Enhancing Community Health Through Patient Navigation, Advocacy and Social Support

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Enhancing Community Health Through Patient Navigation, Advocacy and Social Support

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

Intervention / Treatment
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* Behavioral: ENCOMPASS Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age with two or more of the following: Poorly controlled hypertension (most recent systolic blood pressure > 160 mmHg); Poorly controlled diabetes (A1C > 9% on at least one occasion within the past year); 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 a long-term care facility; physician discretion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENCOMPASS program<br>Clinics assigned to the intervention will receive the ENCOMPASS intervention and a CHN will be matched to their clinic and be available to patients that meet the eligibility criteria. | Behavioral: ENCOMPASS Intervention<br>* 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<br>* Other names: Community Health Navigation Services;|
| No Intervention: Usual care<br>Patients not enrolled in the intervention will continue to receive care as usual until their clinic receives the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute care utilization | All emergency department visits and hospital admissions | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | EQ-5D-5L (Euroqol 5 dimension- 5 level instrument) administration | Up to 24 months | 
| Disease-specific intermediate health outcomes (hypertension) | Blood pressure based on primary data collection | Up to 24 months | 
| Disease-specific intermediate health outcomes (diabetes) | Hemoglobin A1c based on laboratory data | Up to 24 months | 
| Disease-specific intermediate health outcomes (appropriate medication use) | Use of a statin where indicated (according to chronic disease guidelines) | Up to 24 months | 
| Disease-specific intermediate health outcomes (heart failure) | Number exacerbations based on administrative data | Up to 24 months | 
| Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma) | Number exacerbation based on administrative data | Up to 24 months | 
| Patient activation | Patient activation measure (PAM) administration via survey questionnaire | Up to 24 months | 
| Patient experience with chronic illness care | Patient assessment of chronic illness care (PACIC) administration via survey questionnaire | Up to 24 months | 
| Primary care attachment | Usual provider of care index (UPC) based on physician claims data | Up to 24 months | 
| Physician experience | Open-ended questions via semi-structured interview | 6- and 12-months post-implementation | 
| Medication adherence | Pharmaceutical information network (PIN) administrative data | Up to 24 months | 
| Mortality | All-cause mortality based on administrative data | Up to 24 months | 
| Weight | Weight based on primary data collection | Up to 24 months | 
| Social support | Social support based on Medical Outcomes Study Social Support Survey | Up to 24 months | 
| Smoking status | Current smoker Yes/No | 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). | 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). | Up to 24 months | 
| Program costs | Total operational costs | Up to 24 months | 
| Physician costs | Physician claims costs | Up to 24 months | 
| Acute care costs | Costs for emergency department visits and hospital admissions, based on RIW methods | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient navigator, community health navigator, multi-morbidity, primary care, social determinants of health