Patient-Centred Innovations for Persons With Multimorbidity - Ontario
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; Multimorbidity
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 4 other provinces:
      British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). 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 aligned 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 aligned program 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 six categories of stakeholders. This will include: a)
      decision-makers (n = 10); b) providers (n = 10); c) family physicians and specialists (n =
      10); d) a purposive sample of patients with multimorbidity (n = 10); e) family and informal
      caregivers (n=10); and f) referral providers (n = 10) [51]. 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. The data management software NVivo 9.0 [QSR Int. USA] will be used to organize the
      coded data and identify exemplar quotes reflecting the central themes. All written documents
      will undergo a content analysis using NVivo 9.0. 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 socio-demographic data and baseline measures, which will be used to
      document equivalence between groups (groups are defined below). Effectiveness of the aligned
      programs will be assessed using three strategies.

        1. To measure short-term effects (4 months), a randomized controlled trial (RCT) design
           with a before/after arm 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
           control (Group C); The before/after arm (Group B) will receive the intervention without
           being placed into the RCT, as their doctors have deemed them too fragile to risk
           randomization; Control participants (Group C) will receive a list of healthcare
           resources they may contact to assist with their care; questionnaires will be completed
           at baseline (T1), and 4 months post enrollment (Group C) or intervention (Group A & B)
           (T2) for all study participants. This will constitute the short-term measure of
           effectiveness of the intervention.

        2. To measure the mid-term effects, the study participants will complete the same
           questionnaire 16 months post-enrollment (Group C) or intervention (Group A & B) (T3).

        3. To measure mid-term (T3) and long-term effects (T4 after 2 years) on health services
           utilization and cost, study participants in Groups A and B will provide consent to give
           access to their health administrative (HA) data. A control Group D will be constituted
           using anonymized HA data. Patients will be matched for gender, age, region and three
           main 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 D
           using administrative (HA) data.

      Variables and outcome measures: The variables fall into 5 categories: sociodemographic; PC
      context; main covariables of interest; primary outcomes; secondary outcomes. Sociodemographic
      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 (solo or group practices, Family Health
      Team, Community Health Centre). The three main covariables 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
      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: The investigators will first describe participants' baseline characteristics
      in each group and compare among groups. To evaluate short-term effect, Groups A and C will be
      compared on T2 scores with an analysis of covariance (ANCOVA) adjusted for T1 scores [16]. To
      document mid-term effects, a before/after 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 (e.g. CIHI Resource Intensity Weights -
      RIWs) and using CIHI costs per weighted case [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): TIP / IMPACT Plus Care Coordination
Intervention type(s): Behavioral
Intervention description(s): The intervention will involve the patient attending an interdisciplinary team meeting, either through the Ontario Telemedicine Network's teleconferencing technology or in person, along with their caregiver(s), the referring practitioner, inter-professional (IP) teams and home care coordinators to discuss and uncover the patient's condition covering a diverse range of medical, functional and psycho-social issues and the development of a patient-centred treatment plan. The care plans are documented, shared, implemented and monitored by an assigned nurse from the program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other