Baxter et al.

Pilot and Feasibility Studies (2020) 6:123

https://doi.org/10.1186/s40814-020-00655-5

STUDY PROTOCOL Open Access

Improving patient experience and safety at

transitions of care through the Your Care
Needs You (YCNY) intervention: a study
protocol for a cluster randomised
controlled feasibility trial
Ruth Baxter1* , Jenni Murray1, Jane K. O’Hara2, Catherine Hewitt3, Gerry Richardson4, Sarah Cockayne3,
Laura Sheard3, Thomas Mills1, Rebecca Lawton1,5 and on behalf of the PACT research team

Abstract
Background: Patients, particularly older people, often experience safety issues when transitioning from hospital to
home. Although the evidence is currently equivocal as to how we can improve this transition of care, interventions
that support patient involvement may be more effective. The ‘Your Care Needs You’ (YCNY) intervention supports
patients to ‘know more’ and ‘do more’ whilst in hospital in order that they better understand their health condition
and medications, maintain their daily activities, and can seek help at home if required. The intervention aims to
reduce emergency hospital readmissions and improve safety and experience during the transition to home.
Methods: As part of the Partners At Care Transitions (PACT) programme of research, a multi-centred cluster
randomised controlled trial (cRCT) will be conducted to explore the feasibility of the YCNY intervention and trial
methodology. Data will be used to refine the intervention and develop a protocol for a definitive cRCT.
Ten acute hospital wards (the clusters) from varying medical specialties including older peoples’ medicine, trauma
and orthopaedics, cardiology, intermediate care, and stroke will be randomised to deliver YCNY or usual care on a
3:2 basis. Up to 200 patients aged 75 years and over and discharged to their own homes will be recruited to the
study. Patients will complete follow-up questionnaires at 5-, 30-, and 90-days post-discharge and readmission data
up to 90-days post-discharge will be extracted from their medical records.
Study outcomes will include measures of feasibility (e.g. screening, recruitment, and retention data) and processes
required to collect routine data at a patient and ward level. In addition, interviews and observations involving up to
24 patients/carers and 28 staff will be conducted to qualitatively assess the acceptability, usefulness, and feasibility
of the intervention and implementation package to patients and staff. A separate sub-study will be conducted to
explore how accurately primary outcome data (30-day emergency hospital readmissions) can be gathered for the
definitive cRCT.
(Continued on next page)

* Correspondence: [email protected]
1
Yorkshire Quality and Safety Research Group, Bradford Institute for Health
Research, Bradford, UK
Full list of author information is available at the end of the article

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Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 2 of 12

(Continued from previous page)

Discussion: This study will establish the feasibility of the YCNY intervention which aims to improve safety and
experience during transitions of care. It will identify key methodological and implementation issues that need to be
addressed prior to assessing the effectiveness of the YCNY intervention in a definitive cluster randomised controlled
trial.
Trial registration: UK Clinical Research Network Portfolio: 42191; ISTCRN: ISRCTN51154948. Registered 16/07/2019.
Keywords: Transitions of care, Discharge, Cluster randomised controlled trial, Hybrid interventions, Feasibility trial,
Older people, Study protocol

