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Protocol for a cluster-randomized non-inferiority trial of the effect of direct access to publicly subsidized physiotherapy for adults with musculoskeletal pain

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BACKGROUND: In the Danish healthcare system, direct access to physiotherapy is an option, but public subsidy for treatment requires referral from a general practitioner. To relieve general practice of unnecessary consultations and provide patients with easier access to relevant treatment, direct access to publicly subsidized physiotherapy has been suggested.

METHODS: Direct access to subsidized physiotherapy will be evaluated in a controlled design and has a duration of one year. Physiotherapy clinics invite eligible patients to participate in the evaluation. Participants complete questionnaires at baseline and six weeks and six months after baseline. Physical health status (ShortForm-12v2) is the primary outcome. In addition, the evaluation will assess the use of services in general practice, physiotherapy, specialists in private practice and hospitals and referrals to diagnostic imaging. A process evaluation will assess the attitude to and implementation of direct access to subsidized physiotherapy through the experiences and attitudes of local general practitioners, secretaries and physiotherapists in participating clinics.

DISCUSSION: This intervention may affect the point of entry to health care services. For the intervention group the physiotherapists assume responsibility in symptom assessment. During recruitment registration of red flags in physiotherapy is closely monitored. The results of the study may be used to assess if direct access to subsidized physiotherapy is a way to relieve the workload in general practice while maintaining or improving patient level outcomes.

TRIAL REGISTRATION: The project was reported to The Committee on Health Research Ethics of the Capital Region of Denmark with protocol number J.nr.: H-19074802. The Committee assessed the project as not registrable and therefore can be implemented without further permission. This trial has been registered at the Danish Data Protection Agency (J.nr.: P-2019-672). The trial has been registered at ClinicalTrials.gov (identifiers: NCT04900480).

OriginalsprogEngelsk
Artikelnummer106648
TidsskriftContemporary Clinical Trials
Vol/bind113
Sider (fra-til)106648
ISSN1551-7144
DOI
StatusUdgivet - feb. 2022

Bibliografisk note

Copyright © 2021. Published by Elsevier Inc.

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