Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study
Phase: NA
Conditions: Aging
Sponsor: Queen's University, Belfast

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Title. Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A 
Primary Care Feasibility Study 
 
Main objective. To determine the feasibility of a cluster randomised trial to evaluate the 
implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist 
older adults identified as at risk for functional decline by developing a personalized support plan.  
Questions.                                                                                                                                                           
1) Determine the optimal mechanisms for intervention delivery;                                                                          
2) Assess patients, their family carers and health care providers perception of the  
appropriateness, benefits and convenience of the ACP intervention;                                                                  
3)  Determine recruitment / retention rates and outcome variability to inform sample size 
calculations for a full trial;                                                                                                                                     
4) Identify optimal recruitment strategies for general practices and patients for a full trial;                                  
5) Determine outcome measures and economic assessment strategies for a full trial;                                        
6) To determine optimal procedures for conducting a cluster randomised trial.  
Study outcomes. The feasibility study will provide a detailed evidence-based assessment on 
the potential impact of the ACP intervention on patient quality of life, mental health, healthcare 
utilisation, costs, perception of person centred care, and reduction of potentially inappropriate 
prescribing in an all Ireland context. Study outcomes will include: 
1. Methodological and statistical considerations for a definitive randomized trial. 
2. Potential improvements in care for the person at risk of functional decline including: 
a. Improved ability to assess care needs and respond more appropriately. 
b. Enhanced decision making among patients regarding care. 
c. Improved communication between healthcare providers, patients and family 
carers on goals of care. 
3. Considerations on implementation and sustainability of the intervention situated in 
primary care. 
4. Formation of strategic cross-border partnerships committed to further evaluation via a 
definitive cluster randomised trial. 
Background evidence. The provision of high quality, comprehensive care for older adults is 
becoming increasingly challenging because of the ageing of society, shortages of healthcare 
providers, and rising healthcare costs (1-4). Within this landscape primary care is increasingly 
seen as potentially the optimal context to deliver care for people with complex care needs 
because it is accessible, efficient and can address inequalities related to socioeconomic 
deprivation. However the current approach in primary care is reactive and fragmented and does 
not fully meet the needs of older people (3,5,6). A transition toward more proactive primary care 
has been proposed (3,5,6).  Proactive primary care prescribes a timely start in managing a 
patient’s long-term conditions by facilitating anticipatory care planning in order to meet patient 
wishes and needs, relieve symptoms, and prevent future symptoms and problems. A core 
aspect of anticipatory care is personalized care planning (7). This aims to ensure that 
individuals’ values and concerns shape the way long-term conditions are managed. Instead of 
focusing on a standard set of disease management processes determined by health 
professionals, this approach encourages patients to select treatment goals and to work with 
clinicians to determine their specific needs for treatment and support. Personalized care 
planning is anticipatory (forward looking), involving a negotiated series of discussions between 
a patient and a health professional to clarify goals, options and preferences, and to develop an 

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agreed plan of action based on this mutual understanding (7).  
 
