Enhancing Community Health Through Patient Navigation, Advocacy and Social Support (ENCOMPASS)

November 29, 2023 updated by: University of Calgary
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Mosaic Primary Care Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENCOMPASS program
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
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
Other Names:
  • Community Health Navigation Services
No Intervention: Usual care
Patients not enrolled in the intervention will continue to receive care as usual until their clinic receives the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute care utilization
Time Frame: Up to 36 months
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
Time Frame: Up to 24 months
EQ-5D-5L (Euroqol 5 dimension- 5 level instrument) administration
Up to 24 months
Disease-specific intermediate health outcomes (hypertension)
Time Frame: Up to 24 months
Blood pressure based on primary data collection
Up to 24 months
Disease-specific intermediate health outcomes (diabetes)
Time Frame: Up to 24 months
Hemoglobin A1c based on laboratory data
Up to 24 months
Disease-specific intermediate health outcomes (appropriate medication use)
Time Frame: Up to 24 months
Use of a statin where indicated (according to chronic disease guidelines)
Up to 24 months
Disease-specific intermediate health outcomes (heart failure)
Time Frame: Up to 24 months
Number exacerbations based on administrative data
Up to 24 months
Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma)
Time Frame: Up to 24 months
Number exacerbation based on administrative data
Up to 24 months
Patient activation
Time Frame: Up to 24 months
Patient activation measure (PAM) administration via survey questionnaire
Up to 24 months
Patient experience with chronic illness care
Time Frame: Up to 24 months
Patient assessment of chronic illness care (PACIC) administration via survey questionnaire
Up to 24 months
Primary care attachment
Time Frame: Up to 24 months
Usual provider of care index (UPC) based on physician claims data
Up to 24 months
Physician experience
Time Frame: 6- and 12-months post-implementation
Open-ended questions via semi-structured interview
6- and 12-months post-implementation
Medication adherence
Time Frame: Up to 24 months
Pharmaceutical information network (PIN) administrative data
Up to 24 months
Mortality
Time Frame: Up to 24 months
All-cause mortality based on administrative data
Up to 24 months
Weight
Time Frame: Up to 24 months
Weight based on primary data collection
Up to 24 months
Social support
Time Frame: Up to 24 months
Social support based on Medical Outcomes Study Social Support Survey
Up to 24 months
Smoking status
Time Frame: Up to 24 months
Current smoker Yes/No
Up to 24 months
Depression score
Time Frame: 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).
Up to 24 months
Anxiety score
Time Frame: 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).
Up to 24 months
Program costs
Time Frame: Up to 24 months
Total operational costs
Up to 24 months
Physician costs
Time Frame: Up to 24 months
Physician claims costs
Up to 24 months
Acute care costs
Time Frame: Up to 24 months
Costs for emergency department visits and hospital admissions, based on RIW methods
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Innovates Health Solutions
Canadian Diabetes Association

Investigators

  • Principal Investigator: Kerry A McBrien, MD, MPH, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB17-0360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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