Results Summary
What was the research about?
Type 2 diabetes causes a person’s blood sugar level to rise higher than normal. Good health care can prevent diabetes from damaging organs such as the kidneys and heart. But many adults living on the Navajo reservation can’t get the care they need.
Since 2010, the Indian Health Service and the Navajo Nation Department of Health have run an at-home diabetes education program for the Navajo Nation. Community health representatives, or CHRs, carry out the program and are part of the clinic healthcare team. They are from the Navajo community and speak the Navajo language. Doctors and CHRs invite adults with high risks related to diabetes to take part in the program. CHRs visit those in the program at home once or twice a month for up to one year. During home visits, CHRs check health, share information, and give support. People choose topics they want to learn about and decide on healthy changes they want to make. The CHRs leave notes in health records to let doctors at the clinics know about people’s needs.
In this study, the research team wanted to learn if the program improved health and healthcare use. The team compared health records of people in the program with people who weren’t in the program.
What were the results?
Blood sugar levels. People in the program lowered their blood sugar levels more than people who weren’t in the program.
Risks related to diabetes. People in the program reduced some risks related to diabetes, such as high cholesterol, more than people who weren’t in the program. For other risks, such as having high blood pressure or being overweight, the two groups didn’t show differences likely to affect health.
Use of health care. People in the program improved their use of some health services. They had more visits to primary care doctors, counselors, and pharmacies than people who weren’t in the program. The two groups didn’t differ in the number of visits to emergency rooms or hospital stays.
Who was in the study?
The study looked at health records from 173 Navajo adults with type 2 diabetes in the program and 2,885 Navajo adults with type 2 diabetes who weren’t in the program. Of those in the program, 77 percent were age 56 or older, 62 percent were women, and 58 percent preferred to use an indigenous language. Of those not in the program, 77 percent were age 56 or older, 69 percent were women, and 41 percent preferred to use an indigenous language. All received health care from Navajo Area Indian Health Service clinics.
What did the research team do?
Using health records of the Navajo Area Indian Health Service, the research team identified people in the program and people with similar traits, such as age, who weren’t in the program. The team compared blood sugar levels, risks related to diabetes, and healthcare use at the start of the study and again two years later.
Navajo adults who had been in the program, their relatives, tribal leaders, CHRs, doctors, and nurses helped design and carry out the study.
What were the limits of the study?
People who took part in the program chose to do so. They may differ from people who didn’t take part in the program. Also, health records were missing some information.
Future research could test the program in other communities with few healthcare resources or in people with other health problems.
How can people use the results?
Clinics could use these results when planning how best to provide care for people with diabetes.
Professional Abstract
Objective
To evaluate the impact of Community Outreach and Patient Empowerment (COPE), a program that provides home-based health coaching from community health representatives (CHRs), on indicators of diabetes control and healthcare utilization among Navajo adults with type 2 diabetes
Study Design
| Design Elements | Description |
|---|---|
| Design | Observational: cohort study |
| Population | Health records from 3,058 Navajo adults with type 2 diabetes receiving care at 6 NAIHS units |
| Interventions/ Comparators |
|
| Outcomes |
Primary: change in HbA1c Secondary: LDL, change in systolic blood pressure, BMI, and healthcare utilization |
| Timeframe | 2-year follow-up for primary outcome |
This prospective observational study of Navajo adults with type 2 diabetes receiving care from the Navajo Area Indian Health Service (NAIHS) compared outcomes among patients who participated in COPE with those who did not participate. As part of COPE, clinic-based providers and trained Navajo CHRs work together to identify Navajo adults at increased risk of diabetes complications. In addition to community-wide health promotion, CHRs provide individualized care in patients’ homes up to twice per month for at least one year, including
- Checking patients’ vital signs, coaching patients on diabetes self-management, and helping patients set health goals
- Supporting medication adherence
- Helping participants schedule and attend clinic appointments
- Reporting issues encountered during home visits to clinic-based providers
The program strengthens connections between CHRs and clinic-based providers. At some sites, CHRs can leave notes for clinic-based providers in patients’ electronic health records (EHRs).
