- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789800
Patient-Centred Innovations for Persons With Multimorbidity - Quebec (PACEinMM-QC)
Study Overview
Status
Conditions
- Depression
- Heart Failure
- Stroke
- Hypertension
- Cardiovascular Disease
- Diabetes
- Ulcer
- Cancer
- Arthritis
- Rheumatoid Arthritis
- Musculoskeletal Pain
- Asthma
- Gastroesophageal Reflux
- Dementia
- Anxiety
- HIV
- Crohn's Disease
- Osteoporosis
- Ulcerative Colitis
- Chronic Obstructive Pulmonary Disease (COPD)
- Hyperlipidemia
- Alzheimer's Disease
- Chronic Bronchitis
- Diverticulosis
- Kidney Disease
- Transient Ischemic Attacks
- Urinary Tract Problem
- Chronic Hepatitis
- Irritable Bowel
- Thyroid Disorder
Intervention / Treatment
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 #2.1 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 (n=10) [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 documents.[3-4] STUDY #2.2: Evaluation of effects of the aligned Programs Setting: The same consenting participating sites as described in study 2.1. 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.
- 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.
- 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).
- 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 Team's 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 data[19]. Incremental resources in the intervention group will be identified and costed using applicable time/resource inputs and relevant wage rates following guidelines for economic evaluation in health interventions [20].
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Chicoutimi, Quebec, Canada, G7H 5H6
- Université de Sherbrooke
-
Chicoutimi, Quebec, Canada, G7H 7K9
- CIUSSS du Sageunay-Lac-Saint-Jean
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PATIENTS (Studies 2.1 & 2.2):
Inclusion Criteria:
- 3+ Chronic Conditions
- 18 to 80 years of age
- Eligible for DIMAC02 intervention
Exclusion Criteria:
- Unable to reasonably respond to questionnaires or provide informed consent (ie. cognitive impairment or language barrier)
- Deemed by provider to be too fragile
CAREGIVERS (Study 2.1):
- Close family member (wife/husband, parent, son/daughter, brother/sister) and/or caregiver to a patient that has received DIMAC02 intervention (first component)
- Sharing time with the patient (before, during and after the intervention)
- French speaking
DECISION-MAKERS (Study 2.1):
- FMG Physician-Manager, FMG Coordinators, Decision-Makers/Managers
- Involved/Familiar with DIMAC02 program
DIMAC02 INTERDISCIPLINARY team (Study 2.1):
- Nurse, Nutritionist, Kinesiologist, Social Worker, Psychologist
- Has delivered DIMAC02 intervention to at least one patient
REFERRAL PROFESSIONALS (Study 2.1):
- Family physician or nurse/nurse practitioner
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group A
Intervention group (n = 163) Intervention: Participates in DIMAC02 Program
|
Integrated Approach For Chronic Diseases (DIMAC02) is an integrated approach for chronic disease prevention and management services that aims to improve and coordinate different regional initiatives in 11 Family Medicine Groups(FMG) related to : Self-management, Case management, Patient-centred care for persons with multimorbidity, Motivational approach, Interprofessional collaboration.
DIMAC 02 specific objectives are: 1) To make available, in FMG's, an interdisciplinary educational intervention for prevention and management of chronic diseases for patients with low and high risk for complication.
2) To Increase the flow of communications between FMG and hospital facilities to improve continuity of care.
|
NO_INTERVENTION: Group B
Control group (n = 163)
|
|
NO_INTERVENTION: Group C
Health Administrative Data Group (n = 1630) Number of matched data controls.
Not taking part in intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Intervention Effectiveness - Change in Self-Management outcomes
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Health Education Impact Questionnaire (HeiQ).
Score: Reliable improvement
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Intervention Effectiveness - Change in Chronic Diseases
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Multimorbidity/Chronic Disease (MM-21): Score: number of Chronic diseases
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Evaluation of Intervention Effectiveness - Change in Health Status
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Health Status (VR-12): Score: Physical Component Summary (PCS) and the Mental Component Summary (MCS)
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Evaluation of Intervention Effectiveness - Change in Quality of Life
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Quality of Life (EQ5D-5L): Score: mean
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Evaluation of Intervention Effectiveness - Change in Psychological Well-being
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Psychological Well-being (Kessler 6 Scale).Score: mean
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Lifestyle/Health Behaviours Questionnaire.
Score: mean
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Evaluation of Intervention Effectiveness - Equity
Time Frame: T1: Baseline
|
T1: Baseline
|
|
Demographics
Time Frame: T1: Baseline
|
T1: Baseline
|
|
Evaluation of Intervention Effectiveness - Change in Transitions of Care
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Patient Perception of Transitions of Care.
Score: Mean
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Evaluation of Intervention Effectiveness - Change in Self-Efficacy
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Self-Efficacy for Managing Chronic Disease Scale (SEM-CD).
Score: mean
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Evaluation of Intervention Effectiveness - Change in Patient-Centredness
Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Patient Perception of Patient-Centredness (PPPC).
Score: Mean
|
T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Fortin, MD, M.Sc, Université de Sherbrooke
Publications and helpful links
General Publications
- Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25. Erratum In: J Clin Epidemiol. 2012 Mar;65(3):351.
