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

Официальное название

CONSTELLATIONS Living Lab: Development, Implementation and Evaluation of a Patient-oriented Quality Improvement Program Targeting Care Transitions of Older Adults Living with Major Neurocognitive Disorders and Their Caregivers.

Обзор

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.

Подробное описание

1. BACKGROUND

1.1 Context

Patients living with major neurocognitive disorders (MNCDs) often experience inadequate care transitions, a consequence of a healthcare system struggling to adapt to their unique needs. While emergency department (ED) visits by older adults, driven by chronic illnesses, acute conditions, or social challenges, can be lifesaving, they can also lead to adverse events, unplanned readmissions (10-30%), and declines in physical, functional, and cognitive abilities. This results in distress and dissatisfaction among patients, caregivers, and healthcare workers.

Inefficient communication and information sharing between healthcare providers further complicate the care continuum, forcing older adults and their caregivers to navigate a fragmented system they may not fully understand. To address this, the Ministerial Plan on Major Neurocognitive Disorders (The Quebec Alzheimer Plan) emphasizes interprofessional collaboration within Family Medicine Groups (FMGs) to enhance diagnosis, treatment, and follow-up for individuals with MNCDs and their caregivers. Phase 3 of this plan, launched in 2021, specifically targets improving care transitions.

In 2018, the Institut national de santé et services sociaux (INESSS), the Centre intégré de services sociaux de Chaudière-Appalaches (CISSS CA), and a research team initiated the design of a program aimed at improving healthcare transitions for those with MNCDs. Following a pandemic-related pause, they resumed work in September 2021, adapting an existing quality improvement program for implementation within FMGs in the CISSS CA region.

1.2. CoMPAS+ Workshop Program

The Collective for Best Practices and the Improvement of Local Care and Services+ (CoMPAS+), led by INESSS, is a Quebec program fostering a culture of continuous improvement among integrated community service stakeholders. CoMPAS+ aims to enhance the quality of prevention and follow-up for individuals at risk of, or living with, chronic diseases. Its reflective practice workshops establish the foundation for continuous improvement projects by fostering a shared understanding of challenges related to a specific issue and promoting knowledge exchange through team reflexivity.

Workshops commence with presentations on best practices, service utilization data, experiential knowledge from stakeholders (including patients, caregivers, and professionals), and local/regional resources relevant to the targeted disease. This shared understanding enables the identification of priority challenges and subsequent reflection on potential actions to improve quality and address these challenges.

These workshops target key individuals within Family Medicine Groups (FMGs), Local Services Networks (LSNs), and local/regional partners. Importantly, they also include users or caregiver partners selected for their commitment and ability to contribute valuable insights. While group composition varies based on context, it generally includes: * Users or caregivers (mandatory participation) * Family physicians * Medical specialists relevant to the targeted chronic disease * Nurse practitioners specializing in primary care * Other professionals (social workers, respiratory therapists, nutritionists, occupational therapists, special educators, etc.) * Community and institutional pharmacists * Managers * Other individuals deemed relevant by the community

1.3. Levels of assessment

The research activities outlined in this protocol focus solely on evaluating the Program's impacts. This evaluation will be conducted at multiple levels, considering the scale of application for each activity: 1. Micro level: Assessing the impact on users and/or caregivers. 2. Meso level: Examining the effects on the organizations involved in the co-creation, implementation, and participation in the workshops. 3. Macro level: Evaluating the broader impact on the population. 2. OBJECTIVES

2.1 Primary Objective (Micro Level)

Quantitatively evaluate the impact of the Program on care transitions for patients with MNCD and their caregivers by assessing their perceived quality of care and services from the primary care team.

2.2 Secondary Objectives (Micro Level)

Qualitatively assess perceptions of care transition quality to understand patient and caregiver experiences.

Evaluate the Program's impact on the quality of life for individuals with MNCD and their caregivers.

Assess the burden of treatment (e.g., efforts to manage health and its impact on daily life).

Evaluate the Program's impact on caregiver burden for those caring for older adults with MNCD in the CISSS CA region.

Assess the Program's impact on emergency department visits for individuals with MNCD in participating Local Services Networks (LSNs).

2.3 Secondary Objective (Meso Level - Workshop Participants)

Assess the Program's influence on workshop participants' intention to implement best practices in care transitions for individuals with MNCD and their caregivers.

2.4 Secondary Objectives (Meso Level - Organizational)

Identify obstacles and facilitators influencing the sustainability of the Program within the CISSS CA.

Evaluate the potential for scaling up the Program within the CISSS CA based on the current experience.

Recommend actions to improve the feasibility, implementation, sustainability, and scalability of the Program within the CISSS CA's FMGs.

2.5 Secondary Objectives (Macro Level)

Compare performance indicators and their changes over time between participating FMGs in selected LSNs and control LSNs (non-participating FMGs/LSNs).

