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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

Primary Purpose

Major Neurocognitive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GPS clinical intervention
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Neurocognitive Disorder focused on measuring living lab, major neurocognitive disorder, polypharmacy, health outcomes, pharmacists, home care, family medicine groups, deprescribing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GMF Bordeaux-CartiervilleRecruiting
  • GMF AbénakisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exposed FMGs to GPS intervention

Non exposed FMGs to GPS intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
May 12, 2021
Last Updated
January 21, 2022
Sponsor
CHU de Quebec-Universite Laval
Collaborators
CISSS de Chaudière-Appalaches, CIUSSS du Nord-de-l'Île-de-Montréal, Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT04889794
Brief 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
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
CISSS de Chaudière-Appalaches, CIUSSS du Nord-de-l'Île-de-Montréal, Fonds de la Recherche en Santé du Québec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Neurocognitive Disorder
Keywords
living lab, major neurocognitive disorder, polypharmacy, health outcomes, pharmacists, home care, family medicine groups, deprescribing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposed FMGs to GPS intervention
Arm Type
Experimental
Arm Description
Patients who are followed by FMGs exposed to the GPS intervention. They will receive the GPS intervention.
Arm Title
Non exposed FMGs to GPS intervention
Arm Type
No Intervention
Arm Description
Patients who are part of the FMGs not exposed to the GPS intervention. They will receive the usual care and services.
Intervention Type
Other
Intervention Name(s)
GPS clinical intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in number of prescribed medications
Description
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 Outcome Measure Information:
Title
Change in treatment burden
Description
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 Pre-specified Outcome Measures:
Title
Change in number of hospitalizations
Description
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
Title
Change in number of emergency room visits
Description
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
Title
Change in quality of life
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Line Guénette, Ph.D
Phone
418-682-7511
Ext
84694
Email
line.guenette@pha.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Edeltraut Kröger, Ph.D
Phone
418-525-4444
Ext
84834
Email
edeltraut.kroger.ciussscn@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Guénette, Ph.D
Organizational Affiliation
CHU de Québec-Université Laval, Laval University
Official's Role
Study Director
Facility Information:
Facility Name
GMF Bordeaux-Cartierville
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3M 2X6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Guénette, Ph.D
Phone
418-682-7511
Ext
84694
Email
line.guenette@pha.ulaval.ca
Facility Name
GMF Abénakis
City
Saint-Georges
State/Province
Quebec
ZIP/Postal Code
G5Y 5L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Guénette, Ph.D
Phone
418-682-7511
Ext
84694
Email
line.guenette@pha.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Edeltraut Kröger, Ph.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
36264995
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.
Results Reference
derived

Learn more about this trial

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

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