Some patients who have multiple long-term health conditions have significant challenges accessing needed services despite available primary care and social services resources. Patient navigation programs may help those with complex health conditions improve their care and outcomes and if delivered by community health navigators (CHNs) who have close community ties, these programs have the potential to reduce barriers to care and increase access to coordinated, person-centred care. The ENCOMPASS program aims to improve the care and health outcomes for high-risk patients by linking patients with chronic disease with a CHN to help them navigate the health system, facilitate communication between patients and providers, improve patients' understanding of their conditions and treatment plans, and support patients in their self-management. In Canada, patient navigation programs have not been well studied or broadly implemented in patients with chronic disease, making a comprehensive evaluation of ENCOMPASS important. This program has great potential to improve care for patients with chronic diseases in primary care.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
176
Patients will be matched to a CHN who will conduct a needs assessment to determine the frequency of meetings. A CHN may perform any of the following: providing information to a patient's health care provider, translation, advocating for the patient, connecting the patient with resources (i.e., social, financial, insurance), helping patients set health related goals, liaising with a patient's employer, facilitating health care referrals and appointments, monitoring appointments, and facilitating transportation to appointments. These activities may require the CHN to be physically present at appointments or have direct contact with the patient's health care provider. Goal setting and support will be provided in person or over the telephone using motivational interviewing principles
Mosaic Primary Care Network
Calgary, Alberta, Canada
Acute care utilization
All emergency department visits and hospital admissions
Time frame: Up to 36 months
Health-related quality of life
EQ-5D-5L (Euroqol 5 dimension- 5 level instrument) administration
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (hypertension)
Blood pressure based on primary data collection
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (diabetes)
Hemoglobin A1c based on laboratory data
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (appropriate medication use)
Use of a statin where indicated (according to chronic disease guidelines)
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (heart failure)
Number exacerbations based on administrative data
Time frame: Up to 24 months
Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma)
Number exacerbation based on administrative data
Time frame: Up to 24 months
Patient activation
Patient activation measure (PAM) administration via survey questionnaire
Time frame: Up to 24 months
Patient experience with chronic illness care
Patient assessment of chronic illness care (PACIC) administration via survey questionnaire
Time frame: Up to 24 months
Primary care attachment
Usual provider of care index (UPC) based on physician claims data
Time frame: Up to 24 months
Physician experience
Open-ended questions via semi-structured interview
Time frame: 6- and 12-months post-implementation
Medication adherence
Pharmaceutical information network (PIN) administrative data
Time frame: Up to 24 months
Mortality
All-cause mortality based on administrative data
Time frame: Up to 24 months
Weight
Weight based on primary data collection
Time frame: Up to 24 months
Social support
Social support based on Medical Outcomes Study Social Support Survey
Time frame: Up to 24 months
Smoking status
Current smoker Yes/No
Time frame: Up to 24 months
Depression score
Patient Health Questionnaire - 9 item administration via survey questionnaire (PHQ-9). 4 point scale to measure depression ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday).
Time frame: Up to 24 months
Anxiety score
Generalized Anxiety Disorder - 7 item administration via survey questionnaire (GAD-7). 4 point scale to measure anxiety ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday).
Time frame: Up to 24 months
Program costs
Total operational costs
Time frame: Up to 24 months
Physician costs
Physician claims costs
Time frame: Up to 24 months
Acute care costs
Costs for emergency department visits and hospital admissions, based on RIW methods
Time frame: Up to 24 months
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