Clinical Trial: Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics

This study is currently recruiting patients.
Verified by McMaster University September 2005

Sponsored by: McMaster University
Information provided by: McMaster University Identifier: NCT00157638


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 will show 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 will provide 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
 Behavior: integration of pharmacist into primary care
 Drug: optimizing therapeutic treatments
 Behavior: optimizing processes of care
Phase IV

MedlinePlus related topics:  Constipation;   Diabetes;   High Blood Pressure;   Metabolic Disorders;   Pain

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Optimizing Drug Therapy in Primary Care: Integrating Pharmacists with Ontario Family Physician Group Practices.

Further Study Details: 
Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  1400

Study start: February 2004;  Expected completion: March 2006
Last follow-up: February 2006;  Data entry closure: February 2006

The overall goal of IMPACT is to improve patient outcomes by optimizing drug therapy through a community practice model that integrates pharmacists into family practices.

This multi-site demonstration project will involve 7 pharmacists, approximately 70 physicians and cover approximately 150,000 patients. Within each practice site, a pharmacist with special clinical training will work 2.5 days per week for 1 year and coordinate a multifaceted intervention aimed at optimizing drug therapy to improve patient outcomes (blood pressure, cholesterol, diabetes, pain control, constipation, etc.) The integrated pharmacist will conduct patient assessments for medication problems, optimize office system medication management (e.g. develop process for handling of medication samples) provide education (academic detailing ) focussed on key therapeutic areas. Pharmacists will be 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 will work 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) will participate in this project.

Quantitative and qualitative methods will be 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 will be evaluated with the aim of generating a practical and transferable practice model. The main hypothesis is that pharmacist integration into family practice will optimize medication use, clinical care and clinical outcomes.


Ages Eligible for Study:  65 Years and above,  Genders Eligible for Study:  Both

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

Location and Contact Information

Please refer to this study by identifier  NCT00157638

Kathryn Gaebel, MSc      905-522-1155  Ext. 4901
Lisa Dolovich, PharmD, MSc      905-522-1155  Ext. 3968

Canada, Ontario
      McMaster University, Hamilton,  Ontario,  L8N 1G6,  Canada; Recruiting
Kathryn Gaebel, MSc  905-522-1155  Ext. 4901 
Lisa Dolovich, PharmD, MSc,  Principal Investigator

      University of Ottawa, Ottawa,  Ontario,  K1N 5C8,  Canada; Recruiting
Kevin Pottie, MD  613-241-1154 
Kevin Pottie, MD,  Principal Investigator

      University of Toronto, Toronto,  Ontario,  M5S 2S2,  Canada; Completed

Study chairs or principal investigators

Lisa Dolovich, PharmD, MSc,  Principal Investigator,  McMaster University, Hamilton, ON   
Kevin Pottie, MD,  Principal Investigator,  University of Ottawa, Ottawa ON   
Janusz Kaczorowski, PhD,  Principal Investigator,  McMaster University, Hamilton, ON   
Barbara Farrell, PharmD,  Principal Investigator,  Elisabeth Bruyere Research Institute, Ottawa, ON   

More Information

Study ID Numbers:  G03-02671
Last Updated:  September 10, 2005
Record first received:  September 8, 2005 Identifier:  NCT00157638
Health Authority: Canada: Health Canada processed this record on 2005-09-13

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