Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics

Hypertension Clinical Trial

Official title:

Optimizing Drug Therapy in Primary Care: Integrating Pharmacists With Ontario Family Physician Group Practices.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157638
• Other study ID #: G03-02671
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: September 8, 2006
• Start date: February 2004
• Est. completion date: July 2006

Study information

• Verified date: September 2006
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Recent health policy documents have endorsed an integrated model of collaboration between pharmacists and physicians in primary care. The integration of pharmacists into primary care has been identified as a priority for primary health care reform in Canada. However, the best way to do this has not been demonstrated or evaluated. This demonstration project shows the various ways in which pharmacists can be trained and integrated into different family practice settings, the processes and costs associated with doing this, and the outcomes observed. The main hypothesis is that pharmacist integration into family practice will optimize medication use, clinical care and clinical outcomes. This information provides policy makers with necessary information about collaboration between pharmacists and family physicians for their overall goal of reforming the delivery of primary health care to the population.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Constipation
• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Pain

Intervention

Behavioral:
• integration of pharmacist into primary care

Drug:
• optimizing therapeutic treatments

Behavioral:
• optimizing processes of care

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	University of Ottawa	Ottawa	Ontario
Canada	University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and types of patients referred and assessed
Primary	Characterization and quantification of pharmacist activities
Primary	Numbers and types of drug-related problems identified and resolved
Primary	Medication changes made
Primary	Number of recommendations implemented
Primary	Process indicators (measurement of blood pressure, Cholesterol, hemoglobin A1C)
Primary	Surrogate clinical outcomes (values of blood pressure, Cholesterol, hemoglobin A1C)
Primary	Symptom improvement (constipation, pain)
Secondary	Health resource utilization
Secondary	Satisfaction with service
Secondary	Uptake of pharmacist recommendations
Secondary	Extent of knowledge translation
Secondary	Extent of collaboration
Secondary	Satisfaction with integrated pharmacist program
Secondary	Set up costs
Secondary	Pharmacist and physician time costs
Secondary	Travel cost
Secondary	Space requirements
Secondary	Medication costs
Secondary	Health services utilization

External Links

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