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The STavanger osteoARThritis Study (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876120
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Stavanger Municipality
Helse Stavanger HF
Information provided by (Responsible Party):
Nina Osteras, Diakonhjemmet Hospital

Brief 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 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Hip Osteoarthritis Other: Implementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The STavanger osteoARThritis Study in Primary Health Care
Study Start Date : September 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Pre- and post-implementation phases

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

Other: Implementation
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.




Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. Change in the number of PT discharge summaries to the referring GP [ Time Frame: 8 weeks pre-implementation vs. 8 weeks post-implementation ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Persons referred to physiotherapy after a total joint replacement
  • Persons who do not understand the Norwegian language
  • Persons with cognitive dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876120


Sponsors and Collaborators
Diakonhjemmet Hospital
Stavanger Municipality
Helse Stavanger HF
Investigators
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Principal Investigator: Nina Østerås Diakonhjemmet Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nina Osteras, Senior researcher, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT02876120    
Other Study ID Numbers: 2016/1335
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases