Enhancing Community Health Through Patient Navigation, Advocacy and Social Support

Hypertension Clinical Trial

— ENCOMPASS  

Official title:

Enhancing Community Health Through Patient Navigation, Advocacy and Social Support

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03077386
• Other study ID #: REB17-0360
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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:
• 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

Locations

Country	Name	City	State
Canada	Mosaic Primary Care Network	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Innovates Health Solutions, Canadian Diabetes Association

Country where clinical trial is conducted

Canada, 

References & Publications (24)

Bayliss EA, Bayliss MS, Ware JE Jr, Steiner JF. Predicting declines in physical function in persons with multiple chronic medical conditions: what we can learn from the medical problem list. Health Qual Life Outcomes. 2004 Sep 7;2:47. doi: 10.1186/1477-7525-2-47. — View Citation

Condelius A, Edberg AK, Jakobsson U, Hallberg IR. Hospital admissions among people 65+ related to multimorbidity, municipal and outpatient care. Arch Gerontol Geriatr. 2008 Jan-Feb;46(1):41-55. doi: 10.1016/j.archger.2007.02.005. Epub 2007 Apr 2. — View Citation

Fischer SM, Sauaia A, Kutner JS. Patient navigation: a culturally competent strategy to address disparities in palliative care. J Palliat Med. 2007 Oct;10(5):1023-8. doi: 10.1089/jpm.2007.0070. No abstract available. — View Citation

Fortin M, Bravo G, Hudon C, Vanasse A, Lapointe L. Prevalence of multimorbidity among adults seen in family practice. Ann Fam Med. 2005 May-Jun;3(3):223-8. doi: 10.1370/afm.272. — View Citation

Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and quality of life in primary care: a systematic review. Health Qual Life Outcomes. 2004 Sep 20;2:51. doi: 10.1186/1477-7525-2-51. — View Citation

Freeman HP. The history, principles, and future of patient navigation: commentary. Semin Oncol Nurs. 2013 May;29(2):72-5. doi: 10.1016/j.soncn.2013.02.002. No abstract available. — View Citation

Goff SL, Pekow PS, White KO, Lagu T, Mazor KM, Lindenauer PK. IDEAS for a healthy baby--reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial. Trials. 2013 Aug 7;14:244. doi: 10.1186/1745-6215-14-244. — View Citation

Manns BJ, Tonelli M, Zhang J, Campbell DJ, Sargious P, Ayyalasomayajula B, Clement F, Johnson JA, Laupacis A, Lewanczuk R, McBrien K, Hemmelgarn BR. Enrolment in primary care networks: impact on outcomes and processes of care for patients with diabetes. CMAJ. 2012 Feb 7;184(2):E144-52. doi: 10.1503/cmaj.110755. Epub 2011 Dec 5. — View Citation

McAlister FA, Majumdar SR, Eurich DT, Johnson JA. The effect of specialist care within the first year on subsequent outcomes in 24,232 adults with new-onset diabetes mellitus: population-based cohort study. Qual Saf Health Care. 2007 Feb;16(1):6-11. doi: 10.1136/qshc.2006.018648. — View Citation

Parker VA, Lemak CH. Navigating patient navigation: crossing health services research and clinical boundaries. Adv Health Care Manag. 2011;11:149-83. doi: 10.1108/s1474-8231(2011)0000011010. — View Citation

Pedersen A, Hack TF. Pilots of oncology health care: a concept analysis of the patient navigator role. Oncol Nurs Forum. 2010 Jan;37(1):55-60. doi: 10.1188/10.ONF.55-60. — View Citation

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

Ronksley PE, Sanmartin C, Campbell DJ, Weaver RG, Allan GM, McBrien KA, Tonelli M, Manns BJ, Hennessy D, Hemmelgarn BR. Perceived barriers to primary care among western Canadians with chronic conditions. Health Rep. 2014 Apr;25(4):3-10. — View Citation

Saher, MN (2014). Report of the Auditor General of Alberta: Health- Chronic Disease Management. Edmonton, AB: Office of the Auditor General of Alberta.

