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Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics

Primary Purpose

Diabetes, Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
integration of pharmacist into primary care
optimizing therapeutic treatments
optimizing processes of care
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Diabetes focused on measuring pharmacist, physician, primary care, collaboration, therapeutics

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University
  • University of Ottawa
  • University of Toronto

Outcomes

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

Full Information

First Posted
September 8, 2005
Last Updated
September 8, 2006
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00157638
Brief Title
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

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Hyperlipidemia, Constipation, Pain
Keywords
pharmacist, physician, primary care, collaboration, therapeutics

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
integration of pharmacist into primary care
Intervention Type
Drug
Intervention Name(s)
optimizing therapeutic treatments
Intervention Type
Behavioral
Intervention Name(s)
optimizing processes of care
Primary Outcome Measure Information:
Title
Number and types of patients referred and assessed
Title
Characterization and quantification of pharmacist activities
Title
Numbers and types of drug-related problems identified and resolved
Title
Medication changes made
Title
Number of recommendations implemented
Title
Process indicators (measurement of blood pressure, Cholesterol, hemoglobin A1C)
Title
Surrogate clinical outcomes (values of blood pressure, Cholesterol, hemoglobin A1C)
Title
Symptom improvement (constipation, pain)
Secondary Outcome Measure Information:
Title
Health resource utilization
Title
Satisfaction with service
Title
Uptake of pharmacist recommendations
Title
Extent of knowledge translation
Title
Extent of collaboration
Title
Satisfaction with integrated pharmacist program
Title
Set up costs
Title
Pharmacist and physician time costs
Title
Travel cost
Title
Space requirements
Title
Medication costs
Title
Health services utilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Dolovich, PharmD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Pottie, MD
Organizational Affiliation
University of Ottawa, Ottawa ON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janusz Kaczorowski, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Farrell, PharmD
Organizational Affiliation
Elisabeth Bruyere Research Institute, Ottawa, ON
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1G6
Country
Canada
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S2
Country
Canada

12. IPD Sharing Statement

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Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics

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