Clinical trial NCT00157638: Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics
Official title: Optimizing Drug Therapy in Primary Care: Integrating Pharmacists With Ontario Family Physician Group Practices.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Hypertension
Hyperlipidemia
Constipation
Pain
Keywords: pharmacist
physician
primary care
collaboration
therapeutics
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 1400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and types of patients referred and assessed
measure: Characterization and quantification of pharmacist activities
measure: Numbers and types of drug-related problems identified and resolved
measure: Medication changes made
measure: Number of recommendations implemented
measure: Process indicators (measurement of blood pressure, Cholesterol, hemoglobin A1C)
measure: Surrogate clinical outcomes (values of blood pressure, Cholesterol, hemoglobin A1C)
measure: Symptom improvement (constipation, pain)
Secondary outcomes:
measure: Health resource utilization
measure: Satisfaction with service
measure: Uptake of pharmacist recommendations
measure: Extent of knowledge translation
measure: Extent of collaboration
measure: Satisfaction with integrated pharmacist program
measure: Set up costs
measure: Pharmacist and physician time costs
measure: Travel cost
measure: Space requirements
measure: Medication costs
measure: Health services utilization
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: McMaster University
name: Lisa Dolovich, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa, Ottawa ON
name: Kevin Pottie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Janusz Kaczorowski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elisabeth Bruyere Research Institute, Ottawa, ON
name: Barbara Farrell, PharmD
role: PRINCIPAL_INVESTIGATOR
References: