Pragmatic multicentre stepped-wedge cluster randomised trial to investigate the effectiveness of community-based falls prevention programme for older adults with falls risk in Singapore: a protocol paper.

Abstract

Introduction

Falls are an important public health issue with consequences that include injuries, quality of life reduction and high healthcare costs. Studies show that falls prevention strategies are effective in reducing falls rate among community-dwelling older adults. However, the evaluation for effectiveness was usually done in a controlled setting with homogeneous population, and thus may not be generalisable to a wider population. This study aims to evaluate the impact of community falls prevention programmes with group-based strength and balance exercises, on falls risk and health outcomes for older adults with falls risk in Singapore.

Methods and analysis

This is a pragmatic closed cohort stepped-wedge cluster randomised trial design study, which involves sequential crossover of clusters from the waitlist control condition to the intervention condition, with the sequence of crossover randomly determined. The intervention will be sequentially rolled out to 12 clusters (a minimum of 5 participants/cluster), over 6 time periods with 8-week intervals in Central and North regions of Singapore. The primary analysis will be conducted under the intention-to-treat principle. A general linear mixed model or generalised estimating equation analysis appropriate for a multilevel longitudinal study incorporating an appropriate error distribution and link function will be used. Markov model will be developed to estimate the incremental cost per quality-adjusted life years and incremental cost per fall prevented from the implementation of falls prevention strategies from a societal perspective. Conditional on there being clinically relevant differences in short-term outcomes, we will implement simulation modelling to project the long-term divergence in trajectories for outcomes and costs using the Markov model.

Ethics and dissemination

Ethics approval has been obtained. Results will be disseminated in publications and other relevant platforms.

Trial registration number

NCT04788251.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1136/bmjopen-2023-072029

Publication Info

Tan, Pey June, Mimaika Luluina Ginting, Zoe Zon Be Lim, Nivedha Balachandar, Rehena Sultana, Mumtaz Mohamed Kadir, Tianma Xu, Noor Hafizah Ismail, et al. (2023). Pragmatic multicentre stepped-wedge cluster randomised trial to investigate the effectiveness of community-based falls prevention programme for older adults with falls risk in Singapore: a protocol paper. BMJ open, 13(6). p. e072029. 10.1136/bmjopen-2023-072029 Retrieved from https://hdl.handle.net/10161/28681.

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Scholars@Duke

Matchar

David Bruce Matchar

Professor of Medicine

My research relates to clinical practice improvement - from the development of clinical policies to their implementation in real world clinical settings. Most recently my major content focus has been cerebrovascular disease. Other major clinical areas in which I work include the range of disabling neurological conditions, cardiovascular disease, and cancer prevention.
Notable features of my work are: (1) reliance on analytic strategies such as meta-analysis, simulation, decision analysis and cost-effectiveness analysis; (2) a balancing of methodological rigor the needs of medical professionals; and (3) dependence on interdisciplinary groups of experts.
This approach is best illustrated by the Stroke Prevention Patient Outcome Research Team (PORT), for which I served as principal investigator. Funded by the AHCPR, the PORT involved 35 investigators at 13 institutions. The Stroke PORT has been highly productive and has led to a stroke prevention project funded as a public/private partnership by the AHCPR and DuPont Pharma, the Managing Anticoagulation Services Trial (MAST). MAST is a practice improvement trial in 6 managed care organizations, focussing on optimizing anticoagulation for individuals with atrial fibrillation.
I serve as consultant in the general area of analytic strategies for clinical policy development, as well as for specific projects related to stroke (e.g., acute stroke treatment, management of atrial fibrillation, and use of carotid endarterectomy.) I have worked with AHCPR (now AHRQ), ACP, AHA, AAN, Robert Wood Johnson Foundation, NSA, WHO, and several pharmaceutical companies.
Key Words: clinical policy, disease management, stroke, decision analysis, clinical guidelines


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