Enhancing Community Health Through Patient Navigation, Advocacy and Social Support

Not Applicable

Completed

• Conditions: Congestive Heart Failure; Hypertension; Ischemic Heart Disease; Chronic Obstructive Pulmonary Disease; Asthma; Diabetes Mellitus, Type 2; Chronic Kidney Diseases
• Interventions: Behavioral: ENCOMPASS Intervention

• Registration Number: NCT03077386
• Lead Sponsor: University of Calgary

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-13
• Study Start: 2018-06-08
• Primary Completion: 2023-03-03
• Study Completion: 2024-03-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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).

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Exclusion Criteria

• patient unable to provide informed consent;
• patient residing in a long-term care facility;
• physician discretion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENCOMPASS program	ENCOMPASS Intervention	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.

Primary Outcome Measures

Name	Time	Method
Acute care utilization	Up to 36 months	All emergency department visits and hospital admissions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mosaic Primary Care Network; 🇨🇦 Calgary, Alberta, Canada