Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02789800
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2016-03-16
Brief Title:
Patient-Centred Innovations for Persons With Multimorbidity - Quebec
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Patient-Centred Innovations for Persons With Multimorbidity - Quebec
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACEinMM-QC
Brief Summary:
The aim of Patient-Centred Innovations for Persons With Multimorbidity PACE in MM study is to reorient the health care system from a single disease focus to a multimorbidity focus centre on not only disease but also the patient in context and realign the health care system from separate silos to coordinated collaborations in care PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management CDPM that will be grounded in current realities ie Chronic Care Models including Self-Management Programs that are linked to Primary Care PC reform efforts The study will build on this firm foundation will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers decision-makers practitioners and patients The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec QC - Ontario ON collaboration with participation from 3 other provinces British Columbia BC Manitoba MB and Nova Scotia NS The Teams objectives are 1 to identify factors responsible for success or failure of current CDPM programs linked to the PC reform by conducting a realist synthesis of their quantitative and qualitative evaluations 2 to transform consenting CDPM programs identified in Objective 1 by aligning them to promising interventions on patient-centred care for multimorbidity patients and to test these new innovations in at least two jurisdictions and compare among jurisdictions and 3 to foster the scaling-up of innovations informed by Objective 1 and testedproven in Objective 2 and to conduct research on different approaches to scaling-up This registration for Clinical Trials only pertains to Objective 2 of the study
Detailed Description:
A recent systematic review on the prevalence of Multimorbidity MM recommended a count of 3 chronic diseases with no focus on any single chronic disease in particular This definition identifies a more vulnerable population with higher needs lower income or poverty poorer outcomes and challenging processes of care It includes people with a wide array of complexity from the uncomplicated course of minimally interacting chronic diseases to the highly complex MM patients MM is not only important due to the burden on patients but because it accounts for high utilization The definition represents a continuum of vulnerability in which there are many opportunities for prevention and management Despite the high prevalence of MM most research and health care is still based on a single disease paradigm which may not be appropriate as 45 of primary care patients have MM A recent Cochrane systematic review on the impact of interventions for patients with MM has identified a paucity of studies internationally with mixed results thus paving the way for the work of this Team The most promising intervention to date was enhanced teamwork in a multifaceted intervention involving multiple professionals
Patient-Centred Partnerships between Patients and Providers The definition of patient-centred partnerships is derived from Canadian policy reports collaboration between informed respected patients and a healthcare team There is an internationally accepted comprehensive operational definition with four components which will guide many aspects of the proposed research program first exploring the patients diseases and the illness experience second understanding the whole person in context third finding common ground and fourth enhancing the patient-provider relationship There is empirical evidence for the impact of patient-centred partnerships on better patient outcomes and lower costs Systematic reviews of interventions indicated promising results for feasible practice-based interventions targeting both providers and patients
Canadian policy reports defined this second facet of patient-centredness as seamless coordination and integration of care Transitions requiring coordination are a key feature of care for patients with MM Coordination has been shown to positively impact symptom relief social functioning hospital re-admission and related costs Papers reviewed by this Team identified the most promising type of intervention to be structured delivery system re-design
STUDY 21 Qualitative Evaluation of the aligned Programs Purpose The study will assess how the transformed program performs distinguish between components of the interventions and identify contextual factors that may have influenced the content and effectiveness of the intervention It will also examine the local barriers and facilitators as well as the transitions and coordination of care
Methods and design The Team will conduct a qualitative evaluation of the transformed programs to explain how various contexts influence observed effects 1 including the context of the health care systems in each province A recent example of this research approach in Canada is Best et al 2012 2 Data will be obtained from interviews and written documents In-depth interviews will be conducted among the four categories of stakeholders This will include a decision-makers n 10 b primary care physicians n 10 c professionals doing the interventions n 10 and a d purposive sample of patients with multimorbidity n 10 and their informal caregivers n10 51 The number of interviews are estimates and will be guided by the saturation of data 3
Data collection In-depth interviews lasting 30 to 60 minutes will ensure complete and detailed participation The data collection will be held during the second year of the transformed program The interview guides will examine how the context variables influence the effects and the elements that could potentially inform the development of future interventions All interviews will be audiotaped and transcribed verbatim Additionally written documents will be collected program team meeting summaries a sample of 10 medical records or research records at each participating site a checklist describing the fidelity of the intervention all documents produced specifically for the intervention to provide an in-depth understanding of the various contexts in which the interventions occurred
Data analysis The data will be analyzed using an iterative and interpretative approach 4 The data from all participants will be examined through both independent and team analysis occurring in a concurrent manner to build and develop on the emerging themes A coding template will be developed and edited as new themes emerge while others are reclassified or discarded A data management software will be used to organize the coded data and identify exemplar quotes reflecting the central themes All written documents will undergo a content analysis The final step of the analysis will be the triangulation of the synthesis of the themes from the stakeholder participants and the content analysis of the documents3-4 STUDY 22 Evaluation of effects of the aligned Programs Setting The same consenting participating sites as described in study 21 The methods presented below are for one setting and will be duplicated in the second setting Patients are referred to receive the services of these programs by their providers The intervention the investigators are testing here is the aligned programs Patients referred to these programs are new patients and have never been exposed to the intervention In addition to the main reason for referral to the program the referral form will also include eligibility details for the evaluation including diagnoses
Patient sample Patients recruited for the study will be cognitively intact and literate and aged between 18 and 80 years of age The upper limit of 80 years is to avoid recruiting patients at risk of being institutionalized or dependent during the follow-up Patients will present at least three chronic conditions
Methods and Design Patients agreeing to participate will complete questionnaires at baseline T1 collecting the sociodemographic data and baseline measures which will be used to document equivalence between groups groups are defined below Effectiveness of the aligned program will be assessed using three strategies
1 To measure short-term effects 4 months a randomized controlled trial RCT design with a delayed intervention will be used 5 Eligible patients will be randomized after consent to receive either the intervention within a short period of time Group A or 4 months later Group B self-reported mailed questionnaires will be completed at baseline T1 for all patient participants 4 months after the end of the intervention for group A T2 and 4 months after baseline for control group B T2 This will constitute the short-term measure of effectiveness of the intervention Group B will then receive the intervention
2 To measure the mid-term effects one year on patient-reported outcomes a before and after study is proposed combining groups A and B together The patients will complete the same questionnaire 12 months after the end of the intervention T3
3 To measure mid-term T3 and long-term effects T4 after 2 years on health services utilization and cost all patients groups A and B will provide consent to give access to their health administrative HA data At baseline a control Group C will be constituted using anonymized HA data Patients will be matched for gender age region and main three diagnoses The Team will build algorithms for matching every set of controls Groups A and B together will be compared to this propensity matched control group C in a before-after study using administrative HA data
Variables and outcome measures The variables fall into 5 categories sociodemographic PC context main co-variables of interest primary outcomes secondary outcomes Socio-demographic characteristics include gender age education family income marital status occupation housing and number of persons living under the same roof Context variables refer to type of PC organization in which the intervention occurs Family Medicine Group The three main co-variables of interest are the Teams three innovations self-reported multimorbidity measured by the Disease Burden Morbidity Assessment 6 patient-centred partnership Patient Perception of Patient-Centredness Scale 7-9 and Patient centered coordination the Patient Perceptions of Transitions in care adapted by the investigators from Coleman 10 The two primary outcome measures are the Health Education Impact Questionnaire HeiQ that provides a broad profile of the potential impacts of patient education interventions 11 and the level of perceived disease-management self-efficacy using the 6-item Self-Efficacy for Managing Chronic Disease SEM-CD 12 Secondary patient perceived outcomes will be the VR-12 as a measure of health status and the EuroQoL group instrument called EQ5D as a measure of Quality of Life 13 The Kessler psychological distress scale K-6 will measure psychological distress 14 The investigators will also use a questionnaire on health behaviors 15 Finally HA data will also be used as secondary outcomes to compare health care utilization and cost before and after the intervention HA data will include emergency department visits avoidable hospital admissions readmissions time to first primary care visit after emergency department visit and continuity of care
Data analysis Investigators will first describe participants baseline characteristics in each group and compare among groups To evaluate short-term effect Groups A and B will be compared on T2 scores with an analysis of co-variance ANCOVA adjusted for T1 scores 16 To document mid-term effects a before and after measures analysis of variance will be used to study the evolution of continuous variables collected 3 times 17 Sub-analyses by gender will be performed Health system costs in intervention and control groups will be evaluated by using amounts paid to providers based on provincial fee schedules and cost-weighted utilization of institutions including hospitals and long-term care Utilization records obtained from HA data will be multiplied by applicable cost weights 18 The methods employed will model the individual patient-level costs incurred in the health system using methods developed for costing using administrative data19 Incremental resources in the intervention group will be identified and costed using applicable timeresource inputs and relevant wage rates following guidelines for economic evaluation in health interventions 20
Patient-Centred Partnerships between Patients and Providers The definition of patient-centred partnerships is derived from Canadian policy reports collaboration between informed respected patients and a healthcare team There is an internationally accepted comprehensive operational definition with four components which will guide many aspects of the proposed research program first exploring the patients diseases and the illness experience second understanding the whole person in context third finding common ground and fourth enhancing the patient-provider relationship There is empirical evidence for the impact of patient-centred partnerships on better patient outcomes and lower costs Systematic reviews of interventions indicated promising results for feasible practice-based interventions targeting both providers and patients
Canadian policy reports defined this second facet of patient-centredness as seamless coordination and integration of care Transitions requiring coordination are a key feature of care for patients with MM Coordination has been shown to positively impact symptom relief social functioning hospital re-admission and related costs Papers reviewed by this Team identified the most promising type of intervention to be structured delivery system re-design
STUDY 21 Qualitative Evaluation of the aligned Programs Purpose The study will assess how the transformed program performs distinguish between components of the interventions and identify contextual factors that may have influenced the content and effectiveness of the intervention It will also examine the local barriers and facilitators as well as the transitions and coordination of care
Methods and design The Team will conduct a qualitative evaluation of the transformed programs to explain how various contexts influence observed effects 1 including the context of the health care systems in each province A recent example of this research approach in Canada is Best et al 2012 2 Data will be obtained from interviews and written documents In-depth interviews will be conducted among the four categories of stakeholders This will include a decision-makers n 10 b primary care physicians n 10 c professionals doing the interventions n 10 and a d purposive sample of patients with multimorbidity n 10 and their informal caregivers n10 51 The number of interviews are estimates and will be guided by the saturation of data 3
Data collection In-depth interviews lasting 30 to 60 minutes will ensure complete and detailed participation The data collection will be held during the second year of the transformed program The interview guides will examine how the context variables influence the effects and the elements that could potentially inform the development of future interventions All interviews will be audiotaped and transcribed verbatim Additionally written documents will be collected program team meeting summaries a sample of 10 medical records or research records at each participating site a checklist describing the fidelity of the intervention all documents produced specifically for the intervention to provide an in-depth understanding of the various contexts in which the interventions occurred
Data analysis The data will be analyzed using an iterative and interpretative approach 4 The data from all participants will be examined through both independent and team analysis occurring in a concurrent manner to build and develop on the emerging themes A coding template will be developed and edited as new themes emerge while others are reclassified or discarded A data management software will be used to organize the coded data and identify exemplar quotes reflecting the central themes All written documents will undergo a content analysis The final step of the analysis will be the triangulation of the synthesis of the themes from the stakeholder participants and the content analysis of the documents3-4 STUDY 22 Evaluation of effects of the aligned Programs Setting The same consenting participating sites as described in study 21 The methods presented below are for one setting and will be duplicated in the second setting Patients are referred to receive the services of these programs by their providers The intervention the investigators are testing here is the aligned programs Patients referred to these programs are new patients and have never been exposed to the intervention In addition to the main reason for referral to the program the referral form will also include eligibility details for the evaluation including diagnoses
