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Pilot Project for Direct Access to Physical Therapy

Primary Purpose

Musculoskeletal Diseases

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Direct access to publicly subsidized physiotherapy
Sponsored by
Ulla Toft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Musculoskeletal Diseases focused on measuring Physiotherapy, Public subsidy, Direct access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Begin treatment in general physiotherapy within the four municipalities included

Exclusion Criteria:

  • Pregnancy
  • Have a GP referral to home treatment

Sites / Locations

  • Center for Clinical Research and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Public subsidy to physiotherapy continue as usual

Direct access to publicly subsidized physiotherapy

Arm Description

This control arm consists of all physiotherapy clinics with registered provider numbers in two municipalities, where the access and public subsidy to physiotherapy continue as usual.

This intervention arm consists of all physiotherapy clinics with registered provider numbers in two municipalities, introducing temporary exemption on the legal required general practitioner referral for public subsidy for treatment in general physiotherapy.

Outcomes

Primary Outcome Measures

Change from baseline physical functioning at 6 months
Physical functioning will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide physical health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better physical health.
Consultations in general practice
Number of consultations in general practice

Secondary Outcome Measures

Consultations with specialists within rheumatology
Number of Consultations with specialists within rheumatology
Consultations with specialists within neurology
Number of consultations with specialists within neurology
Consultations with specialists within orthopedics
Number of consultations with specialists within orthopedics
Referrals to diagnostic imaging
Number of referrals to diagnostic imaging
Cancer diagnoses
Number of cancer diagnoses
Change from baseline physical functioning at six weeks
Physical functioning will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide physical health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better physical health.
Change from baseline mental health at six weeks
Mental health will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide mental health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better mental health.
Change from baseline mental health at six months
Mental health will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide mental health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better mental health.
Change from baseline pain intensity at 6 months
Pain intensity will be measured by Numeric Rating Scale. The score ranges from 0-10, with 0 indicating no pain and 10 worst possible pain.
Patient satisfaction
Patient satisfaction will be measured by an overall satisfaction question with five levels of severity. Answers will be scored from 1-5. 1 = lowest satisfaction, 5 = highest satisfaction.
Patient satisfaction
Patient satisfaction will be measured by an overall satisfaction question with five levels of severity. Answers will be scored from 1-5. 1 = lowest satisfaction, 5 = highest satisfaction.
Trust in collaboration between physiotherapist and general practitioner
Patient perceived trust in professional collaboration between physiotherapist and general practitioner will be measured by questionnaire consisting of three questions with 5 levels of severity. Answers will be scored from 1-5. 1 = lowest satisfaction, 5 = highest satisfaction.
Change in sickness absence
Sickness absence is measured by two questionnaire items indicating number of full sickness absence days and number of partial sickness absence days the last 30 days. Answers will be between 0-30 for both questions. Fewer days of sickness absence is a better outcome.
Change in sickness absence
Sickness absence is measured by two questionnaire items indicating number of full sickness absence days and number of partial sickness absence days the last 30 days. Answers will be between 0-30 for both questions. Fewer days of sickness absence is a better outcome.
Change in use of pharmaceuticals
Use of pharmaceuticals is measured by two questionnaire items indicating number of days of using over the counter painkillers and number og days using prescribed painkillers on average the last three months. The questions have four levels of severity (0, 1-7, 8-15, 16-30 days on average the last three months). Use of less pharmaceuticals is a better outcome.
Change in use of pharmaceuticals
Use of pharmaceuticals is measured by two questionnaire items indicating number of days of using over the counter painkillers and number og days using prescribed painkillers on average the last three months. The questions have four levels of severity (0, 1-7, 8-15, 16-30 days on average the last three months). Use of less pharmaceuticals is a better outcome.

Full Information

First Posted
February 12, 2020
Last Updated
March 22, 2022
Sponsor
Ulla Toft
Collaborators
Region Hovedstadens Apotek
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1. Study Identification

Unique Protocol Identification Number
NCT04900480
Brief Title
Pilot Project for Direct Access to Physical Therapy
Official Title
Pilot Project for Direct Access to Physical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulla Toft
Collaborators
Region Hovedstadens Apotek

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Physiotherapy, Public subsidy, Direct access

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Public subsidy to physiotherapy continue as usual
Arm Type
No Intervention
Arm Description
This control arm consists of all physiotherapy clinics with registered provider numbers in two municipalities, where the access and public subsidy to physiotherapy continue as usual.
Arm Title
Direct access to publicly subsidized physiotherapy
Arm Type
Experimental
Arm Description
This intervention arm consists of all physiotherapy clinics with registered provider numbers in two municipalities, introducing temporary exemption on the legal required general practitioner referral for public subsidy for treatment in general physiotherapy.
Intervention Type
Other
Intervention Name(s)
Direct access to publicly subsidized physiotherapy
Intervention Description
This pilot project introduces temporary exemption on the legal required GP referral for public subsidy for treatment in general physiotherapy.
Primary Outcome Measure Information:
Title
Change from baseline physical functioning at 6 months
Description
Physical functioning will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide physical health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better physical health.
Time Frame
Six months
Title
Consultations in general practice
Description
Number of consultations in general practice
Time Frame
Six months after intervention period
Secondary Outcome Measure Information:
Title
Consultations with specialists within rheumatology
Description
Number of Consultations with specialists within rheumatology
Time Frame
Six months after intervention period
Title
Consultations with specialists within neurology
Description
Number of consultations with specialists within neurology
Time Frame
Six months after intervention period
Title
Consultations with specialists within orthopedics
Description
Number of consultations with specialists within orthopedics
Time Frame
Six months after intervention period
Title
Referrals to diagnostic imaging
Description
Number of referrals to diagnostic imaging
Time Frame
Six months after intervention period
Title
Cancer diagnoses
Description
Number of cancer diagnoses
Time Frame
Five years after intervention period
Title
Change from baseline physical functioning at six weeks
Description
Physical functioning will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide physical health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better physical health.
Time Frame
Six months
Title
Change from baseline mental health at six weeks
Description
Mental health will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide mental health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better mental health.
Time Frame
Six weeks
Title
Change from baseline mental health at six months
Description
Mental health will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide mental health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better mental health.
Time Frame
Six months
Title
Change from baseline pain intensity at 6 months
Description
Pain intensity will be measured by Numeric Rating Scale. The score ranges from 0-10, with 0 indicating no pain and 10 worst possible pain.
Time Frame
Six months
Title
Patient satisfaction
Description
Patient satisfaction will be measured by an overall satisfaction question with five levels of severity. Answers will be scored from 1-5. 1 = lowest satisfaction, 5 = highest satisfaction.
Time Frame
Six weeks
Title
Patient satisfaction
Description
Patient satisfaction will be measured by an overall satisfaction question with five levels of severity. Answers will be scored from 1-5. 1 = lowest satisfaction, 5 = highest satisfaction.
Time Frame
Six months
Title
Trust in collaboration between physiotherapist and general practitioner
Description
Patient perceived trust in professional collaboration between physiotherapist and general practitioner will be measured by questionnaire consisting of three questions with 5 levels of severity. Answers will be scored from 1-5. 1 = lowest satisfaction, 5 = highest satisfaction.
Time Frame
Six months
Title
Change in sickness absence
Description
Sickness absence is measured by two questionnaire items indicating number of full sickness absence days and number of partial sickness absence days the last 30 days. Answers will be between 0-30 for both questions. Fewer days of sickness absence is a better outcome.
Time Frame
Six weeks
Title
Change in sickness absence
Description
Sickness absence is measured by two questionnaire items indicating number of full sickness absence days and number of partial sickness absence days the last 30 days. Answers will be between 0-30 for both questions. Fewer days of sickness absence is a better outcome.
Time Frame
Six months
Title
Change in use of pharmaceuticals
Description
Use of pharmaceuticals is measured by two questionnaire items indicating number of days of using over the counter painkillers and number og days using prescribed painkillers on average the last three months. The questions have four levels of severity (0, 1-7, 8-15, 16-30 days on average the last three months). Use of less pharmaceuticals is a better outcome.
Time Frame
Six weeks
Title
Change in use of pharmaceuticals
Description
Use of pharmaceuticals is measured by two questionnaire items indicating number of days of using over the counter painkillers and number og days using prescribed painkillers on average the last three months. The questions have four levels of severity (0, 1-7, 8-15, 16-30 days on average the last three months). Use of less pharmaceuticals is a better outcome.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Begin treatment in general physiotherapy within the four municipalities included Exclusion Criteria: Pregnancy Have a GP referral to home treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulla Toft, ph.d.
Organizational Affiliation
Center for Clinical Research and Prevention
Official's Role
Study Director
Facility Information:
Facility Name
Center for Clinical Research and Prevention
City
Copenhagen
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34896641
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.
Results Reference
derived

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Pilot Project for Direct Access to Physical Therapy

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