Musculoskeletal DiseasesNCT04900480
Pilot Project for Direct Access to Physical Therapy
A study testing Direct access to publicly subsidized physiotherapy in people with Musculoskeletal Diseases, run by Ulla Toft at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Direct access to publicly subsidized physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,427 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Begin treatment in general physiotherapy within the four municipalities included
Who cannot join
- Pregnancy
- Have a GP referral to home treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Direct access to publicly subsidized physiotherapy
- Keywords
- Physiotherapy, Public subsidy, Direct access
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct access to publicly subsidized physiotherapyOther
This pilot project introduces temporary exemption on the legal required GP referral for public subsidy for treatment in general physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Public subsidy to physiotherapy continue as usual | No intervention | 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. |
| Direct access to publicly subsidized physiotherapy | Experimental | 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. Receives: Other: Direct access to publicly subsidized physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Consultations in general practice
Number of consultations in general practice
Measured: Six months after intervention period
Secondary outcomes (16)
Consultations with specialists within rheumatology
Number of Consultations with specialists within rheumatology
Measured: Six months after intervention period
Consultations with specialists within neurology
Number of consultations with specialists within neurology
Measured: Six months after intervention period
Consultations with specialists within orthopedics
Number of consultations with specialists within orthopedics
Measured: Six months after intervention period
Referrals to diagnostic imaging
Number of referrals to diagnostic imaging
Measured: Six months after intervention period
Cancer diagnoses
Number of cancer diagnoses
Measured: Five years after intervention period
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.
Measured: Six months
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.
Measured: Six weeks
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.
Measured: Six months
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.
Measured: Six months
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.
Measured: Six weeks
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.
Measured: Six months
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.
Measured: Six months
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.
Measured: Six weeks
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.
Measured: Six months
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.
Measured: Six weeks
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulla Toft
- Sponsor type
- University, hospital or other
- Collaborators
- Region Hovedstadens Apotek
- Responsible party
- Sponsor-investigator, Ulla Toft, Frederiksberg University Hospital
- Investigators
- Ulla Toft, ph.d., Study director, Center for Clinical Research and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900480
- Sponsor's protocol ID
- Direct Access
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34896641
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project for Direct Access to Physical Therapy
- ClinicalTrials.gov ID
- NCT04900480
- Acronym / sponsor ID
- Direct Access
- Conditions
- Musculoskeletal Diseases
- Keywords
- Physiotherapy, Public subsidy, Direct access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,427 participants (actual)
- Lead sponsor
- Ulla ToftUniversity, hospital or other
- Collaborators
- Region Hovedstadens Apotek
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Public subsidy to physiotherapy continue as usual | No intervention | –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. |
| Direct access to publicly subsidized physiotherapy | Experimental | Other: Direct access to publicly subsidized physiotherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Begin treatment in general physiotherapy within the four municipalities included
Key exclusion criteria (2 listed)
- Pregnancy
- Have a GP referral to home treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct access to publicly subsidized physiotherapyThis pilot project introduces temporary exemption on the legal required GP referral for public subsidy for treatment in general physiotherapy. | Other | Direct access to publicly subsidized physiotherapy |
Primary outcome
Change from baseline physical functioning at 6 months
Time frame: Six 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
Time frame: Six months after intervention period
Number of consultations in general practice
16 secondary outcomes
Consultations with specialists within rheumatology
Time frame: Six months after intervention period
Consultations with specialists within neurology
Time frame: Six months after intervention period
Consultations with specialists within orthopedics
Time frame: Six months after intervention period
Referrals to diagnostic imaging
Time frame: Six months after intervention period
Cancer diagnoses
Time frame: Five years after intervention period
Change from baseline physical functioning at six weeks
Time frame: Six months
Change from baseline mental health at six weeks
Time frame: Six weeks
Change from baseline mental health at six months
Time frame: Six months
Change from baseline pain intensity at 6 months
Time frame: Six months
Patient satisfaction
Time frame: Six weeks
Patient satisfaction
Time frame: Six months
Trust in collaboration between physiotherapist and general practitioner
Time frame: Six months
Change in sickness absence
Time frame: Six weeks
Change in sickness absence
Time frame: Six months
Change in use of pharmaceuticals
Time frame: Six weeks
Change in use of pharmaceuticals
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 34896641Dahlerup 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Toft, ph.d. study director
Center for Clinical Research and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct access to publicly subsidized physiotherapy in people with Musculoskeletal Diseases, run by Ulla Toft at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline physical functioning at 6 months (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.