Can occupational therapist-led home environmental assessment prevent falls in older people? A modified cohort randomised controlled trial protocol

Abstract

IntroductionFalls and fall-related injuries are a serious cause of morbidity and cost to society. Environmental hazards are implicated as a major contributor to falls among older people. A recent Cochrane review found an environmental assessment, undertaken by an occupational therapist, to be an effective approach to reducing falls. However, none of the trials included a cost-effectiveness evaluation in the UK setting. This protocol describes a large multicentre trial investigating the clinical and cost-effectiveness of environmental assessment and modification within the home with the aim of preventing falls in older people.Methods and analysisA two-arm, modified cohort randomised controlled trial, conducted within England, with 1299 community-dwelling participants aged 65 years and above, who are at an increased risk of falls. Participants will be randomised 2:1 to receive either usual care or home assessment and modification. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by monthly patient self-report falls calendars. Secondary self-reported outcome measures include: the proportion of single and multiple fallers, time to first fall over a 12-month period, quality of life (EuroQoL EQ-5D-5L) and health service utilisation at 4, 8 and 12 months. A nested qualitative study will examine the feasibility of providing the intervention and explore barriers, facilitators, workload implications and readiness to employ these interventions into routine practice. An economic evaluation will assess value for money in terms of cost per fall averted.Ethics and disseminationThis study protocol (including the original application and subsequent amendments) received a favourable ethical opinion from National Health Service West of Scotland REC 3. The trial results will be published in peer-reviewed journals and at conference presentations. A summary of the findings will be sent to participants.Trial registration numberISRCTN22202133; Pre-results.

Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial

“…This two-arm RCT was embedded within OTIS, which is a UK-based modified cohort RCT. The protocol for the OTIS trial has been published previously 18 . In brief, the OTIS trial aimed to assess whether home environmental assessment and modification, led by an occupational therapist (OT), could reduce risk of falling among community dwelling, older adults at elevated risk of falling.…”

“…In this paper we describe an embedded RCT (or ‘study within a trial’ [SWAT]) designed to evaluate the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults, identified from GP database searches, into the Occupational Therapist Intervention Study (OTIS) 18 . Specifically, this RCT evaluated the impact of providing pens on subsequent recruitment rates into the OTIS trial, as well as return rates of recruitment documentation, eligibility of respondents, and the retention of participants.…”

Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial

“…This trial was embedded within the NIHR Health Technology Assessment (HTA) funded Occupational Therapist Intervention Study (OTIS) 10 (Programme grant number 14/49/149). The OTIS study is an RCT that aims to evaluate the clinical and cost effectiveness of an occupational therapist (OT) intervention to reduce falls in high risk older people.…”

“…Our aim was to undertake a study within a trial (SWAT) to determine whether the number of participants recruited to a trial can be improved by writing the potential participant’s name by hand, versus printing the name, on the invitation letter. By embedding a study within a RCT currently being coordinated by the York Trials Unit (YTU; University of York), the NIHR-funded OTIS study 10 , the effects of the intervention could be tested within a pragmatic context without the additional costs of participant recruitment.…”

What type of environmental assessment and modification prevents falls in community dwelling older people?

“…The OTIS trial aims to evaluate effectiveness of occupational therapist led environmental assessment and modification delivered to older people at moderate to high risk of falls 23. To date, 1331 older people have been randomised to high intensity environmental assessment and modification or usual care control.…”