- Best A, Greenhalgh T, Lewis S, Saul JE, Carroll S, Bitz J. Large-system transformation in health care: a realist review. Milbank Q. 2012 Sep;90(3):421-56. doi: 10.1111/j.1468-0009.2012.00670.x.
- Poitras ME, Fortin M, Hudon C, Haggerty J, Almirall J. Validation of the disease burden morbidity assessment by self-report in a French-speaking population. BMC Health Serv Res. 2012 Feb 14;12:35. doi: 10.1186/1472-6963-12-35.
- Stewart M, Brown JB, Donner A, McWhinney IR, Oates J, Weston WW, Jordan J. The impact of patient-centered care on outcomes. J Fam Pract. 2000 Sep;49(9):796-804.
- Stewart M, Brown JB, Hammerton J, Donner A, Gavin A, Holliday RL, Whelan T, Leslie K, Cohen I, Weston W, Freeman T. Improving communication between doctors and breast cancer patients. Ann Fam Med. 2007 Sep-Oct;5(5):387-94. doi: 10.1370/afm.721.
- Coleman EA, Mahoney E, Parry C. Assessing the quality of preparation for posthospital care from the patient's perspective: the care transitions measure. Med Care. 2005 Mar;43(3):246-55. doi: 10.1097/00005650-200503000-00007.
- Nolte S, Elsworth GR, Sinclair AJ, Osborne RH. The extent and breadth of benefits from participating in chronic disease self-management courses: a national patient-reported outcomes survey. Patient Educ Couns. 2007 Mar;65(3):351-60. doi: 10.1016/j.pec.2006.08.016. Epub 2006 Oct 5.
- Rasanen P, Roine E, Sintonen H, Semberg-Konttinen V, Ryynanen OP, Roine R. Use of quality-adjusted life years for the estimation of effectiveness of health care: A systematic literature review. Int J Technol Assess Health Care. 2006 Spring;22(2):235-41. doi: 10.1017/S0266462306051051.
- Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003 Feb;60(2):184-9. doi: 10.1001/archpsyc.60.2.184.
- Centers for Disease Control and Prevention (CDC), Behavioral Risk Factor Surveillance System Survey Questionnaire. 2007, Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
- Van Breukelen GJ. ANCOVA versus change from baseline: more power in randomized studies, more bias in nonrandomized studies [corrected]. J Clin Epidemiol. 2006 Sep;59(9):920-5. doi: 10.1016/j.jclinepi.2006.02.007. Epub 2006 Jun 23. Erratum In: J Clin Epidemiol. 2006 Dec;59(12):1334.
- Stewart M, Fortin M; Patient-Centred Innovations for Persons with Multimorbidity Team*. Patient-Centred Innovations for Persons with Multimorbidity: funded evaluation protocol. CMAJ Open. 2017 May 9;5(2):E365-E372. doi: 10.9778/cmajo.20160097.
- Pawson R, Tilley N. Realistic evaluation. London: Sage, 1997
- Patton MQ. Qualitative research & evaluation. 3rd ed. Thousand Oaks, CA: Sage Publication. 2002
- Crabtree BF, Miller WL. Doing Qualitative Research. Thousand Oaks, CA: Sage Publications Inc. 1999.
- Stewart M, et al., The patient perception of patient-centeredness questionnaire (PPPC). Working Paper Series #04-1, April 2004.
- Sherer M., et al., The self-efficacy scale: Construction and validation. Psychological Reports. 51: p. 663-671,1982.
- Daniel, W.W., Biostatistics: A foundation for analysis in the health sciences. 9th ed. Hoboken. NJ: Wiley. 2009.
- Canadian Institute for Health Information. Canadian Hospital Reporting Project (CHRP). 2012; https://secure.cihi.ca/free_products/HI2013_Jan30_EN.pdf . Accessed 2016 March 14.
- Wodchis, WP, et al., Guidelines on Person-Level Costing Using Administrative Databases in Ontario. Toronto: Health System Performance Research Network, 2011.
- Drummond, MF, et al., Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press, 2005.
- Ngangue P, Brown JB, Forgues C, Ag Ahmed MA, Nguyen TN, Sasseville M, Loignon C, Gallagher F, Stewart M, Fortin M. Evaluating the implementation of interdisciplinary patient-centred care intervention for people with multimorbidity in primary care: a qualitative study. BMJ Open. 2021 Sep 24;11(9):e046914. doi: 10.1136/bmjopen-2020-046914.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Urologic Diseases
- Pain
- Neurologic Manifestations
- Neurocognitive Disorders
- Gastrointestinal Diseases
- Bronchial Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Gastroenteritis
- Muscular Diseases
- Neurodegenerative Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Brain Ischemia
- Bone Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Lipid Metabolism Disorders
- Dementia
- Tauopathies
- Dyslipidemias
- Inflammatory Bowel Diseases
- Bone Diseases, Metabolic
- Diverticular Diseases
- Cardiovascular Diseases
- Kidney Diseases
- Arthritis
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Ischemic Attack, Transient
- Gastroesophageal Reflux
- Alzheimer Disease
- Crohn Disease
- Osteoporosis
- Musculoskeletal Pain
- Hyperlipidemias
- Bronchitis
- Bronchitis, Chronic
- Diverticulum
Other Study ID Numbers
- 2013-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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