Clinical trial NCT04866316: Protocol for Multi-site Evaluation of New Community-based Frailty Programme
Official title: Protocol for a Mixed Methods and Multi-site Assessment of the Implementation Process and Outcomes of a New Community-based Frailty Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Frail Elderly Syndrome
Frailty Syndrome
Keywords: frailty care
comprehensive geriatric assessment
care coordination
multidisciplinary team care
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Alexandra Hospital
name: Changi General Hospital
name: Ng Teng Fong General Hospital
name: Sengkang General Hospital
name: Singapore General Hospital
First posted: 2021-04-29
Enrollment: 335
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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 .

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional status
timeFrame: April 2019 - September 2022
measure: Health outcomes
timeFrame: April 2019 - September 2022
Secondary outcomes:
measure: Utilisation of appropriate services
timeFrame: April 2019 - September 2022
measure: Patient Satisfaction
timeFrame: April 2019 - September 2022
measure: Shared decision making/ engagement
timeFrame: April 2019 - September 2022
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Geriatric Education and Research Institite
Study officials:
affiliation: Joint Faculty and PI
name: Woan Shin Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan WS, Nai ZL, Tan HTR, Nicholas S, Choo R, Ginting ML, Tan E, Teng PHJ, Lim WS, Wong CH, Ding YY; Geriatric Services Hub Programme Group. Protocol for a mixed-methods and multi-site assessment of the implementation process and outcomes of a new community-based frailty programme. BMC Geriatr. 2022 Jul 15;22(1):586. doi: 10.1186/s12877-022-03254-6.