NCT04889794

Brief Summary

The model of care tested in the GPS project aims to optimize pharmacotherapy for seniors undergoing cognitive assessment or suffering from major neurocognitive disorder (MCND) at home. The goal is to reduce polymedication, inappropriate medications and the treatment burden of seniors and to maintain their cognitive health, quality of life and autonomy. The intervention will include knowledge exchange sessions with nurses, pharmacists, and doctors in FMGs, and increased collaboration between these professionals and home care services teams. Other goal is to increase the satisfaction of the seniors, their families, and the professionals involved in the GPS project.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress89%
Sep 2021Dec 2026

First Submitted

Initial submission to the registry

May 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

3.8 years

First QC Date

May 12, 2021

Last Update Submit

August 20, 2024

Conditions

Keywords

living labmajor neurocognitive disorderpolypharmacyhealth outcomespharmacistshome carefamily medicine groupsdeprescribing

Outcome Measures

Primary Outcomes (1)

  • Change in number of prescribed medications

    The total number of prescribed medications and 2) the number of potentially inappropriate medications (PIMs) according to the Beers criteria or according to the OptimaMed criteria for participants with advanced MCND will be measured in both groups, before, during and after the study.

    Baseline, 3 months and 6 months after inclusion in the study.

Secondary Outcomes (1)

  • Change in treatment burden

    Baseline and 6 months follow-up

Other Outcomes (3)

  • Change in number of hospitalizations

    12 months prior to the start of the intervention and in the 12 months afterwards

  • Change in number of emergency room visits

    12 months prior to the start of the intervention and in the 12 months afterwards

  • Change in quality of life

    Baseline and 6 months follow-up

Study Arms (2)

Exposed FMGs to GPS intervention

EXPERIMENTAL

Patients who are followed by FMGs exposed to the GPS intervention. They will receive the GPS intervention.

Other: GPS clinical intervention

Non exposed FMGs to GPS intervention

NO INTERVENTION

Patients who are part of the FMGs not exposed to the GPS intervention. They will receive the usual care and services.

Interventions

Nurses and doctors in exposed FMGs and home care teams (HCTs) will be asked to refer to the FMG pharmacist all seniors undergoing cognitive evaluation OR referred to a memory clinic OR recently diagnosed with a cognitive disorder, for a complete and critical review of their medication therapy. FMG pharmacists will be asked to conduct an interview with each referred senior and his or her caregiver, if applicable, in order to establish the best possible treatment regimen. They will compare the information collected with another reliable data source (e.g., pharmacy records) in order to perform medication reconciliation and will then evaluate the medication related problems. Pharmacist will establish a care plan and the follow-ups to be carried out with the patient in collaboration with the health care team. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist.

Exposed FMGs to GPS intervention

Eligibility Criteria

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

You may qualify if:

  • All seniors (65 years of age or older) undergoing cognitive evaluation OR referred to a memory clinic OR having been diagnosed with cognitive impairment within the last year OR with MCND and followed up at home AND,
  • referred to the pharmacist, for the FMGs exposed
  • taking prescription medications

You may not qualify if:

  • Seniors in palliative care OR
  • unable to answer questionnaires in French AND without a caregiver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GMF Bordeaux-Cartierville

Montreal, Quebec, H3M 2X6, Canada

RECRUITING

GMF Abénakis

Saint-Georges, Quebec, G5Y 5L6, Canada

RECRUITING

Related Publications (1)

  • Guenette L, Kroger E, Bonnan D, Maheu A, Morin M, Belanger L, Vedel I, Wilchesky M, Sirois C, Durand E, Couturier Y, Sourial N, Dallaire C. Reorganizing Pharmaceutical Care in Family Medicine Groups for Older Adults With or at Risk of Major Neurocognitive Disorders: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2022 Nov 17;11(11):e42577. doi: 10.2196/42577.

Study Officials

  • Line Guénette, Ph.D

    CHU de Québec-Université Laval, Laval University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 17, 2021

Study Start

September 27, 2021

Primary Completion

July 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations