Clinical trial NCT03902743: Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study
Official title: Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Royal College of Surgeons, Ireland
name: National University of Ireland, Galway, Ireland
First posted: 2019-04-04
Enrollment: 64
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged ≥70 years
* 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
* ability to complete a postal questionnaire

Exclusion Criteria:

* receiving specialist palliative care
* 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)
* experiencing a psychotic episode at the time of recruitment
* hospitalised long-term, in a nursing home, homeless or in sheltered accommodation

Primary outcomes:
measure: EQ-5D-5L
timeFrame: 10 minutes
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 10 minutes
Secondary outcomes:
measure: Patient Assessment of Chronic Illness Care (PACIC) Scale
timeFrame: 15 minutes
measure: Health Economic Evaluation
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queens University Belfast
Study officials:
affiliation: Queens University Belfast
name: Kevin Brazil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brazil K, Cardwell C, Carter G, Clarke M, Corry DAS, Fahey T, Gillespie P, Hobbins A, McGlade K, O'Halloran P, O'Neill N, Wallace E, Doyle F. Anticipatory care planning for community-dwelling older adults at risk of functional decline: a feasibility cluster randomized controlled trial. BMC Geriatr. 2022 May 25;22(1):452. doi: 10.1186/s12877-022-03128-x.
citation: Corry DAS, Carter G, Doyle F, Fahey T, Gillespie P, McGlade K, O'Halloran P, O'Neill N, Wallace E, Brazil K. Successful implementation of a trans-jurisdictional, primary care, anticipatory care planning intervention for older adults at risk of functional decline: interviews with key health professionals. BMC Health Serv Res. 2021 Aug 25;21(1):871. doi: 10.1186/s12913-021-06896-1.
citation: Brazil K, Scott D, Wallace E, Clarke M, Fahey T, Gillespie P, O'Halloran P, Cardwell C, Carter G, McGlade K, Doyle F. Anticipatory care planning intervention for older adults at risk of functional decline: study protocol for a primary care cluster feasibility randomised trial. Trials. 2020 Feb 11;21(1):168. doi: 10.1186/s13063-020-4100-2.