Background resume responsibility (as appropriate) for this at

For older people and those with complex needs, the tran- home;
sitional period of moving from hospital to home poses  Managing their medications so that they have the
various risks [1, 2]. As many as one in five patients experi- knowledge and skills required to understand and
ence an adverse event during this time, 62% of which take their medications correctly;
could be prevented or ameliorated [3]. In recent years,  Managing their daily activities to retain autonomy
emergency readmission rates have increased by 23% with and minimise the effects of deconditioning;
around 30% of all readmissions estimated to be avoidable  Escalating their care needs in an appropriate and
[4–6]. As older people are the highest users of the Na- timely manner.
tional Health Service (NHS) in the United Kingdom (UK),
they represent an important target for support to improve Guided by our aim to explore patient involvement, we
transitions of care. developed a ‘theory of change’ as to how transitions of care
A recent meta-analysis of 92 randomised controlled trials may be improved for older people [14]. We posit that sup-
(RCTs) of interventions to improve transitional care for porting older people while they are in hospital to ‘practice
older people observed a significant reduction in hospital being at home’ will better prepare them to manage these
readmissions at multiple time points up to 12 months post- four functional activities at home. However, without sup-
discharge [7]. The existing interventions are all highly com- port, patient involvement, particularly for older people,
plex, adopting multiple and variable components, commen- might be problematic and inconsistent. Patients themselves
cing, and ending at different time-points. As a can fluctuate in how and when they want or are able to be
consequence, deciphering which components are the active involved, and busy staff may fail to recognise or engage with
ingredients is challenging [8–10]. There is some suggestion patient’s attempts to be involved [15].
however that interventions which seek to enhance patient Based on these principles, we co-designed an intervention,
capacity to reliably access and enact post-discharge care are called ‘Your Care Needs You’ (YCNY), which aims to sup-
effective [11, 12]. Supporting patient involvement aligns port older patients and carers to ‘know more’ and ‘do more’
with the patient’s and carer’s position as the common de- whilst in hospital in relation to the identified four key func-
nominator throughout the care pathway. Patient involve- tional aims. The resulting intervention aligns with emergent
ment in care during the hospital stay may be a key thinking about the development of complex interventions
mechanism for enhancing patients’ capacity to ‘reach-in’ to which focus on standardising interventions according to their
the health care system enabling them to optimise their care functional aims rather than their form (i.e. specific compo-
[13]. The mechanism for doing this however has not been nents) [16]. Building on this, YCNY can also be regarded as
fully explored. a ‘hybrid’ intervention whereby certain components of an
To address this knowledge gap, the Partners At Care intervention are fixed, while others can vary according to the
Transitions (PACT) programme of research explores context within which they are implemented [17].
whether greater involvement of older patients and their
families during the hospital stay can improve patient ex- Methods
perience and safety at transitions of care. Through our Study aims and objectives
earlier work, we have modelled transitional care to iden- This study aims to explore the feasibility of the YCNY
tify four key ‘functional aims’ or activities for which pa- intervention and trial methodology. In particular, the
tients are responsible for (to varying degrees) once they study will explore:
are discharged home [14]. These include:
1. The acceptability, usefulness, and feasibility of
 Managing their health and wellbeing so that they intervention components and the implementation
understand what care they received in hospital and package to patients, carers, and staff;
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 3 of 12

2. The feasibility of methods to identify, recruit, and Setting

retain patients in the trial and to determine the best The feasibility trial will be conducted across a range of
way to follow up patients in this population; specialties including older peoples’ medicine, trauma
3. The required approaches for obtaining health and orthopaedics, cardiology, intermediate care, and
economic data, ward level baseline data, and stroke. Eligible wards will be NHS funded, inpatient hos-
accurate routinely collected hospital emergency pital wards where approximately 40% or more of pa-
readmission data; tients are routinely aged 75 years and over. Acute
4. How intervention fidelity might be measured in the medical admission wards, wards without regular medical
definitive cRCT. input, and/or those currently participating in a trial will
be excluded. NHS Trust and ward level agreement will
Ultimately, findings from the study will be used to re- be gained for eligible wards to participate in the study.
fine the intervention and inform the development of a
protocol for the definitive cRCT in which the effective- Randomisation
ness and cost-effectiveness of YCNY will be assessed. The randomisation will be carried out remotely by a
statistician at the York Trials Unit (YTU), University of
Study design York who is not involved in the recruitment of wards or
A cluster randomised controlled feasibility trial will be the enrolment of participants. Clusters (wards) will be
conducted on ten wards (the clusters) within three acute randomised in an unequal allocation ratio (3:2) via mini-
NHS Trusts in the Yorkshire and Humber region of the misation using minimPy [19] (intervention n = 6; control
UK. Cluster designs are used when there is a significant n = 4). An unequal allocation ratio will ensure robust
risk of contamination occurring if individual patients data for exploring the feasibility and acceptability of the
within a ward were randomised. Since this study in- intervention across a representative range of specialties.
cludes a ward level component, it was not possible to Naïve minimisation with a base probability 1.0 (i.e. de-
use individual randomisation. Wards will be randomised terministic minimisation) will be conducted using three
to deliver either the YCNY intervention or usual care. key ward characteristics: ward specialty; percentage of
A minimum of 200 patients (20 per ward) will be re- patients aged 75 years and over; and NHS Trust. The
cruited across intervention and control wards to wards will be informed of which arm they have been al-
complete questionnaires at baseline and then three time- located by a member of the research team. The unequal
points following discharge from hospital—5- to 14-, 30-, allocation of wards prevents blinding of the treatment
and 90-days post-discharge. Routine data regarding the group.
patients’ index hospital admission and any subsequent
readmissions (up to 90-days post-discharge) will be ex- Patient population and sample size
tracted from their medical record. Up to 10 wards (clusters) will be recruited to the study
An embedded qualitative evaluation will assess the based on the need to have at least four clusters per arm
feasibility and acceptability of the intervention and im- to allow for basic statistical analysis [20]. As this is a
plementation package. Up to 24 patients and their carers feasibility trial, we did not undertake a formal sample
will be recruited from intervention wards to participate size calculation. Based on previous experience of recruit-
in patient-level observations of care and individual inter- ment rates for older people in a recently completed trial
views. Up to 28 staff will be recruited to participate in [21] and to ensure that we will have sufficient numbers
interviews and ward-level observations. to explore the feasibility and test the intervention, we
In addition, a sub-study will be conducted alongside considered a minimum of 200 patients (20 per ward)
the feasibility trial to explore the most efficient, cost- would be sufficient. The assumptions underpinning this
effective, and accurate way of gathering primary out- sample size will be assessed through the study. Eligible
come data (30-day emergency hospital readmissions) patients will be 75 years and over; anticipated to be dis-
within the definitive cRCT. Approval has been sought charged to their own home or that of a relative; staying
from the Confidentiality Advisory Group (CAG) to ac- for at least one night on a participating ward; able to
cess the medical records of 100 patients (10 per ward) read and understand English; and willing and able to
without consent to understand the actual destinations of give informed consent. If a patient lacks capacity, a per-
patients who are discharged to their ‘usual place of sonal consultee will advise on their wishes to participate.
residence’. Patients will be considered ineligible if they live out of
Figure 1 details the schedule of study enrolment, inter- the area or plan to be transferred to another acute hos-
ventions, and assessments. The SPIRIT checklist [18], pital, are admitted for psychiatric reasons (other than
which details the recommended items to include in a dementia/delirium), or are identified as being at the end
clinical trial protocol, is available in Additional file 1. of life.
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 4 of 12

Fig. 1 The schedule of enrolment, interventions, and assessments [as per Standard Protocol Items: Recommendations for Interventional Trials
(SPIRIT)] [18]

The Your Care Needs You (YCNY) intervention suggestions as to how they could do this. The booklet
Intervention components contains ‘I would like to talk about’ pages which patients
The intervention comprises three fixed core can use to indicate to staff that there is something they
components: would like to discuss. There are spaces for patients,
carers, or staff to make notes.
YCNY booklet This patient-facing booklet is given to
patients at the start of admission to a participating ward YCNY film Where possible, a short educational film will
and is designed to be used throughout their stay and fol- be shown to patients when introducing the booklet. The
lowing discharge. Focusing on the four key functions, film brings to life and seeks to underline our hypothe-
the booklet provides information as to why patients sised links between retaining and supporting cognitive
should ‘know more’ and ‘do more’ in hospital and gives capability and physical capacity within the hospital, and
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 5 of 12

better outcomes post-discharge. The web address of the delivering specific intervention components (e.g. the care
film is publicised within the booklet so that carers/pa- summary). Posters and handouts will help remind and
tients can also view it independently. support staff to interact with the booklet.
A ‘share and learn’ session will be held 2–3 weeks after
Care summary At discharge, patients will receive a the ward has started implementing the intervention. The
patient-friendly care summary, written in lay termin- session aims to identify and resolve any problems en-
ology, to help them understand why they have been in countered in delivering the core intervention compo-
hospital, any changes to their medication, what to expect nents, to reflect on how the booklet/film may have
following discharge, and when and how to escalate care influenced patient behaviours (e.g. requesting to practice
if needed. This letter will supplement rather than replace their medications) and to discuss how the team have
existing discharge letters which are sent to a patient’s and could respond to meet the functional aims of the
General Practitioner (GP). Template letters will be pro- intervention.
vided for wards to flexibly implement according to their
ward context.
In addition to these fixed core components, ward staff Control wards
will be asked to consider how they currently support pa- Control wards will deliver usual care to their patients ac-
tient involvement with respect to the four key functions cording to their Trust’s standard policies and proce-
and what else they can do to enhance this. The actions dures. Researchers will arrange short briefing sessions
that the teams decide to undertake will not be pre- with the ward manager to inform the ward staff of the
scribed—they will be left to vary according to staff pref- study activity and patient recruitment.
erences, current activities/initiatives on the ward that
already address the four functions, and their patient
Recruitment and consent
population.
Recruitment will commence once ward teams have
started to implement the intervention. A discretionary
Implementation
period of up to a month may be used to embed the
The implementation of YCNY will be supported in four
intervention in the ward. Exact start dates for recruit-
ways.
ment will vary by Trust and ward depending on when
A facilitation meeting, lasting 1–2 h, will be held with
NHS Trust permissions are received and implementation
key staff members (e.g. ward manager, nurses, healthcare
is agreed at ward level. Recruitment is expected to take
assistants, discharge coordinator, therapists, and doc-
up to 4 months.
tors/consultants) to discuss delivery of the intervention
within each wards’ specific context. Through the meet-
ing, staff will (i) decide how to deliver the core interven- Screening and identification
tion components; (ii) map what they currently do to Suitably qualified ward staff will screen and identify eli-
meet the four functional aims; and (iii) think of add- gible patients. All patients aged 75 years and over will be
itional tools or initiatives that they could use to meet screened for eligibility. Detailed screening logs will rec-
these aims. A coach(es) will be identified whom the re- ord numbers of eligible patients, key reasons for ineligi-
search team can work more closely with, and who can bility, and recruitment/refusal rates. Screening data will
act as a point of contact for ward staff as needed. be used to complete a CONSORT diagram for cluster
Deciding on staff roles—To help the intervention fit trials [22].
into each ward’s specific context, the roles that staff
groups will fulfil will vary. The roles required include
introducing the YCNY booklet, showing the patient film, Approach and consent
encouraging patient use of the booklet, and responding In addition to screening patients against the study’s in-
to patient questions. Roles will be discussed and allo- clusion and exclusion criteria, staff will be asked how
cated during the facilitation meeting. and when eligible patients should be approached (e.g.
Staff training will be delivered to multidisciplinary staff whether they are well enough). Researchers will provide
to ensure that they have knowledge of, understand the eligible patients with written information and a verbal
benefits of, and have the skills required to deliver the explanation of the study (see Additional file 2 for an ex-
intervention. Training will be delivered through two ample). Patients will have an opportunity to ask ques-
principal routes: (i) fuller briefings about the interven- tions and consider their participation. If patients wish to
tion at extended multidisciplinary team meetings, staff take part, a written (or witnessed) consent form will be
handovers, or using ad hoc opportunities/drop-in ses- completed. A letter will be sent to the patient’s GP to in-
sions; and (ii) briefing and support for those involved in form them of their participation.
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 6 of 12

