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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorLaval University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

700 Participants
are divided into 3 treatment groups
Group A: Local Services Network (LSN) Alphonse-DesjardinsExperimental treatment 1 intervention
Group B: Local Services Network (LSN) BellechasseExperimental treatment 1 intervention
Group C: Local Services Network (LSN) Montmagny-L IsletExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

The EQ-5D-5L is a widely-used instrument for assessing both health status and health-related quality of life.This standardized tool evaluates five key dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Within each dimension, individuals indicate their level of severity across five response options, allowing for a nuanced understanding of their health state. Primary Comparison: Pre-intervention (T=0) vs. Post-intervention (T=15 months) to assess the overall impact of the CoMPAS+ MNCD Program. Secondary Comparisons: Changes between T=0 and T=9 months, and between T=9 months and T=15 months to track the trajectory of changes over time. Subgroup Analyses: Changes between different subgroups (e.g., recruitment points: ED, HCT, FMG)

Time frame
Between T=0 and T=15 months, with an intermediate measure at T=9 months.
2

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

The Multimorbidity Treatment Burden Questionnaire, French-Canadian version (MTBQ-F), is a brief, 13-item tool designed to assess the treatment burden experienced by adults with chronic conditions. It identifies individuals with high treatment burdens and evaluates the impact of interventions aimed at improving their quality of care and life. MTBQ-F scores categorize treatment burden as follows: no burden (0), low (below 10), medium (10-22), and heavy (22 and over). The questionnaire boasts strong internal consistency and serves as a valuable resource for gauging the effectiveness of interventions intended to reduce treatment burden and enhance care transitions. Primary Comparison: Pre-intervention (T=0) scores vs. Post-intervention (T=15 months) scores to assess the overall impact of the Program on the treatment burden experienced by the older adults living with a MNCD. Subgroup Analyses: Changes between different subgroups (e.g., recruitment points: ED, HCT, FMG)

Time frame
Between T=0 and T=15 months, with an intermediate measure at T=9 months.
3

Caregiver burden: The variation in the Zarit questionnaire scores.

The Zarit Burden Interview is the most widely used standardized tool for assessing caregiver burden. It presents caregivers with a series of 12 questions (shortened version) about the challenges they face in caring for individuals with mild neurocognitive disorder (MNCD). Caregivers respond to each statement on a 5-point Likert scale, indicating their level of agreement. The total score, ranging from 0 to 48, is calculated by summing the responses to all 12 items. Higher scores reflect a heavier burden, with scores above 20 indicating a severe burden. Primary Comparison: Pre-intervention (T=0) scores vs. Post-intervention (T=15 months) scores to assess the overall impact of the Program on the caregivers' burden. Secondary Comparisons: Changes between T=0 and T=9 months, and between T=9 months and T=15 months to track the trajectory of changes over time. Subgroup Analyses: Changes between different subgroups (e.g., recruitment points: ED, HCT, FMG)

Time frame
Between T=0 and T=15 months, with an intermediate measure at T=9 months.
4

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

At the conclusion of each telephone interview, participants will be posed an open-ended question asking the participants what they would change in the healthcare system if they had a magic wand. An inductive approach will be used to iteratively develop codes and themes to categorize patient responses. This question will be asked to both patients and caregivers five times throughout their participation: at baseline (T=0), and at 3, 9, 12, and 15 months.

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

Other outcomes

1

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

This analysis will compare performance indicators (number of ED visits, number of home care services, others) and their evolution over time between two groups: Participating FMGs (Family Medicine Groups) within selected Local Services Networks (LSNs). Control LSNs - These are LSNs with non-participating FMGs, serving as a comparison group. Leveraging data provided and overseen by INESSS, the impact of the CoMPAS+ TNCM workshops will be assessed by comparing performance indicators at two key time points: Baseline: Indicator values from the pre-workshop years (2018-2021). Post-Intervention: Indicator values in the years following the workshop (2023-2025). This comparison will reveal changes in performance indicators over time and any differences between the participating FMGs and the control group.

Time frame
Before intervention and T=18 months

Sponsors and contacts

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Laval University

Lead sponsor

CISSS de Chaudière-Appalaches

Collaborator

Institut national d'excellence en santé et service sociaux

Collaborator