NCT06205238

Brief Summary

The investigators plan to implement a randomised controlled trial to examine the impact of domiciliary (home based) versus 'hub-based' Comprehensive Geriatric Assessment (CGA) on clinical and process outcomes among older adults referred to a community specialist team for older persons in the Mid-West region of Ireland. The population of interest is older adults who are discharged directly from the Emergency Department or referred urgently from their General Practitioner. The outcomes of interest focus on those that matter most to older adults as well as clinical and process measures of care.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jan 2024Jul 2026

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

January 3, 2024

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Functional status

    Barthel Index

    Baseline

  • Functional status

    Barthel Index

    6-weeks

  • Functional status

    Barthel Index

    6-months

  • Functional status

    Barthel Index

    12-months

Secondary Outcomes (25)

  • Unplanned ED revisit

    Baseline

  • Unplanned ED revisit

    6-weeks

  • Unplanned ED revisit

    6-months

  • Unplanned hospitalisation

    Baseline

  • Unplanned hospitalisation

    6-weeks

  • +20 more secondary outcomes

Study Arms (2)

Domiciliary CGA

EXPERIMENTAL

The intervention will consist of domiciliary CGA including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged the ED or referred urgently from their GP and referred to the CST in Limerick. The bulk of this intervention will be delivered in the patient's own home. Each participant will be required to attend the hub for their medical review where they will access specialist geriatric medical expertise. A domiciliary visit to the older person within 24-48 hours of referral from the ED or within 24-48 hours of triage of GP referral by a member of the multidisciplinary team. This person will act as the case coordinator. During this visit, there will be a detailed assessment of the older adult. Referrals will be made for domiciliary care to the appropriate healthcare professionals based on patient. The template proposed by Ellis et al. (2017) will be used to characterise the components of the CGA intervention.

Other: CGA

Hub-based CGA

ACTIVE COMPARATOR

The intervention will consist of CGA as defined above, including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged the ED or referred urgently from their General Practitioner and referred to the CST in Limerick and will be seen in the Out-patient CST setting.

Other: CGA

Interventions

CGAOTHER

CGA is defined as a "multidimensional interdisciplinary diagnostic process focused on determining a frail elderly person's medical, psychological and functional capability in order to develop a coordinated and integrated plan for treatment and long term follow up".

Domiciliary CGAHub-based CGA

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Referred to the CST hub from a General Practitioner (urgent referral) or from the ED at University Hospital Limerick.
  • All of criteria 1-5 must be met
  • years and over
  • Evidence of frailty, scoring between 4 and 6 on the Rockwood Clinical Frailty Scale (pre-frail, mildly frail or moderately frail)
  • Resides within CHO 3 and the catchment area of the relevant ICPOP hub
  • Patient has been assessed in-person by the referrer
  • Patient has not had MDT input within the last three months (excluding OPTIMEND team)
  • And any one of criteria 6-10 must be met:
  • 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
  • Adverse drug reaction within the last month excluding allergic reaction Referred from ED/AMU following review by consultant in Emergency Medicine, Acute Medicine, Geriatric Medicine, General Medicine or Frailty at the Front Door team

You may not qualify if:

  • 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)

Community Specialist Team Hub

Limerick, Munster, Ireland

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to group allocation to reduce detection bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

January 15, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations