Patient-Centred Innovations for Persons With Multimorbidity - Quebec
Condition: Hypertension; Depression; Anxiety; Musculoskeletal Pain; Arthritis; Rheumatoid Arthritis; Osteoporosis; Chronic Obstructive Pulmonary Disease (COPD); Asthma; Chronic Bronchitis; Cardiovascular Disease; Heart Failure; Stroke; Transient Ischemic Attacks; Ulcer; Gastroesophageal Reflux; Irritable Bowel; Crohn's Disease; Ulcerative Colitis; Diverticulosis; Chronic Hepatitis; Diabetes; Thyroid Disorder; Cancer; Kidney Disease; Urinary Tract Problem; Dementia; Alzheimer's Disease; Hyperlipidemia; HIV
MeSH terms: Bronchitis; Bronchitis, Chronic; Arthritis; Osteoporosis; Musculoskeletal Pain; Crohn Disease; Gastroesophageal Reflux; Diverticulum; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Alzheimer Disease; Ischemic Attack, Transient; Kidney Diseases; Cardiovascular Diseases; Hyperlipidemias
Study type: Interventional

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 (i.e. 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 Team's 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 tested/proven 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 #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.

        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 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].
    

Intervention name(s): DIMAC02
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other