ENCOMPASS: Expansion Study C

Enhancing Community Health Through Patient Navigation, Advocacy and Social Support (ENCOMPASS): Expansion Study C, A Randomized Controlled Trial With Waitlist Control

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 WestView Primary Care Network in the Greater Edmonton area, Alberta, Canada.

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 navigation 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 WestView PCN, which represents over 80 physician members. 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 waitlist-controlled trial. This study will employ patient-level block randomization with research staff blinded to block size. Randomization will be concealed and computer-generated. 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.

Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Ischemic Heart Disease, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma

The ENCOMPASS study will evaluate the effectiveness of a community health navigator program using a two-armed, pragmatic, randomized waitlist-controlled trial. The intervention arm will receive the CHN program for six months. The waitlist control arm will have a six month waiting period followed by six months of CHN program. This study will employ patient-level block randomization. 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.

Waitlist control: six-month waiting period followed by six months of community health navigator program

Patients will be matched to a community health navigator (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 (e.g., social, financial, insurance), helping patients set health-related goals, facilitating health care referrals and appointments, and monitoring 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.

EQ-5D-5L (EuroQol 5 dimension- 5 level instrument) Uses a 5 point scale with higher scores indicating a lower health-related quality of life

11-item modification Patient Assessment of Chronic Illness Care (PACIC) Uses a 0-100% scale with higher percentages indicating a greater assessment of care

10-item Patient Activation Measure (PAM-10) Uses a 4 point scale with higher scores indicating greater patient activation

7-item Generalized Anxiety Disorder (GAD-7) Uses 4 point scale to measure anxiety ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday)

9-item Patient Health Questionnaire (PHQ-9) Uses a 4 point scale to measure depression ranging from a positive outcome response (not at all) to negative outcome response (nearly everyday)

8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS) Uses a 5 point scale with higher scores indicating greater levels of social support

3-item Brief Screening Questions for Health Literacy Uses a 5 point scale with higher scores indicating lower health literacy

1-item Self-Rated Health Uses a 4 point scale with higher scores indicating greater self-reported general health

6-item Household Food Security Survey Module (HFSSM) Mix of ordinal and binary variables with affirmative responses being summed and higher scores indicating greater food insecurity

Appropriate use of statin (where indicated) based on pharmaceutical information network (PIN) dispensation data.

Provider attachment based on Usual Provider of Care (UPC) Index in Alberta practitioners claims file.

≥80% of days covered for medications in Care Plan based on pharmaceutical information network (PIN) dispensation data.

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.

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