Impact of a personalised care plan for the elderly calling emergency medical services after a fall at home: The RISING-DOM multi-centre randomised controlled trial protocol

BACKGROUND: A growing number of emergency calls are made each year for elderly people who fall. Many of them are not taken to hospital or are rapidly discharged from the Emergency Department (ED). Evidence shows that, with no further support, this vulnerable population is particularly at risk of injuries, dependency and death. This study aims to determine the effectiveness of a comprehensive geriatric assessment and a tailored intervention in the elderly calling on an Emergency Medical Service (EMS) for a fall at home, but not conveyed to the ED or rapidly discharged from it (less than 24 h from hospitalisation), to the time to institutionalisation or death. METHODS: Rising-Dom is a two-arm randomised (ratio 1:1), interventional, multi-centre and open study. Community-dwelling elderly people (≥ 70 years) who call an EMS for a fall at home are recruited. The intervention group receives home visits by a nurse with a comprehensive fall risk assessment and a personalised intervention care plan with a planned follow-up (six nurse home visits and five nurse phone calls). Subjects enrolled in the usual care-control group continue to receive their routine care for the prevention or treatment of diseases. Primary (time to institutionalisation or death) and secondary (unscheduled hospitalisations, additional EMS calls relating to falls, functional decline and quality of life) outcome data will be collected for both groups through five phone calls made by Clinical Research Associates (CRA) blind to the participants’ group during the follow-up period (24-months). Twelve hospital centres in the South-West of France are participating in the study as study sites. The inclusion period started in October 2019 and will end in March 2022. By the end of this period, 1,190 subjects are expected to be enrolled. DISCUSSION: Studies on elderly home falls have rarely concerned people who were not taken to hospital. The Rising-Dom intervention scheme should enhance understanding of features related to this vulnerable population and investigate the impact of a nurse care at home on delaying death and institutionalisation. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04132544. Registration date: 18/10/2019. Sponsor: University Hospital, Toulouse. https://www.clinicaltrials.gov/ct2/show/NCT04132544?term=rising-dom&draw=2&rank=1