referral to podiatry
recorded in the medical chart. Documented Patient Education and Podiatry Referral Pre- and post-
implementation review of 30 charts revealed that none of the charts had only patient education and
podiatry referral documented in the record. Documented Foot Assessment, Patient Education and
Referral to Podiatry Post-implementation review of 30 health records showed that 6.7% of them
included all of the data such as documented foot assessment, patient education and pamphlet, and
referral to specialist or podiatry post-implementation compared to 23.3% preimplementation of the
diabetic foot care program. Further evaluation of charts revealed that diabetic patients were
referred to specialist or podiatry to obtain diabetic shoes for the prevention of foot injury and not
for treatment of a wound. Interpretation of the results implies the performance of routine foot
assessments and foot health education for 43 patients with diabetes can prevent damage and
reduce the need to refer diabetic patients to specialist or podiatry for treatment of wounds. No
Documented Data On examination of 30 patient records before the implementation of the
evidencedbased diabetic foot care protocol, 10% of the charts had none of the standard information
documented in the file such as documented foot assessment, documented patient education or
documented referral to podiatry/specialist. There was an improvement in documentation during
office encounters with diabetic patients, as evidenced by the post-implementation data. The post-
implementation data showed that none of the 30 medical records audited was left undocumented
for all the variables reviewed for this DNP project. According to Polit (2010), when analyzing the
difference between the two groups, t-tests are used. The question for the project was: How does the
implementation of an evidence-based diabetic foot care protocol impact the health outcomes of
diabetic patients in a primary care clinic? For this practice change project, an independent t-test was
conducted to determine if the identified changes from the comparison of variables of pre-
implementation data from 30 random charts of patients with diabetes for December 2018 and the
variables of post-implementation data results of 30 random charts for February 2019 were
statistically significant. Documented Podiatry Referral and Documented Patient Education with
Podiatry Referral Results of the independent samples t-test showed that the mean differences for
the seven variables were evaluated. It was determined that the t-test could not be computed 44 for
the mean values for the variables Documented Podiatry Referral and Documented Patient Education
with Podiatry Referral for December 2018 and February 2019. The ttest could not be computed
because the standard deviations of both groups’ pre- and postimplementation were 0.00. The t-test
for the differences between the pre- and post-implementation data, showed no significance
differences, except for Documented Foot Assessment and Patient Education which were found to
have results with statistical significance as discussed below. Documented Foot Assessment and
Patient Education There was an improvement in the documentation of Foot Assessment and Patient
Education. The results for documented Foot Assessment and Patient Education, (M = - .400,
SD= .001, n = 30) were found to be statistically significant at the .05 level of significance (t (29) = -
3.40, df = 55.76, p