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

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ..

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.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:14

Enthalten in:

BMJ open - 14(2024), 2 vom: 05. Feb., Seite e080800

Sprache:

Englisch

Beteiligte Personen:

Teng, Min Jiat [VerfasserIn]
Zadro, Joshua R [VerfasserIn]
Pickles, Kristen [VerfasserIn]
Copp, Tessa [VerfasserIn]
Shaw, Miranda J [VerfasserIn]
Khoudair, Isabella [VerfasserIn]
Horsley, Mark [VerfasserIn]
Warnock, Benjamin [VerfasserIn]
Hutchings, Owen R [VerfasserIn]
Petchell, Jeffrey F [VerfasserIn]
Ackerman, Ilana N [VerfasserIn]
Drayton, Alison [VerfasserIn]
Liu, Rong [VerfasserIn]
Maher, Christopher G [VerfasserIn]
Traeger, Adrian C [VerfasserIn]

Links:

Volltext

Themen:

Clinical Trial Protocol
Journal Article
Orthopaedic & trauma surgery
Patient reported outcome measures
Protocols & guidelines
Randomized controlled trial
Research Support, Non-U.S. Gov't
Telemedicine

Anmerkungen:

Date Completed 07.02.2024

Date Revised 14.02.2024

published: Electronic

Citation Status MEDLINE

doi:

10.1136/bmjopen-2023-080800

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM368058549