Effects
Effects
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J Pain Symptom Manage. Author manuscript; available in PMC 2024 April 01.
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Abstract
Context: Critical illness of a family member is associated with high emotional and spiritual
distress and difficult medical decisions.
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Corresponding Author: Alexia Torke, MD, MS,1101 West Tenth Street, Indianapolis, IN 46202,317-274-9221 phone, 317-274-9307
fax, [email protected].
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Disclosure/Conflict of Interest:
This project was supported by the Indiana University School of Medicine and the Daniel F. Evans Center at IU Health
(www.evanscenterindiana.org), directed by Dr. Torke. Dr. Torke is supported by a Midcareer Investigator Award in Patient-Oriented
Research from the National Institute on Aging (2 K24 AG053794–06). The funders did not play a role in design and conduct of
the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and
decision to submit the manuscript for publication.
Alexia Torke is on the National Advisory Board of Transforming Chaplaincy. Shelley Varner Perez conducts educational activities
for Transforming Chaplaincy and has received honoraria from Rush University and Duke Raleigh Clinical Pastoral Education. Bruce
Pfeffer, Tracy Taylor, James Slaven, Emily Burke do not have any disclosures.
Registration: ClinicalTrials.gov number, NCT03702634
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our
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Torke et al. Page 2
endpoint was the surrogate’s anxiety (Generalized Anxiety Disorders-7 scale), 6–8 weeks after
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discharge.
Keywords
Religion; spirituality; proxy decision making; surrogate decision making; intensive care; chaplain;
spiritual care; anxiety
INTRODUCTION
Critical illness of a family member can provoke a life crisis, raise questions of religious
faith, meaning and purpose, and cause emotional and spiritual distress.1–4 Psychological
symptoms experienced by family members of intensive care unit (ICU) patients include
depression, anxiety, and posttraumatic stress and are higher when the family member faces
major health care decisions for the patient or if the patient dies.5
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Observational studies have shown emotional and spiritual support, but not increased
information from clinicians, are associated with improved psychological outcomes for
surrogate decision makers.6 A recent meta-analysis of studies about communication in the
ICU revealed while communication-based interventions affected some aspects of medical
care such as a shortened length of stay among patients who died, most did not improve
psychological outcomes for family members.7,8
Healthcare chaplains are highly trained to address religious, spiritual, and emotional
concerns for patients and family of all faiths, and for those who do not endorse any
faith.9 There are approximately 10,000 healthcare chaplains in the US, and two thirds of
US hospitals have chaplains on staff.10 However, chaplain staffing in the hospital setting
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varies widely, and contact with ICU patients and families is variable.11 Surrogates who are
unable to visit the hospital or who only visit in the evening are less likely to encounter
chaplains and other important members of the interdisciplinary team.12 Unfortunately,
spiritual concerns are rarely addressed by other clinicians such as physicians even when
raised by family members.13 Although two studies have found chaplain support improved
spiritual outcomes for hospitalized patients, studies addressing the effect of spiritual support
on family members are lacking.14,15
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The goal of this trial was to determine whether proactive, semi-structured spiritual care
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by chaplains could improve the psychological and spiritual well-being of family members
who are serving as surrogates for ICU patients. The intervention was developed based
on professional chaplaincy practice standards9 and an international consensus definition of
spirituality as an “intrinsic aspect of humanity” that includes purpose, transcendence, and
relationships.16
METHODS
Trial Design, Setting and Participants
The randomized, allocation-concealed, parallel group, usual care-controlled, single blind
trial took place in 5 ICUs at one Midwestern academic medical center between August
28, 2018, and November 4, 2021. The center has two tertiary/quaternary referral hospitals.
