CONSTELLATIONS Living Lab: Improving the Care Transitions of Older Adults Living with Neurocognitive Disorders

NCT06608589 | Recruiting DMC

• 1 other identifier: 2023-968, SIRUL 134632
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of major neurocognitive disorders (MNCDs), particularly Alzheimer's disease, among older adults is increasing. These individuals and their caregivers often face challenges due to inefficient and poorly coordinated care transitions, negatively impacting patients, caregivers, healthcare professionals, and the healthcare system itself. To address this, the Quebec Ministry of Health and Social Services has released Phase 3 of its Ministerial Guidance on Major Neurocognitive Disorders, aiming to enhance care coordination between primary healthcare professionals and those living with MNCDs and their caregivers. Quebec's healthcare system comprises various organizations providing care and services to individuals with MNCDs. Each organization faces unique challenges hindering improvement initiatives. However, common obstacles persist: inadequate communication systems for sharing vital information, lack of access to data for measuring care transition quality, and the absence of patient/caregiver satisfaction assessments to inform service enhancements. Additionally, organizations require support in managing change. This need for improvement, coupled with the aspiration for a patient-centered learning health system (LHS), motivated the Institut national d'excellence en santé et services sociaux (INESSS), the Centre intégré de santé et de services sociaux de Chaudière-Appalaches (CISSS CA), and the research team to collaborate on adapting a proven continuous improvement program: the CoMPAS+ MNCD Program. The Program will involve reflecting on best practices and identifying local challenges within participating Family Medicine Groups (FMGs) to propose and implement solutions. The CONSTELLATIONS Living Lab project has been tasked with co-developing, implementing, and evaluating the Program's impact on care transitions over two years. These findings will inform decision-makers and stakeholders about the Program's adaptability to the Chaudière-Appalaches region, guiding local and provincial decision-makers on healthcare system improvements and emphasizing the importance of supporting an LHS.

Conditions

Alzheimer Disease; Dementia; Neurocognitive Decline

Keywords

Quality improvement; Older adults; Learning Health Systems; Implementation science; Health care utilisation; Knowledge translation; Context adaptation; Care transitions; Burden of care; Emergency Department; Home care; Family medicine; Data management; Patient-oriented research; Participatory research; Living Lab; Health services; Neurocognitive disorders; Sustainability; Scale-up

Outcome Measures

Primary Outcomes (1)

• Perceived quality of care: The variation in the Physician Enabling Skills Questionnaire (PESQ) scores.

  The PESQ is a 34-item scale with six subscales, used to assess the ability of family physicians to empower their patients. Total scores range from 34 to 170, with higher scores indicating greater patient autonomy facilitation. The PESQ aligns with recommendations from systematic reviews for improving care transitions, emphasizing patient and caregiver participation, provider empowerment, and decision-maker support for incremental change. This questionnaire demonstrates adequate internal consistency and has been validated in French within Quebec. Pre-Post Comparison: Scores will be compared to identify statistically significant changes from the patient's perspective. A variation of 6.8 PESQ points between T=0 and T=15 months will be considered significant. Subgroup Comparisons: Scores will be analyzed across subgroups based on recruitment points (ED, HCT, FMG) to explore any differences in perceived care quality related to the point of initial contact.

  Between T=0 and T=15 months with an intermediate measure at T=9 months.

Secondary Outcomes (8)

• Quality of life: The variation in the EQ-5D-5L questionnaire scores.

  Between T=0 and T=15 months, with an intermediate measure at T=9 months.

• Treatment burden: The variation in the Multimorbidity Treatment Burden Questionnaire-French (MTBQ-F) scores.

  Between T=0 and T=15 months, with an intermediate measure at T=9 months.

• Caregiver burden: The variation in the Zarit questionnaire scores.

  Between T=0 and T=15 months, with an intermediate measure at T=9 months.

• Qualitative content analysis of the patients and caregivers' wishes (Open-ended question).

  Between T=0 and T=15 months, with an intermediate measures at T=3, 9 and 12 months.

• Variation of the intention of the workshops' participants to apply best pratices in the care for older adults living with a MNCD.

  Between T=0 (pre-workshop) and 6 months post-workshops. 4 measuring points for each arm.

