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ENCOMPASS: Expansion Study B, RCT (ENCOMPASS)

Primary Purpose

Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Community Health Navigator Program
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Chronic Disease Management, Health Navigation, Health Navigator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Exclusion Criteria:

  • Patient unable to provide informed consent;
  • Patient residing in long-term care facility;
  • Health care provider discretion.

Sites / Locations

  • Calgary West Central Primary Care Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Community health navigator program for six months.

Usual health care.

Outcomes

Primary Outcome Measures

Acute care service use
Rate of emergency department visits and hospital admissions based on administrative health data.

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2021
Last Updated
May 16, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04790617
Brief Title
ENCOMPASS: Expansion Study B, RCT
Acronym
ENCOMPASS
Official Title
Enhancing Community Health Through Patient Navigation, Advocacy and Social Support (ENCOMPASS): Expansion Study B, A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Ischemic Heart Disease, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma
Keywords
Chronic Disease Management, Health Navigation, Health Navigator

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Community health navigator program for six months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual health care.
Intervention Type
Behavioral
Intervention Name(s)
Community Health Navigator Program
Other Intervention Name(s)
ENCOMPASS Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute care service use
Description
Rate of emergency department visits and hospital admissions based on administrative health data.
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
EuroQol EQ-5D-5L.
Time Frame
Up to 12 months
Title
Patient experience of care
Description
11-item modified Patient Assessment of Chronic Illness Care (PACIC).
Time Frame
Up to 12 months
Title
Patient activation
Description
10-item Patient Activation Measure (PAM-10), score and level.
Time Frame
Up to 12 months
Title
Anxiety symptoms
Description
7-item Generalized Anxiety Disorder (GAD-7).
Time Frame
Up to 12 months
Title
Depressive symptoms
Description
9-item Patient Health Questionnaire (PHQ-9).
Time Frame
Up to 12 months
Title
Perceived social support
Description
8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS).
Time Frame
Up to 12 months
Title
Health literacy
Description
3-item Brief Screening Questions for Health Literacy.
Time Frame
Up to 12 months
Title
General self-rated health
Description
1-item Self-Rated Health (SRH).
Time Frame
Up to 12 months
Title
Household food security
Description
6-item Household Food Security Survey Module (HFSSM).
Time Frame
Up to 12 months
Title
Smoking status
Description
Self-reported smoking status.
Time Frame
Up to 12 months
Title
Weight
Description
Change in self-reported weight in kilograms or pounds.
Time Frame
Up to 12 months
Title
Disease-specific intermediate health outcomes: Diabetes
Description
Change in mean glycosylated hemoglobin (A1C) based on laboratory data.
Time Frame
Up to 24 months
Title
Disease-specific intermediate health outcomes: Hypertension
Description
Change in systolic blood pressure (SBP) in mmHg based on primary data collection.
Time Frame
Up to 12 months
Title
Disease-specific intermediate health outcomes: COPD/asthma
Description
Exacerbations based on administrative health data.
Time Frame
Up to 24 months
Title
Disease-specific intermediate health outcomes: Ischemic heart disease, chronic kidney disease, diabetes
Description
Appropriate use of a statin where indicated based on pharmaceutical information network (PIN) dispensation data.
Time Frame
Up to 24 months
Title
Provider satisfaction
Description
Based on semi-structured interviews.
Time Frame
Up to 12 months
Title
Patient experience
Description
Based on semi-structured interviews.
Time Frame
Up to 12 months
Title
Continuity of care
Description
Provider attachment based on Usual Provider of Care (UPC) Index in Alberta practitioners claims file.
Time Frame
Up to 24 months
Title
Primary Care Network (PCN) multidisciplinary team access
Description
umber of visits to multidisciplinary health team members based on PCN records.
Time Frame
Up to 24 months
Title
Program costs
Description
Administrative, training, and operational costs of program, assessed through PCN financial records.
Time Frame
Up to 24 months
Title
Physician costs
Description
Physician claims based on physician claims files.
Time Frame
Up to 24 months
Title
Acute care costs
Description
Hospital admission and emergency department visit costs based on administrative health data.
Time Frame
Up to 24 months
Title
All-cause mortality
Description
All-cause mortality rate based on administrative data.
Time Frame
Up to 24 months
Title
Medication adherence
Description
≥80% of days covered for medications in Care Plan based on pharmaceutical information network (PIN) dispensation data.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry A McBrien, MD, MPH
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary West Central Primary Care Network
City
Calgary
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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Addressing chronic disease through community health workers: A policy and systems-level approach. Centers for Disease Control and Prevention. 2015.
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Gutierrez Kapheim M, Campbell J. Best Practice Guidelines for Implementing and Evaluating Community Health Worker Programs in Health Care Settings. Sinai Urban Health Institute; Chicago, IL. 2014.
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ENCOMPASS: Expansion Study B, RCT

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