Clinical trial NCT06753643: An Intrinsic Capacity Identification and Management Programme for Older Adults in Singapore's Primary Care
Official title: Implementing the National Frailty Policy in Singapore's Primary Care: A Pilot Feasibility Study of The Intrinsic Capacity ProMotion in PrimAry Care for The Frail Program (IMPACTFrail)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy Ageing
Frailty
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: National Healthcare Group Polyclinics
name: National University Polyclinics
name: SingHealth Polyclinics
First posted: 2024-12-31
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults will be polyclinic patients aged 60 years and above with CFS score 4 or 5 as assigned by a trained healthcare provider at the polyclinic. They should not have done any comprehensive geriatric assessment or be currently receiving geriatric specialist outpatient services.

Healthcare staff can be polyclinic healthcare providers (e.g., polyclinic doctors, nurses, care coordinators, care managers, medical social workers). Healthcare administrators would be from the polyclinic leadership team, who are decision-makers who have the authority to make implementation decisions and are familiar with the overall frailty and IC management strategies in primary care in Singapore.

Brief summary: The IMPACTFrail program is an intrinsic capacity (IC) identification and management program for mildly frail older adults. Specifically, it delivers the three-tier approach recommended in the National Frailty Strategy Policy Report. The program's core functions include the segmentation of older persons using the Clinical Frailty Scale (CFS) score followed by secondary IC screening for CFS 4 to 5 (Tier 1), follow-up clinical assessment to confirm IC losses (Tier 2) and needs-directed management and tracking of their health (Tier 3).

The investigator aims to conduct a multi-site feasibility study on a small group of older adult study participants (n=30 per polyclinic).

The feasibility study has a few components. First, a qualitative study will assess its feasibility (implementation, appropriateness, acceptability, practicality, adaptability) as perceived by older adults, healthcare providers, and healthcare administrators. Second, the investigator aims to collect process indicators to track its implementation progress. Third, program costs will be estimated. Fourth, the investigator will develop a logic model and theory of change, and cluster-specific detailed written program descriptions. Lastly, the investigator aims to triangulate the findings and assess the feasibility for larger-scale implementation. This study is guided by implementation science frameworks and guidelines for conducting feasibility studies.

Detailed description: Background:

The broad goal for older adults is to age well and have healthy ageing. WHO defines healthy ageing as "the process of developing and maintaining the functional ability that enables wellbeing in older age." Functional ability is about having the capabilities that enable all people to be and do what they have reason to value.

Frailty is a clinically recognisable state whereby an older person's ability to cope with daily or acute stressors is compromised as a result of vulnerability from age-related deterioration in physiological reserves and function across multiple organ systems. Frailty is associated with negative health outcomes and is expected to increase in Singapore's ageing population. The National Frailty Strategy Policy Report published in 2023 serves to guide the Singapore Ministry of Health (MOH) Frailty Policy Implementation Workgroup in implementing the National Frailty Policy (NFP). One of the gaps identified in the report was the need for coordinated care and continuity of care across health and social service providers for frail older adults. To address this gap in Singapore's primary care setting, the IMPACTFrail program's core functions are to conduct segmentation of older people by using the Clinical Frailty Scale (CFS) score followed by secondary intrinsic capacity (IC) screening of six domains (locomotion, vision, hearing, vitality, cognition, psychological capacity) for CFS 4 and 5 (Tier 1), follow-up assessments based on IC deficits detected at screening (Tier 2), and coordination, management, and tracking (Tier 3). This study aims to co-develop IMPACTFrail's intervention components and implementation strategies in a small number of polyclinics and test its feasibility using implementation research in real-world local contexts.

Methods:

Prior to this pilot feasibility study, the investigators co-developed the innovation and implementation strategies among GERI, polyclinic cluster representatives, and implementers. This will be guided by the UK Medical Research Council's Framework (MRC) for developing and evaluating complex interventions and Framework of Actions for Intervention Development (FAID). Informal FGDs and interviews with stakeholders were conducted and the findings used to inform the development of the innovation. ERIC strategies will be selected to address CFIR barriers identified from the FGDs/interviews and specify and develop them.

