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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04665908
Other study ID # Triage and hip/knee OA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 26, 2020
Est. completion date December 31, 2025

Study information

Verified date March 2022
Source Sahlgrenska University Hospital, Sweden
Contact Maziar Mohaddes, DR
Phone +46 (730) 701147
Email maziar.mohaddes_ardebili@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 478
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Assessment by PT/Orth surgeon
Assessment by orthopaedic surgeon or a PT

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg Västra Götaland
Sweden Sahlgrenska University hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
Secondary 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 Baseline, 3 and 12 months
Secondary 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. Baseline, 3 and 12 months
Secondary 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 Basline, 3 and 12 months
Secondary 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. Basline, 3 and 12 months
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