Translational Research in Indian Country Success and Future Directions

Transcription

1 Translational Research in Indian Country Success and Future Directions Nicolette I. Teufel-Shone, PhD Chair and Professor of Family and Child Health Mel and Enid Zuckerman College of Public Health University of Arizona

2 Translational Research Effective translation of the new knowledge, mechanisms, and techniques generated by advances in basic science research into new approaches for prevention, diagnosis, and treatment of disease is essential for improving health. Fontanarosa, PB and DeAngelis ( 2002) Basic science and translational research in JAMA. JAMA 287(13):1728.

3 Translational Research Bench-to-bedside Translating research into practice Harnessing new knowledge from basic sciences to produce new drugs, devices, and treatment options Aims to improve quality of care through: Increased access Assisting in behavior change Providing point-of-care decision support tools Strengthening the patient-clinician relationship Woolf, SH (2008) The meaning of translational research and what it matters. JAMA 299 (2);

4 Diabetes Prevention Program (DPP) The DPP was a major multicenter clinical research study initiated in late 1990s, aimed at discovering whether: Weight loss through dietary change and increased physical activity or Treatment with oral diabetes drugs (metformin and triglitazone) Could prevent or delay the onset of type 2 diabetes (DM)

5 DPP Randomized Control Trial Involved 27 clinical centers in the US Randomly divided into 4 treatment groups: Lifestyle intervention (training in diet, physical activity, behavior modification and lifestyle coaching/case management) Metformin (850mg of metformin twice/day) Control group (placebo instead of medication) Triglitazone (drug treatment) discontinued when drug was linked to serious liver damage

6 DPP participants 3,234 participants Overweight Had pre-diabetes (impaired glucose tolerance IGT) 45% were from minority populations Of the 1,079 participants in the lifestyle intervention, 5% were American Indian Predominantly Navajo and Zuni

7 DPP Outcomes Lifestyle intervention - decreased the incidence of developing DM by 58% Participants reported that lifestyle coaching was important to retention Metformin intervention decreased the incidence of developing DM by 31% Research treatment question was resolved earlier than projected Research was halted First results published in NEJM in 2002

8 Translation of DPP outcomes to Indian Country Indian Health Service s (IHS) Special Diabetes Program for AI/AN (SDPI) Congressional mandate, 1997 to present - Funding for community directed diabetes prevention activities In 2004, IHS SDPI announced - the Diabetes Prevention (DP) Demonstration Program to invite tribes to translate DPP strategies in community settings DP activities: 16 week diabetes prevention curriculum Lifestyle coaching and behavior change activities Healthy eating practices Physical activity and weight management Report assessment measures collected by IHS (quarterly) to Univ CO Coordinating Center

9 SPDI-DP in Indian Country DP awarded to 36 sites, serving 80 tribes Urban and reservation settings 2,553 AI/AN participants were recruited by 2008 Retention rates were: 74% post-curriculum 59% after year 1 42% after year 2 33% after year 3

10 DP Success in Indian Country ( ) Implementation of the Lifestyle Intervention across the 3-4 years yielded: Weight loss Significant reduction in blood pressure Significant reduction in lipid levels Attendance in 16 week curriculum was strongly correlated with these variables Findings demonstrate the feasibility and potential of translating the lifestyle intervention in diverse AI/AN communities Jiang, L et al., (2013 ) Translating the DPP into AI/AN communities: Results from the SDPI demonstration project. Diabetes Care 26 (7):

11 Staffing programs Challenges Implementation required a minimum of one licensed health care provider Access to IHS EHRs Recruitment into a structured program Variance of program implementation was limited Retention in a program that required quarterly and annually visits to IHS

12 Benefits Demonstrated impact on reducing risk of DM and reducing incidence of DM Quantitative results relayed to Congress Congress has extended initial 5 years of funding to 10 years! Required working tribe-ihs relationship Skills in the community to support other tribe directed evaluation and research activities

13 Future Directions DP sustainability needs to be addressed Tribe? IHS? Expanding participant eligibility to younger ages? Approach applicability to other health issues in Indian Country With a successful model in place Proposal to apply the model to behavioral health

14 Are Tribes and Research in Behavioral Health ready for Translation? Dowrick 2000 Stein 2003 Clarke 2001 Atlantis 2004 Focus Outcome To determine the acceptability and impact of two psychological interventions (problemsolving treatment and prevention course) for depressed adults in the community. To evaluate the effectiveness of a collaboratively designed school-based intervention for reducing children s symptoms of PTSD and depression that has resulted from exposure to violence. To prevent depressive episodes in at-risk offspring of adults treated for depression using a cognitive therapy prevention program. To investigates the impact of aerobic and weight-training exercise plus behavior modification for mental health and quality of life (QOL) outcomes. Adults with depressive disorders reported that the problem-solving treatment was more acceptable than the prevention course. Both interventions reduced improved subjective function. A 10-session cognitive-behavioral group intervention significantly decreased symptoms of PTSD/depression in students and can be effectively delivered on school by trained mental health clinicians. A group cognitive therapy prevention program can reduce the risk for depression in the offspring of parents with a history of depression. Multimodal exercise is effective treatment for depressive symptoms and, does improve stress symptoms and QOL outcomes.

15 Best science is needed to build healthy future generations Special thanks to 2553 participants in DP Staff who worked to implement the programs Tribal Leaders Diabetes Committee Tribal programs that have shared their insight on directions for securing the health of native peoples