Proof of concept that personalized care planning leads to better outcomes for adults with long-
term health conditions was recently demonstrated in a systematic review (7).  In this review, 
nineteen studies were identified that included a total of 10,856 participants with conditions such 
as diabetes, mental health conditions, heart failure, kidney disease and asthma. The authors 
concluded that personalized care planning led to improvements in physical and psychological 
health status, and people’s capacity to self-manage their condition when compared to usual 
care.  While these findings are encouraging, more trials are required to check the robustness of 
these findings in diverse settings and address a number of reported study limitations including 
failure to include quality of life and cost-effectiveness as outcome measures, lack of statistical 
power to detect important differences between groups, the lack of screening tools that 
demonstrate predictive validity, and poorly described interventions. A crucial stage towards 
evaluating a complex intervention is assessing the feasibility of both the intervention as well as 
the mechanisms for its evaluation (8). This proposed feasibility study will lay the foundation for a 
cluster randomized controlled trial that will address the identified limitations of research 
conducted to date (4,7,9) by incorporating the following features: 1) targeting community 
dwelling older adults with multi-morbidity; 2) screening older adults ( ≥70 years) at risk of 
functional decline using a tool of demonstrated predictive validity; 3) estimating adequate 
sample size to detect clinically important and policy relevant effects; 4) identifying a valid 
primary outcome measure that assesses quality of life; 5) and, developing an approach to 
economic evaluation to assess the cost-effectiveness of the intervention.   
Plan of Investigation 
Design and sample.  We will perform a feasibility cluster randomized controlled trial where 8 
primary care practises will be randomly assigned (4 facilities per arm) to the intervention group 
versus usual care alone. Randomisation will be stratified according to location (Northern Ireland 
/Republic of Ireland – Louth, Monaghan). Primary care practices will be randomly allocated to 
the intervention or usual care arm before patient screening for risk of functional decline. A total 
of 64 patients (32 per study arm, 8 patients, randomly selected, per primary care practise) will 
be enrolled into the study. A sample of 32 patients per study arm is considered adequate to 
allow the size of any definitive trial to be determined more accurately and therefore minimize the 
number of patients required overall (10,11). 
Setting. Practices located in Northern Ireland will be recruited via the Northern Ireland Clinical 
Research Network (Primary Care). In the Republic of Ireland the HRB Primary Care Trials 
Network will recruit primary care practises located in the border counties of Louth and Monahan. 
Practises will be drawn from both urban and rural settings that serve a socioeconomically 
deprived population.   
Patient inclusion and exclusion criteria. Research study nurses will facilitate computer 
searches on the GP database system to identify potential study candidates (12,13,14) . Study 
inclusion criteria are: 1) aged ≥70 years; 2) in receipt of a valid general medical services (GMS) 
card in the Republic of Ireland, or for Northern Ireland registered for NHS primary care services; 
3) ability to complete a postal questionnaire. Exclusion criteria: 1) receiving specialist palliative 
care; 2) record of assessed cognitive impairment at the level that would impact their ability to 
complete screening postal questionnaire, outcome measures and participate in a patient care 
conference(s) (defined as Mini Mental State Examination (MMSE) ≤20); 3) experiencing a 

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psychotic episode at the time of recruitment; 4) hospitalised long-term, in a nursing home, 
homeless or in sheltered accommodation. 
Patient screening.  Patients who meet the study inclusion criteria will be assessed for risk of 
functional decline through a three step process; 1) General Practitioner (GP) database search; 
GP staff will identify candidates who have two or more chronic medical conditions (*Note that 
hypercholesterolemia can be counted as a chronic condition for our purposes); four or more 
prescribed medications; and, availability of informal caregiver if recorded; 2) identified 
candidates will be reviewed by their own GP to confirm suitability for inclusion in the study; 3) 
Eligible candidates will receive a letter from their GP informing them about the project and 
inviting them to complete the PRISMA 7 questionnaire, a seven item questionnaire that includes 
items related to age, gender, mobility, need for assistance in activities of daily living and the 
availability of informal support (15). The instrument identifies frailty and is suitable for postal 
completion. The PRISMA 7 is considered a best practice tool that is recommended by NHS 
England to case find at-risk patients for frailty in general practice. Individuals who obtain a score 
of > 3 are identified as being at risk of functional decline (16,17). If there is no response to the 
initial letter, up to two more follow-up reminders will be mailed in one-week intervals (18). 
Patient enrolment. Individuals who screen as at risk of functional decline will be sent a letter 
from their GP inviting them to participate in the study. A project research assistant will recruit 
consenting patients by telephone. Allocation to the intervention vs. usual care will be 
communicated to the study participant by a member of the research team after the research 
assistant has obtained consent and conducted the baseline-standardised interview. In the case 
of two or more eligible participants in any one household, all will be eligible for enrolment into 
the study. In the intervention arm the study nurse employed by the project will then commence 
arrangements to visit the appropriate patients.  
Anticipatory care planning intervention (ACP). Personalised care and support planning is 
the framework for this intervention. A commitment by both the healthcare provider and patient to 
shared decision making is considered essential for personalised care planning (3,7). In shared 
decision-making, both parties must work together to understand problems, preferred goals and 
outcomes, sharing information and identifying options with the aim of reaching mutual 
agreement on the best course of action for the individual patient (3,7). Four main steps have 
been identified in the care and support process to promote a shared decision making approach 
(3,7,19): 1) prepare - starting from the patient and their family carer point of view gather 
necessary information, typically through patient assessment); 2) discuss - taking a partnership 
approach identify the actions that a person can take and what care and/or support might be 
needed from others; 3) document - the agreed support plan, owned by the patient and shared 
with consent; 4) review - consider options for follow up and set a date for review (19).  
The nurse led ACP intervention will be integrated into regular care where the study nurse will 
involve the patients’ GP in care planning and is informed about patients’ goals and plans.  As a 
first step in the intervention, the study nurse will contact the patient by telephone to schedule an 
initial home visit. This will typically be conducted within 4 weeks of the return of the participant’s 
PRISMA 7 postal questionnaire. At the initial home visit the study nurse will, with the aid of a 
medical summary including current repeat prescription provided by the GP practise, will employ 
a structured protocol conduct a brief Comprehensive Geriatric Assessment (CGA) that will also 
encourage discussion about present and future care and patient goals. New guidance from the 
British Geriatrics Society (17) suggests that it is not feasible for everyone with frailty (from mild 

