Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
1200

Summary

Conditions
  • Asthma
  • Chronic Kidney Diseases
  • Chronic Obstructive Pulmonary Disease
  • Congestive Heart Failure
  • Diabetes Mellitus - Type 2
  • Hypertension
  • Ischemic Heart Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The investigators will test the effectiveness of the ENCOMPASS program using a parallel, two-arm, pragmatic, wait-list control, cluster-randomized trial. Half the clinics will be randomized to receive the intervention immediately, serving as the intervention group, while the other half will receive the intervention after a 6 month waiting period, acting as control sites during their first 6 months. Once implemented, the ENCOMPASS program will remain available to clinics until the end of the funding period. Control patients will continue to receive usual care until their clinic becomes eligible for the program.Masking: Single (Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Although non-communicable chronic disease is the leading cause of death in Canada, many patients with chronic diseases do not receive guideline-recommended therapy for a variety of reasons. Lack of awareness of publicly funded programs, financial constraints, personal circumstances, language and cul...

Although non-communicable chronic disease is the leading cause of death in Canada, many patients with chronic diseases do not receive guideline-recommended therapy for a variety of reasons. Lack of awareness of publicly funded programs, financial constraints, personal circumstances, language and cultural barriers make it challenging for patients to follow recommendations. ENCOMPASS is a patient navigation intervention, delivered by community health navigators (CHNs), that will improve patient-centred care and outcomes by: helping patients navigate the health system, facilitating communication between patients and providers, improving patient understanding of their conditions and treatment plans, connecting patients with community resources and supporting patient self-management. The ENCOMPASS intervention is based on an extensive literature review, and was refined in consultation with patients, operational partners, front-line care providers, and local and provincial policy makers. A pilot study has informed implementation, recruitment and data collection methods. This study will implement and test the intervention using a pragmatic cluster-randomized trial with a concurrent qualitative study. The objectives of this study are to determine the effectiveness of patient navigation, delivered by CHNs, in patients with multiple chronic diseases on: a) emergency department visits and hospital admissions over 12 months (primary outcome), b) patient-reported outcome and experience measures, and c) disease-specific clinical outcomes, compared with usual care. Additional objectives focus on practical aspects including understanding the experience of care from the patient and CHN perspective and factors influencing the intervention's ability to improve care and outcomes. The effectiveness of ENCOMPASS will be studied using a parallel, two-arm, pragmatic, wait-list control, cluster-randomized trial (cRCT) in 16 clusters, with a target size of 1600 patients with chronic disease. If additional funding is realized the trial will be expanded to include additional clusters. Primary care practices with ~5 full-time physicians will be the cluster units and small practices of 2-3 physicians may be combined into one cluster. Half of the clusters will be randomized to receive the program immediately (Early Phase clusters), while the other half will be required to wait 6 months (Late Phase clusters). Randomization will be concealed, computer-generated and stratified by practice size. Although patients and providers cannot be blinded to the intervention, end-point evaluation will be blinded. The primary outcome will be assessed using administrative health data, eliminating risk of assessor bias. Control patients will receive usual care until the intervention is implemented in their clinic, at which time they will be eligible for the ENCOMPASS program. Patients will meet with a research assistant at baseline, 6 and 12 months, with an additional 18 month follow-up for control patients, to assess clinical data, including weight, blood pressure, and patient-reported measures. Other endpoints (i.e., through administrative and laboratory data) will be assessed at 6, 12, and 24 months. Once implemented, the ENCOMPASS program will remain available to clinic patients until the end of the program funding period, which may be extended subject to budget decisions and preliminary results. A concurrent qualitative study will provide contextual information and will be used to make program refinements in the Late Phase, the impacts of which will be explored in a comparative analysis.

Tracking Information

NCT #
NCT03077386
Collaborators
  • Alberta Innovates Health Solutions
  • Canadian Diabetes Association
Investigators
Principal Investigator: Kerry A McBrien, MD, MPH University of Calgary