NCT05527223

Brief Summary

Comprehensive Geriatric Assessment (CGA) demonstrates positive outcomes amoung community-dwelling older people living with frailty. However, there is currently no evidence of benefit for CGA with General Practitioner (GP) participation within the Irish Primary Care setting. This study aims to explore the clinical and process outcomes of older adults living with frailty who are screened by and referred to one of the three Ambulatory Care Hub's in the primary care setting in the Mid-West of Ireland by their GP, where they undergo a CGA .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

February 2, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 10, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

August 11, 2022

Last Update Submit

February 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of functional decline

    The number of participants who experience functional decline or do not as measured by the Barthel Index (BI). Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI. The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.

    30-days

  • Incidence of functional decline

    The number of participants who experience functional decline or do not as measured by the Barthel Index (BI). Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI. The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.

    6-months

Secondary Outcomes (11)

  • Primary healthcare use (within and outside of ACH healthcare utilisation)

    30-days

  • Primary healthcare use (within and outside of ACH healthcare utilisation)

    6-months

  • Secondary healthcare use

    30-days

  • Secondary healthcare use

    6-months

  • Quality of integrated care from the perspective of participants

    30-days

  • +6 more secondary outcomes

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All older adults aged ≥75 years who are referred to the ACH by their GP between February 2022 and January 2023 (inclusive) will be considered eligible for participation in the study, if they meet the inclusion criteria.

You may qualify if:

  • Referred to the ACH by their GP
  • Score between 4 and 6 on the Rockwood Clinical Frailty Scale
  • Reside within CHO 3 and the catchment area of the relevant ACH hub
  • Have been assessed in-person by the referrer
  • Has not had MDT input within the last three months
  • And any one of the following criteria:
  • Fall within the last month unrelated to acute cardiac or neurological cause \& no previous falls assessment
  • Increased dependency or increased carer burden in the last month
  • A deterioration in swallow in the last month including symptoms of recurrent chest infections
  • Weight loss
  • Coughing when eating/drinking
  • Self-modifying diet secondary to difficulties or experienced an adverse drug reaction within the last month excluding allergic reaction.

You may not qualify if:

  • Patients will be excluded if they:
  • Present with an acute neurological or cardiovascular event
  • Are more appropriate to an alternative care pathway or service e.g. primary care or geriatric medicine clinic
  • Present with injuries, unless the injury has already been appropriately managed,
  • Are experiencing an acute medical illness requiring treatment in an acute hospital setting
  • If care is being provided by other health care professionals at the time of referral and it is apparent that they are working to meet goals aligned with the current service
  • They require investigation or treatment not available in the relevant ICPOP hub (unless these investigations are already being arranged elsewhere)
  • They have had MDT input in the last three months
  • Have confirmed or suspected Covid-19 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Allied Health, University of Limerick.

Limerick, Munster, V94 T9PX, Ireland

Location

Related Publications (9)

  • Liljas AEM, Brattstrom F, Burstrom B, Schon P, Agerholm J. Impact of Integrated Care on Patient-Related Outcomes Among Older People - A Systematic Review. Int J Integr Care. 2019 Jul 24;19(3):6. doi: 10.5334/ijic.4632.

    PMID: 31367205BACKGROUND
  • Mann J, Thompson F, McDermott R, Esterman A, Strivens E. Impact of an integrated community-based model of care for older people with complex conditions on hospital emergency presentations and admissions: a step-wedged cluster randomized trial. BMC Health Serv Res. 2021 Jul 16;21(1):701. doi: 10.1186/s12913-021-06668-x.

    PMID: 34271945BACKGROUND
  • World Health Organisation. Integrated Care for older people: Realigning primary health care to respond to population ageing. 2018.

    BACKGROUND
  • Everink IHJ, van Haastregt JCM, Tan FES, Schols JMGA, Kempen GIJM. The effectiveness of an integrated care pathway in geriatric rehabilitation among older patients with complex health problems and their informal caregivers: a prospective cohort study. BMC Geriatr. 2018 Nov 16;18(1):285. doi: 10.1186/s12877-018-0971-4.

    PMID: 30445923BACKGROUND
  • Roe L, Normand C, Wren MA, Browne J, O'Halloran AM. The impact of frailty on healthcare utilisation in Ireland: evidence from the Irish longitudinal study on ageing. BMC Geriatr. 2017 Sep 5;17(1):203. doi: 10.1186/s12877-017-0579-0.

    PMID: 28874140BACKGROUND
  • Briggs R, McDonough A, Ellis G, Bennett K, O'Neill D, Robinson D. Comprehensive Geriatric Assessment for community-dwelling, high-risk, frail, older people. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012705. doi: 10.1002/14651858.CD012705.pub2.

    PMID: 35521829BACKGROUND
  • Glynn LG, Valderas JM, Healy P, Burke E, Newell J, Gillespie P, Murphy AW. The prevalence of multimorbidity in primary care and its effect on health care utilization and cost. Fam Pract. 2011 Oct;28(5):516-23. doi: 10.1093/fampra/cmr013. Epub 2011 Mar 24.

    PMID: 21436204BACKGROUND
  • World Health Organization. World report on ageing and health: World Health Organization; 2015

    BACKGROUND
  • Hayes C, Whiston A, Fitzgerald C, Devlin C, Condon B, Manning M, Leahy A, Robinson K, Galvin R. Community Specialist Teams for Older Persons (CST-OP) at risk of, or living with frailty in Ireland: a prospective cohort study of a new model of integrated care for community dwelling older adults. BMC Prim Care. 2025 Jun 5;26(1):193. doi: 10.1186/s12875-025-02895-x.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rose Galvin

    University of Limerick

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2022

First Posted

September 2, 2022

Study Start

February 2, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 10, 2025

Record last verified: 2025-01

Locations