NCT03902743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

April 2, 2019

Last Update Submit

November 6, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • EQ-5D-5L

    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.

    10 minutes

  • Center for Epidemiological Studies Depression Scale (CES-D)

    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.

    10 minutes

Secondary Outcomes (2)

  • Patient Assessment of Chronic Illness Care (PACIC) Scale

    15 minutes

  • Health Economic Evaluation

    15 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive an Anticipatory Care Plan

Other: Anticipatory Care Plan group

Control group

NO INTERVENTION

Usual care

Interventions

The Anticipatory Care Plan will be delivered by a trained nurse. At the initial visit, the nurse will conduct a hollistic assessment using the EasyCare Assessment Tool. Following this visit, the nurse will draft a strucutred summary report of the home visit to include patient goals, preferences for care, identified problems and action list. The nurse will then consult with a pharmacist to identify any potential inappropriate prescribing. The nurse will then meet with the participants GP and review and provide feedback. The nurse will then re visit participants and discuss the report and agree a support plan and actions for follow up.

Intervention group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queens University Belfast

Belfast, BT9 7BL, United Kingdom

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Kevin Brazil, PhD

    Queens University Belfast

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Brazil, PhD

CONTACT

David Scott, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Kevin Brazil

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

March 12, 2019

Primary Completion

February 1, 2020

Study Completion

August 1, 2020

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Plan in preparation

Shared Documents
STUDY PROTOCOL
Time Frame
August 2021
Access Criteria
Those requesting access will be required to submit a letter of intent to the study PI after which the research team will review their request

Locations