Here, the investigators aim to conduct a multi-site feasibility study, with a few components. Each polyclinic has highly contextualised barriers, workflows, and infrastructure. Thus, each polyclinic is conceptualised as a single site for feasibility testing. There is no comparator arm.

First, FGDs/IDIs will be conducted to assess the program's feasibility (implementation, acceptability, practicality, adaptability) as perceived by older adults, healthcare providers, and healthcare administrators.

Second, the investigators aim to collect process indicators to track the program's implementation progress.

Third, program costs will be estimated.

Fourth, the investigators will develop a logic model and theory of change, and cluster-specific detailed written program descriptions.

Lastly, the investigators aim to triangulate our findings and assess the feasibility for larger-scale implementation.

This study is guided by implementation science frameworks and guidelines for conducting feasibility studies.

Discussion:

This project aims to improve the lives of older people through early detection and management of IC deficits for those with mild frailty (CFS 4-5) in primary care. This promotes longer-term outcomes including functional ability, improved quality of life, reduced healthcare use, and lower mortality.

Additionally:

First, the project translates evidence on the optimisation of IC and functional ability for healthy ageing to practice and policy in Singapore's primary care. Second, there is knowledge creation. This study contributes to the local evidence on screening and management strategies for delaying frailty progression by addressing IC deficits in frail older persons. The investigators inform the adaptations to implement the WHO ICOPE framework in local primary care contexts. Additionally, the project contributes to a better understanding on the optimisation of resources to groups who may benefit the most, by targeting CFS 4 and 5 for IC screening and delivering resource-intensive assessment and downstream interventions to this subgroup. Third, this study involves engaging all three clusters from the outset to accelerate national-level implementation and scaling up.

Additionally, to increase the likelihood of scalability, the investigators will involve 3 clusters and 1-2 polyclinics from each cluster. Fourth, the study offers opportunities for knowledge exchange.

Lastly, the project is aligned with national strategies like HealthierSG (informs frailty protocols for management in primary care), Age Well SG (enables frail community-dwelling persons to age in place), and the 2023 Action Plan for Successful Ageing (optimising IC and functional ability through a health program).

Eligibility criteria: Older Adults

Inclusion Criteria:

* being a patient of the polyclinic site
* aged 60 years and above
* Clinical frailty score (CFS) of 4 - 5
* Not done comprehensive geriatric assessment (CGA) in the past 12 months (based on available medical records or self-report)
* Not a current patient of geriatric specialist outpatient clinic (based on available medical records or self-report).

Exclusion Criteria:

* Do not meet inclusion criteria above

Healthcare Staff (for qualitative study)

Inclusion Criteria:

* aged 21 years and above
* Involved in the IMPACTFrail program as an implementer and/or a healthcare administrator with authority to make implementation decisions.

Exclusion Criteria:

* Do not meet inclusion criteria above

Primary outcomes:
measure: Qualitative study 1
timeFrame: Mar 2025 - Feb 2026
measure: Qualitative study 2
timeFrame: Mar 2025 - Feb 2026
measure: Qualitative study 3
timeFrame: Mar 2025 - Feb 2026
measure: Qualitative study 4
timeFrame: Mar 2025 - Feb 2026
measure: Programme cost
timeFrame: Mar 2025 - Feb 2026
measure: Logic model and theory of change
timeFrame: Mar 2025 - Feb 2026
measure: Written programme description
timeFrame: Mar 2025 - Feb 2026
measure: Process indicators
timeFrame: Mar 2025 - Feb 2026
measure: Fidelity of implementation strategy: Educational meetings, Part 1
timeFrame: Mar 2025 - Feb 2026
measure: Fidelity of implementation strategy: Educational meetings, Part 2
timeFrame: Mar 2025 - Feb 2026
measure: Fidelity of implementation strategy: Educational meetings, Part 3
timeFrame: Mar 2025 - Feb 2026
measure: Fidelity of implementation strategy: Educational meetings, Part 4
timeFrame: Mar 2025 - Feb 2026
measure: Fidelity of implementation strategy: Educational meetings, Part 5
timeFrame: Mar 2025 - Feb 2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Geriatric Education and Research Institute
name: Grace Sum, PhD
role: PRINCIPAL_INVESTIGATOR
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