Four of the ICUs are located in one hospital and include: 1) cardiac medical critical care,
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with 28 beds serving patients with cardiac arrest, advanced heart failure and/or cardiogenic
shock, 2) cardiovascular critical care, with 35 beds serving surgical cardiac patients, 3)
multispecialty critical care, a 13-bed unit serving patients with renal, respiratory, and liver
failure alongside multiple comorbidities including cancer and other chronic conditions; and
neurological/neurosurgical critical care, a 33 bed unit serving patients with neurological
trauma, stroke and neurosurgery. The fifth ICU is located in a hospital serving primarily
cancer patients and is an 18-bed unit treating major organ failure in patients with cancer and
other comorbidities. The study was approved by the Indiana University Institutional Review
Board.
We enrolled patient/surrogate dyads. Patients were eligible if judged to lack decision making
capacity based on either: a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9–13
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with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians
to be unresponsive, comatose or unable to respond to or follow commands). Patients were
excluded if they were being discharged within 24 hours, were intubated only for surgery,
were expected to be extubated within 24 hours, were imminently dying or a terminal wean
was planned with death expected at extubation, or if they could not be enrolled within 96
hours of ICU admission. Patients in the custody of law enforcement, followed by Adult
Protective Services, or appointed a state guardian were also excluded. Patients had to have
a surrogate who could be contacted to confirm eligibility. Eligible surrogates were legally
authorized based on prior appointment by the patient or based on Indiana’s medical consent
law and able to provide informed consent. Surrogates were excluded if they were subject to
care contracts due to prior disruptive behavior or were unable to complete study procedures
in English.
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interview to obtain demographics of the surrogate and some information about the patient
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not routinely stored in the EMR, such as the patient’s religious or spiritual affiliation. After
the enrollment interview, surrogates were randomized to either the intervention or control
group, stratified by anxiety levels based on GAD-7 scores dichotomized as “low to none”
(4 or less) or “high” (5 or greater). Randomization and all data entry were conducted
using Research Electronic Data Capture (REDCap) software, a secure, web-based software
platform designed to support data capture for research studies.17 Another research staff
member conducted randomization for each participant to ensure allocation concealment and
blinding for later outcomes assessment.
Intervention
The Spiritual Care Assessment and Intervention (SCAI) Framework was developed by a
diverse, interdisciplinary team of individuals with varying racial and religious identities. The
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The intervention was conducted by board-certified chaplains who were not the primary
chaplains assigned to each ICU (to reduce contamination with usual care). Five study
chaplains included three women and two men, four Protestant and one Jewish, and four
white and one black chaplain.
The study protocol included an initial spiritual care visit and two follow-up visits generally
scheduled 48–72 hours apart. Visit duration was up to the chaplain’s discretion and
evaluation of the surrogate’s needs.
After the enrollment and two follow-up visits were complete, the chaplain contacted the
surrogate at least weekly. Additional chaplain visits were offered if deemed appropriate by
the chaplain.
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If a patient moved from the ICU to another unit, the study chaplain continued to follow the
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surrogate. Assigned unit chaplains were also able to visit with surrogates and patients upon
request. In general, contact with the study chaplain ended when the patient was discharged
from the hospital. However, if the patient died during the hospitalization, study chaplains
attempted a bereavement visit, in-person or by phone within 48 hours of the patient’s death.
If all four dimensions were not addressed during the first chaplain visit, remaining
dimensions could be assessed during follow-up visits. If all four dimensions were addressed
during the initial visit, then subsequent visits would include at least one question from any
spiritual dimension.
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by a full-time Board-Certified Staff Chaplain who covers 2–3 other non-ICUs. Chaplain
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learners (Chaplain Interns, Residents, and Fellows) provide coverage on these units during
off-shifts and may assist more regularly as part of a clinical rotation.
EMR review was conducted by trained nurses and research assistants after hospitalization
to determine length of stay, medical treatments received, hospice enrollment, patient death,
and number and duration of non-study chaplain visits with the surrogate. To maintain high
interrater reliability, charts were reviewed by 2 raters until achieving 70% agreement or
higher.
