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

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ClinicalTrials.gov Identifier: NCT03077386
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Canadian Diabetes Association
Information provided by (Responsible Party):
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.

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: ENCOMPASS Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators will test the effectiveness of the ENCOMPASS program using a parallel, two-arm, pragmatic, wait-list control, cluster-randomized trial. Half the clinics will be randomized to receive the intervention immediately, serving as the intervention group, while the other half will receive the intervention after a 6 month waiting period, acting as control sites during their first 6 months. Once implemented, the ENCOMPASS program will remain available to clinics until the end of the funding period. Control patients will continue to receive usual care until their clinic becomes eligible for the program.
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Enhancing Community Health Through Patient Navigation, Advocacy and Social Support
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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 Name: 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.



Primary Outcome Measures :
  1. Acute care utilization [ Time Frame: Up to 36 months ]
    All emergency department visits and hospital admissions


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: Up to 24 months ]
    EQ-5D-5L (Euroqol 5 dimension- 5 level instrument) administration

  2. Disease-specific intermediate health outcomes (hypertension) [ Time Frame: Up to 24 months ]
    Blood pressure based on primary data collection

  3. Disease-specific intermediate health outcomes (diabetes) [ Time Frame: Up to 24 months ]
    Hemoglobin A1c based on laboratory data

  4. 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)

  5. Disease-specific intermediate health outcomes (heart failure) [ Time Frame: Up to 24 months ]
    Number exacerbations based on administrative data

  6. Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma) [ Time Frame: Up to 24 months ]
    Number exacerbation based on administrative data

  7. Patient activation [ Time Frame: Up to 24 months ]
    Patient activation measure (PAM) administration via survey questionnaire

  8. Patient experience with chronic illness care [ Time Frame: Up to 24 months ]
    Patient assessment of chronic illness care (PACIC) administration via survey questionnaire

  9. Primary care attachment [ Time Frame: Up to 24 months ]
    Usual provider of care index (UPC) based on physician claims data

  10. Physician experience [ Time Frame: 6- and 12-months post-implementation ]
    Open-ended questions via semi-structured interview

  11. Medication adherence [ Time Frame: Up to 24 months ]
    Pharmaceutical information network (PIN) administrative data

  12. Mortality [ Time Frame: Up to 24 months ]
    All-cause mortality based on administrative data

  13. Weight [ Time Frame: Up to 24 months ]
    Weight based on primary data collection

  14. Social support [ Time Frame: Up to 24 months ]
    Social support based on Medical Outcomes Study Social Support Survey

  15. Smoking status [ Time Frame: Up to 24 months ]
    Current smoker Yes/No

  16. 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).

  17. 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).

  18. Program costs [ Time Frame: Up to 24 months ]
    Total operational costs

  19. Physician costs [ Time Frame: Up to 24 months ]
    Physician claims costs

  20. Acute care costs [ Time Frame: Up to 24 months ]
    Costs for emergency department visits and hospital admissions, based on RIW methods



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077386


Contacts
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Contact: Kerry McBrien, MD MPH 403-210-8625 kamcbrie@ucalgary.ca
Contact: Natalie Ludlow, PhD 403-210-7075 natalie.ludlow@ucalgary.ca

Locations
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Canada, Alberta
Mosaic Primary Care Network Recruiting
Calgary, Alberta, Canada
Contact: Rachel AC Clare, MSW    403-464-3145    rachel.clare@mosaicpcn.ca   
Sponsors and Collaborators
University of Calgary
Alberta Innovates Health Solutions
Canadian Diabetes Association
Investigators
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Principal Investigator: Kerry A McBrien, MD, MPH University of Calgary

Publications:
Public Health Agency of Canada. Chronic Disease and Injury Framework Quick Stats, 2016 Edition. Retreived from http://www.phac-aspc.gc.ca/publicat/hpcdp-pspmc/36-8/assets/pdf/ar-04-eng.pdf
Saher, MN (2014). Report of the Auditor General of Alberta: Health- Chronic Disease Management. Edmonton, AB: Office of the Auditor General of Alberta.

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03077386     History of Changes
Other Study ID Numbers: REB17-0360
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
patient navigator
community health navigator
multi-morbidity
primary care
social determinants of health
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Kidney Diseases
Renal Insufficiency, Chronic
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases