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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Arthritis Network
Michael Smith Foundation for Health Research
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00391859
First received: October 24, 2006
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pharmacist-initiated Intervention Trial in OsteoArthritis (PhIT-OA)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • (Baseline, months 2 and 6 ) [ Time Frame: Months 2 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • There are four secondary outcome measures that will be compared between intervention and usual care subjects at baseline, months 2 and 6: [ Time Frame: Months 2 and 6 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • The difference in knee pain (as assessed by five questions on the WOMAC); [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • The difference in Health Utilities Index Mark 3 (HUI3); and [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • The direct medical resource utilization using a questionnaire validated for use in musculoskeletal diseases. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: September 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)
See Detailed Description.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391859

Locations
Canada, British Columbia
Mary Pack Arthritis Center
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Canadian Arthritis Network
Michael Smith Foundation for Health Research
Investigators
Principal Investigator: Carlo Marra, Ph.D University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00391859     History of Changes
Other Study ID Numbers: H06-70373, H06-70373
Study First Received: October 24, 2006
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Pharmacist-initiated Intervention Trial in OsteoArthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014