Patients who lack capacity Most data will be self-reported by patients or consultees
A significant proportion of patients within this older but, where this is not possible, data will be gathered via
population (75 years and over) are likely to lack the cap- staff or from patient medical records.
acity to make decisions about their care. These patients
are often more vulnerable to safety incidents and/or Patient post-discharge follow-up questionnaires
poorer experience during transitions of care [21]. To be Following discharge from hospital, patients will be sent
as inclusive as possible, it is important that this particu- postal questionnaires at three time points—5-, 30-, and
lar patient population is included in the study. Capacity 90-days post-discharge. These time points represent a
will be assessed during the screening process and the critical safety period (immediately post-discharge), are
initial approach. If patients lack capacity, attempts will policy-relevant (30-days), and allow assessment of
be made to identify and recruit an informal carer (e.g. longer-term effects (90-days). To try and increase re-
family member or friend) who can act as a personal con- sponse rates, patients will receive a £5 voucher with the
sultee for the patient. A written declaration will be questionnaire at each time point [29]. Measures include
gained from all participating consultees. the Partners At Care Transitions Measure (PACT-M)
[26], Care Transitions Measure (3 items—CTM-3) [27],
Withdrawal EuroQol 5-Dimension Health Questionnaire (5 levels)
The rights of patients and consultees to withdraw from (EQ5D-5 L) and Proxy EQ5D-5 L [24], and the adapted
the study will be respected. They can do so without giv- Client Service Receipt Inventory (CSRI) [28] (see Table
ing a reason and without their care or treatment being 1 for further details). Questions will also be asked to as-
affected. Data previously collected will be used in ana- sess receipt and thereafter, the usefulness of the
lyses (unless consent for this is withdrawn) and, where intervention.
possible, a reason for withdrawal will be recorded. If pa- Figure 2 outlines the process for collecting post-
tients are unexpectedly discharged from the hospital into discharge follow-up data. Patients will choose to be
24-h care such as nursing/care homes (other than for a followed up by post alone or to additionally receive tele-
temporary period of rehabilitation), they will become in- phone support. Those choosing the latter will be tele-
eligible and will be withdrawn. phoned approximately 3 days after the first postal
questionnaire is sent. If questionnaires are not returned,
Outcomes a postal reminder will be sent 10 days later and a final
The main outcomes for this study are process-based, as attempt to collect data will be made via telephone to all
the study aims to assess the feasibility of YCNY and the patients regardless of follow-up choice. We will attempt
trial methodology, rather than the effectiveness of the to collect data at each time point unless patients expli-
intervention. Outcomes, therefore, include measures of citly withdraw from the study. The mortality status of
feasibility namely: (i) screening, recruitment, and reten- patients will be checked prior to each follow-up time
tion data; (ii) the processes required to collect accurate point.
data from consented patients, routine medical records,
and the ward (via information services); (iii) the ap- Patient-level routine data
proach required to collect health economic data; and (iv) In addition to the self-report data outlined above, rou-
qualitative data relating to the acceptability of YCNY tine data will be extracted from the consented patients’
and feasibility of implementing it. Patients will be asked medical records. Data includes:
to complete a number of validated measures which are
outlined in the section below.  Recorded discharge date for the index admission—to
ensure accurate discharge dates are recorded during
Data collection the trial;
Data will be collected at the level of the patient and the  Emergency hospital readmission dates up to 90-days
ward through a mix of self-report and routinely collected post-discharge—to assess the feasibility of collecting
data. our primary outcome measure in the definitive
cRCT, and to calculate the length of stay for any
Patient baseline questionnaires readmissions;
Following recruitment, researchers will support patients  Ward moves that occurred prior to discharge during
to complete a baseline questionnaire. This includes basic index admission—to assess intervention fidelity and
demographic information, contact details to conduct contamination between wards.
post-discharge follow-ups, the Barthel Index [23],
EQ5D-5 L [24], and the Functional Comorbidity Index Due to funding and progression of the PACT
[25] (all validated measures are outlined in Table 1). programme of work, the research team face tight
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 7 of 12

