Clinical trial NCT03077386: Enhancing Community Health Through Patient Navigation, Advocacy and Social Support
Official title: Enhancing Community Health Through Patient Navigation, Advocacy and Social Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus, Type 2
Chronic Kidney Diseases
Ischemic Heart Disease
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Asthma
Keywords: patient navigator
community health navigator
multi-morbidity
primary care
social determinants of health
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
name: Canadian Diabetes Association
First posted: 2017-03-13
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Acute care utilization
timeFrame: Up to 36 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Up to 24 months
measure: Disease-specific intermediate health outcomes (hypertension)
timeFrame: Up to 24 months
measure: Disease-specific intermediate health outcomes (diabetes)
timeFrame: Up to 24 months
measure: Disease-specific intermediate health outcomes (appropriate medication use)
timeFrame: Up to 24 months
measure: Disease-specific intermediate health outcomes (heart failure)
timeFrame: Up to 24 months
measure: Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma)
timeFrame: Up to 24 months
measure: Patient activation
timeFrame: Up to 24 months
measure: Patient experience with chronic illness care
timeFrame: Up to 24 months
measure: Primary care attachment
timeFrame: Up to 24 months
measure: Physician experience
timeFrame: 6- and 12-months post-implementation
measure: Medication adherence
timeFrame: Up to 24 months
measure: Mortality
timeFrame: Up to 24 months
measure: Weight
timeFrame: Up to 24 months
measure: Social support
timeFrame: Up to 24 months
measure: Smoking status
timeFrame: Up to 24 months
measure: Depression score
timeFrame: Up to 24 months
measure: Anxiety score
timeFrame: Up to 24 months
measure: Program costs
timeFrame: Up to 24 months
measure: Physician costs
timeFrame: Up to 24 months
measure: Acute care costs
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Mosaic Primary Care Network
state: Alberta
Study officials:
affiliation: University of Calgary
name: Kerry A McBrien, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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