The Impact of Domiciliary Versus 'Hub' Based Comprehensive Geriatric Assessment on Clinical and Process Outcomes Among Older Adults Attending Community Specialist Teams: a Randomised Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Older Adults; Comprehensive Geriatric Assessment; Domiciliary Care
• Intervention / Treatment: Other: CGA

Detailed Description

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" (1). The CST hub in Limerick provides a rapid, single point of access to an outpatient specialist geriatrician and allied health professional assessment. The bulk of this therapy is delivered in each of the hubs. This is considered 'usual' or routine care for the purposes of this trial.

The intervention will consist of domiciliary multidisciplinary CGA and intervention including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged from the ED, or referred urgently from their General Practitioner 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 will be carried out. This person will act as the case coordinator for the duration of the intervention. During this visit, there will be a detailed assessment of the older adult. The assessment will include but not be limited to a falls assessment, assessment of mobility and stairs, transfer, personal care, activities of daily living (ADLs), social supports, cognition, lying & standing blood pressures and nutritional assessment. Referrals will be made for domiciliary care to the appropriate healthcare professionals (nursing, OT, physiotherapy, dietetics etc) based on the findings of this holistic assessment. Interventions prescribed will be individualised based on patient needs. The investigators will use the template proposed by Ellis et al. (2017) to characterise the components of the CGA intervention.

The trial will assess the benefits of this domiciliary model of care on outcomes including the following: function, quality of life, patient satisfaction, primary and secondary healthcare use, nursing home admission, mortality and cost-effectiveness. Baseline measurement will be taken at their index visit with follow-up at six weeks and 6 months.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rose Galvin; Phone Number: 061234149; Email: rose.galvin@ul.ie
• Study Contact Backup: Name: Christina Hayes, BSc; Phone Number: 061234149; Email: christina.hayes@ul.ie

Study Locations

• Ireland
  • Munster
    • Limerick, Munster, Ireland
      • Recruiting
      • Community Specialist Team Hub
      • Contact: Christina Hayes; Email: christina.hayes@ul.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

1. 75 years and over
2. Evidence of frailty, scoring between 4 and 6 on the Rockwood Clinical Frailty Scale (pre-frail, mildly frail or moderately frail)
3. Resides within CHO 3 and the catchment area of the relevant ICPOP hub
4. Patient has been assessed in-person by the referrer

5. Patient has not had MDT input within the last three months (excluding OPTIMEND team)

   And any one of criteria 6-10 must be met:

6. Fall within the last month unrelated to acute cardiac or neurological cause & no previous falls assessment
7. Increased dependency or increased carer burden in the last month
8. 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
9. 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

Exclusion Criteria:

• 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
• Or other exclusions at the discretion of the integrated care team based on clinical expertise and available resource.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Domiciliary CGA; 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; 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".
Active Comparator: Hub-based CGA; 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; 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	Barthel Index	Baseline
Functional status	Barthel Index	6-weeks
Functional status	Barthel Index	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned ED revisit	Process measure for hospital data base	Baseline
Unplanned ED revisit	Process measure for hospital data base	6-weeks
Unplanned ED revisit	Process measure for hospital data base	6-months
Unplanned hospitalisation	Process measure for hospital data base	Baseline
Unplanned hospitalisation	Process measure for hospital data base	6-weeks
Unplanned hospitalisation	Process measure for hospital data base	6-months
Nursing Home admission	Process measure	6-weeks
Nursing Home admission	Process measure	6-months
Mortality	The number of participants who died following their index visit	6-weeks
Mortality	The number of participants who died following their index visit	6-months
Health related quality of life (HRQOL)	EuroQoL-5D-5L	Baseline
Health related quality of life (HRQOL)	EuroQoL-5D-5L	6-weeks
Health related quality of life (HRQOL)	EuroQoL-5D-5L	6-months
Patient satisfaction with care	Patient Assessment of Integrated Elderly Care Questionnaire	6-weeks
Patient satisfaction with care	Patient Assessment of Integrated Elderly Care Questionnaire	6-months
Primary healthcare use (outside of community specialist team for older persons)	Process measure	6-weeks
Primary healthcare use (outside of community specialist team for older persons)	Process measure	6-months
Number of healthcare professional encounters by the community specialist team for older persons	Process measure	6-weeks
Number of healthcare professional encounters by the community specialist team for older persons	Process measure	6-months

Collaborators and Investigators

• Sponsor: University of Limerick

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: HRB RL2020-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No