ENCOMPASS: Expansion Study B, RCT

Hypertension Clinical Trial

— ENCOMPASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790617
• Other study ID #: REB20-0009
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 10, 2023

Study information

• Verified date: May 2024
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Chronic Kidney Diseases
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Coronary Artery Disease
• Diabetes Mellitus, Type 2
• Heart Failure
• Hypertension
• Ischemic Heart Disease
• Kidney Diseases
• Lung Diseases, Obstructive
• Myocardial Ischemia
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Canada	Calgary West Central Primary Care Network	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (18)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute care service use	Rate of emergency department visits and hospital admissions based on administrative health data.	Up to 36 months
Secondary	Health-related quality of life	EuroQol EQ-5D-5L.	Up to 12 months
Secondary	Patient experience of care	11-item modified Patient Assessment of Chronic Illness Care (PACIC).	Up to 12 months
Secondary	Patient activation	10-item Patient Activation Measure (PAM-10), score and level.	Up to 12 months
Secondary	Anxiety symptoms	7-item Generalized Anxiety Disorder (GAD-7).	Up to 12 months
Secondary	Depressive symptoms	9-item Patient Health Questionnaire (PHQ-9).	Up to 12 months
Secondary	Perceived social support	8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS).	Up to 12 months
Secondary	Health literacy	3-item Brief Screening Questions for Health Literacy.	Up to 12 months
Secondary	General self-rated health	1-item Self-Rated Health (SRH).	Up to 12 months
Secondary	Household food security	6-item Household Food Security Survey Module (HFSSM).	Up to 12 months
Secondary	Smoking status	Self-reported smoking status.	Up to 12 months
Secondary	Weight	Change in self-reported weight in kilograms or pounds.	Up to 12 months
Secondary	Disease-specific intermediate health outcomes: Diabetes	Change in mean glycosylated hemoglobin (A1C) based on laboratory data.	Up to 24 months
Secondary	Disease-specific intermediate health outcomes: Hypertension	Change in systolic blood pressure (SBP) in mmHg based on primary data collection.	Up to 12 months
Secondary	Disease-specific intermediate health outcomes: COPD/asthma	Exacerbations based on administrative health data.	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	Provider satisfaction	Based on semi-structured interviews.	Up to 12 months
Secondary	Patient experience	Based on semi-structured interviews.	Up to 12 months
Secondary	Continuity of care	Provider attachment based on Usual Provider of Care (UPC) Index in Alberta practitioners claims file.	Up to 24 months
Secondary	Primary Care Network (PCN) multidisciplinary team access	umber of visits to multidisciplinary health team members based on PCN records.	Up to 24 months
Secondary	Program costs	Administrative, training, and operational costs of program, assessed through PCN financial records.	Up to 24 months
Secondary	Physician costs	Physician claims based on physician claims files.	Up to 24 months
Secondary	Acute care costs	Hospital admission and emergency department visit costs based on administrative health data.	Up to 24 months
Secondary	All-cause mortality	All-cause mortality rate based on administrative data.	Up to 24 months
Secondary	Medication adherence	=80% of days covered for medications in Care Plan based on pharmaceutical information network (PIN) dispensation data.	Up to 24 months