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The prespecified primary outcome was anxiety at follow-up as measured by the Generalized
Anxiety Disorders-7 (GAD-7; score range from 0–21 with scores of 5–9, 10–14 and 15
and above indicating mild, moderate and severe anxiety).24 Other psychological outcomes
included change in depression (Patient Health Questionnaire-9 (PHQ-9); score range
0–27),25 posttraumatic stress symptoms (Impact of Events Scale-Revised; score range
0–88)26 and overall distress assessed by a 0–10 distress scale.27 Spiritual well-being
was measured using the Functional Assessment of Chronic Illness Therapy—Spirituality
(FACIT-Sp) non-illness version (score range 0–48, with higher scores indicating higher well-
being).28 Religious coping was assessed using the positive and negative scales of the Brief
RCOPE. Scores on each subscale range from 0–21, with higher scores indicating greater
positive or negative well-being.29 Satisfaction with spiritual care was assessed using the
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Exploratory analyses were conducted to assess care at the end of life, including receipt of
life-sustaining treatments at end of life or hospice for patients who died in the hospital
setting. Life-sustaining treatment was defined as receipt of any of the following at the time
of death: dialysis/CVVH, ICU location, intubation, cardiopulmonary resuscitation, artificial
nutrition or extracorporeal membrane oxygenation.
Data Analysis
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Demographic and clinical characteristics were generated for patients and surrogates.
Descriptive statistics were generated for chaplain visit information. All analyses were
conducted based on original group assignment (intention to treat). We first compared
follow-up GAD-7 total scores between the intervention and control groups. The secondary
outcomes of depression, posttraumatic stress, general distress, decision conflict spiritual
well-being, and religious coping were analyzed in the same manner. Comparisons were
analyzed using Wilcoxon rank-sum tests due to the skewness of the data. For the exploratory
analysis on end of life outcomes, the proportion of patients who received hospice were
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compared between groups using Fisher’s exact tests. A similar analysis was repeated for
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patients who received life sustaining interventions in the 30 days before death.
To determine the clinical importance of the effect on anxiety, we identified the minimally
clinically important differences (MCID) for the GAD-7 range to be 2 based on prior
literature. 33,34 We compared the proportion of participants in each group who had a
decrease of 2 or more using logistic regression. This analysis was then repeated with
additional covariates conceptually likely to be associated with the outcome of anxiety
(patient age, in-hospital death; surrogate age, education, sex, race, income, relationship
to patient and baseline anxiety score). We repeated this approach with other variables
available at both baseline and follow-up. For spirituality outcomes, we also adjusted for
organizational and non-organizational religious activity and intrinsic spirituality. MCID’s
were obtained from published data when available (PHQ-9; IES-R).35,36 Other MCID’s
were calculated using the standard error of measurement and Cronbach’s alpha as a
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measure of reliability. For outcome variables without baseline measures (posttraumatic stress
symptoms, communication quality, decision conflict, satisfaction with the hospital stay
and satisfaction with spiritual care), we used generalized linear models of the continuous
outcome variable, adjusting all analyses for prespecified variables as described above. All
analytic assumptions were verified, and all analyses were performed using SAS v9.4 (SAS
Institute, Cary, NC).
Sample Size
For the primary outcome of anxiety, sample size was determined based upon an effect
size of a half standard deviation between groups on the GAD-7 score. The sample size
was determined to be 128 using an alpha level of .05 and a power of 0.80. We originally
expected a loss to follow up rate of 20% and planned for a sample of 160. Due to higher-
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than-expected loss to follow-up, enrollment was continued until 128 outcome assessments
were completed. We enrolled 192 dyads.
