Clinical trial NCT04889794: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Neurocognitive Disorder
Keywords: living lab
major neurocognitive disorder
polypharmacy
health outcomes
pharmacists
home care
family medicine groups
deprescribing
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: CISSS de Chaudière-Appalaches
name: Ciusss de L'Est de l'Île de Montréal
name: Fonds de la Recherche en Santé du Québec
First posted: 2021-05-17
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: : 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of prescribed medications
timeFrame: Baseline, 3 months and 6 months after inclusion in the study.
Secondary outcomes:
measure: Change in treatment burden
timeFrame: Baseline and 6 months follow-up
Other outcomes:
measure: Change in number of hospitalizations
timeFrame: 12 months prior to the start of the intervention and in the 12 months afterwards
measure: Change in number of emergency room visits
timeFrame: 12 months prior to the start of the intervention and in the 12 months afterwards
measure: Change in quality of life
timeFrame: Baseline and 6 months follow-up
Locations:
city: Montréal
country: Canada
facility: GMF Bordeaux-Cartierville
state: Quebec
city: Saint-Georges
country: Canada
facility: GMF Abénakis
state: Quebec
Study officials:
affiliation: CHU de Québec-Université Laval, Laval University
name: Line Guénette, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.