Patient falls in hospitals lead to patient harm, staff distress and economic burden on health systems. There are few strategies with robust evidence demonstrating benefit for the prevention of falls, especially in acute hospital settings. Education and multicomponent fall prevention approaches are promising. Rigorous systematic measurement of implementation has been lacking in most hospital fall prevention trials. This paper describes the protocol for a trial that will evaluate the impact of supported implementation of tailored multicomponent fall prevention interventions on patient falls in hospital.

A stepped-wedge hybrid type I effectiveness implementation cluster randomised trial will be conducted. Twelve inpatient wards across four metropolitan hospitals will be enrolled in the trial, clustered into groups of four and randomised to commence the intervention at one of three time periods. Patients and ward staff will be recruited to complete pre-implementation surveys, which, combined with analysis of routinely collected local falls data and staff brainstorming, will inform tailored multicomponent fall prevention interventions for each ward. Wards will receive quality improvement training, clinical facilitation and staff education for at least 4 months to support implementation of their fall prevention interventions. The primary outcome—rate of falls—will be measured using routinely collected hospital falls data from the incident management system and medical records. Pre-implementation and post-implementation patient and staff surveys, qualitative interviews and bedside audits will measure secondary effectiveness and implementation outcomes. Healthcare utilisation from hospital data will inform the cost-effectiveness analysis.

The Sydney Local Health District Human Research Ethics Committee (RPAH Zone) approved this trial (protocol number X24-0087 and 2024/ETH00583). The trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572). Data collection commenced in October 2024, due for completion in May 2026. Results will be published in reputable international journals and presented at relevant conferences.

Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572).

Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.

Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.

The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.

CTRI/2024/06/068838.