- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00157638
Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics
Optimizing Drug Therapy in Primary Care: Integrating Pharmacists With Ontario Family Physician Group Practices.
Study Overview
Status
Conditions
Detailed Description
The overall goal of IMPACT was to improve patient outcomes by optimizing drug therapy through a community practice model that integrates pharmacists into family practices.
This multi-site demonstration project involved 7 pharmacists, approximately 70 physicians and approximately 150,000 patients. Within each practice site, a pharmacist with special clinical training worked 2.5 days per week for 2 years and coordinated a multifaceted intervention aimed at optimizing drug therapy to improve patient outcomes (blood pressure, cholesterol, diabetes, pain control, constipation, etc.) The integrated pharmacist conducted patient assessments for medication problems, optimized office system medication management (e.g. develop process for handling of medication samples), and provided education (academic detailing ) focussed on key therapeutic areas. Pharmacists were provided with ongoing support from a training and mentorship program and the services of the Ontario Pharmacists' Association Drug Information Centre.
The family physicians and other members of the practice worked closely with the pharmacist in implementing these strategic interventions. Family physicians from a range of practice models (Ontario Family Health Networks, Primary Care Networks, and other types of family physician group practices) participated in this project.
Quantitative and qualitative methods were used to evaluate the process of integration, pharmacist service uptake, drug-related patient outcomes, and the costs associated with program implementation for sustainability. The integration of the physicians and pharmacists at the practice sites were evaluated with the aim of generating a practical and transferable practice model. The main hypothesis was that pharmacist integration into family practice will optimize medication use, clinical care and clinical outcomes.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 1G6
- McMaster University
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Ottawa, Ontario, Canada, K1N 5C8
- University of Ottawa
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Toronto, Ontario, Canada, M5S 2S2
- University of Toronto
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
65 + years and any two of the following:
- Elevated blood pressure
- Elevated hemoglobin A1C
- Elevated LDL-C
- Diagnosis of hypertension and no blood pressure readings in past 12 months
- Diagnosis of diabetes and no hemoglobin A1C readings in past 12 months
- Diagnosis of hyperlipidemia and no cholesterol readings in past 12 months
- Diagnosis of osteoarthritis or rheumatoid arthritis
- Using narcotics
- Diagnosis of hypertension, diagnosis of diabetes and not using an ACE inhibitor
- Diagnosis of hypertension, elevated blood pressure and using an NSAID
- Diagnosis of hyperlipidemia, elevate dLDL-C and not using a lipid lowering agent
- Diagnosis of hypertension, high blood pressure and not using a potassium wasting diuretic
Exclusion Criteria:
- Less than one visit to family physician in past 12 months
- More than 20 visits to family physician in past 12 months
- Awaiting placement to a nursing home or long-term care facility
- Alcoholism
- Palliative care patient
- Family physician only sees patient as a home visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number and types of patients referred and assessed
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Characterization and quantification of pharmacist activities
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Numbers and types of drug-related problems identified and resolved
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Medication changes made
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Number of recommendations implemented
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Process indicators (measurement of blood pressure, Cholesterol, hemoglobin A1C)
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Surrogate clinical outcomes (values of blood pressure, Cholesterol, hemoglobin A1C)
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Symptom improvement (constipation, pain)
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Secondary Outcome Measures
Outcome Measure |
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Health resource utilization
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Satisfaction with service
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Uptake of pharmacist recommendations
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Extent of knowledge translation
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Extent of collaboration
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Satisfaction with integrated pharmacist program
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Set up costs
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Pharmacist and physician time costs
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Travel cost
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Space requirements
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Medication costs
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Health services utilization
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Collaborators and Investigators
Investigators
- Principal Investigator: Lisa Dolovich, PharmD, MSc, McMaster University
- Principal Investigator: Kevin Pottie, MD, University of Ottawa, Ottawa ON
- Principal Investigator: Janusz Kaczorowski, PhD, McMaster University
- Principal Investigator: Barbara Farrell, PharmD, Elisabeth Bruyere Research Institute, Ottawa, ON
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G03-02671
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