RECITAL: a non-inferiority randomised control trial evaluating a virtual fracture clinic compared with in-person care for people with simple fractures (study protocol)

BMJ Open. 2024 Feb 5;14(2):e080800. doi: 10.1136/bmjopen-2023-080800.

Abstract

Introduction: Most simple undisplaced fractures can be managed without surgery by immobilising the limb with a splint, prescribing medication for pain, and providing advice and early rehabilitation. Recent systematic reviews based on retrospective observational studies have reported that virtual fracture clinics can deliver follow-up care that is safe and cost-effective. However, no randomised controlled trial has investigated if a virtual fracture clinic can provide non-inferior physical function outcomes compared with an in-person clinic for patients with simple fractures.

Methods and analysis: 312 participants will be recruited from 2 metropolitan hospitals located in Sydney, Australia. Adult patients will be eligible if they have an acute simple fracture that can be managed with a removable splint and is deemed appropriate for follow-up at either the virtual or in-person fracture clinic by an orthopaedic doctor. Patients will not be eligible if they have a complex fracture that requires a cast or surgery. Eligible participants will be randomised to receive their follow-up care either at the virtual or the in-person fracture clinic. Participants at the virtual fracture clinic will be reviewed within 5 days of receiving a referral through video calls with a physiotherapist. Participants at the in-person fracture clinic will be reviewed by an orthopaedic doctor within 7-10 days of receiving a referral. The primary outcome will be the patient's function measured using the Patient-Specific Functional Scale at 12 weeks. Secondary outcomes will include health-related quality of life, patient-reported experiences, pain, health cost, healthcare utilisation, medication use, adverse events, emergency department representations and surgery.

Ethics and dissemination: The study has been approved by the Sydney Local Health District Ethics Review Committee (RPAH Zone) (X23-0200 and 2023/ETH01038). The trial results will be submitted for publication in a reputable international journal and will be presented at professional conferences.

Trial registration number: ACTRN12623000934640.

Keywords: orthopaedic & trauma surgery; patient reported outcome measures; protocols & guidelines; randomized controlled trial; telemedicine.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Fractures, Bone* / therapy
  • Humans
  • Orthopedics*
  • Pain
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Retrospective Studies