GPS Project Evaluation of the Impact of the Reorganization of Work Into a Family Medicine Group on Pharmacotherapy and Support for the Autonomy of Seniors With Major Neurocognitive Disorders

NCT ID: NCT04889794

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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: The GPS project is part of the desire to keep seniors with major neurocognitive disorder (MCND) in their homes for as long as possible. Medication can contribute to cognitive loss in seniors and affect their functional autonomy. The arrival of pharmacists in FMGs and the expansion of their practice is opening up new opportunities to promote interdisciplinary collaboration and optimize pharmacotherapy for seniors. During the project, a new model of care, called GPS, is being tested with seniors. A group of seniors (approximately 200) will receive the new care team's new interventions in the FMGs in the "intervention" group. Another group of seniors (about 200) will receive the usual care in other FMGs that will serve as a "control" group. By comparing the results of the two groups, it will be possible to evaluate the effects of new interventions. A period of 12 months will be allocated for the inclusion of seniors. The follow-up of each senior will be approximately 6 months.

Conditions

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Major Neurocognitive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Exposed FMGs to GPS intervention

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

Group Type EXPERIMENTAL

GPS clinical intervention

Intervention Type OTHER

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.

Non exposed FMGs to GPS intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GPS clinical intervention

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Seniors in palliative care OR
* unable to answer questionnaires in French AND without a caregiver.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CISSS de Chaudière-Appalaches

OTHER_GOV

Sponsor Role collaborator

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Dre Edeltraut Kröger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Line Guénette, Ph.D

Role: STUDY_DIRECTOR

CHU de Québec-Université Laval, Laval University

Locations

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GMF Bordeaux-Cartierville

Montreal, Quebec, Canada

Site Status RECRUITING

GMF Abénakis

Saint-Georges, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Line Guénette, Ph.D

Role: CONTACT

418-682-7511 ext. 84694

Edeltraut Kröger, Ph.D

Role: CONTACT

418-525-4444 ext. 84834

Facility Contacts

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Line Guénette, Ph.D

Role: primary

418-682-7511 ext. 84694

Line Guénette, Ph.D

Role: primary

418-682-7511 ext. 84694

References

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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.

Reference Type DERIVED
PMID: 36264995 (View on PubMed)

Other Identifiers

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MP-23-2020-732 - GPS

Identifier Type: -

Identifier Source: org_study_id

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