Pharmacist-initiated Intervention Trial in OsteoArthritis (PhIT-OA)

NCT ID: NCT00391859

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2010-06-30

Brief Summary

Osteoarthritis (OA) is a major public health concern. Currently, there are at least 3 million Canadians afflicted with this condition with a 50% increase predicted by 2020. It is estimated that 85% of Canadians are afflicted with OA by age 70. As such, using the current health care structure, it is doubtful that the health system can keep pace with this increasing demand. Alternative health care delivery strategies must be investigated.

The purpose of this study is to assess if a pharmacist-initiated intervention for individuals with knee pain with a high likelihood of knee OA will lead to an improvement in the quality of care for these individuals.

We are hopeful that results of this study will show better management of knee osteoarthritis by a pharmacist-initiated intervention (which means that it is the pharmacist who will start the process for an intervention that includes exercise and an educational program when compared to no intervention. If this is the case, by implementing the proposed intervention program, subjects could be diagnosed earlier, the burden of illness on individuals could be diminished through an appropriate intervention program, and economic savings could be embraced.

Hypothesis: Community pharmacists can identify patients with likely knee OA and initiate a multidisciplinary intervention that will improve quality of care and outcomes.

Detailed Description

This will be a pilot study of a multidisciplinary intervention for individuals with knee pain with a high likelihood of knee OA that could be a model for other chronic diseases. The intervention will be multidisciplinary such that it will be initiated by community pharmacists with referral to a comprehensive OA treatment program at the provincial arthritis center involving physiotherapists. In addition, formal communication will be initiated with their family doctor. Those in the usual care group will receive an educational OA pamphlet. The primary objective of this pilot project is to determine the proportion of patients who meet the Arthritis Foundation's Quality Indicator Set for osteoarthritis in the treatment arm compared to those in the usual care arm. Specifically, this indicator set focuses on health service provision within the first few months of diagnosis which includes physical examination, radiographs, education, exercise, weight loss, assistive devices and pharmacologic therapy.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Health service provision

Health service provision within the first few months of diagnosis which includes physical examination, radiographs, education, exercise, weight loss, assistive devices and pharmacologic therapy.

Group Type: EXPERIMENTAL

Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)

Intervention Type: PROCEDURE

See Detailed Description.

Interventions

Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)

See Detailed Description.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age >50 years

2. ≥ 4 weeks of pain, aching or discomfort in or around the knee

3. Overweight or obese defined as BMI defined as ≥ 27 kg/m2

4. Not actively participating in a formal exercise program within the past 6 months

5. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking one quarter of a mile, getting in and out of a chair, or going up and down stairs.

6. Meet eligibility using the criteria on the pharmacist screening form (see attachment) - This form was adapted from the PhIND-OA study and amended to include points #3 to 6 above.

Exclusion Criteria

1. Significant co-morbid disease that would pose a safety threat or impair ability to participate in an exercise program

2. Inability or unwillingness to modify dietary or exercise behaviours.

3. Knee X-Ray within the last 2 years

4. Inability to speak and write English

5. Knee pain due only to referred pain from osteoarthritis of the hip

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Arthritis Network

NETWORK

Sponsor Role: collaborator

Michael Smith Foundation for Health Research

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Marra, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Mary Pack Arthritis Center

Vancouver, British Columbia, Canada

Countries

Canada

References

Marra CA, Cibere J, Grubisic M, Grindrod KA, Gastonguay L, Thomas JM, Embley P, Colley L, Tsuyuki RT, Khan KM, Esdaile JM. Pharmacist-initiated intervention trial in osteoarthritis: a multidisciplinary intervention for knee osteoarthritis. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1837-45. doi: 10.1002/acr.21763.

Reference Type: DERIVED

PMID: 22930542 (View on PubMed)

Other Identifiers

H06-70373

Identifier Type: -

Identifier Source: secondary_id

H06-70373

Identifier Type: -

Identifier Source: org_study_id