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up to severe, life-limiting frailty) to undergo a full multi-disciplinary CGA review with geriatrician 
involvement. Nevertheless, all patients at risk of functional decline can benefit from a holistic 
medical review based on the principles of CGA. Completion of the brief CGA will enable the 
development of both a problem and action list that will inform care planning.  
Following the initial home visit the study nurse will draft a structured summary report of the 
home visit that will include patient goals, preferences for care, identified problems and action 
list.  The study nurse will forward to a pharmacist, who will be an adjunct to the study, the 
summary report generated from the brief CGA highlighting the patient medication list and the 
identification of potentially inappropriate prescribing (PIP). The pharmacist will cross check and 
verify the presence of PIPs. A record will be maintained by the pharmacist on the accuracy of 
the study nurse identifying PIPs during the trial.  The results of this audit will contribute to the 
finalisation of the intervention.  Subsequent to PIP feedback from the pharmacist the study 
nurse will finalize the summary report and will meet with the GP who will be informed through a 
structured format patients goals and wishes, results of the patient assessment, problem list and 
recommended actions.  The GP with appropriate participation of other members of the health 
care team, will review, provide feedback and confirm agreement with the plan of care.  
In the second home visit the study nurse will meet with the patient and family carer to discuss 
identified problems, review proposed options for support, document the agreed support plan 
and consider options for follow up and set a date for review. The study nurse may conduct, 
depending on clinical need, the second visit in the patients’ home or the GP practise so the GP 
can be present.  The finalised care plan will be left with the patient and a copy will be placed in 
the patient’s chart in the GP practise. Throughout the intervention, participants will be 
encouraged to take an active part in their health care. While the number and frequency of visits 
will vary by the needs of participants, it is expected that participants in the intervention group will 
receive up to 5 hours of nursing contact over 6 months of the intervention. This will include two 
home visits per patient, as well as telephone contacts with the patient, and meeting(s) with the 
GP and contacts other health and social care providers.  
Usual care group. Patients in the usual care group will not receive the ACP intervention but will 
receive usual care from their GP.  The PRISMA 7 score with an explanation will not be sent to 
the GP in the usual care group.  
Training. Study nurses from both jurisdictions will receive combined training in Belfast. Training 
will take place over three days. The first day will include an overview of the study, principles and 
practise of personalised care, shared-decision making and comprehensive geriatric assessment 
(CGA). The second day will be on medications review and the identification of potential 
inappropriate prescribing. The third day will include shadowing patient CGA conducted by a 
skilled nurse from the department of Older People’s Services, Belfast Health and Social Care 
Trust (BHSCT). The development of the training module will include a review of resources and 
protocols relevant to both Northern Ireland and the Republic of Ireland.   
Methods of data collection and methods of data analysis.  
The RE-AIM conceptual framework will guide considerations for the evaluation of the ACP 
intervention (20-22).  Four of the five factors included in the RE-AIM framework apply to the 
parameters of the proposed study: 1) Reach - describes the number, proportion and 
representativeness of primary care practises and patients who participate in the initiative; 2) 
Effectiveness – the impact of the intervention on outcomes; 3 Adoption – the willingness of 
primary care practises exposed to the intervention who are willing to initiate the intervention; 

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and 4) Implementation – fidelity of intervention protocol and consistency of implementation 
across primary care practises and jurisdictions. Maintenance usually refers to on-going 
implementation into routine care for at least 2 years post-intervention, and is therefore beyond 
the scope of this feasibility study. 
 