Assess the Program's impact on emergency department visits for people with MNCD in participating LSNs compared to non-participating LSNs (control LSNs). 3. STUDY DESIGN

To achieve the research objectives, a mixed-methods approach will be employed. The project design involves a pre-post quasi-experimental multi-level study evaluating the impact of the CoMPAS+ MNCD Program intervention. This intervention targets clusters of professionals working within the same Local Services Network (LSN) and focuses on a specific Family Medicine Group (FMG) within that LSN. 4. STUDY POPULATIONS

4.1 Study Population for Impact Evaluation at the User and Caregiver Level (Micro Level)

To assess the CoMPAS+ MNCD Program's impact within each participating Local Services Network (LSN), three distinct LSNs will establish three cohorts. Each cohort will consist of dyads comprising individuals living with a Major Neurocognitive Disorder (MNCD) and their caregivers. Recognizing that individuals with MNCD may face challenges participating, caregivers may represent their dyad independently.

Individuals with MNCD: Must reside within the socio-sanitary region served by the CISSS CA.

Caregivers: While ideally residing within the same socio-sanitary region, caregivers from other regions may also be included.

4.2. Study Populations at the Meso Level

Impact of workshops on participants' intentions to apply good practices: Workshop participants

Identification of obstacles and facilitators influencing the sustainability of the Program: Workshops participants, organizers and research team.

Evaluation of the potential for scaling up the Program: Workshops participants, organizers and research team.

See Eligibility section for details. 5. RECRUITMENT PROCESSES

5.1. Micro Level Recruitment (Patients and Caregivers)

Within each of the 3 participating LSNs, participants will be recruited from three service points: Emergency Department (ED), Home Care Team (HCT), and Family Medicine Group (FMG). The following steps will be followed at each point:

Вмешательства

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

Первичные конечные точки

• Perceived quality of care: The variation in the Physician Enabling Skills Questionnaire (PESQ) scores. [Срок оценки: Between T=0 and T=15 months with an intermediate measure at T=9 months.]

Вторичные конечные точки (8)

• Quality of life: The variation in the EQ-5D-5L questionnaire scores. [Срок оценки: 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. [Срок оценки: Between T=0 and T=15 months, with an intermediate measure at T=9 months.]
• Caregiver burden: The variation in the Zarit questionnaire scores. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: Between T=0 (pre-workshop) and 6 months post-workshops. 4 measuring points for each arm.]
• Identification of the obstacles and levers to the sustainability of the Program [Срок оценки: T=0 and T=12 months with every arm.]
• Program Scale-Up Potential: Variation of the ISSaQ 4.0 scores. [Срок оценки: T=0 and T=12 months with every cohort.]
• Preparedness of caregivers to transitions: Variation of the Family Caregiver Activation in Transitions (FCAT) scores. [Срок оценки: Between T=0 and T=15 months, with an intermediate measure at T=9 months.]

Критерии участия

Study population for the evaluation of the impact of the CoMPAS+ MNCD Program on the care transitions of patients living with MNCD and their caregivers (Micro level)

Критерии включения

• 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.).

OR

• 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.

Критерии исключения

• 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)

Критерии включения

● 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);

Критерии исключения

• Research team members
• Workshop facilitators
• INESSS professionals
• Users and partner caregivers
• Person unable to consent
• Person refusing to consent

Study population for the evaluation of the potential to scale-up and sustainability of the CoMPAS+ MNCD Program within the CISSS CA (Meso level)

Критерии включения

● Be part of one of the following categories of actors and be involved in the implementation of the CoMPAS+ MNCD Program:

• Health professionals working at the CISSS CA or in the community participating in the CoMPAS+ MNCD workshops;
• CISSS CA decision-makers;
• Users and partner caregivers;
• Community service representatives (e.g., Alzheimer's Society, L'APPUI);
• Members of the research team (except the person in charge of this component (Laetitia Bert), Alexander Cornea (research assistant), Martyne Audet (scientific coordinator), Clémence Dallaire, André Côté, Félix Pageau, Catherine Paquet);
• Research coordinator responsible for the involvement of partner users in the conduct of the workshops (Émilie Côté);
• INESSS professionals;
• Workshop facilitators
• Representative of the Ministry of Health and Social Services (MSSS).

Критерии исключения

• Person unable to consent;
• A person refusing to consent;
• Member of the research team responsible for carrying out this part of the study or by the scientific coordination of this project (Laetitia Bert, Alexander Cornea, Martyne Audet (scientific coordinator), Clémence Dallaire, André Côté, Félix Pageau, Catherine Paquet).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Канада · 1 центр

• Patrick Archambault — Québec

Публикации

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Идентификаторы

NCT: NCT06608589 · 2023-968, SIRUL 134632

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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