Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608589
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
CONSTELLATIONS Living Lab Improving the Care Transitions of Older Adults Living with Neurocognitive Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of major neurocognitive disorders MNCDs particularly Alzheimers 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
Quebecs 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 patientcaregiver 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 dexcellence 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 Programs impact on care transitions over two years These findings will inform decision-makers and stakeholders about the Programs adaptability to the Chaudière-Appalaches region guiding local and provincial decision-makers on healthcare system improvements and emphasizing the importance of supporting an LHS
Quebecs 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 patientcaregiver 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 dexcellence 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 Programs impact on care transitions over two years These findings will inform decision-makers and stakeholders about the Programs adaptability to the Chaudière-Appalaches region guiding local and provincial decision-makers on healthcare system improvements and emphasizing the importance of supporting an LHS
Detailed Description:
1 BACKGROUND
11 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
12 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 localregional 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 localregional 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
13 Levels of assessment
The research activities outlined in this protocol focus solely on evaluating the Programs 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 andor 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
21 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
22 Secondary Objectives Micro Level
Qualitatively assess perceptions of care transition quality to understand patient and caregiver experiences
Evaluate the Programs impact on the quality of life for individuals with MNCD and their caregivers
Assess the burden of treatment eg efforts to manage health and its impact on daily life
Evaluate the Programs impact on caregiver burden for those caring for older adults with MNCD in the CISSS CA region
Assess the Programs impact on emergency department visits for individuals with MNCD in participating Local Services Networks LSNs
23 Secondary Objective Meso Level - Workshop Participants
Assess the Programs influence on workshop participants intention to implement best practices in care transitions for individuals with MNCD and their caregivers
24 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 CAs FMGs
25 Secondary Objectives Macro Level
Compare performance indicators and their changes over time between participating FMGs in selected LSNs and control LSNs non-participating FMGsLSNs
Assess the Programs 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
41 Study Population for Impact Evaluation at the User and Caregiver Level Micro Level
To assess the CoMPAS MNCD Programs 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
42 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
51 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
Generate Lists Using local administrative software generate lists of patients who have received healthcare services within the past 6 months applying inclusion criteria
Verify Eligibility Research assistants will review each potential participants record to confirm they meet the inclusion criteria
Eliminate Duplicates Compare lists across service points to remove any duplicate entries
Randomize Lists Randomize the remaining lists of potential participants
Contact and Consent Research assistants will attempt to contact potential participants and their caregivers by telephone up to five attempts to introduce the study and assess their capacity to provide informed consent If eligible and interested participants will be sent a participant kit mail or email and recontacted after 8 days to answer any questions Consent or refusal will be documented and verbal e-consent forms will be securely stored in the REDCap platform
52 Meso Level Recruitment Workshop Participants
All workshop participants except the research team INESSS stakeholders and facilitators will be invited to participate in the research evaluating their intent to apply best practices in care transitions
Email Invitation A few days before the launch workshop an email with a personalized REDCap link will be sent to solicit participation
Information and Consent An integrated REDCap form will provide details about this research component
Alternative Format Paper-based consent forms and questionnaires will be available at the first workshop for those who prefer them
Future Participation Participants will be invited to express interest in future research involvement after the workshops
53 Meso Level Recruitment Sustainability and Scale-Up
Key individuals involved in implementing the CoMPAS MNCD Program will receive email invitations to participate in research on sustainability and scale-up potential
Information and Consent The form will clearly explain this research aspect and ensure voluntary participation without negative consequences for refusal
Participation Participants will
Complete an online questionnaire twice 12-15 months apart assessing sustainability factors and scale-up potential
Engage in two focus groups before and after each workshop series to discuss questionnaire results
Optionally participate in up to two individual interviews to discuss sustainability and scaling further
6 DATA COLLECTION
61 Evaluation of CoMPAS MNCD Program Impact on Care Transitions Micro Level
Cohort Formation Three cohorts of dyads individuals with MNCD and their caregivers will be recruited from three service points ED HCT FMG within each of the three participating LSNs before the CoMPAS MNCD workshops begin T0
Data Collection Telephone questionnaires will be administered to consenting users and caregivers Caregivers may answer on behalf of users with MNCD if necessary Clinical-administrative data will also be collected from users medical records
Initial Interview T0 The first telephone interview will cover sociodemographic characteristics quality of life treatment burden care quality information and transition experiences and trust in the care team for users or their caregivers Caregivers will also be interviewed about their own sociodemographic characteristics quality of life involvement with their loved one and caregiver burden
Follow-up Questionnaires
Longer questionnaires Administered at 9 and 15 months after the initial call Shorter questionnaires Administered at 3 and 12 months to capture recent transition experiences and maintain contact with participants
Data Entry Data collected during telephone questionnaires will be entered into the REDCap platform
62 Evaluation of Workshop Participants Intent to Apply Best Practices
Questionnaire Completion Participants will complete questionnaires at multiple time points before the launch workshop T0 after the launch workshop T1 at the end of each subsequent workshop T2 T3 and 6 months after the last workshop T6 months
Workshop Introduction During the launch workshop 10 minutes will be allocated to explain this research component provide the link to the online questionnaire and consent form and offer paper-based options
63 Evaluation of Program Implementation Sustainability and Scale-Up Potential
Data Collection Timeframe Data will be collected during and after Program implementation 12-15 months post-workshops to assess changes over time
Questionnaire Key actors will complete a questionnaire twice 12-15 months apart assessing sustainability factors and scale-up potential
Focus Groups and Interviews Focus groups will discuss aggregate questionnaire results followed by semi-structured individual interviews to explore barriers levers and perspectives in more depth
Interview Selection Interviewees will be selected based on diverse opinions expertise or preference for individual discussions
7 MEASURING INSTRUMENTS
71 Questionnaires for Impact Evaluation at the User and Caregiver Level Micro Level
This study employs Patient-Reported Outcome Measures PROMs and Patient-Reported Experience Measures PREMs to assess the impact of the CoMPAS MNCD Program on care transitions These instruments include both generic and specific measures to evaluate various multidimensional aspects of care transition quality such as
Health and health-related quality of life EQ-5D-5L
Perceived quality of care provided by the primary care team PESQ
Users relationship with their care team PESQFCAT
Treatment burden and social support MTBQ-F
Caregiver burden Zarits Scale or Burden Inventory
Caregiver preparedness during transitions FCAT
Participant verbatim on satisfaction with recent transitions open questions
Sociodemographic data
Service utilization data
Clinical-administrative data from medical records
Instrument selection was based on statistical measures reliability and validity popularity of use and language availability The research team prioritized validated French questionnaires primarily from Canada and then France The choice of sociodemographic clinical-administrative and health service utilization data was informed by the teams extensive experience in longitudinal studies particularly with older adults
Further details about these instruments can be found in the Outcome Measures section
72 Tool for Measuring Professional Intent Following Continuing Professional Development CPD-reaction Meso Level
The CPD-reaction questionnaire is a validated tool based on theory including the Theory of Planned Behavior that evaluates the impact of training activities on healthcare professionals behavior change It comprises 12 items grouped into 5 dimensions
Behavioral intent Beliefs about abilities Social influence Beliefs about consequences Moral norm
73 Measurement Tools for Assessing Sustainability and Scalability Potential Meso Level
1 National Health Services Sustainability Model NHS-SM This empirically tested theoretical framework accompanied by measurement tools will be used to assess factors influencing the sustainability of the Program guiding project leaders on priority areas for action
2 ISSaQ-40 Tool Developed from a systematic synthesis of scientific knowledge on scaling up health innovations this tool proposes 14 components for evaluating scaling potential including Health problem Scaling up Characteristics of innovation Strategic political and environmental context of scale-up Evidence on effectiveness Costs and benefits Implementation fidelity Adaptability Coverage Acceptability Adoption at scale Scaling medium Infrastructure Sustainability
8 SAMPLE SIZE
The sample size calculation was based on the following factors
Population The number of individuals aged 65 and over living with an MNCD in the community excluding those in long-term care facilities within the CISSS CA socio-sanitary region as of March 31 2021