Patient standardized interview (RE-AIM Effectiveness factor) 
On obtaining consent from the patient to participate in the study, a baseline patient standardized 
survey interview will be conducted by a trained project research assistant in the home. In order 
to assess the impact of the intervention, all patients will participate in the individual standardized 
survey interviews at baseline, six week and six month follow-up.  Home Interviews are 
estimated to be 45 minutes to one hour in duration.  
 
Baseline measures                                                                                                                                             
Information on variables expected to predict responsiveness to the intervention (demographic 
factors, social support, medical conditions, prescribed medications, and cognitive impairment) 
will be obtained during the initial (baseline) in-person interview by a research assistant.      
a) Demographic data.  Demographic data will include age, gender, education, living 
arrangements, income and economic resources.  
b) The Medical Outcomes Study Social Support Survey (MOS) (23). Is a 20-item instrument 
designed for use with chronically ill patients.  It assesses four categories of social support; 
tangible support, affectionate support, positive social interaction, and informational support. 
Respondents use a Likert-type scale to rate each item ranging from ‘None of the Time’ to ‘All of 
the Time’.  Psychometric properties are sound having good reliability, internal consistency and 
construct validity. 
Outcome Measures                                                                                                                                             
All outcome measures will be assessed at baseline, six weeks and six months. All selected 
measures have been used on this population in previous research as both outcome and 
observational measures (24,25,26)   
Primary outcome measures (RE-AIM – effectiveness factor)  
a) EQ-5D-5L (27) Is a widely used self-reported generic measure of health reported quality of 
life that has been validated in different patient populations. The five-level version contains the 
same dimensions as the earlier three-level version but has been designed to provide greater 
reliability and sensitivity.  
b) Center for Epidemiological Studies Depression Scale (CES-D) (28) This 20- item scale 
has been used extensively with older adults. Respondents use a four choice scale to rate how 
they have felt in the past week expressing depressed mood.  
Secondary outcome measures (RE-AIM - effectiveness factor) 
a) Patient Assessment of Chronic Illness Care (PACIC) Scale (29) This 20 item scale was 
designed to assess from the patient perspective the receipt of patient-centered care and self-
management behaviors.  
 

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b) Health Economic Evaluation. The health economic analysis will consist of trial-based 
economic evaluation and will incorporate both cost effectiveness analysis and cost utility 
analysis to compare the alternative treatment strategies: (1) the Anticipatory Care Planning 
(ACP) Intervention; and (2) usual care in general practice. The basic tasks of the evaluation are 
to identify, measure, value and compare the costs and outcomes of the alternatives being 
considered. Evidence collected on resource use and outcome measures alongside the trial will 
provide the basis for the analysis over the trial follow up period. With respect to costing, a health 
service perspective will be adopted. Resource use associated with delivery of the ACP 
Intervention will be measured and costed. Other resource use to be captured will include usage 
of medications, primary care, community care, and hospital care services. Unit costs will be 
applied to convert data on resource use to resource costs and total cost variables will be 
calculated. As detailed above, significant attention will be paid to collecting relevant data on 
health outcomes alongside the trial. For the cost effectiveness analysis, the treatment strategies 
will be compared on the basis of the effectiveness data for the primary outcomes of interest. For 
the cost utility analysis, effectiveness will be evaluated on the basis of Quality Adjusted Life-
Years (QALYs) which will be estimated using the EuroQol EQ-5D-5L survey instrument. The 
health economic analysis will employ the standard approach for the comparison of alternative 
treatment strategies in terms of costs and health outcomes. An incremental analysis will be 
undertaken to provide information on the marginal costs and effects of the ACP Intervention 
relative to usual care through the calculation of incremental cost effectiveness ratios and 
incremental net benefits. Univariate, multivariate and probabilistic sensitivity analyses will be 
employed to address uncertainty in the study 
c). Katz Index of Independence in Activities of Daily living (30).  This well-established 
instrument is a measure of performance describing what the person does rather what they are 
capable of doing. It assesses six activities: ability to bathe, dress, toilet, transfer, feed self and 
maintain bowel and bladder continence.  A three-category scoring model is used for each 
activity. 
 
d) Generalized anxiety disorder (GAD) (31) In the GAD patients are asked how often, during 
the last 2 weeks, they were bothered by 7 anxiety related symptoms.  
 
e) Potential inappropriate prescribing (PIP) (32). Will be assessed on the proportion of 
patients with PIP drugs. We will assess the mean number of PIP drugs between the intervention 
and usual care groups.  
 
