ENCOMPASS: Expansion Study B, RCT

NCT04790617 | Completed

• 1 other identifier: REB20-0009
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Acute care service use

  Rate of emergency department visits and hospital admissions based on administrative health data.

  Up to 36 months

Secondary Outcomes (24)

• Health-related quality of life

  Up to 12 months

• Patient experience of care

  Up to 12 months

• Patient activation

  Up to 12 months

• Anxiety symptoms

  Up to 12 months

• Depressive symptoms

  Up to 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Community health navigator program for six months.

Behavioral: Community Health Navigator Program

Control

NO INTERVENTION

Usual health care.

Interventions

Community Health Navigator Program BEHAVIORAL

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.

Also known as: ENCOMPASS Program

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Calgary West Central Primary Care Network

Calgary, Alberta, Canada

Location

Related Publications (18)

• Lehmann U, Sanders, D. Community health workers: What do we know about them? The state of the evidence on programmes, activities, costs an impact on health outcomes of Using community health workers. Geneva: World Health Organization. 2007.

  BACKGROUND

• Najafizada SA, Bourgeault IL, Labonte R, Packer C, Torres S. Community health workers in Canada and other high-income countries: A scoping review and research gaps. Can J Public Health. 2015 Mar 12;106(3):e157-64. doi: 10.17269/cjph.106.4747.

  PMID: 26125243 BACKGROUND

• Addressing chronic disease through community health workers: A policy and systems-level approach. Centers for Disease Control and Prevention. 2015.

  BACKGROUND

• 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.

  BACKGROUND

• Kangovi S, Grande D, Trinh-Shevrin C. From rhetoric to reality--community health workers in post-reform U.S. health care. N Engl J Med. 2015 Jun 11;372(24):2277-9. doi: 10.1056/NEJMp1502569. No abstract available.

  PMID: 26061832 BACKGROUND

• Burns ME, Galbraith AA, Ross-Degnan D, Balaban RB. Feasibility and evaluation of a pilot community health worker intervention to reduce hospital readmissions. Int J Qual Health Care. 2014 Aug;26(4):358-65. doi: 10.1093/intqhc/mzu046. Epub 2014 Apr 16.

  PMID: 24744082 BACKGROUND

• Enard KR, Ganelin DM. Reducing preventable emergency department utilization and costs by using community health workers as patient navigators. J Healthc Manag. 2013 Nov-Dec;58(6):412-27; discussion 428.

  PMID: 24400457 BACKGROUND

• Herman D, Conover S, Felix A, Nakagawa A, Mills D. Critical Time Intervention: an empirically supported model for preventing homelessness in high risk groups. J Prim Prev. 2007 Jul;28(3-4):295-312. doi: 10.1007/s10935-007-0099-3. Epub 2007 Jun 1.

  PMID: 17541827 BACKGROUND

• Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public Health. 2017 Oct;107(10):1660-1667. doi: 10.2105/AJPH.2017.303985. Epub 2017 Aug 17.

  PMID: 28817334 BACKGROUND

• Kangovi S, Mitra N, Grande D, White ML, McCollum S, Sellman J, Shannon RP, Long JA. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):535-43. doi: 10.1001/jamainternmed.2013.14327.

  PMID: 24515422 BACKGROUND

• Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.

  PMID: 26890177 BACKGROUND

• Carrasquillo O, Lebron C, Alonzo Y, Li H, Chang A, Kenya S. Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):948-954. doi: 10.1001/jamainternmed.2017.0926.

  PMID: 28459925 BACKGROUND

• Morgan AU, Grande DT, Carter T, Long JA, Kangovi S. Penn Center for Community Health Workers: Step-by-Step Approach to Sustain an Evidence-Based Community Health Worker Intervention at an Academic Medical Center. Am J Public Health. 2016 Nov;106(11):1958-1960. doi: 10.2105/AJPH.2016.303366. Epub 2016 Sep 15.

  PMID: 27631747 BACKGROUND

• McBrien KA, Ivers N, Barnieh L, Bailey JJ, Lorenzetti DL, Nicholas D, Tonelli M, Hemmelgarn B, Lewanczuk R, Edwards A, Braun T, Manns B. Patient navigators for people with chronic disease: A systematic review. PLoS One. 2018 Feb 20;13(2):e0191980. doi: 10.1371/journal.pone.0191980. eCollection 2018.

  PMID: 29462179 BACKGROUND

• Ali-Faisal SF, Colella TJ, Medina-Jaudes N, Benz Scott L. The effectiveness of patient navigation to improve healthcare utilization outcomes: A meta-analysis of randomized controlled trials. Patient Educ Couns. 2017 Mar;100(3):436-448. doi: 10.1016/j.pec.2016.10.014. Epub 2016 Oct 17.

  PMID: 27771161 BACKGROUND

• Walkinshaw E. Patient navigators becoming the norm in Canada. CMAJ. 2011 Oct 18;183(15):E1109-10. doi: 10.1503/cmaj.109-3974. Epub 2011 Sep 19. No abstract available.

  PMID: 21930738 BACKGROUND

• Desveaux L, McBrien K, Barnieh L, Ivers NM. Mapping variation in intervention design: a systematic review to develop a program theory for patient navigator programs. Syst Rev. 2019 Jan 8;8(1):8. doi: 10.1186/s13643-018-0920-5.

  PMID: 30621796 BACKGROUND

• Shommu NS, Ahmed S, Rumana N, Barron GR, McBrien KA, Turin TC. What is the scope of improving immigrant and ethnic minority healthcare using community navigators: A systematic scoping review. Int J Equity Health. 2016 Jan 15;15:6. doi: 10.1186/s12939-016-0298-8.

  PMID: 26768130 BACKGROUND

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Myocardial Ischemia; Heart Failure; Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kerry A McBrien, MD, MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: March 10, 2021
• Study Start: March 1, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)