Instrument Validation parameters of the Physician Enabling Skills Questionnaire PESQ
Study Design Longitudinal follow-up of the same participants with questionnaires before and after the workshops and action plan implementation necessitating a sample size calculation based on the difference of two matched averages
Statistical Parameters Alpha 005 power 080 bilateral assumption
Modifiable Parameters The clinically significant effect size of the action plan chosen by the continuous improvement team and the correlation between repeated measurements in the same individuals over time
Measurement Points Three PESQ collection points at specific time points T0 T9 months T15 months
Estimated Sample Size Based on these parameters an estimated sample size of 94 dyads per LSN would be sufficient to detect a clinically significant variation of 68 PESQ points
9 DATA ANALYSIS
1 Micro Level Analysis
Descriptive Analyses Basic socio-demographic data will be summarized using descriptive statistics eg means medians frequencies percentages
Bivariate Analyses Potential associations between selected variables and primarysecondary outcomes will be explored using bivariate analyses eg t-tests chi-square tests correlation analyses
Comparative Analyses Repeated measures pre- and post-intervention will be compared within each LSN cohort using appropriate statistical tests eg paired t-tests Wilcoxon signed-rank tests
Sub-cohort Analysis Comparative analyses will also be performed on sub-cohorts based on recruitment points ED HCT FMG adjusting for basic socio-demographic variables
2 Meso Level Analysis
Linear Regression Linear regression analysis will be conducted on DPC-Reaction constructs to identify the construct with the strongest influence on the intention to apply best practices in care transitions
Inferential Thematic Analysis Focus group recordings and individual interviews will undergo inferential thematic content analysis utilizing the NHS Sustainability Model NHS-SM and ISSaQ-40 as theoretical frameworks
3 Macro Level Analysis
Indicator Comparison Under the leadership of INESSS performance indicators will be compared between pre-workshop years 2018-2021 and post-workshop years 2023-2025 using data provided by INESSS This will assess changes over time and potential Program impact at the population level
10 DATA MANAGEMENT
Data Storage
Personal and Sensitive Information Sensitive data pertaining to users and caregivers will be stored securely on the CISSS CAs server
Other Data All other collected data will be entered into the REDCap database hosted by Valeria at Laval University
Access Control
REDCap Access Access to the REDCap database will be restricted to a limited number of research assistants and managed by the projects research coordinators
Full Dataset Access Only project coordinators the REDCap manager and the data analysis team will have access to the complete dataset within REDCap
Study Staff List A list detailing study staff members and their assigned tasks will be maintained in the projects regulatory binder which will be stored securely under lock and key at the CISSS CA Research Centre This list will also be submitted to the research ethics board and will be regularly updated
11 ETHICS
This project was approved by the Research Ethics Board of the CISSS CA Nagano - 2023-968 SIRUL 134632
12 FUNDING
This project was funded by the Fonds de recherche du Québec - Santé
13 CONFLICT OF INTEREST
The researcher involved in this study report having no conflict of interest
11 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
12 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 localregional 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 localregional 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
13 Levels of assessment
The research activities outlined in this protocol focus solely on evaluating the Programs 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 andor 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
21 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
22 Secondary Objectives Micro Level
Qualitatively assess perceptions of care transition quality to understand patient and caregiver experiences
Evaluate the Programs impact on the quality of life for individuals with MNCD and their caregivers
Assess the burden of treatment eg efforts to manage health and its impact on daily life
Evaluate the Programs impact on caregiver burden for those caring for older adults with MNCD in the CISSS CA region
Assess the Programs impact on emergency department visits for individuals with MNCD in participating Local Services Networks LSNs
23 Secondary Objective Meso Level - Workshop Participants
Assess the Programs influence on workshop participants intention to implement best practices in care transitions for individuals with MNCD and their caregivers
24 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 CAs FMGs
25 Secondary Objectives Macro Level
Compare performance indicators and their changes over time between participating FMGs in selected LSNs and control LSNs non-participating FMGsLSNs
Assess the Programs 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
41 Study Population for Impact Evaluation at the User and Caregiver Level Micro Level
To assess the CoMPAS MNCD Programs 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
42 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
51 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
Generate Lists Using local administrative software generate lists of patients who have received healthcare services within the past 6 months applying inclusion criteria
