Patient-Centred Innovations for Persons With Multimorbidity - Ontario
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.
- Evaluation of Intervention Effectiveness - Change in Self-Management outcomes
- Evaluation of Intervention Effectiveness - Change in Transitions of Care
- Evaluation of Intervention Effectiveness - Change in Self-Efficacy
- Evaluation of Intervention Effectiveness - Change in Patient-Centredness
- Evaluation of Intervention Effectiveness - Change in Chronic Diseases
- Evaluation of Intervention Effectiveness - Change in Health Status
- Evaluation of Intervention Effectiveness - Change in Quality of Life
- Evaluation of Intervention Effectiveness - Change in Psychological Well-being
- Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours
- Evaluation of Intervention Effectiveness - Change in Equity
- Evaluation of Intervention Effectiveness - Change in Demographics
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
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  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 . 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) . Number of
interviews are estimates and will be guided by the saturation of data .
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 .
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.
To measure short-term effects (4 months), a randomized controlled trial (RCT) design
with a before/after arm will be used . 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.
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).
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 ; patient-centred partnership (Patient Perception of
Patient-Centredness Scale [7-9]); and Patient centreed coordination (the Patient Perceptions
of Transitions in care, adapted by the investigators from Coleman ). 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  and the level of
perceived disease-management self-efficacy using the 6-item Self-Efficacy for Managing
Chronic Disease (SEM-CD) . 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 . The Kessler
psychological distress scale K-6 will measure psychological distress . The investigators
will also use a questionnaire on health behaviours . 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
. To document mid-term effects, a before/after analysis of variance will be used to
study the evolution of continuous variables collected 3 times . 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
- RIWs) and using CIHI costs per weighted case  The methods employed
will model the individual patient-level costs incurred in the health system, using methods
developed for costing using administrative data. 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
View this trial on ClinicalTrials.gov