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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|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|
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.
- Acute care utilization [ Time Frame: Up to 36 months ]All emergency department visits and hospital admissions
- Health-related quality of life [ Time Frame: Up to 24 months ]EQ-5D-5L (Euroqol 5 dimension- 5 level instrument) administration
- Disease-specific intermediate health outcomes (hypertension) [ Time Frame: Up to 24 months ]Blood pressure based on primary data collection
- Disease-specific intermediate health outcomes (diabetes) [ Time Frame: Up to 24 months ]Hemoglobin A1c based on laboratory data
- 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)
- Disease-specific intermediate health outcomes (heart failure) [ Time Frame: Up to 24 months ]Number exacerbations based on administrative data
- Disease-specific intermediate health outcomes (chronic obstructive pulmonary disease and asthma) [ Time Frame: Up to 24 months ]Number exacerbation based on administrative data
- Patient activation [ Time Frame: Up to 24 months ]Patient activation measure (PAM) administration via survey questionnaire
- Patient experience with chronic illness care [ Time Frame: Up to 24 months ]Patient assessment of chronic illness care (PACIC) administration via survey questionnaire
- Primary care attachment [ Time Frame: Up to 24 months ]Usual provider of care index (UPC) based on physician claims data
- Physician experience [ Time Frame: 6- and 12-months post-implementation ]Open-ended questions via semi-structured interview
- Medication adherence [ Time Frame: Up to 24 months ]Pharmaceutical information network (PIN) administrative data
- Mortality [ Time Frame: Up to 24 months ]All-cause mortality based on administrative data
- Weight [ Time Frame: Up to 24 months ]Weight based on primary data collection
- Social support [ Time Frame: Up to 24 months ]Social support based on Medical Outcomes Study Social Support Survey
- Smoking status [ Time Frame: Up to 24 months ]Current smoker Yes/No
- 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).
- 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).
- Program costs [ Time Frame: Up to 24 months ]Total operational costs
- Physician costs [ Time Frame: Up to 24 months ]Physician claims costs
- Acute care costs [ Time Frame: Up to 24 months ]Costs for emergency department visits and hospital admissions, based on RIW methods
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
|Contact: Kerry McBrien, MD MPHfirstname.lastname@example.org|
|Contact: Natalie Ludlow, PhDemail@example.com|
|Mosaic Primary Care Network||Recruiting|
|Calgary, Alberta, Canada|
|Contact: Rachel AC Clare, MSW 403-464-3145 firstname.lastname@example.org|
|Principal Investigator:||Kerry A McBrien, MD, MPH||University of Calgary|