RESULTS
Participants
There were 8117 ICU admissions screened for eligibility via chart review. There were 5785
found to be ineligible based on chart review. A research assistant attempted to contact
the 2332 remaining potentially eligible surrogates; (Figure). Upon contact, 648 surrogates
declined further screening or participation, 1492 were determined to be ineligible, and 192
dyads were enrolled. The most common reason for exclusion was that the patient had
decision making capacity. Enrolled patients were older than screening refusals (mean age
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55.4 v. 60.0, p=.0016) but did not differ by sex (p=.8930) or white v. other race (p=.9368).
Four participants withdrew during the study. The follow-up interview was completed for
67/97 (69.1%) patients in the intervention group and 61/95 (64.2%) in the control group.
Chart review was conducted to evaluate care at the end of life for the 40 enrolled patients
who died in the hospital.
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Patients had a median age of 59 and surrogates 55 (Table 1). Patients were 45.7% female
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and surrogates were 71.8% female. Patients were 20.7% Black and surrogates were 20.7%
Black. The majority of patients (70.2%) and surrogates (70.7%) were Protestant. Surrogates
were most commonly the patient’s spouse (35.1%), daughter (20.2%), parent (20.2%), or
sibling (11.7%). There were no major differences in characteristics between study groups.
The most common reasons for hospitalization were neurological conditions (31.9%),
respiratory disease (29.8%), and cardiovascular disease (24.5%). There were 23 patients
with COVID-19 (12.2%).
Intervention delivery
Of the 97 patients in the intervention, 92.7% had the initial visit and 71.1% had one or
more follow-up visits (Table 2). The majority (71.4%) of chaplain visits were delivered by
telephone. Initial visits had a median length of 23 minutes, follow-up visits of 12 minutes,
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and bereavement visits of 5 minutes. The most common chaplain interventions involved
active listening and acknowledging emotions. The most common religious intervention was
prayer.
Primary Outcome
Post intervention, median GAD-7 score for the intervention participants was 1 (interquartile
range 0, 6) and for control participants was 4 (1, 9) (Table 3). This difference was significant
in unadjusted analysis (p=.0057). Participants in the intervention group were more likely to
experience an MCID of 2 points in anxiety between the enrollment and 6–8 weeks after
patient discharge in analysis controlling for baseline anxiety and other covariates (65.2%
versus 49.2%; adjusted odds ratio (OR) 3.11, 95% confidence interval (CI) 1.18, 8.21;
p=.0218; Table 4).
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Secondary Outcomes
In unadjusted analysis, intervention follow-up scores were significantly lower for depression
(p=.0026), posttraumatic stress (p=.0259), and decisional conflict (p=.0367) and were higher
for spiritual well-being (p=.0413) and satisfaction with spiritual care (p=.0005; Table 3).
Positive and negative religious coping, overall distress, ratings of communication quality in
the hospital and overall satisfaction with the hospital stay were not significantly different
at follow-up between groups. The number of patients who achieved an MCID in spiritual
well-being (OR 3.79 CI 1.41, 10.17; p=.0081) and mean total scores for satisfaction with
spiritual care (adjusted means 3.5±0.1 v. 2.9±0.1, p<.0001) were higher in the intervention
versus control group in adjusted analysis, (Table 4).
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Among the 40 patients who died in the hospital, there were no between-group differences in
hospice enrollment or life sustaining interventions.
DISCUSSION
This trial demonstrates that proactive, semi-structured spiritual care delivered by chaplains
can improve the psychological well-being, spiritual well-being, and satisfaction with
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spiritual care for surrogate decision makers of ICU patients. Patients in the intervention
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group had both lower anxiety levels at follow-up and were three times more likely to have
a clinically important reduction in anxiety. Given that over 5 million adults are admitted to
ICUs every year in the U.S. alone, the potential impact of spiritual care on the psychological
health of family members is high.37 The COVID-19 pandemic has only increased the need
to support ICU family members.38 This study provides evidence for the role health care
chaplains can play in improving outcomes for family members, especially when equipped
with tools that facilitate a comprehensive, proactive, tailored approach to spiritual care.
