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Geriatric medicine
Protocol
A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT)
  1. Julie Bruce1,
  2. Ranjit Lall1,
  3. Emma J Withers1,
  4. Susanne Finnegan1,
  5. Martin Underwood1,
  6. Claire Hulme2,
  7. Ray Sheridan3,
  8. Dawn A Skelton4,
  9. Finbarr Martin5,
  10. Sarah E Lamb1,6
  11. on behalf of PreFIT Study Group
    1. 1Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK
    2. 2Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
    3. 3Royal Devon & Exeter Hospital, Exeter, UK
    4. 4School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK
    5. 5Older Persons' Unit, Guys and St Thomas’ NHS Foundation Trust, St Thomas’ Hospital, London, UK
    6. 6Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK
    1. Correspondence to Professor Sarah E Lamb; sarah.lamb{at}ndorms.ox.ac.uk

    Abstract

    Introduction Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults.

    Methods and analysis A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver ‘active’ interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to ‘active’ intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data.

    Ethics and dissemination The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties.

    Trial registration number ISRCTN 71002650; Pre-results.

    • GERIATRIC MEDICINE
    • Falls prevention
    • Fracture
    • Exercise
    • PRIMARY CARE

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    https://doi.org/10.1136/bmjopen-2015-009362

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