Table 1 Validated measures collected from patients at baseline and during post-discharge follow-ups
Measure Description Collected when
Functional Co-morbidity Index (FCI) [25] 18 self-reported comorbid conditions with a score of 0 to 18 with each item scoring 1. A Baseline
higher FCI score indicates greater comorbidity and is associated with impairment in physical
function 1 year later.
Barthel Index (BI) [23] 10 items measuring a person’s daily functioning, particularly the activities of daily living and Baseline
mobility. Total possible scores range from 0 to 20, with lower scores indicating increased
disability.
EuroQol 5-Dimension Health Questionnaire (5 The EQ5D-5 L and Proxy EQ5D-5 L measures quality of life comprising five dimensions: mobil- Baseline and post-
levels) (EQ5D-5 L) & Proxy EQ5D-5 L [24] ity, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is discharge follow-ups
scored on a five-point ordinal scale: no problems, slight problems, moderate problems, severe
problems, unable. Scores can be used to calculate quality-adjusted life-years (QALYs).
Partners At Care Transitions Measure (PACT-M) The PACT-M assesses patient perceptions of the quality and safety of transitions from hospital Post-discharge
[26] to home, relevant to a UK population. In total, eight items are scored on a five-point Likert follow-ups
scale: strongly disagree, disagree, neither agree nor disagree, agree, strongly agree with an
additional option of ‘not applicable’. The PACT-M also measures the incidence (yes or no) of
seven adverse events following discharge from the hospital.
Care Transitions Measure 3 items (CTM-3) [27] The CTM-3 (derived from the 15-item CTM) is a patient-centred measure of the quality of care Post-discharge
transitions. Three items are scored on a five-point Likert scale ranging from strongly agree to follow-ups
strongly disagree.
Client Service Receipt Inventory (CSRI) [28] The CSRI will be used to assess patients’ use of health-related resources. Questions have been Post-discharge
adapted to assess the health resources that are pertinent to care transitions from hospital to follow-ups
home for older people.

timescales between finishing the feasibility trial and focus on descriptive summaries for each treatment
starting the definitive trial. As this study does not assess group including the number of wards and patients
effectiveness, if the Trial Management Group decide that approached, randomly assigned, receiving intended
we already have enough data to assess the feasibility of treatment, and providing outcome data. A CONSORT
progressing to a definitive trial, we may decide not to diagram for cluster trials will document the flow of par-
collect questionnaire and routine readmission data up to ticipants through the study. The percentage of partici-
the full 90-days post-discharge for patients who are re- pants readmitted will be determined. The degree of
cruited later in the study. clustering using intracluster correlation coefficients
(with 95% confidence intervals) may also be quantified,
acknowledging that this may be unreliable due to the
Ward-level routine data
small sample size [30].
To explore what ward level baseline data are required
Participant withdrawals, reasons for withdrawal, and
for the definitive cRCT, the following non-identifiable
non-responses at each data collection point will be
data will be extracted for each participating ward over
summarised and compared by trial arm. Recruitment
the most recent 12-month period:
and attrition rates (ward and patient) across the two
arms will be compared, along with outcomes data at
 The total number of patients discharged from a
follow-up. All baseline and outcome data will be sum-
participating ward and the total number of these
marised descriptively by trial arm using means and
patients who are readmitted to the hospital Trust
standard deviations for continuous variables and
(any ward) within a 30-day period (split by patients
counts and percentages for categorical data. Partici-
who are < 75 years and ≥ 75 years);
pants will be summarised by their randomised ward
 Average length of stay for patients admitted to each
irrespective of whether they received the actual allo-
participating ward (split by patients who are < 75
cation or not. PACT-M data will also be analysed to
years and ≥ 75 years with monthly totals);
define cut-offs for a high versus low-quality transition.
There are no planned interim analyses.
In addition, the total number of admissions to partici-
Qualitative and quantitative data will be used to assess
pating wards during the recruitment period (split by <
the following criteria when deciding whether to progress
75 years and ≥ 75 years) will be used to identify how
to a definitive cRCT:
many patients aged 75 years and over were admitted to
the ward but not screened.
– 2–8 eligible wards exist within participating trusts
(depending on size) and narrative indications of staff
Statistical analysis interest
A full statistical analysis plan will be drafted before the – Average of 4 patients per ward per month recruited
completion of data collection. Quantitative analysis will – Attrition less than 10% for the primary outcome
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 8 of 12