2. Tracking intervention patterns and intensity (RE-AIM Implementation)                                                   
Records will be maintained describing the patterns and intensity of care provided to each 
participant in the intervention group.  Nurses will maintain logs to record the amount of time 
spent with each participant including home visits, phone calls, and consultations with family 
physicians and other professionals.  
3. Qualitative interviews (RE-AIM - Adoption)                                                                                                  
User perceptions on the appropriateness, benefits, and convenience of the intervention will be 
recorded through qualitative interview approaches. Patient  (n = 32) acceptability of the 
intervention will be assessed using several additional questions embedded in the structured 
interview schedule conducted on the six-week follow-up for participants in the intervention arm 
of the study. These questions will assess perceptions about the intervention in terms of: (a) the 
overall intervention; (b) its component parts (the patient meetings, assessment, patient 

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education on advance care planning); (c) implementation (was the home environment suitable 
for meetings); (d) were the contents reviewed in the meetings useful; and (e) suggestions for 
refining the intervention (change the format of the meeting). The study nurses (n = 4) will also 
be interviewed on aspects of the intervention reviewing: (a) what experience a registered nurse 
should have to fulfill the position; (b) training requirements; (c) how to build relationships with 
participants; (d) if the home environment was suitable for the meetings; (e) if the ACP model 
fitted into the running of a GP practice; (f) their best and worst experience related to ACP 
meetings; and (g) the recommendations they would make to improve the ACP intervention. GP 
practice staff (GPs and associated healthcare providers) (estimate n = 12) will also have a brief 
interview that will examine perceptions on the appropriateness, benefits, and convenience of 
the intervention.  Community health professionals (estimate = 12) will be interviewed to identify 
the facilitators and barriers that reside at the regional system level that may influence how the 
intervention is implemented.  
4. Metrics to be collected (RE-AIM - Reach).  
Records will be maintained that will collect indicators on: (a) number of eligible participants 
identified on the GP patient list; (b) number of participants found to be ineligible and reasons 
why; and (c) number of eligible participants who consent to participate and reasons for non-
participation. Nurses in the intervention group will maintain logs to record the amount of time 
spent with each participant including home visits, phone calls, and consultations with family 
physicians and other professionals. 
 
Analyses. Quantitative analysis: data will be expressed as a mean, standard deviation (SD) or 
median (minimum-maximum) for continuous variables and count (percent) for categorical 
variables. The analysis of indicators will be based on descriptive statistics reported as estimates 
with confidence intervals. Outcome analyses will be conducted to compare the intervention and 
control groups, recognizing that this analysis will be underpowered for statistical analyses. 
Means and SD will be reported for each combination of baseline-final data. Frequency and 
percentage will be reported in the same manner for categorical variables. The standard 
deviation of the change in primary outcome EuroQol EQ-5D-5L at six months will be determined 
and the intra cluster correlation of this change will be estimated to inform the sample size 
required for the main trial. The recruitment and retention rates at 6 months will also be 
determined to inform the sample size calculation.  The investigators will also consider 
acceptability of the mode and timing of the administration of impact measures. Incremental cost 
effectiveness and cost utility analyses will be conducted for the purposes of the economic 
evaluation. All quantitative analysis will be conducted in a manner consistent with guidelines for 
the analysis of data from cluster RCTs.  Qualitative analysis: the qualitative software program, 
NVivo 10.0 (33) will be used to help organize and analyze the data. We will analyze interview 
data following the template analysis style outlined by Miles and Huberman (34) and will develop 
an open-ended and modifiable codebook (template). We will use this tool to generate themes, 
patterns, and interrelationships in an interpretive fashion, drawing on the expertise of our 
research team and our Public Involvement Panel. 
 
Criteria for progression to a full trial. A protocol for a full trial will be developed if the study 
findings demonstrate that the ACP intervention is acceptable to most (> 70%) patients, their 
carers and to health professionals; if the ACP can be readily implemented; if recruitment (> 35% 
GP practices, > 50% patients), and > 65% patient retention rate will likely be adequate for a full 
trial; if there is a detected change in the primary and secondary expected outcomes between 

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the intervention and usual care group; and, the features of the economic evaluation (35). 
 