Scott LB, Gravely S, Sexton TR, Brzostek S, Brown DL. Examining the effect of a patient navigation intervention on outpatient cardiac rehabilitation awareness and enrollment. J Cardiopulm Rehabil Prev. 2013 Sep-Oct;33(5):281-91. doi: 10.1097/HCR.0b013e3182972dd6. — View Citation

Shah BR, Hux JE, Austin PC. Diabetes is not treated as a coronary artery disease risk equivalent. Diabetes Care. 2007 Feb;30(2):381-3. doi: 10.2337/dc06-1654. No abstract available. — View Citation

Shlay JC, Barber B, Mickiewicz T, Maravi M, Drisko J, Estacio R, Gutierrez G, Urbina C. Reducing cardiovascular disease risk using patient navigators, Denver, Colorado, 2007-2009. Prev Chronic Dis. 2011 Nov;8(6):A143. Epub 2011 Oct 17. — View Citation

Sirois C, Moisan J, Poirier P, Gregoire JP. Suboptimal use of cardioprotective drugs in newly treated elderly individuals with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1880-2. doi: 10.2337/dc06-2257. Epub 2007 Mar 23. No abstract available. — View Citation

Supina AL, Guirguis LM, Majumdar SR, Lewanczuk RZ, Lee TK, Toth EL, Johnson JA. Treatment gaps for hypertension management in rural Canadian patients with type 2 diabetes mellitus. Clin Ther. 2004 Apr;26(4):598-606. doi: 10.1016/s0149-2918(04)90062-8. — View Citation

Tonelli M, Bohm C, Pandeya S, Gill J, Levin A, Kiberd BA. Cardiac risk factors and the use of cardioprotective medications in patients with chronic renal insufficiency. Am J Kidney Dis. 2001 Mar;37(3):484-9. — View Citation

Tonelli M, Gill J, Pandeya S, Bohm C, Levin A, Kiberd BA. Barriers to blood pressure control and angiotensin enzyme inhibitor use in Canadian patients with chronic renal insufficiency. Nephrol Dial Transplant. 2002 Aug;17(8):1426-33. doi: 10.1093/ndt/17.8.1426. — View Citation

Toth EL, Majumdar SR, Guirguis LM, Lewanczuk RZ, Lee TK, Johnson JA. Compliance with clinical practice guidelines for type 2 diabetes in rural patients: treatment gaps and opportunities for improvement. Pharmacotherapy. 2003 May;23(5):659-65. doi: 10.1592/phco.23.5.659.32203. — 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

Wells KJ, Battaglia TA, Dudley DJ, Garcia R, Greene A, Calhoun E, Mandelblatt JS, Paskett ED, Raich PC; Patient Navigation Research Program. Patient navigation: state of the art or is it science? Cancer. 2008 Oct 15;113(8):1999-2010. doi: 10.1002/cncr.23815. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute care utilization	All emergency department visits and hospital admissions	Up to 36 months
Secondary	Health-related quality of life	EQ-5D-5L (Euroqol 5 dimension- 5 level instrument) administration	Up to 24 months
Secondary	Disease-specific intermediate health outcomes (hypertension)	Blood pressure based on primary data collection	Up to 24 months
Secondary	Disease-specific intermediate health outcomes (diabetes)	Hemoglobin A1c based on laboratory data	Up to 24 months
Secondary	Disease-specific intermediate health outcomes (appropriate medication use)	Use of a statin where indicated (according to chronic disease guidelines)	Up to 24 months
Secondary	Disease-specific intermediate health outcomes (heart failure)	Number exacerbations based on administrative data	Up to 24 months
Secondary	Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma)	Number exacerbation based on administrative data	Up to 24 months
Secondary	Patient activation	Patient activation measure (PAM) administration via survey questionnaire	Up to 24 months
Secondary	Patient experience with chronic illness care	Patient assessment of chronic illness care (PACIC) administration via survey questionnaire	Up to 24 months
Secondary	Primary care attachment	Usual provider of care index (UPC) based on physician claims data	Up to 24 months
Secondary	Physician experience	Open-ended questions via semi-structured interview	6- and 12-months post-implementation
Secondary	Medication adherence	Pharmaceutical information network (PIN) administrative data	Up to 24 months
Secondary	Mortality	All-cause mortality based on administrative data	Up to 24 months
Secondary	Weight	Weight based on primary data collection	Up to 24 months
Secondary	Social support	Social support based on Medical Outcomes Study Social Support Survey	Up to 24 months
Secondary	Smoking status	Current smoker Yes/No	Up to 24 months
Secondary	Depression score	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).	Up to 24 months
Secondary	Anxiety score	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).	Up to 24 months
Secondary	Program costs	Total operational costs	Up to 24 months
Secondary	Physician costs	Physician claims costs	Up to 24 months
Secondary	Acute care costs	Costs for emergency department visits and hospital admissions, based on RIW methods	Up to 24 months