NCT03822533

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 6, 2024

Completed
Last Updated

May 6, 2024

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

January 28, 2019

Results QC Date

August 8, 2022

Last Update Submit

May 3, 2024

Conditions

Keywords

Primary assessorcost efficiencyphysiotherapistquality of life

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

OTHER

The 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.

Other: Physiotherapist as primary assessor

Physician as primary assessor

OTHER

The 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.

Other: Physician as primary assessor

Interventions

Physiotherapist diagnose and treat the patient.

Physiotherapist as primary assessor

Physician diagnose and treat the patient.

Physician as primary assessor

Eligibility Criteria

Age38 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Medpro Clinic Brålanda-Torpa Vårdcentral

Brålanda, Västra Götaland County, Sweden

Location

Medpro Clinic Lilla Edet Vårdcentral

Lilla Edet, Västra Götaland County, Sweden

Location

Närhälsan Lilla Edets Rehabmottagning

Lilla Edet, Västra Götaland County, Sweden

Location

Capio Läkarhus Hjortmossen

Trollhättan, Västra Götaland County, Sweden

Location

Närhälsan Trollhättan Rehabmottagning

Trollhättan, Västra Götaland County, Sweden

Location

Primapraktiken

Trollhättan, Västra Götaland County, Sweden

Location

Medpro Clinic Torpa Vårdcentral

Vänersborg, Västra Götaland County, Sweden

Location

Vårdcentralen Nordstan

Vänersborg, Västra Götaland County, Sweden

Location

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: 25084132BACKGROUND
  • Walters 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: 16110932BACKGROUND
  • Brazier 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: 10515649BACKGROUND
  • Ho-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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical TherapistsPhysicians

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

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

  • Lena Nordeman, PhD

    Närhälsan Research and development center Södra Älvsborg

    PRINCIPAL INVESTIGATOR

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
Model Details: Participants with suspected knee osteoarthritis are either randomised to a physiotherapist or a physician as primary assessor for assessment and treatment. After the first assessment that the patients are assigned to, the patients can choose to seek the other health care provider if they want to. This study focuses on analysing cost efficiency of the health care processes for patients with suspected knee osteoarthritis in primary care.
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

Locations