Fig. 2 Process for collecting post-discharge follow-up data

– Staff, patients, and carers positively evaluate the Embedded qualitative assessment of feasibility
intervention (or modifications can be made to Qualitative methods will be embedded within the feasi-
address any concerns). bility study to explore the acceptability, usefulness, and
feasibility of the intervention, and explore how fidelity
Fulfilment of these progression criteria will be dis- can be assessed.
cussed and agreed with our Trial and Programme Man-
agement Groups, our independent Trial Steering Sample
Committee, and the funders (the National Institute for On intervention wards, purposive and opportunity sam-
Health Research). pling will be used to recruit a nested sample of 20–24
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 9 of 12

patients (3–4 patients per ward). Patients will consent to at the 30-day post-discharge follow-up if they received a
patient-level observations and interviews in addition to YCNY booklet in hospital and, if so, whether they would
the quantitative post-discharge follow-ups. Carers (e.g. be willing to return it to the research team. Any
spouse or child) who are involved in a patient’s care will returned booklets will be analysed to explore how they
also be recruited to participate. Patients will receive up have been used.
to £30 as a thank you for their participation.
Multidisciplinary staff involved in the facilitation meet- Qualitative data analysis
ings and implementing the intervention will be purpos- Qualitative data will be analysed using a ‘pen portrait’
ively sampled to participate in interviews and/or ward- method [31]. Pen portraits are typically used to synthe-
level observations. In addition, one staff member on each sise data across sources. Data related to each ward will
control ward will be recruited at the end of the study to be drawn together to describe how the intervention was
participate in an interview (n ≤ 28). implemented, how staff and patients engaged with the
intervention, and what the experience was for patients
Data collection methods following discharge. Pen portraits will subsequently form
the unit of analysis and be subjected to a thematic ana-
Interviews Semi-structured interviews will be conducted lysis [32], before being synthesised, with coding specific-
with patients, carers, and staff to explore acceptability, ally pertaining to issues of acceptability and feasibility.
usability, usefulness, and feasibility of the intervention
components (both fixed and flexible) and to explore how Sub-study to assess discharge destinations
implementation worked within the ward context. Sug- The target patient population for this programme of
gestions about optimising the intervention and imple- work is older people who transition from hospital back
mentation package will be gathered. Patient interviews into their own home (rather than 24-h care, e.g. a nurs-
lasting 30–60 min will take place just after discharge and ing or care home). To test the effectiveness of the inter-
will be conducted either at the patient’s home or over vention in the definitive cRCT, primary outcome data
the telephone. If patients continue to use the interven- (30-day emergency readmissions) are required from
tion at home, a second interview will be conducted at 7000 patients which we had planned to gather at a ward
30-days post-discharge. Staff interviews will last 15–30 level via routinely collected administrative data. How-
min. Interviews with staff on control wards will explore ever, our previous work has highlighted that patients are
any activities that are similar to those that would meet coded as being discharged to their ‘usual place of resi-
the functional aims of the intervention (e.g. End PJ Par- dence’ which does not distinguish those who go from
alysis Initiatives) and thus appear to ‘dilute’ the effect of and to their own homes (our target population) and
the intervention, or serve as evidence of contamination. those who go from and to 24-h care/nursing homes. Not
Interviews will be audio-recorded where possible, other- understanding the size of this coding problem represents
wise, detailed field notes will be taken. a major threat to the internal validity of the definitive
trial. As such, a separate sub-study will explore the ac-
Observations Patient- and ward-level observations will tual discharge destinations of patients on participating
explore how patients, carers, and staff interact with the wards who are aged 75 years or over and are coded as
intervention during the patient stay and at discharge. being discharged to their ‘usual place of residence’.
Patient-level observations will include the introduction Confidentiality Advisory Group permissions have been
of the booklet, occasions where staff and patients inter- gained to access patient medical records without con-
act as part of routine care (e.g. ward and medicine sent. Trusts will identify a consecutive sample of 10 pa-
rounds), and at discharge. Ward-level observations are tients from each participating ward who are aged 75
likely to include the facilitation session and support re- years and over and have been coded as discharged to
quired to embed the intervention, staff training, staff their ‘usual place of residence’. Their medical records
roles in using the booklet, and ward level activities (e.g. will be accessed to identify their actual discharge address
daily cares, ward rounds, medication rounds, meetings, and this will be categorised as being either: their own or
briefings, and handovers). Observations will be captured a relative’s home; a nursing or care home; intermediate
through field notes and ‘contact summary forms’ will be care; or other. The research team will receive anon-
completed for each ‘contact’ (e.g. a discrete piece of ob- ymised, aggregated ward-level data detailing the total
servation, or something less bounded such as a day number of patients discharged to each category.
spent observing ward activity).
Data management, monitoring, and safety reporting
Documentary analysis All participants who consent to Patient data will be recorded on case report forms
the quantitative arm of the feasibility trial will be asked (CRFs). Participants will be assigned a unique
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 10 of 12