Existing research infrastructure.  The project will be maintained in the School of Nursing 
and Midwifery (SNM) Queen’s University Belfast.  The study will have two governance 
bodies Project Management Team (PMT) (KB, PH, GC, KM, FD, EW, TF, PD) that will meet 
every two months and a Study Steering Committee (SSC) that will meet bi-annually. KB will 
head the PMT as chief investigator with overall responsibility for the research project and 
will oversee day-to-day research work by the research fellow. The PMT will present 
progress and findings to the SSC and consult its members. Collaborative dialogue between 
PMT and SSC (via project progress reports and bi-annual meetings, and on a frequent ad 
hoc basis) will facilitate consideration of how best to translate research findings into service 
improvements, ensuring healthcare service context and patients and staff needs are 
considered. A Public Involvement Panel (PIP) for family carers and older adults living with 
chronic conditions will be established. The panel will contribute to the development of the 
training module for study nurses, and interpretation of study data collection.  
 
Ethical and governance approvals. In Northern Ireland ethics approval will be obtained from 
the Office of Research Ethics Committee Northern Ireland (ORECNI) and governance from the 
Queen’s University Belfast Research Governance Office. In the Republic of Ireland application 
will be made to the Irish College of General Practitioners (ICGP) Research Ethics Committee.   
Dissemination and knowledge transfer plan. Our research team members will be well 
positioned to disseminate project awareness, and outcomes to the broader research and 
practice/ policy community.  Dissemination products will be held on a project website hosted by 
the School of Nursing and Midwifery QUB website. Social media such as twitter and the use of 
a blog will also be developed. Academic dissemination will include submissions to conferences 
(e.g., Irish Gerontological Society Annual Conference, Society of Academic Primary Care 
Conference UK) and peer review journals (e.g., Age and Aging, BMC Family Medicine).  
 
Envisaged outcome for future work. Based on the outcomes of the project we anticipate that 
we will target the Health Research Board and National Institute for Health Research, Health 
Services and Delivery Research programme in the winter of 2019 to fund the implementation of 
a national trial.  
 
 
Timetable and milestones 
Activity / Months 
1-4 
4-8 
8-12 
12-
16 
16-
20 
20-
24 
Application for ethics approval 
 
 
 
 
 
 
Secure Research Staff (Research Asst. ½ time for 14 
months) 
 
 
 
 
 
 
Develop research training module  
 
 
 
 
 
 
Train Research Nurse(s) in ACP 
 
 
 
 
 
 
 
Finalize GP Practice enrolment to study 
 
 
 
 
 
 
 
Recruit patients 
 
 
 
 
 
 
Patients/Family Carers – standardised interviews 
(baseline & follow-up) 
 
 
 
 
 
 
Intervention implementation 
 
 
 
 
 
 

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Quantitative data input and analysis 
 
 
 
 
 
 
Qualitative interviews and analysis  
 
 
 
 
 
 
Final analysis & report write-up 
 
 
 
 
 
 
Project management team meetings (bi-monthly) 
 
 
 
 
 
 
 
 
 
 
 
 
Study Steering Committee  meetings x 4 (Quarterly) 
 
 
 
 
 
 
Knowledge transfer \ develop grant proposal for full 
trial 
 
 
 
 
 
 
 
 

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STUDY DESIGN FLOW CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Allocation 
 
Analysis
Assessment & Follow-Up  
Baseline  
alysis 
Within 4 weeks 
Baseline Standardised Interview (n = 64) 
Qualitative interviews – intervention group only 
 
A.
 Patient - Structured interview questions (n=32) 
B.
Study nurse - Semi-structured interviews (n=4) 
C.
GP and Practice staff - Semi structured interviews (n=12) 
D. Community professionals - Semi-structured interviews (n=12) 
Intervention  
8 GP Practices (GPP) to be recruited as cluster sites  
4 GPP Northern Ireland (NI)  
4 GPP Southern Ireland (ROI)  
INTERVENTION 
(NI) 
(n= 16)  
USUAL CARE  
(NI) 
 (n= 16)  
INTERVENTION 
(ROI) 
(n= 16)  
USUAL CARE 
 (ROI) 
(n= 16)  
Follow-up standardised interviews @ 6 weeks and 6 months (n=64)  
GP database search & patient screening 
8 participants per GPP 
Total n = 64 [32 in INTERVENTION; 32 in USUAL CARE] 
GPP allocated to 
INTERVENTION 
(n= 2)  
GPP allocated to 
USUAL CARE 
 (n= 2)  
GPP allocated to 
INTERVENTION 
(n= 2)  
GPP allocated to 
USUAL CARE 
 (n= 2)  