This study adds to the small but growing literature empirically demonstrating the value of
chaplains on the well-being of patients and families. Given the importance of providing high
value care, such studies are important for health policy and healthcare leaders addressing
ICU staffing. Because chaplains are usually do not directly bill for services, they are a cost
center for health systems and are often at risk when cost cutting measures are considered.
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Expanding the empirical literature demonstrating the value of chaplains is important for the
healthcare field as well as the profession of chaplaincy.
Although two prior ICU family interventions also showed improvement in family
psychological outcomes, most similar interventions have not.7,39–41 Our results may have
differed from most prior studies because the intervention focused directly on emotional and
spiritual support rather than on more cognitive aspects of the surrogate’s experience, such as
provision of information or decision making support.42 Such cognitive-focused studies may
even worsen psychological outcomes; prior work has found when controlling for emotional
support, higher information provided to surrogates may worsen posttraumatic stress.6 One
intervention focused on information and decision making also led to significantly higher
posttraumatic stress scores.43 Provision of direct emotional and spiritual support may be
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Similar to a small number of prior chaplain intervention studies showing improved spiritual
well-being for patients, we found that the spiritual wellbeing was also higher for surrogates
in the intervention group.14,15 While there is overlap between psychological and spiritual
wellbeing, the latter includes concepts such as spiritual beliefs and sense of meaning and
life purpose that are not a core component of psychological concepts such as anxiety or
depression. These spiritual constructs have also been shown to be important for coping with
life crises. Our study extends the findings from prior studies examining patients’ experiences
to surrogates, for whom the patient’s life-threatening illness may also be a major spiritual
crisis.
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Our study has several limitations. There was low representation of faiths other than
Christianity. We enrolled few Asian or Latino participants, consistent with the demographics
of central Indiana. Additionally, we did not have adequate sample size to evaluate end of life
treatment.
In conclusion, results of this study can inform hospitals, payors and policymakers about the
value of chaplain-delivered spiritual care to improve emotional and spiritual support for ICU
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families. These results provide evidence for greater inclusion of chaplains in palliative and
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intensive care and inform the field about important elements of high-quality spiritual care
such as proactive contact, comprehensive assessment, and tailored interventions.
Acknowledgements:
The authors would like to thank Robyn M. Axel-Adams, MS, MDiv, BCC for work as chaplain interventionist,
Sarah Koch, RN, MSN and Melissa A. Cavanaugh, RN, BSN for chart review, Olivia J. Smith, BS for research
assistance, and George Fitchett, DMin, PhD and Jesse C. Stewart, PhD for study oversight on the Data Safety
Monitoring Board.
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Key Message
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Figure.
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Table 1.
Demographic characteristics and hospital course. Values are medians (ranges) for continuous variables and
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Education, median (range) 12 (5, 20) 14 (7, 20) 12 (10, 20) 12 (5, 20) 14 (7, 20) 14 (10, 20)
Sex
Race
Marital status
Married opposite sex 75 (39.9) 117 (62.2) 34 (35.1) 41 (45.1) 59 (60.8) 58 (63.7)
Comfort of Income
Surrogate health
Patient residence
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Relationship to Patient
Organization Religious
Activity (attend services
weekly or more
IR experience presence of
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Intrinsic religiosity, median 13.5 (3, 15) 13 (3, 15) 14 (3, 15)
(range)
Hospital Course
Length of ICU Stay (days) 9 (0, 100) 8 (1, 48) 9 (0, 100)
Discharge Diagnoses
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Table 2.
