Clinical trial NCT04900480: Pilot Project for Direct Access to Physical Therapy
Official title: Pilot Project for Direct Access to Physical Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Physiotherapy
Public subsidy
Direct access
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Region Hovedstadens Apotek
First posted: 2021-05-25
Enrollment: 2427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this pilot study is to evaluate the effect of publicly subsidized physiotherapy for all patients receiving general treatment in physiotherapy clinics with an official provider number. This study will evaluate effects on physical and mental health, number of consultations in physiotherapy; number of contacts with general practitioner; referrals to diagnostic imaging; number of contacts with specialists within rheumatology, neurology and orthopedics and patient satisfaction.

Detailed description: In Denmark, patients in physiotherapy with a referral from their general practitioner (GP) get 40% of their expenses paid by public subsidy. This study aims to test the effects of direct access to physiotherapy with public subsidy without a referral from the GP.

GPs are by default the gatekeeper to all public health care services in Denmark. However, increasing demand in terms of task complexity and patient volume is putting pressure on GPs. In this study, physiotherapists may become the first point of access for patients with musculoskeletal problems.

The hypothesis is, that direct access may decrease use of health services and increase patient satisfaction by shortening the time between occurrence of symptoms and beginning treatment in physiotherapy a) by eliminating the time needed to get a referral from the GP and b) by making access to physiotherapy easier, thus encouraging patients to seek and begin treatment earlier.

The effect of direct access to physiotherapy with public subsidy will be tested in a controlled design. Four similar municipalities located in the Capital Region of Denmark were selected to participate in the study. The four municipalities have been grouped in pairs to ensure similarity on size, health utilization, urbanization and commuting patterns. Two grouped municipalities have been assigned to the intervention group by lottery; the matching pair of municipalities have been assigned to the control group.

From November 2020 to November 2021, citizens living in the two intervention municipalities can get public subsidy for general physiotherapy without a GP referral. For all citizens in the control group access to physiotherapy is provided as usual; thus, public subsidy physiotherapy is only provided for patients with a GP referral. The study includes all physiotherapy clinics in all four municipalities. All included clinics must have an official provider number, i.e. be approved to offer services with public subsidy.

All patients with residence within one of the four municipalities who seeks general treatment in included physiotherapy clinics within their own municipality will be invited to participate in the study. Both patients with and without a GP referral will be included. Participation involves giving consent to providing data for the evaluation.

Data in the study consists of health care contacts accessed through the Capital Region of Denmark's own price mechanism registers logging all transactions between relevant service providers and the Capital Region of Denmark. In addition, all patients are asked to fill in a survey before their 1st diagnostic consultation with a physiotherapist and a follow up survey at six weeks and six months. Finally, the study will collect data through interviews with general practitioners and physiotherapists as well as their respective receptionists.

Eligibility criteria: Inclusion Criteria:

* Begin treatment in general physiotherapy within the four municipalities included

Exclusion Criteria:

* Pregnancy
* Have a GP referral to home treatment

Primary outcomes:
measure: Change from baseline physical functioning at 6 months
timeFrame: Six months
measure: Consultations in general practice
timeFrame: Six months after intervention period
Secondary outcomes:
measure: Consultations with specialists within rheumatology
timeFrame: Six months after intervention period
measure: Consultations with specialists within neurology
timeFrame: Six months after intervention period
measure: Consultations with specialists within orthopedics
timeFrame: Six months after intervention period
measure: Referrals to diagnostic imaging
timeFrame: Six months after intervention period
measure: Cancer diagnoses
timeFrame: Five years after intervention period
measure: Change from baseline physical functioning at six weeks
timeFrame: Six months
measure: Change from baseline mental health at six weeks
timeFrame: Six weeks
measure: Change from baseline mental health at six months
timeFrame: Six months
measure: Change from baseline pain intensity at 6 months
timeFrame: Six months
measure: Patient satisfaction
timeFrame: Six weeks
measure: Patient satisfaction
timeFrame: Six months
measure: Trust in collaboration between physiotherapist and general practitioner
timeFrame: Six months
measure: Change in sickness absence
timeFrame: Six weeks
measure: Change in sickness absence
timeFrame: Six months
measure: Change in use of pharmaceuticals
timeFrame: Six weeks
measure: Change in use of pharmaceuticals
timeFrame: Six months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Clinical Research and Prevention
Study officials:
affiliation: Center for Clinical Research and Prevention
name: Ulla Toft, ph.d.
role: STUDY_DIRECTOR
References:
citation: Dahlerup J, Toft U, Schiotz ML, Grew J, Thrysoe R, Ottosen J, Jakobsen LM. Protocol for a cluster-randomized non-inferiority trial of the effect of direct access to publicly subsidized physiotherapy for adults with musculoskeletal pain. Contemp Clin Trials. 2022 Feb;113:106648. doi: 10.1016/j.cct.2021.106648. Epub 2021 Dec 10.