Clinical trial NCT04790617: ENCOMPASS: Expansion Study B, RCT
Official title: Enhancing Community Health Through Patient Navigation, Advocacy and Social Support (ENCOMPASS): Expansion Study B, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus, Type 2
Chronic Kidney Diseases
Ischemic Heart Disease
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Asthma
Keywords: Chronic Disease Management
Health Navigation
Health Navigator
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The ENCOMPASS study will evaluate the effectiveness of a community health navigator program using a two-armed, pragmatic, randomized controlled trial. The intervention arm will receive the CHN program for six months. The control arm will receive their usual health care. This study will employ patient-level block randomization stratified by study site. Research staff will be blinded to block size. In the case where participants live together in the same residence, they will be randomly assigned to the same study arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Some patients living with multiple long-term health conditions have difficulty accessing the services they need, despite available primary care and community resources. Patient navigation programs may help those with complex health conditions to improve their care and outcomes. Community health navigators (CHNs) are community members who help guide patients through the health care system. CHNs are not health professionals like a doctor or nurse, but they are specially trained to help patients get the most out of their health care and connect them to resources. The ENCOMPASS program of research evaluates a patient navigation program that connects patients living with long-term health conditions to CHNs. To understand if the CHN program can be scaled to a provincial level, the ENCOMPASS program of research is expanding to select primary care settings across Alberta. This study implements and evaluates the CHN program at Calgary West Central Primary Care Network in Calgary, Alberta, Canada.

Detailed description: Community Health Navigators (CHNs) are defined as community health workers that provide patient navigation. Based on evidence to date, CHNs for chronic disease management are likely to beneficially impact patient experience, clinical outcomes and costs; however, contextual evidence is lacking given that most studies to date have been conducted in the United States. In Canada, patient navigation programs currently exist in only a few settings (primarily cancer treatment and transitional care), with few navigation programs implemented in chronic disease care.

The ENCOMPASS program of research was initiated in 2016, when researchers with the University of Calgary's Interdisciplinary Chronic Disease Collaboration partnered with Mosaic Primary Care Network (PCN) to develop, implement and evaluate a community health navigation program for patients with multiple chronic conditions. The program was based on a systematic literature review and refined in consultation with key stakeholders. A cluster-randomized controlled trial is currently ongoing with Mosaic PCN to determine the impact of the program on acute care use, patient-reported outcomes and experience, and disease-specific clinical outcomes (NCT03077386).

Alberta Primary Care Networks (PCNs) are comprised of groups of family physicians and other health care professionals working together to provide comprehensive patient care to Albertans. To understand if the community health navigator program can be feasibly scaled and spread to PCNs across Alberta, we are expanding research to examine and evaluate community health navigation program implementation to other geographic areas and populations. This study expands the ENCOMPASS program of research to select Calgary West Central PCN primary care clinics. The current study employs the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to examine the scalability of the community health navigation program.

The objectives of this study are to (1) assess the impact of the intervention on the target population and health system (effectiveness); (2) explore the feasibility and appropriateness of practical intervention scale-up (reach, adoption, implementation, and maintenance), and (3) identify the required resources and infrastructure necessary to maintain and scale the intervention provincially.

The effectiveness of the community health navigator program will be studied using a two-armed, pragmatic, randomized controlled trial. This study will employ patient-level block randomization stratified by study site. Randomization will be concealed and computer-generated, and research staff will be blinded to block size. Primary outcomes will be assessed using administrative health data. Secondary outcomes will be measured using a patient health survey administered by a research assistant at baseline, 6 months, and 12 months. A concurrent qualitative study will provide contextual information on the effectiveness of the community health navigator program from patient, provider, and CHN perspectives. Process evaluation metrics and interviews with program stakeholders will inform the feasibility and sustainability of the community health navigator program in Alberta PCNs.

Eligibility criteria: Inclusion Criteria:

* Poorly controlled hypertension (most recent systolic blood pressure \> 160 mmHg or labile);
* Poorly controlled diabetes (A1C \> 9% on at least one occasion within the past year or labile);
* Stage 3b or greater chronic kidney disease (estimated glomerular filtration rate \< 45 mL/min/1.73m2 in past year);
* Established ischemic heart disease (at least one instance of a physician billing diagnosis with a relevant International Classification of Diseases, 9th Edition \[ICD-9\] code recorded in electronic medical record (EMR), or known to health care team);
* Congestive heart failure (at least one instance of a physician billing diagnosis with a relevant ICD-9 code recorded in EMR, or known to health care team);
* Chronic obstructive pulmonary disease OR Asthma with at least two visits in the past year (at least 2 instances of a physician billing diagnosis with a relevant ICD-9 code, or known to health care team).

Exclusion Criteria:

* Patient unable to provide informed consent;
* Patient residing in long-term care facility;
* Health care provider discretion.

Primary outcomes:
measure: Acute care service use
timeFrame: Up to 36 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Up to 12 months
measure: Patient experience of care
timeFrame: Up to 12 months
measure: Patient activation
timeFrame: Up to 12 months
measure: Anxiety symptoms
timeFrame: Up to 12 months
measure: Depressive symptoms
timeFrame: Up to 12 months
measure: Perceived social support
timeFrame: Up to 12 months
measure: Health literacy
timeFrame: Up to 12 months
measure: General self-rated health
timeFrame: Up to 12 months
measure: Household food security
timeFrame: Up to 12 months
measure: Smoking status
timeFrame: Up to 12 months
measure: Weight
timeFrame: Up to 12 months
measure: Disease-specific intermediate health outcomes: Diabetes
timeFrame: Up to 24 months
measure: Disease-specific intermediate health outcomes: Hypertension
timeFrame: Up to 12 months
measure: Disease-specific intermediate health outcomes: COPD/asthma
timeFrame: Up to 24 months
measure: Disease-specific intermediate health outcomes: Ischemic heart disease, chronic kidney disease, diabetes
timeFrame: Up to 24 months
measure: Provider satisfaction
timeFrame: Up to 12 months
measure: Patient experience
timeFrame: Up to 12 months
measure: Continuity of care
timeFrame: Up to 24 months
measure: Primary Care Network (PCN) multidisciplinary team access
timeFrame: Up to 24 months
measure: Program costs
timeFrame: Up to 24 months
measure: Physician costs
timeFrame: Up to 24 months
measure: Acute care costs
timeFrame: Up to 24 months
measure: All-cause mortality
timeFrame: Up to 24 months
measure: Medication adherence
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary West Central Primary Care Network
state: Alberta
Study officials:
affiliation: University of Calgary
name: Kerry A McBrien, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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