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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCHU de Quebec-Universite Laval

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Seniors in palliative care OR

unable to answer questionnaires in French AND without a caregiver.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GPS clinical intervention

    Other 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Exposed FMGs to GPS interventionExperimental treatment 1 intervention
Group B: Non exposed FMGs to GPS interventionNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Change in treatment burden

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)

Time frame
Baseline and 6 months follow-up

Other outcomes

1

Change in number of hospitalizations

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

Time frame
12 months prior to the start of the intervention and in the 12 months afterwards
2

Change in number of emergency room visits

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.

Time frame
12 months prior to the start of the intervention and in the 12 months afterwards
3

Change in quality of life

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.

Time frame
Baseline and 6 months follow-up

Sponsors and contacts

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CHU de Quebec-Universite Laval

Lead sponsor

CISSS de Chaudière-Appalaches

Collaborator

Ciusss de L'Est de l'Île de Montréal

Collaborator

Fonds de la Recherche en Santé du Québec

Collaborator