NCT02963636

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

February 17, 2016

Last Update Submit

November 14, 2016

Conditions

Keywords

family medicine grouppharmacistsprimary health carepharmaceutical servicesinterprofessional relations

Outcome Measures

Primary Outcomes (1)

  • Number of drug related problems

    3 to 6 months

Secondary Outcomes (3)

  • Regimen complexity

    3 to 6 months

  • Medication adherence

    3 to 6 months

  • Quality of care provided by the clinical team (pharmacists, doctors, nurses, etc.)

    3 to 6 months

Study Arms (1)

Pharmacist clinical intervention

EXPERIMENTAL

Patients exposed to the pharmacist intervention

Other: Pharmacist clinical intervention

Interventions

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.

Pharmacist clinical intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS de la Capitale-Nationale

Québec, Quebec, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 17, 2016

First Posted

November 15, 2016

Study Start

August 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations