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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326206
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Eastern Research Group
Information provided by (Responsible Party):
Sonya Sunhi Shin, Brigham and Women's Hospital

Tracking Information
First Submitted Date October 24, 2017
First Posted Date October 31, 2017
Last Update Posted Date November 1, 2017
Actual Study Start Date November 1, 2013
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2017)
Change in hemoglobin A1c [ Time Frame: 12 and 24 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 27, 2017)
  • Change in systolic blood pressure [ Time Frame: 12 and 24 months ]
  • Change in low-density lipoprotein [ Time Frame: 12 and 24 months ]
  • Change in body mass index [ Time Frame: 12 and 24 months ]
  • Change in primary outpatient services [ Time Frame: 12 and 24 months ]
    Primary outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
  • Change in specialty outpatient services [ Time Frame: 12 and 24 months ]
    Specialty outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
  • Change in emergency and inpatient services [ Time Frame: 12 and 24 months ]
    Emergency encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis. For inpatient services, the primary data point is the presence of a DRG code indicating the patient was hospitalized. However, we also included clinic listings for labor and delivery and for observation as inpatient utilization.
  • Change in counseling / behavioral services [ Time Frame: 12 and 24 months ]
    Counseling / behavioral encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 27, 2017)
  • Change in self-reported health [ Time Frame: 12 months ]
    Health status is assessed by three questions using a 5-point scale response to the General Health question from the Short Form 12 survey: "Would you say that in general your health is…" "Compared to your health a year ago, would you say your health is" and "Compared to other people your age, would you say your health is" (Excellent=5, Very Good=4, Good=3, Fair=2, Poor=1), where higher values are more favorable.
  • Change in self-reported sense of control [ Time Frame: 12 months ]
    Empowerment is assessed using a 4-point scale response to the question "Do you feel you are in control of your health?" (Always Never=1, Rarely=2, Sometimes=3, Almost Always=4) with a higher value representing a favorable outcome.
  • Change in self-report coping [ Time Frame: 12 months ]
    Coping will be assessed using a 4-point scale response to two questions "how often have you found that you couldn't cope with all the things that you had to do to?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) and "In the last month, how often have you been upset because of something that happened unexpectedly?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) with a higher value representing a favorable outcome
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
Official Title Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
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?
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals receiving care at a Navajo Area Indian Health Service facility, living with diabetes
Condition
  • Diabetes Mellitus
  • Metabolic Syndrome
  • Hypertension
  • Chronic Disease
Intervention Other: COPE Program
The COPE Program is a programmatic model that is designed to support to providers, Community Health Representatives, and patients/family members. Patients are referred to the COPE Program under program auspices. COPE referral and participation is part of routine care at all service units in Navajo Area Indian Health Services, and enrollment is not influenced by study participation. Patients receive the same health care services in the same manner and intensity, whether or not they are not enrolled in this observational study.
Other Names:
  • Health systems strengthening
  • Community Health Worker integration
  • Community outreach
Study Groups/Cohorts
  • COPE participants
    Individuals living with diabetes seen at a study site who were enrolled in the COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs use structured patient coaching materials to support behavior change. CHRs also check vital signs, monitor blood glucose levels through finger sticks, and facilitate access to appointments and medical refills. CHRs communicate regularly with providers through electronic health record documentation and case management rounds. In-person or telephone communication is be used to address acute issues that may arise.
    Intervention: Other: COPE Program
  • Non-COPE participants
    Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 27, 2017)
28813
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2015
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03326206
Other Study ID Numbers AD-1304-6566
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Sonya Sunhi Shin, Brigham and Women's Hospital
Original Responsible Party Same as current
Current Study Sponsor Brigham and Women's Hospital
Original Study Sponsor Same as current
Collaborators Eastern Research Group
Investigators
Principal Investigator: Sonya S Shin, MD MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date October 2017