- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866316
Protocol for Multi-site Evaluation of New Community-based Frailty Programme
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 768024
- Geriatric Education and Research Institite
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
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
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
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
- 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
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
Collaborators
Investigators
- Principal Investigator: Woan Shin Tan, PhD, Joint Faculty and PI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/00925
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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