NCT00157638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Feb 2004

Typical duration for phase_4 diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

September 8, 2005

Last Update Submit

September 8, 2006

Conditions

Keywords

pharmacistphysicianprimary carecollaborationtherapeutics

Outcome Measures

Primary Outcomes (8)

  • 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 (12)

  • Health resource utilization

  • Satisfaction with service

  • Uptake of pharmacist recommendations

  • Extent of knowledge translation

  • Extent of collaboration

  • +7 more secondary outcomes

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McMaster University

Hamilton, Ontario, L8N 1G6, Canada

Location

University of Ottawa

Ottawa, Ontario, K1N 5C8, Canada

Location

University of Toronto

Toronto, Ontario, M5S 2S2, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionHyperlipidemiasConstipationPain

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Study Completion

July 1, 2006

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations