ENCOMPASS: Expansion Study B, RCT
- Conditions
- Ischemic Heart DiseaseHypertensionDiabetes Mellitus, Type 2Congestive Heart FailureChronic Kidney DiseasesChronic Obstructive Pulmonary DiseaseAsthma
- Interventions
- Behavioral: Community Health Navigator Program
- Registration Number
- NCT04790617
- Lead Sponsor
- University of Calgary
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
- 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).
- Patient unable to provide informed consent;
- Patient residing in long-term care facility;
- Health care provider discretion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Community Health Navigator Program Community health navigator program for six months.
- Primary Outcome Measures
Name Time Method Acute care service use Up to 36 months Rate of emergency department visits and hospital admissions based on administrative health data.
- Secondary Outcome Measures
Name Time Method Patient experience of care Up to 12 months 11-item modified Patient Assessment of Chronic Illness Care (PACIC).
Weight Up to 12 months Change in self-reported weight in kilograms or pounds.
Disease-specific intermediate health outcomes: COPD/asthma Up to 24 months Exacerbations based on administrative health data.
Patient activation Up to 12 months 10-item Patient Activation Measure (PAM-10), score and level.
Depressive symptoms Up to 12 months 9-item Patient Health Questionnaire (PHQ-9).
Provider satisfaction Up to 12 months Based on semi-structured interviews.
Primary Care Network (PCN) multidisciplinary team access Up to 24 months umber of visits to multidisciplinary health team members based on PCN records.
Physician costs Up to 24 months Physician claims based on physician claims files.
Perceived social support Up to 12 months 8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS).
Health-related quality of life Up to 12 months EuroQol EQ-5D-5L.
Smoking status Up to 12 months Self-reported smoking status.
Disease-specific intermediate health outcomes: Diabetes Up to 24 months Change in mean glycosylated hemoglobin (A1C) based on laboratory data.
Medication adherence Up to 24 months ≥80% of days covered for medications in Care Plan based on pharmaceutical information network (PIN) dispensation data.
Anxiety symptoms Up to 12 months 7-item Generalized Anxiety Disorder (GAD-7).
Health literacy Up to 12 months 3-item Brief Screening Questions for Health Literacy.
Disease-specific intermediate health outcomes: Ischemic heart disease, chronic kidney disease, diabetes Up to 24 months Appropriate use of a statin where indicated based on pharmaceutical information network (PIN) dispensation data.
Patient experience Up to 12 months Based on semi-structured interviews.
Program costs Up to 24 months Administrative, training, and operational costs of program, assessed through PCN financial records.
General self-rated health Up to 12 months 1-item Self-Rated Health (SRH).
Household food security Up to 12 months 6-item Household Food Security Survey Module (HFSSM).
Disease-specific intermediate health outcomes: Hypertension Up to 12 months Change in systolic blood pressure (SBP) in mmHg based on primary data collection.
All-cause mortality Up to 24 months All-cause mortality rate based on administrative data.
Continuity of care Up to 24 months Provider attachment based on Usual Provider of Care (UPC) Index in Alberta practitioners claims file.
Acute care costs Up to 24 months Hospital admission and emergency department visit costs based on administrative health data.
Trial Locations
- Locations (1)
Calgary West Central Primary Care Network
🇨🇦Calgary, Alberta, Canada