- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665908
PT-led Triage for Patients With Hip o Knee Osteoarthritis
PT-led Triage in Secondary Care Settings for Patients With Hip or/and Knee Osteoarthritis
The aim of this project is to compare PT-led triage in secondary care setting for patients with hip or/and knee osteoarthritis (OA) with standard care (i.e. assessment of orthopedic surgeon). Comparison between cost-effectiveness, selection accuracy, patients perceived quality of care, quality of life and physical function will be made.
A further aim is to explore patients expectations and experiences of PT-led triage in a secondary care setting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA) is a common musculoskeletal disorder and the number of people in need of surgical treatment for hip and knee OA is increasing. The waiting time for consultation with an orthopedic surgeon (OS) is long and the majority of the patient referred for assessment are not appropriate for surgical intervention. To reduce the number of patients seen by an OS and thereby shorten the waiting time, Sahlgrenska University Hospital started a Physiotherapist-led (PT-led) triage project in 2017. With PT-led triage the patients are assessed by a physiotherapist to establish the most appropriate care management; if the patient is appropriate for surgery, should be referred for continued rehabilitation, or referred back to the referring physician. To our knowledge this model of care with PT-led triage in secondary care setting have not been scientifically evaluated in Sweden.
The aim of this project is to compare PT-led triage in a secondary care setting with standard care (i.e. assessment of OS for patients with knee or /and hip OA). A further aim is to determine if a digital triage tool can accurately predict when a primary knee or hip referral is deemed for nonsurgical versus surgical intervention by the surgeon following the first consultation.
Patients referred from primary care to Sahlgrenska University hospital with primary hip and/or knee OA will be included and randomized to consultation with either PT (triage) or OS (standard practice). Data about patient reported health-related quality of life, pain, function, and patients' perception of quality of care will be collected using questionnaires at baseline, 3 and 12 months after the consultation.
Data about waiting time for consultation, proportion of patients appropriate for surgery, further investigations, and data to be able to perform cost analysis will be collected from patients´ journals, the patient administration systems, both locally and via the region Västra Götaland´s database (VEGA).
A qualitative approach will be used to further investigate patients expectations and experience of a PT-led trige.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Gothenburg, Sweden
- Sahlgrenska University Hospital
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Västra Götaland
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Gothenburg, Västra Götaland, Sweden
- Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Referred to Sahlgrenska University hospital
- Primary osteoarthritis in the hip or knee
- Understanding and speaking Swedish
Exclusion Criteria:
- Prior assessment by and referral from an orthopedic surgeon for the current problem
- Secondary osteoarthritis (posttraumatic osteoarthritis, femoral head necrosis), when stated on the referral
- Referred to a specific surgeon
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: PT-led triage
Patients are assessed by PT
|
Assessment by orthopaedic surgeon or a PT
|
|
Other: Standard care
The patiens are assessed by a orthopedic surgeon
|
Assessment by orthopaedic surgeon or a PT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short form of the Quality from Patients Perspective (QPP)
Time Frame: Baseline
|
A Measure of patients' perception of quality of care regarding four dimensions: caregivers' medical-technical competence; care organizations' physical-technical conditions; degree of identity-orientation in the caregivers' attitudes and actions; and the care organizations' socio-cultural atmosphere
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heath-related quality of life - EuroQol (EQ5-D)
Time Frame: Baseline, 3 and 12 months
|
Measure of health-related quality of life and consists of 5 items.
General health is measured using a VAS scale (0 to 100) with 100 being the best possible health state
|
Baseline, 3 and 12 months
|
|
Pain Disability index (PDI
Time Frame: Baseline, 3 and 12 months
|
A questionnaire where respondents are asked to rate disability on a numeric rating scale ranging from 0 (no disability) to 10 (maximum disability) in seven areas; family and home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity.
|
Baseline, 3 and 12 months
|
|
Forgotten Joint Score (FJS)
Time Frame: Basline, 3 and 12 months
|
A questionnaire that was developed to find subtle differences between patients who grade their hip / knee as "very good" and "excellent".
The score is graded from 0 to 100, where a high score is better
|
Basline, 3 and 12 months
|
|
Oxford Hip/Knee Score (OHS/OHK
Time Frame: Basline, 3 and 12 months
|
A questionnaire consisting of 12 questions that concern areas such as pain and disabilities the patient has experienced during the past four weeks.
|
Basline, 3 and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients expectations and experiences of PT-led triage
Time Frame: Interviews sep 2024-nov 2024
|
Qualitative semistructured one to one interviews
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Interviews sep 2024-nov 2024
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Triage and hip/knee OA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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