Researchers abstracted data from the NAIHS EHR systems to identify the study cohort of 173 patients in COPE. They matched 2,885 patients not in COPE based on age, gender, clinic, HbA1c, and systolic blood pressure. At baseline, 77% of both cohorts were age 56 or older; 62% of the COPE and 69% of non-COPE cohorts were female; and 58% of COPE and 41% of non-COPE cohorts reported an indigenous language as their preferred language. Researchers compared changes over two years on clinical outcomes and healthcare utilization between the two cohorts.
Patients who previously participated in COPE, relatives of patients, tribal leaders, CHRs, clinicians, and administrators helped design and conduct the study.
Results
Compared with patients in the non-COPE cohort, patients in the COPE cohort had
- Clinically meaningful improvements in HbA1c and low-density lipoprotein (LDL). The baseline HbA1c average was 8.39% among the COPE cohort and 8.23% among the non-COPE cohort. Relative to baseline values, HbA1c decreased by 0.56% among the COPE cohort but increased by 0.07% among the non-COPE cohort (p<0.0001). LDL decreased by an average of 8.04 mg/dL among the COPE cohort and 3.21 mg/dL among the non-COPE cohort (p=0.02).
- Statistically significant, but not clinically meaningful, increases in systolic blood pressure. Systolic blood pressure increased by 1.43 mmHg among the COPE cohort and increased by 0.28 mmHg among the non-COPE cohort (p=0.004).
- Statistically significant improvements in utilization of outpatient primary care (p=0.024), counseling and behavioral health services (p=0.013), and pharmacy services (p<0.001).
The two cohorts did not differ significantly in change in body mass index and the number of emergency department visits or hospital stays.
Limitations
Patients self-selected into COPE, which could bias study results. In addition, missing EHR data limited matching of patients in and not in COPE and reduced the sizes of cohorts analyzed.
Conclusions and Relevance
Home-based coaching and greater coordination between clinic-based providers and CHRs led to improvement in several indicators of diabetes control and healthcare utilization among Navajo adults in this study. This approach may be promising for improving type 2 diabetes self-management among adults living in other medically underserved areas.
Future Research Needs
Future research could examine the impact of COPE among individuals living with other chronic health problems and in other communities.
Final Research Report
View this project's final research report.
More to Explore...
Blogs
In the Navajo Nation, a Focus on Health Data
Native Americans have disproportionately high rates of diabetes. Two PCORI studies, including this study, are searching for answers in the Navajo Nation and its health data. Challenges abound—including far-flung geography, low health resources, and language barriers—but together Navajo researchers and community health workers are meeting them. This blog was co-authored by Sonya Shin, MD, MPH, this study's principal investigator.
Journal Citations
Article Highlight: Native Americans have the highest rate of diabetes of all US racial and ethnic groups. In response, this study trained laypeople known as community health representatives to coach and help coordinate care for people in their own Navajo communities. As reported in International Journal for Equity in Health, compared to those not in the program, people in it lowered blood sugar and cholesterol levels at a greater level, and they also were more likely to make and keep appointments with doctors and other health providers.
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers expressed concern about identifying themes from the very small number of patients, seven, who participated in the portion of the study involving qualitative interviews. The researchers said the small number reflected the number of patients who had completed both baseline and follow-up surveys but that survey responses available from a somewhat larger set of patients, followed many of the same themes.
- Reviewers wondered why a relatively small number of patients received the intervention given the much larger pool considered. Reviewers asked whether the selection process may have introduced bias, perhaps magnifying the effects of the intervention. The researchers said the number of community health representatives available limited the study’s size. The researchers acknowledged that since patients volunteered to participate, and the study did not collect systematic data on the reasons why other patients did not participate, the findings might not be generalizable.