identification number and all data will be completely Dissemination

anonymised for purposes of analysis and reporting. Elec- Findings will contribute to the on-going progression of
tronic data and wet ink copies of the CRFs will be stored the PACT programme of work. They will be dissemi-
securely at YTU. Data will be monitored for quality and nated widely to a broad audience including academics,
completeness by YTU. Missing data, except that from clinicians, healthcare managers, policymakers, and pa-
post-discharge follow-ups, will be chased until they are tients and the public and participants within the study.
received or confirmed as not available. Most data will be The findings will be written up for publication in peer-
collected directly from participants and so cannot be reviewed journals and will be presented at national and
subject to data verification. All qualitative data and con- international conferences, workshops, and learning
sent forms will be held securely by the Yorkshire Quality events.
and Safety Research Group (YQSR) at the Bradford In-
stitute for Health Research. Discussion
The trial is overseen by the Trial Management Group Transitions from hospital to home can be risky, particu-
(TMG) comprising of the chief investigator, key co- larly for older people who often have complex health
applicants, and the operational members of YQSR and and/or social care needs [3]. Although the evidence is
YTU. An independent Trial Steering Committee (TSC) and equivocal, there is some suggestion that interventions
Data Monitoring Committee (DMC) comprising academic, that support patient involvement may improve transi-
NHS England, clinical, and a patient representative meet tional care outcomes [10, 12]. The PACT programme of
annually. Further details are available on request. research, therefore, asks whether supported involvement
In this patient population, acute illness, deterioration of of older patients and their families in their care improves
health, and readmissions are likely and so will not be re- patient experience and safety at transitions of care.
ported during this study. The death of participants is also Through our earlier work [14, 33, 34], we have designed
expected. All expected and unrelated deaths will be re- an intervention which supports patients to ‘know more’
ported to the TMG and reported annually to the REC and and ‘do more’ during their hospital stay so that they can
TSC/DMC. Any unexpected and related serious adverse manage their care at home post-discharge. The present
outcomes will be reviewed by the chief investigator and re- study assesses the feasibility of delivering this interven-
ported to the sponsor and ethics committee. tion and the trial methodology in order to refine the
intervention and protocol for a definitive cRCT trial. As
Trial organisation and administration with any complex intervention various challenges out-
The feasibility study is being conducted as part of a five and lined below are anticipated throughout the study.
a half year Programme Grant for Applied Health Research
(RP-PG-1214-20,017) funded by the National Institute for Recruitment
Health Research. The trial is sponsored by Bradford Teach- The study will assess the feasibility of implementing the
ing Hospitals NHS Foundation Trust and is coordinated by intervention and recruiting patients on different types of
YQSR at the Bradford Institute for Health Research, and the ward (i.e. different acute specialties). It may be that
YTU at the University of York. some specialties (e.g. stroke care) are less suited due to
Approvals were gained from the Wales Rec 7 Research their specified patient pathways, provision of extensive
Ethics Committee, Confidentiality Advisory Group, and post-discharge rehabilitation, and/or low patient turn-
the Health Research Authority prior to starting the study over. Further to this, patient movement between inter-
(REC reference [19]/WA/0162, CAG reference [19]/ vention, control, and other hospital wards prior to
CAG/0105). Local NHS capability and capacity ap- discharge will be assessed in order to explore issues of
provals were granted by all participating NHS Trusts. contamination and fidelity.
Any amendments to the protocol will be submitted for
the required regulatory approval. The study is registered Post-discharge follow-ups
on the UK Clinical Research Network Study Portfolio Challenges are also anticipated when conducting post-
(42191) and the ISTCRN (ISRCTN51154948). discharge follow-ups. First, the study team will be reliant
on participating Trusts regularly tracking patient dis-
Patient and public involvement charges to trigger the processes for post-discharge
The PACT programme grant has an active patient panel follow-ups. Patients who are discharged to their home
who have been involved in co-designing the YCNY interven- address may do so via a different address. Some of this
tion, and have advised and supported the development of variation will be observed by tracking discharge destina-
study procedures and documents. Panel members will be in- tions (e.g. to intermediate care beds) but some of it may
volved in the analysis, dissemination of results, intervention not (e.g. if a patient temporarily stays at a relative’s
iteration, and protocol development for the definitive cRCT. home). The proportion of unreturned questionnaires
Baxter et al. Pilot and Feasibility Studies (2020) 6:123 Page 11 of 12