Frequency Percent
a
Number of participants with each visit type of chaplain visit
Four 5 5.2
Five 4 4.1
Six 1 1.0
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Seven 1 1.0
b
Location of visits (any visit)
Patient room 59 16.9
Relationships 86 95.6
Transcendence 83 92.2
Self-worth 83 92.2
b
Follow-up visits dimensions addressed (n=197 visits)
Relationships 86 43.7
Transcendence 75 38.1
Self-worth 99 50.3
Relationships 3 15.8
Transcendence 3 15.8
Self-worth 1 5.3
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Frequency Percent
Active Listening 285 81.4
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Normalization 90 25.7
Prayer 81 23.1
Overall follow-up visit duration (non-bereavement) (med, r); n=195 12 (1, 120)
a
This excludes bereavement visits. Provide the total number of patients who had an initial visit, then the total who had one follow-up, etc.
b
There may be multiple visits per participant.
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Table 3.
a
Follow-up values
Satisfaction with spiritual care 3.33 (3.00, 3.76) 2.94 (2.47, 3.30) .0005
Overall satisfaction with hospital stay 9 (8, 10) 9 (7, 10) .2235
Decisional Conflict (highest score for each surrogate) 21.5 (18, 33) 30 (21, 36) .0367
End of Life Outcomes for Patients who Died in the Hospital (n=40) Deaths (n=22) Deaths (n=18)
a
Values are medians (IQRs) or percentages for the follow-up values. P-values are from Wilcoxon tests for surrogate reported outcomes and Fisher’s
exact tests for end of life outcomes.
b
Includes dialysis/central venovenous hemodialysis, intensive care location, intubation, cardiopulmonary resuscitation, artificial nutrition or
extra-corporeal membrane oxygenation.
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Torke et al. Page 22
Table 4.
Surrogate Reported Outcomes Number of Unadjusted odds ratio for Adjusted Odds Ratio for a change
patients with an a change of the Minimum in the MCID, controlling for
MCID (percent) Clinically Important Difference conceptually relevant covariates
in the expected direction a
and the baseline value
Depression, MID=decrease of 2 0.95 (0.47, 1.90); p=.8854 1.13 (0.45, 2.80); p=.7993
Intervention 31/67 (46.3%)
Control 29/61 (47.5%)
Distress Thermometer MID = decrease 1.17 (0.58, 2.34); p=.6648 1.36 (0.57, 1.01); p=.4904
of 2 35/66 (53.0%)
Intervention 30/61 (49.2%)
Control
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Spiritual well-being, MID = increase of 2.58 (1.15, 3.79 (1.41, 10.17); p=.0081
3 35/66 (53.0%) 5.78);p=.0219
Intervention 22/60 (36.7%)
Control
Positive Religious Coping, MID= 1.84 (0.76, 4.46); p=.1780 2.61 (0.82, 8.34); p=.1051
increase of 2 17/66 (25.8%)
Intervention 10/61 (16.4%)
Control
Measures with no baseline scores Unadjusted analysis of the Adjusted analysis of the
Continuous continuous
Communication Quality
107.6 (3.0) 110.3 (4.2)
Intervention 104.1 (3.1); P=.4162 106.3 (4.8); P=.3690
Control
Measures with no baseline scores Unadjusted analysis of the Adjusted analysis of the
Continuous outcome variable continuous outcome variable*
Decisional Conflict
Intervention 25.8 (1.6) 26.7 (2.3)
Control 29.6 (1.5); P=.0898 30.8 (2.8); P=.0973
a
For outcomes of anxiety, depression, distress thermometer, posttraumatic stress, communication quality, decision conflict and hospital satisfaction,
analyses are adjusted for: patient age, surrogate age, education, sex, race, comfort with income, relationship to patient, hospital death of the patient.
For spiritual outcomes of spiritual well-being, positive and negative religious coping and satisfaction with spiritual care, analyses are adjusted for
patient age, surrogate age, education, sex, race, comfort with income, relationship to patient, hospital death of the patient, organizational religious
activity, non-organizational religious activity and intrinsic religiosity. Adjusted odds ratios for analyses involving MCIDs also include baseline
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Torke et al. Page 23
values of each respective measure. Continuous measures without baseline values are given as mean values for unadjusted models and adjusted least
square means for multivariable models.
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