Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults

Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults: a Pilot Randomized Trial

In this study, participants will be randomly assigned to receive either the intervention or control treatment for up to 6 months. Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant:

(i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences).

Participants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans.

We are interested in learning about the number and demographic characteristics of participants we will be able to recruit to the study, who will remain in the study and who will be adherent to their prioritized treatment recommendations. We are also interested in learning about changes in participants' quality of life, proportion of IADLs being completed independently or with support, emergency department visit rate, and hospitalization rate at 3 and 6 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Older Adults; Social Isolation
• Intervention / Treatment: Other: Intensive geriatric service worker model of care; Other: Information brochure and telephone follow-up support

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Watt; Phone Number: 1+416-864-5015; Email: jennifer.watt@utoronto.ca

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

(i) adults aged ≥65 years old (ii) socially isolated, defined as living alone (iii) identified by the multidisciplinary Acute Care of the Elderly team, Internal Consultation Team, or Elders' Clinic as having one or more instrumental activity of daily living (IADL) impairments (defined as per the Lawton IADL scale) that could be supported by the intensive geriatric service worker (iv) capable of consenting to study participation or have a substitute decision-maker who can provide consent on their behalf (v) able to understand and communicate in English (e.g., if a participant is hearing impaired, but they can lip read or hear sufficiently with a hearing aid, they will be included) or know someone who can help with translation (vi) living in a private dwelling (e.g., apartment, house, condominium) within a geographical catchment area (i.e., boundaries will be Bloor St, Don Valley Parkway, Lakeshore Blvd, and Yonge St) (vii) a patient of a family physician or nurse practitioner (or be willing to become a patient of a family physician or nurse practitioner).

Exclusion Criteria:

(i) live in a retirement home, long-term care home or shelter (because there is varying availability of resources to support patients' activities of daily living (ADLs) and IADLs in these settings and we want to implement the IGSW care model where we hypothesize that it will have the greatest impact (ii) do not have a fixed address (iii) are participating in another study (iv) are being transferred to a rehabilitation facility other than Providence Healthcare prior to discharge home (Providence Healthcare is a collaborating study site; our team has an ongoing research collaboration with the medical rehabilitation unit at Providence Healthcare [where ACE and ICT medical consultation patients are transferred]

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Participants in this arm will receive the intervention.	Other: Intensive geriatric service worker model of care; Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant: (i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences).
Placebo Comparator: Control; Participants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans. Participants in this arm will also receive telephone follow-up support.	Other: Information brochure and telephone follow-up support; Participants will be e-mailed or mailed a booklet containing information about locally available resources including (1) meal preparation, (2) grocery delivery, (3) housekeeping, (4) pharmacies that deliver medications, (5) home care, and (6) Wheel-Trans. Participants will receive a scripted phone call from the study research coordinator one and three months after study enrolment to see if they have questions about the booklet material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Feasibility	The number of participants (i) recruited (over the entire 12-month recruitment period and per month), (ii) retained (remain in the IGSW care model until prioritized recommendations are implemented, are discharged from the program because they are admitted to a retirement or LTC home, or complete the intervention; number of participants in the control group who provide follow-up data at 3 and 6 months) (iii) fully adherent to patients' prioritized recommendations during the trial period (% full adherence to [a] all prioritized recommendations, [b] >75% of prioritized recommendations, and [c] ≥1 prioritized recommendation at 3 and 6 months) and (iv) sustained linkages to community agencies to provide ADL and IADL support (number of participants with linkages to [a] all community agencies, [b] ≥1 community agency at 3 and 6 months).	Between 3 months to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Change in quality of life will be measured with the EQ-5D-5L	3 and 6 months
Proportion of IADLs being completed independently or with support		3 and 6 months
Emergency department visit rate		3 and 6 months
Hospitalization rate		3 and 6 months
Long-term care home admission rate		3 and 6 months
Length of hospitalization	This will be measured for study participants admitted to hospital.	6 months

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: older adults; social isolation
• Other Study ID Numbers: 23-277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No