due to non-receipt by the patient or another reason may Abbreviations

remain unknown. Second, over recent years, the lengths CAG: Confidentiality Advisory Group; CONSORT: Consolidated Standards for
Reporting Trials; cRCT: Cluster randomised controlled trial; CRFs: Case report
of hospital admissions have reduced [35] and so patients forms; CSRI: Client Service Receipt Inventory; CTM: Care Transitions Measure;
are increasingly going home with ongoing care needs DMC: Data Monitoring Committee; GP: General practitioner; NHS: National
such as wound care management or medication moni- Health Service; NIHR: National Institute for Health Research; PACT: Partners At
Care Transitions; RCT: Randomised controlled trial; QALYs: Quality-adjusted
toring. Collecting data during the initial post-discharge life-years; TMG: Trial Management Group; TSC: Trial Steering Committee;
period when patients may still be unwell and/or particu- UK: United Kingdom; YCNY: Your Care Needs You; YQSR: Yorkshire Quality
larly vulnerable to hospital readmissions [36] may im- and Safety Research group; YTU: York Trials Unit

pact our CRF return rates. Third, retention and attrition Acknowledgements
will need to be monitored as follow-ups are being con- The authors would like to thank members of the PACT Programme
ducted up to 90-days post-discharge. Up to 15% of pa- Management Group and the PACT patient panel for their thoughtful
contributions to the development of this study protocol. This paper was
tients are likely to be readmitted within 30 days [37] written by the authors on behalf of the PACT team. Thank you to Joe
which is likely to impact patients’ ability to respond to Langley, Rebecca Partridge, Ricardo Barker, and the staff and patient
questionnaires accurately and within the necessary time representatives who contributed to the development of the YCNY
intervention. The authors would also like to thank and acknowledge the
frames. In addition, attrition is expected as people re- ongoing support from staff and patients within all the participating wards
quest to withdraw or become lost to follow-up. Death and NHS Trusts.
within this older patient population is also expected dur-
ing the follow-up period. Authors’ contributions
JoH, RL, CH, and GR contributed to the conception of the study. All authors
contributed to the study design and JoH was the study lead. RB drafted the
Implementation manuscript. All authors revised the manuscript for intellectual content and
A key aim of this study is to assess the feasibility of the approved the final version
intervention and implementation package. The qualita-
Funding
tive evaluation will be conducted to monitor the use of This report is independent research funded by the National Institute for
the intervention by staff, patients, and carers in order to Health Research (NIHR) (National Institute for Health Research Programme
identify barriers and enablers. These data will be used to Grants for Applied Health Research, Partners at Care Transitions (PACT)):
Improving patient experience and safety at transitions in care, RP-PG-1214-
refine the YNCY intervention and implementation pack- 20017. The views expressed in this publication are those of the author(s) and
age used in the definitive trial. As hybrid interventions not necessarily those of the NIHR or the Department of Health and Social
are relatively novel within health services research [17], Care.

the qualitative data will also be of particular importance Availability of data and materials
in guiding the research team on how they can support Requests to access the PACT data should be made to the corresponding
flexible implementation within the confines of a cRCT author and will be considered on a case-by-case basis by the Chief Investiga-
tor and Trial Management Group. All data requests for quantitative data will
study design. be managed in accordance with YTU, University of York, processes and
procedures.
Trial status
This article refers to protocol version 3 dated 19/11/2019. Ethics approval and consent to participate
This protocol gained ethical approval from the Wales Rec 7 Research Ethics
Recruitment began on 15/11/2019 with completion ex- Committee, Confidentiality Advisory Group, and the Health Research
pected by the end of March 2020. Post-discharge data col- Authority.
lection is due to finish in June 2020.
This feasibility trial will support the identification of key Consent for publication
Not applicable.
methodological issues that will be faced when implement-
ing and assessing the effectiveness of the YCNY interven- Competing interests
tion. The results of the study will be used to develop a The authors declare that they have no competing interests.
protocol for the definitive cRCT which is due to commence Author details
in the summer of 2020. 1
Yorkshire Quality and Safety Research Group, Bradford Institute for Health
Research, Bradford, UK. 2School of Healthcare, University of Leeds, Leeds, UK.
3
York Trials Unit, University of York, York, UK. 4Centre for Health Economics,
Supplementary information University of York, York, UK. 5School of Psychology, University of Leeds,
Supplementary information accompanies this paper at https://doi.org/10.
Leeds, UK.
1186/s40814-020-00655-5.
Received: 24 February 2020 Accepted: 30 July 2020
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