Aging Clinical Trial
Official title:
Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study
The purpose of this study is to explore the feasibility of delivering anticipatory care planning provided by nurses through a series of home visits. Many people with long-term health conditions can benefit from an anticipatory care plan as it helps them feel more in control of their life and allows them to manage changes in their health and well-being. The purpose of this study is to find out if effect of home visits by specially trained nurses for people aged 70 years and over who have been identified as being 'at risk' of developing frailty would be beneficial. Half of the patients in this study will receive home visits from trained nurses in addition to their usual care. Nurses will work with their GP, other healthcare providers and possibly family caregivers to plan and arrange any additional services that the participants require. The other half of patients in the study will receive usual care.
Aim: 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 personalised
support plan.
Design and sample:
We will perform a feasibility cluster randomised 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 minimise the number of patients required overall.
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
Monaghan. Practises will be drawn from both urban and rural settings that serve a
socioeconomically deprived population.
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.
Intervention:
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.
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.
All outcome measures will be assessed at baseline, six weeks and six months.
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