A Cost-efficiency Analysis of Primary Assessors for Patients With Knee Pain in Primary Care

Osteoarthritis, Knee Clinical Trial

Official title:

A Cost-efficiency Analysis of Physiotherapist or Physicians as Primary Assessors for Patients With Knee Pain in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822533
• Other study ID #: 115841healthecon
• Status: Completed
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: March 17, 2022

Study information

• Verified date: April 2022
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Problem statements:

What is the difference in cost efficiency between a healthcare process with a physiotherapists as primary assessor and a physician as primary assessor for patients with suspected knee osteoarthritis?

Which effect does a clinical pathway with a physiotherapists as primary assessor for patients with suspected knee osteoarthritis have on quality adjusted life years compared with a physician as primary assessor?

What are the differences in costs between the two healthcare processes initiated by either a physiotherapist or a physician set against the differences in effects?

Patient recruitment:

Some data has already been collected for another clinical trial (ID: NCT03715764), which will be used in this study too. The patient recruitment is finished, while data collection regarding cost variables has not started yet.

Patients were recruited from primary care centers and rehabilitation centers in southwestern Sweden.

Screening procedure:

Nurses and administration personnel at the recruitment units got information about the study and the screening protocol from the data collector and project leader. Each recruiting unit had a contact person that were responsible for the protocols and to contact the data collector when an eligible patient was found. It was regular contact between the project leader and the contact persons at the recruiting units. All screening protocols were sent to the data collector. All participants got orally and written information about the study from the data collector, and patients provided written informed consent.

Randomization:

A computer-generated list of random numbers was used, where participants were randomly assigned to being assessed, diagnosed and treated either by a physiotherapist or a physician first. The project coordinator managed the sequence generation, allocation concealment, enrolment and assignments of participants and kept the concealed randomization scheme and sequentially numbered, sealed envelopes in a locked cupboard (in the same building where the enrolment was), only available for the project coordinator. The project coordinator revealed the allocation to the participant shortly after the baseline measurement and to the health care providers. Data collector, data analyst and statistician were blinded of allocation until completion of data collection for the primary outcome measures at the 12 months follow up for the last recruited patient. Group allocation was revealed when analysing data for the other clinical trial (ID: NCT03715764).

The project coordinator was not involved in the screening procedure nor the data collection, and was not included among the healthcare providers in the study. The blinded data collector and analyst, whom is a physiotherapists, were not involved in assessing, diagnosing and treating patients with knee osteoarthritis while the first study (ID: NCT03715764) was conducted.

Data collection:

Demographic data and measurements of health-related quality of life (HrQoL) has already been collected for another clinical trial (ID: NCT03715764). These data will also be used for the cost-efficiency analysis. Demographic data were collected at baseline. Measurements of HrQoL were measured with EuroQol 5 dimensions 3 levels (EQ5D-3L) and collected at baseline (before randomization), 3- , 6- and 12 months follow ups.

New data collection will be made for cost variables. Data regarding costs for the healthcare processes will be extracted from patient journals. The costs for visits to physiotherapists, physician or other healthcare providers will be collected from the healthcare organization. The drug prices will be collected from the Swedish Association of Local Authorities and Regions for the time period the drugs were prescribed. Production loss due to sick-leave and health care visits will be valued according to mean gross salary (including taxes and social fees).

Calculating total costs (number of contacts per patient * costs ) for:

• Physiotherapy contacts in primary care

• Physician contacts in primary care

• Referrals to x-ray

• Referrals to other healthcare givers

• Drug prescriptions

• Sick-leave days

Data management:

All data will be coded and managed according to the General Data Protection Regulation. All data will be confidential and only authorized will have access to the patient registry. No individual information can be identified since the results will be presented at group level. Data will be saved for at least 10 years to enable audit.

Sample size:

A sample size of 50 patients per group will be necessary to detect a minimal clinical improvement of 0.121(SD 0.2) on the EQ5D-3L-index, given an anticipated dropout rate of 14%. The sample size calculation was calculated with a two-sided 5% significance level and a power of 80%.

Statistical analysis plan:

Data will be analyzed descriptively and presented as numbers and percent, mean and standard deviation or median and 25th to 75th percentiles. Statistical analysis will be made in SPSS Windows and the analysis will be applied with intention-to-treat (ITT).

The economic evaluation will be developed together with a health economist. The method will be a cost-effectiveness analysis alongside the clinical trial comparing costs and effects for the two alternatives based on collected data from the trial. The EQ5D-3L measurements will be used for analyzing quality adjusted life years. The result will be presented as an incremental cost-effectiveness ratio (ICER) and a non-parametric bootstrapping will be conducted to demonstrate the uncertainties surrounding the ICER.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Years and older

Eligibility

Inclusion Criteria:

• Knee pain most of the days the last month

• Over 38 years old

• Crepitus on active motion

• Morning stiffness less than 30 minutes

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Other:
• Physiotherapist as primary assessor
Physiotherapist diagnose and treat the patient.
• Physician as primary assessor
Physician diagnose and treat the patient.

Locations

Country	Name	City	State
Sweden	Medpro Clinic Brålanda-Torpa Vårdcentral	Brålanda	Vastra Gotaland
Sweden	Medpro Clinic Lilla Edet Vårdcentral	Lilla Edet	Vastra Gotaland
Sweden	Närhälsan Lilla Edets Rehabmottagning	Lilla Edet	Vastra Gotaland
Sweden	Capio Läkarhus Hjortmossen	Trollhättan	Vastra Gotaland
Sweden	Närhälsan Trollhättan Rehabmottagning	Trollhättan	Vastra Gotaland
Sweden	Primapraktiken	Trollhättan	Vastra Gotaland
Sweden	Medpro Clinic Torpa Vårdcentral	Vänersborg	Vastra Gotaland
Sweden	Närhälsan Vänersborg Rehabmottagning	Vänersborg	VastraGotaland
Sweden	Vårdcentralen Nordstan	Vänersborg	Vastra Gotaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Costs for Physiotherapy Visits	Number of visits registered in patients journal multiplied with the cost.	12 months
Secondary	Costs for Physician Visits	Number of visits registered in patients journal multiplied with cost	12 months
Secondary	Costs for Referrals to Radiography	Number of referrals to radiography registered in patients journal multiplied with its costs	12 months
Secondary	Costs for Referrals to Orthopedic Surgeon	Number of referrals to orthopedic surgeon registered in patients journal multiplied with the costs	12 months
Secondary	Costs for Collected Prescribed Drugs	Data extraction from a drug database for prescribed drugs belonging to the Anatomical Therapeutic Chemical Classification groups M01 anti-inflammatory and anti-rheumatic products, M02 topical products for joint and muscular pain, M03 muscle relaxants, M09 other drugs for disorders of the musculoskeletal system, N02A opioids, N02B other analgesics and antipyretics.	12 months
Secondary	Costs for Productivity Loss	Productivity loss included the time for visiting health care, telephone calls, traveling, waiting time and costs for sick leave days. The costs was calculated with gross salary including social fees.	12 months
Secondary	Costs for Unpaid Work Compensation	The costs for the time the patients were visiting health care or consulting via telephone, including traveling and waiting time. Production loss was calculated with net mean salary. Included participants that reported they were retired or unemployed.	12 months