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References 
1. 
WHO. Global status report on noncommunicable diseases 2010: description of the 
global burden of NCDs, their risk factors and determinants.  Geneva: World Health 
Organisation, 2011.  http://www.who.int/nmh/publications/ncd_report2010/en 
(accessed July 2017). 
2. 
Christensen K, Dodlhammer G, Rau R, Vaupel J. Aging populations: the challenges 
ahead.  Lancet. 2009; 374: 1196-1208. 
3. 
Coulter A, Roberts, S., Dixon, A. Delivering Better Services for People with Long-Term 
Conditions: Building the House of Care. London: King's Fund; 2013. 
4. 
Smith S, Soubhi H, Fortin M, Hudon C, O’Dowd T.  Managing patients with multi-
morbidity: systematic review of interventions in primary care and community settings.  
BMJ. 2012; 345 :e5205 doi: 10.1136/bmj.e5205 
5. 
Health and Social Care Northern Ireland. Transforming your care: a review of health 
and social care in Northern Ireland. 2011;  Available from: 
http://www.transformingyourcare.hscni.net/wp-content/uploads/2012/10/Transforming-
Your-Care-Review-of-HSC-in-NI.pdf  (accessed July 2017) 
6. 
Department of Health.  Future health; a strategic framework for reform of the health 
service 2012-2015. 2012; Available from http://health.gov.ie/wp-
content/uploads/2014/03/Future_Health.pdf 
7. 
Coulter A, Entwistle VA, Eccles A, Ryan S, Shepperd S, Perera R. Personalised care 
planning for adults with chronic or long-term health conditions.  Cochrane Database of 
Systematic Reviews. 2015: 3; CD10523.  Doi: 10.1002/1461858 
8. 
Craig P, Dieppe P, MacIntyre S, Michie S, Navareth I Petticrew M.  Developing and 
evaluating complex interventions: the new MRC guidance.  BMJ 2008; 337:a1655 
9. 
Ploeg J, Feightner J, Hutchison B, Patterson C, Sigouin C, Gauld M.  Effectiveness of 
preventative primary care outreach interventions aimed at older people: meta-analysis 
of randomized controlled trials.  Canadian Family Physician.  2005;51:1244-1255 
10. 
Teare D, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters S.  Sample size 
requirements to estimate key design parameters from external pilot randomised 
controlled trials: a simulation study.  Trials. 2014:15; 264-277. 
11. 
Billingham S, Whitehead A, Julious S.  An audit of sample sizes for pilot and feasibility 
trials being undertaken in the United Kingdom registered in the United Kingdom 
Clinical Research Network database.  BMC Medical Research Methodology. 2013: 13; 
104  
12. 
Wallace E, McDowell R, Bennett K, Fahey T, Smith S.  External validation of the 
probability of repeated admission risk prediction tool in older community-dwelling 
people attending general practice: a prospective cohort study.  BMJ Open. 2016: 6; 
11: e012336. Doi10.1136/bmjopen-2016-012336 
13. 
Morley J, Vellas B, van Ken A, Anker S et al.  Frailty consensus: a call to action.  
Journal of American Medical Directors Association.  2013: 16(6); 392-397. 
14. 
NHS England.  Using case finding and risk stratification: a key service component for 
personalised care and support planning.  Redditch: NHS England, 2015.  
https://www.england.nhs.uk/wp-content/uploads/2015/01/2015-01-20-CFRS-v0.14-
FINAL.pdf (Accessed August 2017). 
15. 
Clegg A, Rogers L, Young J.  Diagnostic test accuracy of simple instruments for 
identifying frailty in community-dwelling older people: a systematic review.  Age and 
Ageing.  2015: 44; 148-152. 
16. 
Lyndon H, Stevens, G. Toolkit for General Practice in supporting older people with 
frailty and achieving the requirements of unplanned admissions: Enhanced service 
2014. London: NHS; 2014. 
17. 
British Geriatrics Society. Fit for Frailty - consensus best practice guidance for the care 
of older people living in community and outpatient settings - a report from the British 
Geriatrics Society. London; 2014. 
18. 
Dillman D, Smyth JD, Christian L.M. Internet, mail, and mixed-mode surveys: The 
tailored design method. 3rd ed. New York, NY: John Wiley & Sons; 2009. 

