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

NCT00391859 | Completed

• 1 other identifier: H06-70373
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Pharmacist-initiated Intervention Trial in OsteoArthritis

Outcome Measures

Primary Outcomes (2)

• The primary outcome will be the difference in proportion of patients who receive ≥ 5 of the Arthritis Foundation's quality indicators during the six months of the study.

  6 months

• (Baseline, months 2 and 6 )

  Months 2 and 6

Secondary Outcomes (5)

• There are four secondary outcome measures that will be compared between intervention and usual care subjects at baseline, months 2 and 6:

  Months 2 and 6

• The difference in change of physical functioning (using the mean score from 17 questions from the WOMAC that are directed towards this construct) between intervention and usual care. This outcome has been used in recent, well-designed trials of OA.

• The difference in knee pain (as assessed by five questions on the WOMAC);

• The difference in Health Utilities Index Mark 3 (HUI3); and

• The direct medical resource utilization using a questionnaire validated for use in musculoskeletal diseases.

Study Arms (1)

Health service provision

EXPERIMENTAL

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

Procedure: Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)

Interventions

Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA) PROCEDURE

See Detailed Description.

Health service provision

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>50 years
• ≥ 4 weeks of pain, aching or discomfort in or around the knee
• Overweight or obese defined as BMI defined as ≥ 27 kg/m2
• Not actively participating in a formal exercise program within the past 6 months
• 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.
• 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.

You may not qualify if:

• Significant co-morbid disease that would pose a safety threat or impair ability to participate in an exercise program
• Inability or unwillingness to modify dietary or exercise behaviours.
• Knee X-Ray within the last 2 years
• Inability to speak and write English
• Knee pain due only to referred pain from osteoarthritis of the hip

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Arthritis Network: collaborator
• Michael Smith Foundation for Health Research: collaborator

Study Sites (1)

Mary Pack Arthritis Center

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• 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.

  PMID: 22930542 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Carlo Marra, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 25, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (1)