Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00157638
First received: September 8, 2005
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Diabetes
Hypertension
Hyperlipidemia
Constipation
Pain
Behavioral: integration of pharmacist into primary care
Drug: optimizing therapeutic treatments
Behavioral: optimizing processes of care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Optimizing Drug Therapy in Primary Care: Integrating Pharmacists With Ontario Family Physician Group Practices.

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Number and types of patients referred and assessed
  • Characterization and quantification of pharmacist activities
  • Numbers and types of drug-related problems identified and resolved
  • Medication changes made
  • Number of recommendations implemented
  • Process indicators (measurement of blood pressure, Cholesterol, hemoglobin A1C)
  • Surrogate clinical outcomes (values of blood pressure, Cholesterol, hemoglobin A1C)
  • Symptom improvement (constipation, pain)

Secondary Outcome Measures:
  • Health resource utilization
  • Satisfaction with service
  • Uptake of pharmacist recommendations
  • Extent of knowledge translation
  • Extent of collaboration
  • Satisfaction with integrated pharmacist program
  • Set up costs
  • Pharmacist and physician time costs
  • Travel cost
  • Space requirements
  • Medication costs
  • Health services utilization

Estimated Enrollment: 1400
Study Start Date: February 2004
Estimated Study Completion Date: July 2006
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157638

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 1G6
University of Ottawa
Ottawa, Ontario, Canada, K1N 5C8
University of Toronto
Toronto, Ontario, Canada, M5S 2S2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00157638     History of Changes
Other Study ID Numbers: G03-02671
Study First Received: September 8, 2005
Last Updated: September 8, 2006
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
pharmacist
physician
primary care
collaboration
therapeutics

Additional relevant MeSH terms:
Constipation
Hyperlipidemias
Hypertension
Signs and Symptoms, Digestive
Signs and Symptoms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014