Knee OsteoarthritisSTARTNCT02876120
The STavanger osteoARThritis Study
A study testing Implementation in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Diakonhjemmet Hospital.
Trial summary
The START study will implement osteoarthritis (OA) treatment recommendations to increase the use of recommended treatment modalities and reduce non-desired events (e.g. unnecessary referrals to secondary care, unnecessary use of costly imaging modalities and use of treatment modalities supported by low quality of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Nov 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PT working in private practice in Stavanger Municipality
- GP working in Stavanger Municipality
- Person with complaints due to hip and/or knee osteoarthritis referred to physiotherapy in Stavanger Municipality
- Person with complaints due to hip and/or knee osteoarthritis referred for assessment of joint replacement at Stavanger University Hospital
Who cannot join
- Persons referred to physiotherapy after a total joint replacement
- Persons who do not understand the Norwegian language
- Persons with cognitive dysfunction
About this study
Official title: The STavanger osteoARThritis Study in Primary Health Care
The START study will implement osteoarthritis (OA) treatment recommendations to increase the use of recommended treatment modalities and reduce non-desired events (e.g. unnecessary referrals to secondary care, unnecessary use of costly imaging modalities and use of treatment modalities supported by low quality of evidence). The purpose of the STavanger osteoARThritis (START) study is to improve the quality of OA care and increase the collaboration between health care professionals in primary health care and across health care levels.
Read the detailed description
Previous research has shown that the osteoarthritis care for persons with hip or knee osteoarthritis in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. The purpose of the STavanger osteoARThritis (START) study is to improve the quality of OA care and increase the collaboration between health care professionals in primary health care and across health care levels.
Based on international treatment recommendations for OA care and previous research, a tailored implementation strategy targeting high quality, integrated care for people with OA in Stavanger Municipality will be developed, implemented and evaluated. The care will mainly be provided in the Stavanger primary health care services by physiotherapists (PT) (in private practice) and general practitioners (GP), but will also include collaboration with orthopaedic surgeons in specialist health care at Stavanger University Hospital.
The main aim of the present study is to develop, implement and evaluate effects of a tailored implementation strategy for the START study in Stavanger Municipality.
To evaluate the effects of the START implementation strategy, an interrupted time series design method will be applied. The study period will be divided into three phases: pre-implementation, implementation/transition and post-implementation. Data will be collected at 16 time points; 8 before and 8 after the implementation/ transition phase.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Being tested
- Implementation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplementationOther
Multifaceted implementation strategy to implement evidence based international osteoarthritis treatment recommendations among GPs and PTs in private practice, template for PT discharge reports to GP, patient osteoarthritis education programs, and facilitate multidisciplinary collaboration between the PTs and GPs.
| Study group | Role | What they receive |
|---|---|---|
| Pre- and post-implementation phases | Other | Pre-implementation phase: during the pre-implementation period persons with hip or knee osteoarthritis will receive "usual care" as it is currently delivered by physiotherapists and general practitioners.
Post-implementation phase: during the post-implementation phase the GPs and PTs will treat persons with hip or knee osteoarthritis according to the START treatment model including providing information/patient education program, supervised exercise and advice/support to loose weight and other non-surgical evidence based treatments modalities prior to being referred to an orthopaedic surgeon Receives: Other: Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported quality of osteoarthritis care
Using the "OsteoArthritis Quality Indicator questionnaire"
Measured: 8 weeks pre-implementation vs. 8 weeks post-implementation
Secondary outcomes (4)
Change in the number of PT discharge summaries to the referring GP
Measured: 8 weeks pre-implementation vs. 8 weeks post-implementation
Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that has explored non-surgical treatment modalities beforehand
Measured: 8 weeks pre-implementation vs. 8 weeks post-implementation
Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that has taken an MRI and/or conventional radiographs for OA assessment
Measured: 8 weeks pre-implementation vs. 8 weeks post-implementation
Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that leads to scheduled joint surgery
Measured: 8 weeks pre-implementation vs. 8 weeks post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2017
- Study completionNov 2017
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 Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stavanger Municipality, Helse Stavanger HF
- Responsible party
- Principal investigator, Nina Osteras, Diakonhjemmet Hospital
- Investigators
- Nina Østerås, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876120
- Sponsor's protocol ID
- 2016/1335
- Acronym
- START
- Status last verified
- Jan 2018
- First submitted
- 15 Aug 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Osteras N, Blaker IB, Hjortland T, Cottrell E, Quicke JG, Dziedzic KS, Blackburn S, Paulsen A. Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study. BMC Musculoskelet Disord. 2021 Jan 14;22(1):79. doi: 10.1186/s12891-021-03959-6.
