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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Perceived quality of care: The variation in the Physician Enabling Skills Questionnaire (PESQ) scores.
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Inclusion criteria:
- •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.
排除标准
- •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)
- •Inclusion criteria:
- •● 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);
- •Exclusion criteria:
- •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)
- •Inclusion criteria
- •● 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).
- •Exclusion criteria
- •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).
研究组 & 干预措施
Local Services Network (LSN) Alphonse-Desjardins
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.
干预措施: CoMPAS+ MNCDs Program - Quality improvement program targeting the care transitions of patients living with a major neurocognitive disorder and their caregivers (Other)
Local Services Network (LSN) Bellechasse
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.
干预措施: CoMPAS+ MNCDs Program - Quality improvement program targeting the care transitions of patients living with a major neurocognitive disorder and their caregivers (Other)
Local Services Network (LSN) Montmagny-L Islet
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.
干预措施: CoMPAS+ MNCDs Program - Quality improvement program targeting the care transitions of patients living with a major neurocognitive disorder and their caregivers (Other)
结局指标
主要结局
Perceived quality of care: The variation in the Physician Enabling Skills Questionnaire (PESQ) scores.
时间窗: Between T=0 and T=15 months with an intermediate measure at T=9 months.
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.
次要结局
- 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.)
- Identification of the obstacles and levers to the sustainability of the Program(T=0 and T=12 months with every arm.)
- Program Scale-Up Potential: Variation of the ISSaQ 4.0 scores.(T=0 and T=12 months with every cohort.)
- Preparedness of caregivers to transitions: Variation of the Family Caregiver Activation in Transitions (FCAT) scores.(Between T=0 and T=15 months, with an intermediate measure at T=9 months.)
研究者
Patrick Archambault
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.
Laval University