A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care
1 other identifier
interventional
363
1 country
9
Brief Summary
Background: Almost half of the Swedish population are overweight or obese. This will probably affect the incidence of osteoarthritis since overweight is a strong risk factor. Osteoarthritis consultations is expected to increase with 30-50% within the next 20 years. Today, in Swedish primary care, both physicians and physiotherapists are primary assessors for patients with suspected knee osteoarthritis. A task shifting with physiotherapists as the only primary assessor could increase the access rate to physicians in primary care for patients with more severe disorders. Yet, it is unclear what effects these different healthcare processes have and the costs of it. Purpose: The overall purpose of this study is to perform an economic evaluation of two healthcare processes, where a healthcare process initiated by a physiotherapist is compared with when it is initiated with a physician for patients with suspected knee osteoarthritis. Methods: 100 patients will be randomized either to a physiotherapists or to a physician for first assessment, diagnosis and treatment. Measurements of health-related quality of life and costs for visits to physiotherapists, physician or other healthcare provider, drug prescriptions and sick-leave will be collected. A cost-effectiveness analysis will be conducted, presenting incremental cost-effectiveness ratio (ICER) and a non-parametric bootstrapping will be conducted to demonstrate the uncertainties surrounding the ICER. Expected results: It is expected that this randomized controlled study will show the effects on quality adjusted life years, cost-efficiency and cost-utility of two different primary assessors for patients with suspected knee osteoarthritis consulting primary care. The results could clarify which profession that is most appropriate to be the primary assessor for patients with suspected knee osteoarthritis in primary care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
February 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2022
CompletedResults Posted
Study results publicly available
May 6, 2024
CompletedMay 6, 2024
April 1, 2022
2.1 years
January 28, 2019
August 8, 2022
May 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Mean Difference in Quality Adjusted Life Years (QALY)
Health-related quality of life was used as the generic measure for health improvement and was measured at baseline, 3-, 6- and 12-month follow-up. The Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) was used to assess perceived self-rated health-related quality of life. The questionnaire contained five dimensions and resulted in an index ranging from -0,549 to 1 using the United Kingdom tariffs. An index of 1 indicate full health. For each participant, EQ-5D-3L index was used when calculating quality adjusted life years (QALY) using linear interpolation between each measurement point and the trapezoidal rule to calculate the "area under the curve". QALY range from 0 to 1, where 0 means death and 1 equals full health.
12 months
Mean Difference in Total Costs (Societal Perspective)
Total costs with the societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation. Data were retrieved from medical records.
12 months
Mean Difference in Total Costs (Health Care Perspective)
Health care perspective includes health care visits and prescribed drugs. Data were collected through medical records.
12 months
Incremental Cost-effectiveness Ratio (ICER) - Societal Perspective
Mean difference in costs divided by mean difference in quality adjusted life years (QALYs). Presenting the results of the cost-effectiveness analysis (ICER). Societal perspective includes health care visits, prescribed drugs, productivity loss and unpaid work compensation Incremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model
12 months
Incremental Cost-effectiveness Ratio (ICER) - Health Care Perspective
Mean difference in costs divided by mean difference in quality adjusted life years (QALYs). Presenting the results of the cost-effectiveness analysis (ICER). Health care perspective includes health care visits and prescribed drugs. Incremental Cost-effectiveness Ratio was derived from the model where a measure of dispersion was not an output of the model
12 months
Secondary Outcomes (7)
Costs for Physiotherapy Visits
12 months
Costs for Physician Visits
12 months
Costs for Referrals to Radiography
12 months
Costs for Referrals to Orthopedic Surgeon
12 months
Costs for Collected Prescribed Drugs
12 months
- +2 more secondary outcomes
Study Arms (2)
Physiotherapist as primary assessor
OTHERThe healthcare process will be started with a physiotherapist assessment and treatment. Treatments could involve individual or group treatment including patient education and physical exercise. Patients can seek a physician anytime after the first assessment with the physiotherapist.
Physician as primary assessor
OTHERThe healthcare process will be started with a physician assessment and treatment. Treatments could involve drug prescription, referral to x-ray, referral to other healthcare providers and sick-leave. Patients can seek a physiotherapist anytime after the first assessment with the physician.
Interventions
Physiotherapist diagnose and treat the patient.
Physician diagnose and treat the patient.
Eligibility Criteria
You may qualify if:
- Knee pain most of the days the last month
- Over 38 years old
- Crepitus on active motion
- Morning stiffness less than 30 minutes
You may not qualify if:
- Not been diagnosed for current knee pain
- Non-traumatic cause due to current knee pain
- No other rheumatic, severe somatic or psychological diseases that can affect the outcome measures.
- Not pregnant
- Does not know enough Swedish to answer questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Närhälsan Vänersborg Rehabmottagning
Vänersborg, VastraGotaland, Sweden
Medpro Clinic Brålanda-Torpa Vårdcentral
Brålanda, Västra Götaland County, Sweden
Medpro Clinic Lilla Edet Vårdcentral
Lilla Edet, Västra Götaland County, Sweden
Närhälsan Lilla Edets Rehabmottagning
Lilla Edet, Västra Götaland County, Sweden
Capio Läkarhus Hjortmossen
Trollhättan, Västra Götaland County, Sweden
Närhälsan Trollhättan Rehabmottagning
Trollhättan, Västra Götaland County, Sweden
Primapraktiken
Trollhättan, Västra Götaland County, Sweden
Medpro Clinic Torpa Vårdcentral
Vänersborg, Västra Götaland County, Sweden
Vårdcentralen Nordstan
Vänersborg, Västra Götaland County, Sweden
Related Publications (4)
Turkiewicz A, Petersson IF, Bjork J, Hawker G, Dahlberg LE, Lohmander LS, Englund M. Current and future impact of osteoarthritis on health care: a population-based study with projections to year 2032. Osteoarthritis Cartilage. 2014 Nov;22(11):1826-32. doi: 10.1016/j.joca.2014.07.015. Epub 2014 Jul 30.
PMID: 25084132BACKGROUNDWalters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
PMID: 16110932BACKGROUNDBrazier JE, Harper R, Munro J, Walters SJ, Snaith ML. Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology (Oxford). 1999 Sep;38(9):870-7. doi: 10.1093/rheumatology/38.9.870.
PMID: 10515649BACKGROUNDHo-Henriksson CM, Svensson M, Thorstensson CA, Nordeman L. Physiotherapist or physician as primary assessor for patients with suspected knee osteoarthritis in primary care - a cost-effectiveness analysis of a pragmatic trial. BMC Musculoskelet Disord. 2022 Mar 17;23(1):260. doi: 10.1186/s12891-022-05201-3.
PMID: 35300671DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Major organizational changes in Vastra Gotaland Region, where the study was conducted, affected the recruiting process. The research project was probably de-prioritized since the patient flow declined drastically. Hence the target number of participants needed to achieve target power was not reached due to early termination of the recruiting process.
Results Point of Contact
- Title
- Chan-Mei Ho-Henriksson, PhD-student, RPT
- Organization
- Region Västra Götaland, Närhälsan
Study Officials
- PRINCIPAL INVESTIGATOR
Lena Nordeman, PhD
Närhälsan Research and development center Södra Älvsborg
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2019
First Posted
January 30, 2019
Study Start
February 7, 2019
Primary Completion
March 17, 2021
Study Completion
March 17, 2022
Last Updated
May 6, 2024
Results First Posted
May 6, 2024
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share