PT-led Triage for Patients With Hip o Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis, Hip Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Assessment by PT/Orth surgeon
Sponsored by
About this trial
This is an interventional health services research trial for Knee Osteoarthritis focused on measuring PT-led triage, Osteoarthritis, Knee, Hip
Eligibility Criteria
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
Sites / Locations
- Sahlgrenska University HospitalRecruiting
- Sahlgrenska University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PT-led triage
Standard care
Arm Description
Patients are assessed by PT
The patiens are assessed by a orthopedic surgeon
Outcomes
Primary Outcome Measures
Short form of the Quality from Patients Perspective (QPP)
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
Secondary Outcome Measures
Heath-related quality of life - EuroQol (EQ5-D)
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
Pain Disability index (PDI
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.
Forgotten Joint Score (FJS)
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
Oxford Hip/Knee Score (OHS/OHK
A questionnaire consisting of 12 questions that concern areas such as pain and disabilities the patient has experienced during the past four weeks.
Full Information
NCT ID
NCT04665908
First Posted
December 7, 2020
Last Updated
April 5, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04665908
Brief Title
PT-led Triage for Patients With Hip o Knee Osteoarthritis
Official Title
PT-led Triage in Secondary Care Settings for Patients With Hip or/and Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 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.
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 digital triage tool will be developed and tested in a cohort of 50 patients before the ortohpedic consultation.
A qualitative approach will be used to further investigate patients experience of a PT-ledtrige
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Hip Osteoarthritis
Keywords
PT-led triage, Osteoarthritis, Knee, Hip
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Due to the design of the study, it is not possible to blind either caregivers or participants regarding group distribution
Allocation
Randomized
Enrollment
478 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PT-led triage
Arm Type
Other
Arm Description
Patients are assessed by PT
Arm Title
Standard care
Arm Type
Other
Arm Description
The patiens are assessed by a orthopedic surgeon
Intervention Type
Other
Intervention Name(s)
Assessment by PT/Orth surgeon
Intervention Description
Assessment by orthopaedic surgeon or a PT
Primary Outcome Measure Information:
Title
Short form of the Quality from Patients Perspective (QPP)
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Heath-related quality of life - EuroQol (EQ5-D)
Description
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
Time Frame
Baseline, 3 and 12 months
Title
Pain Disability index (PDI
Description
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.
Time Frame
Baseline, 3 and 12 months
Title
Forgotten Joint Score (FJS)
Description
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
Time Frame
Basline, 3 and 12 months
Title
Oxford Hip/Knee Score (OHS/OHK
Description
A questionnaire consisting of 12 questions that concern areas such as pain and disabilities the patient has experienced during the past four weeks.
Time Frame
Basline, 3 and 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maziar Mohaddes, DR
Phone
+46 (730) 701147
Email
maziar.mohaddes_ardebili@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Linnéa Gustavsson, MS
Phone
+46 731575998
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maziar Mohaddes, DR
Facility Name
Sahlgrenska University hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maziar Mohaddes, M.D
12. IPD Sharing Statement
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PT-led Triage for Patients With Hip o Knee Osteoarthritis
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