ENCOMPASS: Expansion Study B, RCT (ENCOMPASS)

May 16, 2023 updated by: University of Calgary

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

183

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
        • Calgary West Central 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:

  • 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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Community health navigator program for six months.
Behavioral: 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.
Other Names:
  • ENCOMPASS Program
No Intervention: Control
Usual health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute care service use
Time Frame: Up to 36 months
Rate of emergency department visits and hospital admissions based on administrative health data.
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: Up to 12 months
EuroQol EQ-5D-5L.
Up to 12 months
Patient experience of care
Time Frame: Up to 12 months
11-item modified Patient Assessment of Chronic Illness Care (PACIC).
Up to 12 months
Patient activation
Time Frame: Up to 12 months
10-item Patient Activation Measure (PAM-10), score and level.
Up to 12 months
Anxiety symptoms
Time Frame: Up to 12 months
7-item Generalized Anxiety Disorder (GAD-7).
Up to 12 months
Depressive symptoms
Time Frame: Up to 12 months
9-item Patient Health Questionnaire (PHQ-9).
Up to 12 months
Perceived social support
Time Frame: Up to 12 months
8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS).
Up to 12 months
Health literacy
Time Frame: Up to 12 months
3-item Brief Screening Questions for Health Literacy.
Up to 12 months
General self-rated health
Time Frame: Up to 12 months
1-item Self-Rated Health (SRH).
Up to 12 months
Household food security
Time Frame: Up to 12 months
6-item Household Food Security Survey Module (HFSSM).
Up to 12 months
Smoking status
Time Frame: Up to 12 months
Self-reported smoking status.
Up to 12 months
Weight
Time Frame: Up to 12 months
Change in self-reported weight in kilograms or pounds.
Up to 12 months
Disease-specific intermediate health outcomes: Diabetes
Time Frame: Up to 24 months
Change in mean glycosylated hemoglobin (A1C) based on laboratory data.
Up to 24 months
Disease-specific intermediate health outcomes: Hypertension
Time Frame: Up to 12 months
Change in systolic blood pressure (SBP) in mmHg based on primary data collection.
Up to 12 months
Disease-specific intermediate health outcomes: COPD/asthma
Time Frame: Up to 24 months
Exacerbations based on administrative health data.
Up to 24 months
Disease-specific intermediate health outcomes: Ischemic heart disease, chronic kidney disease, diabetes
Time Frame: Up to 24 months
Appropriate use of a statin where indicated based on pharmaceutical information network (PIN) dispensation data.
Up to 24 months
Patient experience
Time Frame: Up to 12 months
Based on semi-structured interviews.
Up to 12 months
Provider satisfaction
Time Frame: Up to 12 months
Based on semi-structured interviews.
Up to 12 months
Continuity of care
Time Frame: Up to 24 months
Provider attachment based on Usual Provider of Care (UPC) Index in Alberta practitioners claims file.
Up to 24 months
Physician costs
Time Frame: Up to 24 months
Physician claims based on physician claims files.
Up to 24 months
Acute care costs
Time Frame: Up to 24 months
Hospital admission and emergency department visit costs based on administrative health data.
Up to 24 months
All-cause mortality
Time Frame: Up to 24 months
All-cause mortality rate based on administrative data.
Up to 24 months
Medication adherence
Time Frame: Up to 24 months
≥80% of days covered for medications in Care Plan based on pharmaceutical information network (PIN) dispensation data.
Up to 24 months
Primary Care Network (PCN) multidisciplinary team access
Time Frame: Up to 24 months
umber of visits to multidisciplinary health team members based on PCN records.
Up to 24 months
Program costs
Time Frame: Up to 24 months
Administrative, training, and operational costs of program, assessed through PCN financial records.
Up to 24 months

Collaborators and Investigators

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

Sponsor

University of Calgary

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)

March 10, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB20-0009

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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