Protocol Version 2 _ 19/03/2019 
19. 
Person Centred Care/Coalition for collaborative care/Medical Directorate.  
Personalised care and support planning handbook: the journey to person centred care.  
Core information.  Redditch: NHS England, 2016.  https://www.england.nhs.uk/wp-
content/uploads/2016/04/core-info-care-support-planning-1.pdf (Accessed August 
2017). 
20. 
Glasgow RE, Vogt TM, Boles SM.  Evaluating the public health impact of health 
promotion interventions: the RE-AIM Framework.  American Journal of Public Health.  
1999: 89; 1322-1327. 
21. 
Gaglio B, Glasgow RE.  The Re-AIM Framework: a systematic review of use over 
time.  American Journal of Public Health.  2013. 103: 6; e38-e46. Doi: 
10.2105/AJPH.2013.301299 
22. 
Gaglio B, Phillips S, Heurtin-Roberts S, Sanchez, M Glasgow R.  How pragmatic is it? 
Lessons learned using PRECIS and RE-AIM for determining pragmatic characteristics 
of research.  Implementation Science. 2014. 9; 96.  doi: 10.1186/s13012-014-0096-x. 
23. 
Sherbourne CD, Stewart AL, Wells KB.  Role functioning measures.  In Stewart AL, 
Ware JE Jr, eds.  Measuring functioning and wellbeing: the Medical Outcomes Study 
approach.  Durham, North Carolina: Duke University Press, 1992: 173-181. 
24. 
Kane RL, Kane RA.  Assessing older persons: measures, meaning and practical 
applications.  New York: Oxford University Press; 2000. 
25. 
Man MS, Chaplin K, Mann C, Bower P, Brookes S, Fitzpatrick B, et al.  Improving the 
management of multi-morbidity in general practice: protocol of a cluster randomized 
controlled trial (The 3D Study).  BMJ Open. 2016: 6(4); doi: 10.1136bmjopen-2016-
011261.   
26. 
Bleijenberg N, Drubbel I, Schuurmans MJ, tenDam H, Zuithoff N, Numans M, et al.  
Effectiveness of a proactive primary care program on preserving daily functioning of 
older people: a cluster randomized controlled trial.  Journal of the American Geriatrics 
Society.  2016: 64; 1779-1788. 
27. 
Devlin N, Shah K, Feng Y, Mulhern B, van Hout B.  Valuing health related quality of 
life: an EQ-5D-L value set for England.  Office of Health Economics, London, England; 
2016. Research Paper 16/01 
28. 
Radloff LS.  The Centre for Epidemiological Studies – Depression Scale: A self-report 
depression scale for research in the general population.  Applied Psychological 
Measurements.  1977.  3; 385-401. 
29. 
Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM.  
Development and validation of the Patient Assessment of Chronic Illness (PACIC).  
Medical Care.  2005: 43(5); 436-444. 
30. 
Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffee MW.  Studies of illness in the 
aged.  The index of ADL: A standardized measure of biological and psychological 
function.  Journal of the American Medical Association.  1963: 185(12); 914-919. 
31. 
Spitzer RL, Kroenke K, Williams J, Lowe B.  A brief measure for assessing generalized 
medical disorder: The GAD 7.  Archives of Internal Medicine.  2006: 166; 1092-1097. 
32. 
Clyne B, Smith S, Hughes C, Boland F, Bradley M, Cooper J et al.  Effectiveness of a 
multi-faceted intervention for potentially inappropriate prescribing in older patients in 
primary care: a cluster-randomized controlled trial (OPTI-SCRIPT study).  Annals of 
Family Medicine.  2015: 13(6); 545-553. 
33. 
NVIVO 11. 11 ed. Victoria, Australia: QSR International. 
34. 
Miles MB and Huberman HA. Qualitative Data Analysis. Second ed. Thousand Oaks, 
California: Sage Publications; 1994. 
35. 
Avery K, Williamson P, Gamble C, O’Connell-Francischetto E, Metcalfe C, Davidson P 
et al.  Informing efficient randomized controlled trials: exploration of challenges in 
developing progression criteria for internal pilot studies.  BMJ OPEN.  2016: 7; 
e013537.  doi: 10.1136/bmjopen-2016-013537 
36. 
Stuck A, Siu A, Wieland G, Adams J, Rubenstein L. Comprehensive geriatric 
assessment: a meta-analysis of controlled trials. Lancet 1993 Oct 23:342(8878):   
1032-6.