Verify Eligibility Research assistants will review each potential participants record to confirm they meet the inclusion criteria
Eliminate Duplicates Compare lists across service points to remove any duplicate entries
Randomize Lists Randomize the remaining lists of potential participants
Contact and Consent Research assistants will attempt to contact potential participants and their caregivers by telephone up to five attempts to introduce the study and assess their capacity to provide informed consent If eligible and interested participants will be sent a participant kit mail or email and recontacted after 8 days to answer any questions Consent or refusal will be documented and verbal e-consent forms will be securely stored in the REDCap platform
52 Meso Level Recruitment Workshop Participants
All workshop participants except the research team INESSS stakeholders and facilitators will be invited to participate in the research evaluating their intent to apply best practices in care transitions
Email Invitation A few days before the launch workshop an email with a personalized REDCap link will be sent to solicit participation
Information and Consent An integrated REDCap form will provide details about this research component
Alternative Format Paper-based consent forms and questionnaires will be available at the first workshop for those who prefer them
Future Participation Participants will be invited to express interest in future research involvement after the workshops
53 Meso Level Recruitment Sustainability and Scale-Up
Key individuals involved in implementing the CoMPAS MNCD Program will receive email invitations to participate in research on sustainability and scale-up potential
Information and Consent The form will clearly explain this research aspect and ensure voluntary participation without negative consequences for refusal
Participation Participants will
Complete an online questionnaire twice 12-15 months apart assessing sustainability factors and scale-up potential
Engage in two focus groups before and after each workshop series to discuss questionnaire results
Optionally participate in up to two individual interviews to discuss sustainability and scaling further
6 DATA COLLECTION
61 Evaluation of CoMPAS MNCD Program Impact on Care Transitions Micro Level
Cohort Formation Three cohorts of dyads individuals with MNCD and their caregivers will be recruited from three service points ED HCT FMG within each of the three participating LSNs before the CoMPAS MNCD workshops begin T0
Data Collection Telephone questionnaires will be administered to consenting users and caregivers Caregivers may answer on behalf of users with MNCD if necessary Clinical-administrative data will also be collected from users medical records
Initial Interview T0 The first telephone interview will cover sociodemographic characteristics quality of life treatment burden care quality information and transition experiences and trust in the care team for users or their caregivers Caregivers will also be interviewed about their own sociodemographic characteristics quality of life involvement with their loved one and caregiver burden
Follow-up Questionnaires
Longer questionnaires Administered at 9 and 15 months after the initial call Shorter questionnaires Administered at 3 and 12 months to capture recent transition experiences and maintain contact with participants
Data Entry Data collected during telephone questionnaires will be entered into the REDCap platform
62 Evaluation of Workshop Participants Intent to Apply Best Practices
Questionnaire Completion Participants will complete questionnaires at multiple time points before the launch workshop T0 after the launch workshop T1 at the end of each subsequent workshop T2 T3 and 6 months after the last workshop T6 months
Workshop Introduction During the launch workshop 10 minutes will be allocated to explain this research component provide the link to the online questionnaire and consent form and offer paper-based options
63 Evaluation of Program Implementation Sustainability and Scale-Up Potential
Data Collection Timeframe Data will be collected during and after Program implementation 12-15 months post-workshops to assess changes over time
Questionnaire Key actors will complete a questionnaire twice 12-15 months apart assessing sustainability factors and scale-up potential
Focus Groups and Interviews Focus groups will discuss aggregate questionnaire results followed by semi-structured individual interviews to explore barriers levers and perspectives in more depth
Interview Selection Interviewees will be selected based on diverse opinions expertise or preference for individual discussions
7 MEASURING INSTRUMENTS
71 Questionnaires for Impact Evaluation at the User and Caregiver Level Micro Level
This study employs Patient-Reported Outcome Measures PROMs and Patient-Reported Experience Measures PREMs to assess the impact of the CoMPAS MNCD Program on care transitions These instruments include both generic and specific measures to evaluate various multidimensional aspects of care transition quality such as
Health and health-related quality of life EQ-5D-5L
Perceived quality of care provided by the primary care team PESQ
Users relationship with their care team PESQFCAT
Treatment burden and social support MTBQ-F
Caregiver burden Zarits Scale or Burden Inventory
Caregiver preparedness during transitions FCAT
Participant verbatim on satisfaction with recent transitions open questions
Sociodemographic data
Service utilization data
Clinical-administrative data from medical records