Other Outcomes (1)

• Impact of the Program at the population level: Variations of performance indicators for every LSN

  Before intervention and T=18 months

Study Arms (3)

Local Services Network (LSN) Alphonse-Desjardins

EXPERIMENTAL

The local services network (LSN) Alphonse-Desjardins is set in a urban region with the most important community hospital of the greater region of Chaudière-Appalaches. The CoMPAS+ TNCM workshops (intervention) in the LSN Alphonse-Desjardins will be conducted with health professionals and caregiver partners from the FMG of Lévis (GMF-U de Lévis), the home support services team, and the emergency department of the Hotel-Dieu de Lévis. The population that will be recruited to evaluate the impact of the intervention will have either 1) received home care services within the last 6 months before the intervention; 2) visited the emergency department of Hotel-Dieu de Lévis within the last 6 months before the intervention; or 3) consulted with their primary health care team within the last 6 months before the intervention.

Other: CoMPAS+ MNCDs Program - Quality improvement program targeting the care transitions of patients living with a major neurocognitive disorder and their caregivers

Local Services Network (LSN) Bellechasse

EXPERIMENTAL

The local services network (LSN) of Bellechasse is set in a rural area. The population requiring urgent medical care are lead to Hotel-Dieu de Lévis (45 km, Alphonse-Desjardins) or Hopital de Montgagny (30 km, Montmagny-L'Islet). The CoMPAS+ TNCM workshops (intervention) in the LSN of Bellechasse will be conducted with health professionals and caregiver partners from the FMG Rive de l'Etchemin (GMF Rive de l'Etchemin) which comprises the organisational merging of 2 medical clinics. Will also participate in the workshops members the home care team. The population that will be recruited to evaluate the impact of the intervention will have either 1) received home care services within the last 6 months before the intervention; 2) visited one of the 2 emergency departments (Hotel-Dieu de Lévis or Hopital de Montmagny) within the last 6 months before the intervention; or 3) consulted with their primary care team within the last 6 months before the intervention.

Other: CoMPAS+ MNCDs Program - Quality improvement program targeting the care transitions of patients living with a major neurocognitive disorder and their caregivers

Local Services Network (LSN) Montmagny-L Islet

EXPERIMENTAL

The local services network (LSN) Montmagny-L'Islet is set in a semi-urban region with a small community hospital. The CoMPAS+ TNCM workshops (intervention) in the LSN Montmagny-L'Islet will be conducted with health professionals and careviver partners from the FMG of Montmagny (GMF de Montmagny) which comprises the organisational merging of 5 different medical clinics in the region. Will also participate in the workshops are healthcare professionals from the home care services team, and from the emergency department of the Hopital de Montmagny. The population that will be recruited to evaluate the impact of the intervention will have either 1) received home care services within the last 6 months before the intervention; 2) visited the emergency department of Hopital de Montmagny within the last 6 months before the intervention; or 3) consulted with their family doctor within the last 6 months before the intervention.

Other: CoMPAS+ MNCDs Program - Quality improvement program targeting the care transitions of patients living with a major neurocognitive disorder and their caregivers

Interventions

CoMPAS+ MNCDs Program - Quality improvement program targeting the care transitions of patients living with a major neurocognitive disorder and their caregivers OTHER

COMPAS+ is a collaborative approach to improving healthcare quality. It brings together around 30 individuals, including healthcare professionals, deciders, and patient partners, to identify improvement goals, develop action plans, and enhance the prevention and management of chronic diseases. In this study, the investigators adapt COMPAS+ to focus on improving care transitions for patients with major neurocognitive disorders (MNCDs) and their caregivers. Through reflective workshops and collaborative problem-solving, this diverse group will identify best practices and create action plans to enhance care quality.

Local Services Network (LSN) Alphonse-Desjardins; Local Services Network (LSN) Bellechasse; Local Services Network (LSN) Montmagny-L Islet

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Be 65 years of age or older;
• Be living with a major neurocognitive disorder in the process of clinical evaluation or already diagnosed;
• Reside in the socio-sanitary region of the CISSS CA;
• Be able to consent independently to research (for users without caregivers at the beginning of their illness);
• Reside at home or in a retirement home or in an intermediate residence or a family-type resources;
• Consent to the research team collecting data in their medical records (FMG Electronic Medical Record (EMR) when accessible, Hospital Electronic Patient Record (EPR) when accessible, etc.).
• Be the caregiver of a person 65 years of age and older living with a major neurocognitive disorder in the process of clinical evaluation or already diagnosed;
• The person being cared for must reside in the socio-sanitary region of the CISSS CA;
• Consent to the research team collecting data from the medical records of the person being cared for (FMG Electronic Medical Record (EMR) when accessible, Hospital Electronic Patient Record (EPR) when accessible, etc.);
• Be able to consent independently to research.

