Protocol for Multi-site Evaluation of New Community-based Frailty Programme

February 20, 2023 updated by: Geriatric Education and Research Institute

Protocol for a Mixed Methods and Multi-site Assessment of the Implementation Process and Outcomes of a New Community-based Frailty Programme

Background: Frailty is increasing in prevalence internationally with population ageing. Frailty can be managed or even reversed through community-based interventions delivered by a multi-disciplinary team of professionals, but to varying degrees of effectiveness. However, many of the implementation insights of these care models are contextual, and may not be applicable in different cultural contexts. The Geriatric Service Hub (GSH) is a novel frailty care programme in Singapore, that includes key components of frailty care such as comprehensive geriatric assessments, care coordination and the assembly of a multidisciplinary team. The aim of this study is to gain insights on the factors influencing the implementation approaches adopted by five participating sites, and the effectiveness of the programme.

Methods: We will adopt a mixed-methods approach that includes a qualitative evaluation among key stakeholders and participants taking part in the programme, through in depth-interviews and focus group discussions. The main topics covered includes factors that affected the development and implementation of each programme, operations and other contextual factors that influenced implementation outcomes. The quantitative evaluation (1) monitors each programme's care process through quality indicators, (2) a multiple-time point survey study to compare programme participants' pre- and post- outcomes on patient engagement (collaboRATE and 13-item Patient Activation Measure;PAM), healthcare experiences (Consumer Assessment of Healthcare Providers and System Clinician and Group Survey Version 3.0; CG-CAHPS), health status and quality of life (Barthel Index of Activities of Daily Living, fall counts, the EuroQol questionnaire and the Control, Autonomy, Self-realization and Pleasure scale; CASP-19), impact on caregivers (Zarit Burden Interview) and societal costs (Client Service Receipt Inventory). (3) A retrospective cohort design to assess healthcare and cost utilisation between participants of the programme and a propensity score matched comparator group.

Discussion: The GSH sites share a common goal to increasing accessibility of essential services to frail older adults, and providing comprehensive care. The results of this evaluation study will provide valuable evidence to the impact and effectiveness of the GSH, and inform to the design of similar programmes targeting frail older adults.

Study Overview

Study Type

Observational

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 768024
        • Geriatric Education and Research Institite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Given that the study involves a mixed method evaluation evaluation methodology, to gain a comprehensive understanding of the factors influencing the effectiveness of the implementation approaches adopted by the GSH programmes, and their impacts, the study population will comprise of professional stakeholders playing critical roles in the development and implementation of the new model of community-based frailty care, and the participants of the GSH programme services .

Description

  1. Qualitative In depth Interviews/ Policy owners & administrators

    Inclusion Criteria:

    • Decision-makers who are higher-level administrators or clinicians who have the authority to make policy and implementation decisions and/ or
    • Individuals who are familiar with the hospital's overall frailty strategy; and/ or
    • Individuals that who led the development and implementation of the programme

    Exclusion Criteria:

    • Do not meet inclusion criteria above
  2. Qualitative Focus group discussions/ Implementation team

    Inclusion Criteria:

    • Individuals with time funded through the programme who have been providing services in the GSH for at least six month

    Exclusion Criteria:

    • Do not meet inclusion criteria above
  3. Qualitative Focus group discussions/ partner organizations

    Inclusion Criteria:

    • healthcare professionals and administrative staff who provided services within the new programme for at least six months

    Exclusion Criteria:

    • Do not meet inclusion criteria above
  4. Qualitative Focus group discussions/ GSH participants

    Inclusion Criteria:

    • Participants who receive care under the new model for at least three months

    Exclusion Criteria:

    • Do not meet inclusion criteria above
  5. Quantitative survey questionnaire / GSH participants

Inclusion Criteria:

  • Patients that meet the necessary clinical criteria for enrollment in the respective GSH programme
  • Age: 65 and above
  • Clinical Frailty Score (CFS): 4-7

Exclusion Criteria:

  • Do not meet inclusion criteria above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GSH Participants

Qualitative - Semi-structured focus group discussions with care recipients

Quantitative - Pre-test post-test design using survey-based data collection

Quantitative - Retrospective cohort design with propensity score matched comparators

There is no active intervention as this is a service evaluation
Policy owners, implementers & care partners, health and social care professionals

Qualitative - Semi-structured in-depth interview with key policy and programme decision-makers

Qualitative - Semi-structured focus group discussions with health and social care professionals

Qualitative - Participant observations

Quantitative - Longitudinal monitoring of process indicators

There is no active intervention as this is a service evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status
Time Frame: April 2019 - September 2022

It is hypothesised that better functional status, might reduce the healthcare utilisation (emergency hospitalisation, nursing home admission), caregiver burden and the associated indirect cost. In turn, we might expect overall costs to be lower compared to the comparison group.

Changes in functional status will be measured using the Barthel Index of Activities of Daily Living (ADL) and Count of falls questionnaire.

April 2019 - September 2022
Health outcomes
Time Frame: April 2019 - September 2022

It is hypothesised that better health outcomes, might reduce the healthcare utilisation (emergency hospitalisation, nursing home admission), caregiver burden and the associated indirect cost. In turn, we might expect overall costs to be lower compared to the comparison group.

Health outcomes will be measured using Quality of Life Questionnaire (EuroQol-5D-5L) and 19-item Quality of Life Scale (CASP-19).

April 2019 - September 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilisation of appropriate services
Time Frame: April 2019 - September 2022

GSH sites offer a range of medical, social and other services through either direct provision or referrals. Given that the model is intended to bridge service gaps (conduct of Comprehensive Geriatric Assessment/ CGA in the community), in the short-term, we hypothesis an increase in the utilisation of appropriate services (rehabilitation, ambulatory services) in this time-limited programme.

Utilisation of services will be measured using Client Service Receipt Inventory (CSRI).

April 2019 - September 2022
Patient Satisfaction
Time Frame: April 2019 - September 2022

GSH participants are expected to benefit from the comprehensive package of health and social services and multidisciplinary team approach. With better care coordination and improved access, it is likely to elicit a higher level of satisfaction relative to comparator groups.

Patient satisfaction will be measured using the Consumer Assessment of Healthcare Providers and System Clinician & Group Survey Version 3.0 (CG-CAHPS) tool.

April 2019 - September 2022
Shared decision making/ engagement
Time Frame: April 2019 - September 2022

Education of the client about self-care, and making decisions about potential care options with inputs from a multidisciplinary team, is expected to result in higher level of shared decision making and engagement relative to comparator groups.

Shared decision making/ engagement will be measured using the collaboRATE For Patient - 5-point anchor scale, and 13-item Patient Activation Measure (PAM-13).

April 2019 - September 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information will not be shared due to confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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