Proximity Work in Family Medicine Groups : the Impact of Pharmacists (FMG)

November 14, 2016 updated by: Line Guénette, Laval University
The project objective is to evaluate the impact of the recent addition of pharmacists within family medicine groups (FMGs) on organizational and clinical parameters. The process by which changes occur and the level of pharmacists' activities will also be assessed. The ultimate goal of the project is the development of an accompanying guide to facilitate the work of the pharmacist in monitoring complex patients in primary care medical clinics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada
        • CIUSSS de la Capitale-Nationale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing to meet with the pharmacist and;
  • Consuming drugs of four or more different pharmacological classes or having to take at least four doses per day and;
  • aged 70 or over with at least two criteria of vulnerability or aged less than 70 with at least 3 criteria of vulnerability or had a recent loss of autonomy or in post- hospitalization with medication changes in the hospital.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist clinical intervention
Patients exposed to the pharmacist intervention
Other: Pharmacist clinical intervention
Pharmacists will make a clinical intervention with patients. They will review patient drug therapy already prescribed in their usual care. This includes a medication reconciliation, an assessment of drug related problems, an assessment of the regimen complexity and adherence to treatment. A care plan will be elaborated. Moreover, immediate and future interventions with the patient or other health professionals will be implemented and monitored. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of drug related problems
Time Frame: 3 to 6 months
3 to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regimen complexity
Time Frame: 3 to 6 months
Medication regimen complexity index (MRCI)
3 to 6 months
Medication adherence
Time Frame: 3 to 6 months
Proportion of days covered (PDC)
3 to 6 months
Quality of care provided by the clinical team (pharmacists, doctors, nurses, etc.)
Time Frame: 3 to 6 months
Quality indicators (proposed by INESSS)
3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

McGill University
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 106238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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