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

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ClinicalTrials.gov Identifier: NCT02963636
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Collaborators:
McGill University
Fonds de la Recherche en Santé du Québec
Université de Sherbrooke
Information provided by (Responsible Party):
Line Guénette, Laval University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Health Services Other: Pharmacist clinical intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Proximity Work in Family Medicine Groups : the Impact of Pharmacists
Study Start Date : August 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of drug related problems [ Time Frame: 3 to 6 months ]

Secondary Outcome Measures :
  1. Regimen complexity [ Time Frame: 3 to 6 months ]
    Medication regimen complexity index (MRCI)

  2. Medication adherence [ Time Frame: 3 to 6 months ]
    Proportion of days covered (PDC)

  3. Quality of care provided by the clinical team (pharmacists, doctors, nurses, etc.) [ Time Frame: 3 to 6 months ]
    Quality indicators (proposed by INESSS)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963636


Locations
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Canada, Quebec
CIUSSS de la Capitale-Nationale
Québec, Quebec, Canada
Sponsors and Collaborators
Laval University
McGill University
Fonds de la Recherche en Santé du Québec
Université de Sherbrooke
More Information
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Responsible Party: Line Guénette, Assistant professor, Laval University
ClinicalTrials.gov Identifier: NCT02963636    
Other Study ID Numbers: 106238
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Line Guénette, Laval University:
family medicine group
pharmacists
primary health care
pharmaceutical services
interprofessional relations