PubMed 33446167
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STavanger osteoARThritis Study in Primary Health Care
- ClinicalTrials.gov ID
- NCT02876120
- Acronym / sponsor ID
- START / 2016/1335
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Stavanger Municipality, Helse Stavanger HF
- Study start
- Sep 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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 START study will implement osteoarthritis (OA) treatment recommendations to increase the use of recommended treatment modalities and reduce non-desired events (e.g. unnecessary referrals to secondary care, unnecessary use of costly imaging modalities and use of treatment modalities supported by low quality of evidence). The purpose of the STavanger osteoARThritis (START) study is to improve the quality of OA care and increase the collaboration between health care professionals in primary health care and across health care levels.
Detailed description
Previous research has shown that the osteoarthritis care for persons with hip or knee osteoarthritis in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. The purpose of the STavanger osteoARThritis (START) study is to improve the quality of OA care and increase the collaboration between health care professionals in primary health care and across health care levels.
Based on international treatment recommendations for OA care and previous research, a tailored implementation strategy targeting high quality, integrated care for people with OA in Stavanger Municipality will be developed, implemented and evaluated. The care will mainly be provided in the Stavanger primary health care services by physiotherapists (PT) (in private practice) and general practitioners (GP), but will also include collaboration with orthopaedic surgeons in specialist health care at Stavanger University Hospital.
The main aim of the present study is to develop, implement and evaluate effects of a tailored implementation strategy for the START study in Stavanger Municipality.
To evaluate the effects of the START implementation strategy, an interrupted time series design method will be applied. The study period will be divided into three phases: pre-implementation, implementation/transition and post-implementation. Data will be collected at 16 time points; 8 before and 8 after the implementation/ transition phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre- and post-implementation phases | Other | Other: ImplementationPre-implementation phase: during the pre-implementation period persons with hip or knee osteoarthritis will receive "usual care" as it is currently delivered by physiotherapists and general practitioners. Post-implementation phase: during the post-implementation phase the GPs and PTs will treat persons with hip or knee osteoarthritis according to the START treatment model including providing information/patient education program, supervised exercise and advice/support to loose weight and other non-surgical evidence based treatments modalities prior to being referred to an orthopaedic surgeon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- PT working in private practice in Stavanger Municipality
- GP working in Stavanger Municipality
- Person with complaints due to hip and/or knee osteoarthritis referred to physiotherapy in Stavanger Municipality
- Person with complaints due to hip and/or knee osteoarthritis referred for assessment of joint replacement at Stavanger University Hospital
Key exclusion criteria (3 listed)
- Persons referred to physiotherapy after a total joint replacement
- Persons who do not understand the Norwegian language
- Persons with cognitive dysfunction
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 |
|---|---|---|
| ImplementationMultifaceted implementation strategy to implement evidence based international osteoarthritis treatment recommendations among GPs and PTs in private practice, template for PT discharge reports to GP, patient osteoarthritis education programs, and facilitate multidisciplinary collaboration between the PTs and GPs. | Other | Pre- and post-implementation phases |
Primary outcome
Change in patient-reported quality of osteoarthritis care
Time frame: 8 weeks pre-implementation vs. 8 weeks post-implementation
Using the "OsteoArthritis Quality Indicator questionnaire"
4 secondary outcomes
Change in the number of PT discharge summaries to the referring GP
Time frame: 8 weeks pre-implementation vs. 8 weeks post-implementation
Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that has explored non-surgical treatment modalities beforehand
Time frame: 8 weeks pre-implementation vs. 8 weeks post-implementation
Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that has taken an MRI and/or conventional radiographs for OA assessment
Time frame: 8 weeks pre-implementation vs. 8 weeks post-implementation
Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that leads to scheduled joint surgery
Time frame: 8 weeks pre-implementation vs. 8 weeks post-implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 33446167Osteras N, Blaker IB, Hjortland T, Cottrell E, Quicke JG, Dziedzic KS, Blackburn S, Paulsen A. Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study. BMC Musculoskelet Disord. 2021 Jan 14;22(1):79. doi: 10.1186/s12891-021-03959-6.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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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.
Nina Østerås principal investigator
Diakonhjemmet Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Implementation in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Diakonhjemmet Hospital.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in patient-reported quality of osteoarthritis care (time frame: 8 weeks pre-implementation vs. 8 weeks post-implementation). 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 NCT02876120, 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 1 Feb 2018.