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The STavanger osteoARThritis Study (START)

Primary Purpose

Knee Osteoarthritis, Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implementation
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Pre- and post-implementation phases

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Change in patient-reported quality of osteoarthritis care
    Using the "OsteoArthritis Quality Indicator questionnaire"

    Secondary Outcome Measures

    Change in the number of PT discharge summaries to the referring GP
    Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that has explored non-surgical treatment modalities beforehand
    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
    Change in the proportion of people with OA referred to orthopaedic surgeon in secondary care that leads to scheduled joint surgery

    Full Information

    First Posted
    August 15, 2016
    Last Updated
    January 30, 2018
    Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Stavanger Municipality, Helse Stavanger HF
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02876120
    Brief Title
    The STavanger osteoARThritis Study
    Acronym
    START
    Official Title
    The STavanger osteoARThritis Study in Primary Health Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    November 2017 (Actual)
    Study Completion Date
    November 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Stavanger Municipality, Helse Stavanger HF

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Hip Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    N/A
    Enrollment
    330 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pre- and post-implementation phases
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Implementation
    Intervention Description
    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 Measure Information:
    Title
    Change in patient-reported quality of osteoarthritis care
    Description
    Using the "OsteoArthritis Quality Indicator questionnaire"
    Time Frame
    8 weeks pre-implementation vs. 8 weeks post-implementation
    Secondary Outcome Measure Information:
    Title
    Change in the number of PT discharge summaries to the referring GP
    Time Frame
    8 weeks pre-implementation vs. 8 weeks post-implementation
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nina Østerås
    Organizational Affiliation
    Diakonhjemmet Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33446167
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    The STavanger osteoARThritis Study

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