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NCT Number: 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

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.

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Key information

Conditions

Major Neurocognitive Disorder

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GMF Bordeaux-Cartierville, Montreal, Quebec, Canada

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About this study

: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GPS clinical intervention

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.

Primary outcomes

  1. Change in number of prescribed medications

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

    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.

Secondary outcomes

  1. Change in treatment burden

    Time frame: Baseline and 6 months follow-up

    The treatment burden level will be measured with the 13-item Multimorbidity Treatment burden questionnaire in the intervention and control groups before and after the study. Each item will be scored as follows: zero (not difficult/ does not apply), one (a little difficult), two (quite difficult), three (very difficult), four (extremely difficult).Scores will be interpreted as suggested by the authors of the original MTBQ instrument: no burden (score 0), low burden (score <10), medium burden (10-22), high burden (>=22)

Other outcomes

  1. Change in number of hospitalizations

    Time frame: 12 months prior to the start of the intervention and in the 12 months afterwards

    The number of hospitalizations in the 12 months prior to the start of the intervention and in the 12 months afterwards will be evaluated by the exploration of the RAMQ data record with the consent of the participant in the intervention and control groups

  2. Change in number of emergency room visits

    Time frame: 12 months prior to the start of the intervention and in the 12 months afterwards

    The number of emergency room visits in the 12 months prior to the start of the intervention and in the 12 months afterwards will be evaluated by the exploration of the RAMQ data record with the consent of the participant in the intervention and control groups.

  3. Change in quality of life

    Time frame: Baseline and 6 months follow-up

    The measure of quality of live will be perform two times with the EQ-5D-5L in the intervention and control groups before and after the study. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' is always coded as '2'. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state. For example, 21111 means slight problems in the mobility dimension and no problems in any of the other dimensions.

Study contacts

Contact information is provided by the study sponsor or research team.

Edeltraut Kröger, Ph.D

CONTACT

[email protected]

418-525-4444 ext. 84834

Line Guénette, Ph.D

CONTACT

[email protected]

418-682-7511 ext. 84694

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • CISSS de Chaudière-Appalaches
  • Ciusss de L'Est de l'Île de Montréal
  • Fonds de la Recherche en Santé du Québec

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 17, 2021
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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