Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program



Status:Completed
Conditions:High Blood Pressure (Hypertension), Endocrine, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/25/2017
Start Date:November 1, 2013
End Date:December 31, 2015

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Since 2009, a programmatic community-based strategy (COPE) has been implemented to address
health disparities among Navajo individuals living with multiple chronic conditions. COPE
(Community Outreach and Patient Empowerment) targets individual, family, and health
system-level factors through four activities: 1) coordination between community health
representatives (CHRs) and Indian Health Service providers; 2) CHR competency with
standardized training; 3) a culturally-sensitive health promotion curriculum for patients and
families; and 4) strong CHR supervision.

COPE has been implemented throughout Navajo Nation. Enrollment is programmatic; in other
words, the decision to enroll a patient in COPE occurs independently of whether the patient
is in this study. Participants receive the COPE intervention in the same manner and
intensity, whether they are included in this observational study or not.

The main goal of this observational research is to understand if COPE improves the lives of
participating community members. The Primary Aim is to assess the impact of the COPE Project
on changes in HbA1c and other CVD risk factors. Hypothesis: Patients enrolled in the COPE
program will experience a reduction in HbA1c compared to the control group. Secondary aims
are: 1) To understand if COPE improves patients' own self-reported outcomes. Hypothesis: COPE
patients will report better health compared with their own baseline at 12 months. 2) To
Identify factors associated with increased effectiveness of the COPE Project at the
individual, community, and health system level using a mixed-model approach. 3) To understand
diverse stakeholder perspectives on COPE impact and value among CHRs, providers and the
health care system. Hypothesis: Compared with baseline, CHRs will report greater empowerment
in their work, providers will report greater confidence in CHRs.

The observational cohort will be comprised of individuals with diabetes receiving care at one
of the participating health facilities. Cases include individuals participating in the COPE
intervention; controls are non-COPE participants identified within the same hospital and
matched based on similar baseline characteristics. Study findings will improve clinical and
patient-decision making and the health of marginalized AI/ANs by informing policies to
promote CHR interventions in rural and underserved communities.

Study population: The study will take place on the Navajo Reservation and within Navajo Area
IHS clinical facilities. The Navajo Reservation covers over 27,000 square miles in rural New
Mexico and Arizona. The proposed evaluation will occur at the six sites, including two which
are currently implementing COPE as well as four sites which will implement COPE in the next
two years. The health care centers included in this evaluation represent a mix of federally
and tribally operated programs and together provide care for over 200,000 individuals. All
sites use a common suite of software applications to record electronic health care data: the
IHS RPMS (Resource Patient Management System).

Study Design: The research is aligned with PCORI's definition of patient-centered research by
answering questions that will allow patients and other stakeholders to make informed health
care decisions. This will be completed by incorporating patient input at all stages;
comparatively assessing the benefits and weaknesses of COPE; capturing the "voice" of
stakeholders through qualitative methods; choosing outcomes that have been cited as relevant
to patients' own priorities and decision-making; and studying cross-site variation to capture
individual and community factors associated with impact. The study will address the following
questions:

1. Do clinical outcomes (hemoglobin A1c, blood pressure, cholesterol, and body mass index)
improve more among COPE participants, compared with similar patients who do not
participate in COPE?

2. Do COPE patients experience improvements in self-rated overall health, quality of life,
empowerment and satisfaction compared with similar patients who do not participate in
COPE?

3. As COPE is implemented in six different service units across the Navajo Nation, can we
identify any factors among patients, CHRs, and hospitals that are "key ingredients" for
COPE to be effective?

4. Does COPE benefit the health system and population served from diverse stakeholder
perspectives including CHRs, providers, and the local health care delivery system?

Inclusion Criteria:

- Diagnosis of diabetes

- Treated at a participating IHS facility corresponding to their home residence

Exclusion Criteria:

- Not seen in one of the six participating clinical sites
We found this trial at
6
sites
Shiprock, New Mexico 87420
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Shiprock, NM
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Chinle, AZ
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Crownpoint, New Mexico 87313
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Crownpoint, NM
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Fort Defiance, Arizona 86504
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Fort Defiance, AZ
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516 Nizhoni Boulevard
Gallup, New Mexico 87301
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Gallup, NM
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394.3 Highway 160
Kayenta, Arizona 86033
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Kayenta, AZ
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