Clinical trial NCT03326206: Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
Official title: Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Metabolic Syndrome
Hypertension
Chronic Disease
Keywords: Navajo
Community Health Workers
Community Health Representatives
Tribal health systems
American Indian
Rural
Health disparities
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Eastern Research Group
First posted: 2017-10-31
Enrollment: 28813
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals receiving care at a Navajo Area Indian Health Service facility, living with diabetes

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Change in hemoglobin A1c
timeFrame: 12 and 24 months
Secondary outcomes:
measure: Change in systolic blood pressure
timeFrame: 12 and 24 months
measure: Change in low-density lipoprotein
timeFrame: 12 and 24 months
measure: Change in body mass index
timeFrame: 12 and 24 months
measure: Change in primary outpatient services
timeFrame: 12 and 24 months
measure: Change in specialty outpatient services
timeFrame: 12 and 24 months
measure: Change in emergency and inpatient services
timeFrame: 12 and 24 months
measure: Change in counseling / behavioral services
timeFrame: 12 and 24 months
Other outcomes:
measure: Change in self-reported health
timeFrame: 12 months
measure: Change in self-reported sense of control
timeFrame: 12 months
measure: Change in self-report coping
timeFrame: 12 months
Locations:
city: Chinle
country: United States
facility: Chinle Comprehensive Health Care Facility
state: Arizona
city: Fort Defiance
country: United States
facility: Tsehootsooi Medical Center
state: Arizona
city: Kayenta
country: United States
facility: Kayenta Health Center
state: Arizona
city: Crownpoint
country: United States
facility: Crownpoint Health Center Facility
state: New Mexico
city: Gallup
country: United States
facility: Gallup Indian Medical Center
state: New Mexico
city: Shiprock
country: United States
facility: Northern Navajo Medical Center
state: New Mexico
Study officials:
affiliation: Brigham and Women's Hospital
name: Sonya S Shin, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franz C, Atwood S, Orav EJ, Curley C, Brown C, Trevisi L, Nelson AK, Begay MG, Shin S. Community-based outreach associated with increased health utilization among Navajo individuals living with diabetes: a matched cohort study. BMC Health Serv Res. 2020 May 25;20(1):460. doi: 10.1186/s12913-020-05231-4.
citation: Brown C, Lalla A, Curley C, King C, Muskett O, Salt S, Ray K, Begay MG, Nelson AK, Shin S. Community-clinic linkages: qualitative provider perspectives on partnering with community health representatives in Navajo Nation. BMJ Open. 2020 Feb 12;10(2):e031794. doi: 10.1136/bmjopen-2019-031794.
citation: Lalla A, Salt S, Schrier E, Brown C, Curley C, Muskett O, Begay MG, Shirley L, Clark C, Singer J, Shin S, Nelson AK. Qualitative evaluation of a community health representative program on patient experiences in Navajo Nation. BMC Health Serv Res. 2020 Jan 8;20(1):24. doi: 10.1186/s12913-019-4839-x.
citation: Trevisi L, Orav JE, Atwood S, Brown C, Curley C, King C, Muskett O, Sehn H, Nelson KA, Begay MG, Shin SS. Integrating community health representatives with health care systems: clinical outcomes among individuals with diabetes in Navajo Nation. Int J Equity Health. 2019 Nov 27;18(1):183. doi: 10.1186/s12939-019-1097-9.