Patient sample Patients recruited for the study will be cognitively intact and literate and aged between 18 and 80 years of age The upper limit of 80 years is to avoid recruiting patients at risk of being institutionalized or dependent during the follow-up Patients will present at least three chronic conditions
Methods and Design Patients agreeing to participate will complete questionnaires at baseline T1 collecting the sociodemographic data and baseline measures which will be used to document equivalence between groups groups are defined below Effectiveness of the aligned program will be assessed using three strategies
1 To measure short-term effects 4 months a randomized controlled trial RCT design with a delayed intervention will be used 5 Eligible patients will be randomized after consent to receive either the intervention within a short period of time Group A or 4 months later Group B self-reported mailed questionnaires will be completed at baseline T1 for all patient participants 4 months after the end of the intervention for group A T2 and 4 months after baseline for control group B T2 This will constitute the short-term measure of effectiveness of the intervention Group B will then receive the intervention
2 To measure the mid-term effects one year on patient-reported outcomes a before and after study is proposed combining groups A and B together The patients will complete the same questionnaire 12 months after the end of the intervention T3
3 To measure mid-term T3 and long-term effects T4 after 2 years on health services utilization and cost all patients groups A and B will provide consent to give access to their health administrative HA data At baseline a control Group C will be constituted using anonymized HA data Patients will be matched for gender age region and main three diagnoses The Team will build algorithms for matching every set of controls Groups A and B together will be compared to this propensity matched control group C in a before-after study using administrative HA data
Variables and outcome measures The variables fall into 5 categories sociodemographic PC context main co-variables of interest primary outcomes secondary outcomes Socio-demographic characteristics include gender age education family income marital status occupation housing and number of persons living under the same roof Context variables refer to type of PC organization in which the intervention occurs Family Medicine Group The three main co-variables of interest are the Teams three innovations self-reported multimorbidity measured by the Disease Burden Morbidity Assessment 6 patient-centred partnership Patient Perception of Patient-Centredness Scale 7-9 and Patient centered coordination the Patient Perceptions of Transitions in care adapted by the investigators from Coleman 10 The two primary outcome measures are the Health Education Impact Questionnaire HeiQ that provides a broad profile of the potential impacts of patient education interventions 11 and the level of perceived disease-management self-efficacy using the 6-item Self-Efficacy for Managing Chronic Disease SEM-CD 12 Secondary patient perceived outcomes will be the VR-12 as a measure of health status and the EuroQoL group instrument called EQ5D as a measure of Quality of Life 13 The Kessler psychological distress scale K-6 will measure psychological distress 14 The investigators will also use a questionnaire on health behaviors 15 Finally HA data will also be used as secondary outcomes to compare health care utilization and cost before and after the intervention HA data will include emergency department visits avoidable hospital admissions readmissions time to first primary care visit after emergency department visit and continuity of care
Data analysis Investigators will first describe participants baseline characteristics in each group and compare among groups To evaluate short-term effect Groups A and B will be compared on T2 scores with an analysis of co-variance ANCOVA adjusted for T1 scores 16 To document mid-term effects a before and after measures analysis of variance will be used to study the evolution of continuous variables collected 3 times 17 Sub-analyses by gender will be performed Health system costs in intervention and control groups will be evaluated by using amounts paid to providers based on provincial fee schedules and cost-weighted utilization of institutions including hospitals and long-term care Utilization records obtained from HA data will be multiplied by applicable cost weights 18 The methods employed will model the individual patient-level costs incurred in the health system using methods developed for costing using administrative data19 Incremental resources in the intervention group will be identified and costed using applicable timeresource inputs and relevant wage rates following guidelines for economic evaluation in health interventions 20
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