Instrument selection was based on statistical measures reliability and validity popularity of use and language availability The research team prioritized validated French questionnaires primarily from Canada and then France The choice of sociodemographic clinical-administrative and health service utilization data was informed by the teams extensive experience in longitudinal studies particularly with older adults
Further details about these instruments can be found in the Outcome Measures section
72 Tool for Measuring Professional Intent Following Continuing Professional Development CPD-reaction Meso Level
The CPD-reaction questionnaire is a validated tool based on theory including the Theory of Planned Behavior that evaluates the impact of training activities on healthcare professionals behavior change It comprises 12 items grouped into 5 dimensions
Behavioral intent Beliefs about abilities Social influence Beliefs about consequences Moral norm
73 Measurement Tools for Assessing Sustainability and Scalability Potential Meso Level
1 National Health Services Sustainability Model NHS-SM This empirically tested theoretical framework accompanied by measurement tools will be used to assess factors influencing the sustainability of the Program guiding project leaders on priority areas for action
2 ISSaQ-40 Tool Developed from a systematic synthesis of scientific knowledge on scaling up health innovations this tool proposes 14 components for evaluating scaling potential including Health problem Scaling up Characteristics of innovation Strategic political and environmental context of scale-up Evidence on effectiveness Costs and benefits Implementation fidelity Adaptability Coverage Acceptability Adoption at scale Scaling medium Infrastructure Sustainability
8 SAMPLE SIZE
The sample size calculation was based on the following factors
Population The number of individuals aged 65 and over living with an MNCD in the community excluding those in long-term care facilities within the CISSS CA socio-sanitary region as of March 31 2021
Instrument Validation parameters of the Physician Enabling Skills Questionnaire PESQ
Study Design Longitudinal follow-up of the same participants with questionnaires before and after the workshops and action plan implementation necessitating a sample size calculation based on the difference of two matched averages
Statistical Parameters Alpha 005 power 080 bilateral assumption
Modifiable Parameters The clinically significant effect size of the action plan chosen by the continuous improvement team and the correlation between repeated measurements in the same individuals over time
Measurement Points Three PESQ collection points at specific time points T0 T9 months T15 months
Estimated Sample Size Based on these parameters an estimated sample size of 94 dyads per LSN would be sufficient to detect a clinically significant variation of 68 PESQ points
9 DATA ANALYSIS
1 Micro Level Analysis
Descriptive Analyses Basic socio-demographic data will be summarized using descriptive statistics eg means medians frequencies percentages
Bivariate Analyses Potential associations between selected variables and primarysecondary outcomes will be explored using bivariate analyses eg t-tests chi-square tests correlation analyses
Comparative Analyses Repeated measures pre- and post-intervention will be compared within each LSN cohort using appropriate statistical tests eg paired t-tests Wilcoxon signed-rank tests
Sub-cohort Analysis Comparative analyses will also be performed on sub-cohorts based on recruitment points ED HCT FMG adjusting for basic socio-demographic variables
2 Meso Level Analysis
Linear Regression Linear regression analysis will be conducted on DPC-Reaction constructs to identify the construct with the strongest influence on the intention to apply best practices in care transitions
Inferential Thematic Analysis Focus group recordings and individual interviews will undergo inferential thematic content analysis utilizing the NHS Sustainability Model NHS-SM and ISSaQ-40 as theoretical frameworks
3 Macro Level Analysis
Indicator Comparison Under the leadership of INESSS performance indicators will be compared between pre-workshop years 2018-2021 and post-workshop years 2023-2025 using data provided by INESSS This will assess changes over time and potential Program impact at the population level
10 DATA MANAGEMENT
Data Storage
Personal and Sensitive Information Sensitive data pertaining to users and caregivers will be stored securely on the CISSS CAs server
Other Data All other collected data will be entered into the REDCap database hosted by Valeria at Laval University
Access Control
REDCap Access Access to the REDCap database will be restricted to a limited number of research assistants and managed by the projects research coordinators
Full Dataset Access Only project coordinators the REDCap manager and the data analysis team will have access to the complete dataset within REDCap
Study Staff List A list detailing study staff members and their assigned tasks will be maintained in the projects regulatory binder which will be stored securely under lock and key at the CISSS CA Research Centre This list will also be submitted to the research ethics board and will be regularly updated
11 ETHICS
This project was approved by the Research Ethics Board of the CISSS CA Nagano - 2023-968 SIRUL 134632
12 FUNDING
This project was funded by the Fonds de recherche du Québec - Santé
13 CONFLICT OF INTEREST
The researcher involved in this study report having no conflict of interest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None