The STavanger osteoARThritis Study (START)

January 30, 2018 updated by: Nina Osteras, Diakonhjemmet Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
8 weeks pre-implementation vs. 8 weeks post-implementation

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the number of PT discharge summaries to the referring GP
Time Frame: 8 weeks pre-implementation vs. 8 weeks post-implementation
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
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
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
8 weeks pre-implementation vs. 8 weeks post-implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonhjemmet Hospital

Collaborators

Helse Stavanger HF
Stavanger Municipality

Investigators

  • Principal Investigator: Nina Østerås, Diakonhjemmet Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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