You may not qualify if:

• Users living with major neurocognitive disorder under 65 years of age;
• User living in a provincial long-term care facility at the time of recruitment;
• User 65 years of age and older living with a major neurocognitive disorder, unable to consent independently to research, without a caregiver, or without a caregiver able to consent independently to research;
• Users aged 65 and over living with a major neurocognitive disorder, residing in a territory other than that of the CISSS CA;
• User refusing to consent to the collection of data in their medical records; OR
• Caregiver of a user living with a major neurocognitive disorder who does not reside in the CISSS CA territory or who is not 65 years of age or does not live at home, in a retirement home or in an IR or who died before the start of the study (T=0).
• Caregiver refusing to consent to the collection of data in the medical records of the person being cared for.
• Study population for the assessment of the intention to apply best practices of CoMPAS+ MNCD workshop participants (Meso level)
• ● Be a participant in the CoMPAS+ MNCD workshops and be part of at least one of the following categories of participants:
• Health professionals working in a CISSS CA health facility or with a community organization;
• CISSS CA decision-makers or local managers;
• Community service representative (e.g., Alzheimer's Society, L'APPUI);
• Research team members
• Workshop facilitators
• INESSS professionals

Sponsors & Collaborators

• Laval University: lead
• CISSS de Chaudière-Appalaches: collaborator
• Institut national d'excellence en santé et service sociaux: collaborator

Study Sites (1)

Patrick Archambault

Québec, Quebec, G6V 3Z1, Canada

RECRUITING

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Related Links

• Publications du ministère de la Santé et des Services sociaux. Orientations ministérielles sur les troubles neurocognitifs majeurs - Phase 3
• Publications du ministère de la Santé et des Services sociaux. Politique nationale pour les personnes proches aidantes - Reconnaître et soutenir dans le respect des volontés et des capacités d\'engagement.
• Publications du ministère de la Santé et des Services sociaux. Guide de mise en oeuvre pour le déploiement des meilleures pratiques cliniques et organisationnelles dans les CISSS et les CIUSSS - Seconde phase des travaux 2016 à 2019.
• Projet GPS : Évaluation de l'impact de la réorganisation du travail dans les Groupes de médecine de famille (GMF) sur la Pharmacothérapie et le Soutien à l'autonomie des personnes âgées.
• The National Leader In Patient and Family Centered Care Transitions Under the direction of Eric A. Coleman, MD, MPH, The Care Transitions Program provides insights and tools for how to improve quality and manage risk during care hand-overs.
• Implementation Practice and Science: Authors Dean Fixsen, Karen Blase, and Melissa Van Dyke summarize and synthesize advancements in implementation practice and science over the past 50 years.

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Emergencies; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick M Archambault, MD, MSc, FRCPC

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick M Archambault, MD MSc FRCPC

CONTACT

4189552552; patrick.archambault.med@ssss.gouv.qc.ca

Martyne Audet, MSc

CONTACT

4186090734; martyne.audet.cisssca@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patrick Archambault, MD, MSc, FRCPC. FRQS Senior Clinical Research Scholar. Professor, Department of Family Medicine and Emergency Medicine Department of Anesthesiology and Intensive Care, Université Laval.

Model Details: This study employs a mixed-methods, multilevel, quasi-experimental design with a pre-post evaluation to assess the impact of the CoMPAS+ MNCD Program intervention. Micro level: Quantitative and qualitative assessment of the impact of the CoMPAS+ MNCD Program on the patient reported experience in care transitions. Meso level (behaviour): Quantitative assessment of the intention of participating health care professionals to apply best practices in care transitions of patients living with a MNCD. Meso level (organisational): Quantitative and qualitative assessment of the implementation process, sustainability factors and scaling potential of the Program. Macro level: Comparison of administrative performance indicators between the arms and the control population (non participating LSNs in the greater Chaudière-Appalaches region and other socio-sanitary regions in the province of Quebec)

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: March 14, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)