ENCOMPASS: Expansion Study B, RCT

Sponsor

University of Calgary (Other)

Overall Status

Recruiting

CT.gov ID

NCT04790617

Collaborator

(none)

400

Enrollment

Location

Arms

26.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Diabetes Mellitus, Type 2 Chronic Kidney Diseases Ischemic Heart Disease Congestive Heart Failure Chronic Obstructive Pulmonary Disease Asthma	Behavioral: Community Health Navigator Program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The ENCOMPASS study will evaluate the effectiveness of a community health navigator program using a two-armed, pragmatic, randomized controlled trial. The intervention arm will receive the CHN program for six months. The control arm will receive their usual health care. This study will employ patient-level block randomization stratified by study site. Research staff will be blinded to block size. In the case where participants live together in the same residence, they will be randomly assigned to the same study arm.The ENCOMPASS study will evaluate the effectiveness of a community health navigator program using a two-armed, pragmatic, randomized controlled trial. The intervention arm will receive the CHN program for six months. The control arm will receive their usual health care. This study will employ patient-level block randomization stratified by study site. Research staff will be blinded to block size. In the case where participants live together in the same residence, they will be randomly assigned to the same study arm.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 10, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Acute care service use [Up to 36 months]
Rate of emergency department visits and hospital admissions based on administrative health data.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).