Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases.

Including target populations in the design and implementation of research trials has been one response to the growing health disparities endemic to our health care system, as well as an aid to study generalizability. One type of community-based participatory research is "Patient Centered-Research", in which patient perspectives on the germane research questions and methodologies are incorporated into the study. The Patient-Centered Outcomes Research Institute (PCORI) has mandated that meaningful patient and stakeholder engagement be incorporated into all applications. As of March 2015, PCORI funded seven clinically-focused studies of patients with kidney disease. The goal of this paper is to synthesize the experiences of these studies to gain an understanding of how meaningful patient and stakeholder engagement can occur in clinical research of kidney diseases, and what the key barriers are to its implementation. Our collective experience suggests that successful implementation of a patient- and stakeholder-engaged research paradigm involves: (1) defining the roles and process for the incorporation of input; (2) identifying the particular patients and other stakeholders; (3) engaging patients and other stakeholders so they appreciate the value of their own participation and have personal investment in the research process; and (4) overcoming barriers and challenges that arise and threaten the productivity of the collaboration. It is our hope that the experiences of these studies will further interest and capacity for incorporating patient and stakeholder perspectives in research of kidney diseases.

Exercise Intervention Improves the Metabolic Profile and Body Composition of Southwestern American Indian Adolescents.

INTRODUCTION/PURPOSE: The Southwestern American Indian population carries a high prevalence of metabolic syndrome and obesity, placing this group at higher risk than the general population for developing early type 2 diabetes and cardiovascular disease, likely impacting overall lifespan. This study aims to evaluate the impact of early lifestyle interventions which promote healthy eating and regular exercise on risk factors contributing to the development of the metabolic syndrome among the adolescent Zuni Pueblo population. MATERIALS AND METHODS: We describe a prospective, single site, community-based cohort study performed among sixty-five adolescent Zuni Indians aged 13.9 ± 1.7 years who were recruited between March 2011 and January 2014. The study intervention consisted of a targeted, tri-weekly exercise regimen with nutritional counselling, and the primary study outcomes included changes from baseline in metabolic profile (fasting lipids, A1c), vital signs (blood pressure, resting heart rate) and anthropometric characteristics of the study group. RESULTS: 41 participants have anthropometric data measured at baseline and after completion, biochemical data are available from 30 participants, and body composition data from 26 patients. Using the paired Student's t-test with Bonferroni correction, significant improvements were shown in pediatric BMI percentile, fasting lipid profile, A1C, total body fat, and fat free mass after six months of exercise and nutritional intervention. CONCLUSIONS: A simple, standardized fitness program among Southwest American Indian adolescents was effective at reducing fasting lipids and adiposity, as well as improving glycemic indices over the course of six months.

A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians.

INTRODUCTION: One in three people will be diagnosed with diabetes by 2050, and the proportion will likely be higher among Native Americans. Diabetes control is currently suboptimal in underserved populations despite a plethora of new therapies. Patient empowerment is a key determinant of diabetes control, but such empowerment can be difficult to achieve due to resource limitation and cultural, language and health literacy barriers. We describe a home-based educational intervention using Community Health Representatives (CHRs), leading to improvement in Patient Activation Measures scores and clinical indicators of diabetes control. METHODS: Sixty participants with type 2 diabetes (T2D) completed a baseline evaluation including physical exam, Point of Care (POC) testing, and the Patient Activation Measure (PAM) survey. Participants then underwent a one hour group didactic session led by Community Health Representatives (CHRs) who subsequently carried out monthly home-based educational interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey were repeated. RESULTS: PAM scores were increased by at least one level in 35 (58%) participants, while 24 participants who started at higher baseline score did not change. Six months after intervention, mean levels of A1C decreased by 0.7 ± 1.2%; fasting blood glucose decreased by 24.0 ± 38.0 mg/dl; BMI decreased by 1.5 ± 2.1 kg/m2; total cholesterol decreased by 12.0 ± 28.0 mg/dl; and triglycerides decreased by 52.0 ± 71.0 mg/dl. All of these changes were statistically significant (p < 0.05). CONCLUSION: This six month, CHR led and community-oriented educational intervention helps inform standards of practice for the management of diabetes, engages diabetic populations in their own care, and reduces health disparities for the underserved population of Zuni Indians. TRIAL REGISTRATION: ClinicalTrials.gov NCT02339311.

Assessing knowledge and attitudes of diabetes in Zuni Indians using a culture-centered approach.

INTRODUCTION: The Zuni Pueblo, in collaboration with the University of New Mexico, have formed the Zuni Health Initiative (ZHI) engaged in community-based participatory research to plan and implement educational interventions to reduce health disparities. We conducted the first phase of ZHI study and identified barriers to healthcare. We concluded that the burden presented by these barriers ultimately translates into a lack of patient activation and engagement in their health care including for diabetes, effectively hindering adoption of healthy behaviors. METHODS: Community health representatives (CHRs) led 10 one-hour focus group sessions to elicit information on diabetes knowledge and self-management strategies at which a total of 84 people participated. Audiotapes were translated and transcribed by bilingual ZHI staff. We reduced the text to thematic categories, constructed a coding dictionary and inserted the text into NVivo 9 program. RESULTS: The focus groups revealed that despite extensive personal or family experiences with diabetes or complications, participants identified knowledge gaps in the disease progression and disease management. However, we gained insight into how many Zunis conceptualize the etiology of diabetes, risk factors associated with diabetes, sources of knowledge and self-management practices. CONCLUSION: We concluded that many of the Zuni diabetics experience significant impacts on their life when they were diagnosed with diabetes and suffered the plight of stigmatization. We further concluded that developing Zuni culture specific diabetes care should focus on family involvement with continued education.

Identifying barriers to healthcare to reduce health disparity in Zuni Indians using focus group conducted by community health workers.

The Zuni Pueblo is home to an economically disadvantaged population, which faces a public health challenge from the interrelated epidemics of obesity, diabetes and kidney disease. Efforts to decrease the impact of these epidemics have been complicated by historical, economic and cultural barriers, which may limit healthcare utilization. The NIH supported Zuni Health Initiative (ZHI) conducted a study to identify barriers to healthcare in the Zuni Pueblo. Community health representatives (CHRs) led 14 one-hour focus group sessions at which a total of 112 people participated posed unique questions that took into account the Zuni culture to elicit information on perceived barriers to healthcare. Audiotapes were translated and transcribed by bilingual ZHI staff. We reduced the text to thematic categories, constructed a coding dictionary and inserted the text into NVivo 9 program. We identified nine themes emerged regarding the barriers experienced in receiving healthcare and adhering to medical advice. These included distance; transportation; embarrassment; relating to healthcare professionals; navigating the medical system; awareness of available resources; waiting times; adhering to medication; and incentives in health promotion. In conclusion the implementation of culturally appropriate community-based health promotion programs and preventive screening techniques will improve access to healthcare and diminish health disparities.