Current and Future Challenges in Designing Behavioral Interventions: From Randomized Trials to Community Implementation

Transcription

1 Current and Future Challenges in Designing Behavioral Interventions: From Randomized Trials to Community Implementation Preconference Workshop The Gerontological Society of America 65 th Annual Scientific Meeting Chairs: Laura N. Gitlin, Ph.D. Director, Center for Innovative Care in Aging Johns Hopkins University School of Nursing 525 North Wolfe Street, Suite 316 Baltimore, MD Phone: Fax: Sara J. Czaja, Ph.D. Leonard M. Miller Professor Department of Psychiatry and Behavioral Sciences Scientific Director, Center on Aging University of Miami Miller School of Medicine 1695 N.W. 9th Ave, Suite 3208H Miami, Fl., fax:

2 Table of Contents 1. Overview 2. Workshop Objectives 3. Agenda 4. Presenter Information 5. Select Readings 6. Worksheets Overview: The increased complexities associated with population aging are creating enormous challenges for research and clinical communities. At the same time there is an increased emphasis on the implementation of evidenced-based programs and on translating research findings into treatment, diagnostic and prevention approaches that improve the health and wellbeing of older adults and their families. Meeting these challenges requires new models of research and innovative research tools to reduce the growing barriers between research and clinical and community practice. The proposed preconference workshop represents a continuation of the theme we presented last year at GSA as a preconference workshop. At that workshop we had over 60 participants at varying stages of behavioral intervention research who attended. As suggested by the Institute on Medicine, a 17+ year gap between research and its implementation in practice continues to haunt science and practice. Thus, we seek to continue the conversation we began last year and present this preconference workshop. The proposed topics and speakers for this proposed forthcoming workshop seek to advance new approaches to conducting behavioral intervention research that may shorten the time from discovery, testing, and ultimately implementation. Workshop Objectives: This workshop will examine emerging challenges for behavioral intervention research. The goal is to impart an understanding of the concept of pipelines, and new designs and analytic strategies for advancing intervention research designs that have potential for real world implementation, Topics will include: traditional and hybrid pipelines in moving an intervention from discovery, proof of concept to implementation (Laura Gitlin); challenges and solutions for embedding trials in community and practice contexts (Sara Czaja); critical design considerations including approaches to measuring fidelity (Barbara Resnick); analytic strategies to advance implementation including mediational models (David Roth); and the specific challenges of translation and implementation, two stages of moving a tested intervention that are poorly understood or considered at the outset of developing a trial (Thomas Prohaska). Case studies and real world examples will be provided throughout the discussions. The intent is to stimulate new research paradigms and interactions and to build the capacity for current and future intervention researchers in aging who understand translation/implementation challenges.

3 Agenda: Part I: Pipelines Laura N. Gitlin, PhD From Randomized Trial to Practice Contexts: What are the pipelines that can shorten the research-practice gap Sara J. Czaja, PhD Challenges and Strategies for Implementing Randomized Clinical Trials in Community Settings Part II: Design Considerations Barbara Resnick, PhD, CRNP Treatment Fidelity in Behavioral Intervention research: Where We Are and Where We Need to Go David L. Roth, PhD Analytic Strategies that Strengthen Population Impact Part III - Translating RCT Evidence for Implementation Thomas R. Prohaska, PhD Translation and Implementation Challenges in Community based Behavioral Interventions

4 Presenter Information: Sara J. Czaja, PhD, Center on Aging University of Miami Miller School of Medicine Leonard M. Miller Professor Department of Psychiatry and Behavioral Sciences Scientific Director, 1695 N.W. 9th Ave, Suite 3208H Miami, Fl., Dr. Sara J. Czaja is a Leonard M. Miller Professor of the Psychiatry and Behavioral Sciences, and a Professor of Industrial Engineering at the University of Miami. She is also the Scientific Director of the Center on Aging at the University of Miami Miller School of Medicine and the Director of the Center on Research and Education for Aging and Technology Enhancement (CREATE). CREATE is funded by the National Institute on Aging involves collaboration with the Georgia Institute of Technology and Florida State University. The focus of CREATE is on making technology more accessible, useful, and usable for older adult populations. Dr. Czaja has extensive experience in aging research and a long commitment to developing strategies to improve the quality of life for older adults. Her research interests include: aging and cognition, aging and healthcare informatics, caregiving, older workers, humancomputer interaction, training, and functional assessment. Dr. Czaja is very well published in the field of aging and has written numerous book chapters and scientific articles. She recently co-authored a book with other members of the CREATE team concerning the design of technology systems for older adult populations. She is a fellow of the American Psychological Association, the Human Factors and Ergonomics Society and the Gerontological Society of America. She is also a member of the National Academy of Science/National Research Council Board on Human Systems Integration. Dr. Laura N. Gitlin PhD, Johns Hopkins University School of Nursing Professor Department of Health Systems and Outcomes Joint appointment, Department of Psychiatry, School of Medicine Director, Johns Hopkins University School of Nursing Center for Innovative Care in Aging 525 North Wolfe Street, Suite 316 Baltimore, MD lgitlin1@jhu.edu Dr. Laura N. Gitlin, an applied research sociologist, is nationally and internationally recognized in the areas of nonpharmacologic approaches in dementia care, family caregiving, functional disability and aging in place. She is a well-funded researcher, having received continuous research and training grants from both federal agencies and private foundations, including the Alzheimer s Association and the National Institutes of Health for over 25 years. Her current funded research programs include testing home-based interventions to enhance life quality for older adults with disabilities, testing a tailored activity program to address neuropsychiatric behaviors in individuals with dementia, mental health disparities in older African Americans and depression treatments, and translating and implementing evidence-based interventions for family caregivers, individuals with dementia, and older adults with functional difficulties. In 2011, Dr. Gitlin joined the Johns Hopkins University School of Nursing as a Professor in the Department of Community Public Health with joint appointments in the Department of Psychiatry, and Division of Geriatrics and Gerontology, School of Medicine. She is the director of a new inter-professional initiative, the Center for Innovative Care in Aging, examining issues related to developing, testing and implementing health promoting interventions and models of care for older adults and their families. Dr. Gitlin is the recipient of numerous awards including the 2009 Eastern Pennsylvania Geriatric Society, Charles Ewing Presidential Award for outstanding contribution to geriatric care; the 2010 United Way Champion Impact Award for Healthy Aging at Home, the 2010

5 National Institute of Senior Centers Award with Center in the Park, the 2010 MetLife Award for translating the Skills 2 Care Program (a dementia caregiver intervention program) with Fox Rehabilitation (a home health agency); and the 2011 John Mackey Award for Excellence in Dementia Care, from Johns Hopkins University. She is the author of over 150 scientific publications and has authored or coauthored 4 books, two of which are entering their 4 th edition. Dr. Thomas Prohaska PhD, George Mason University Dean, College of Health and Human Services 440 University Drive Fairfax Virginia Dr. Thomas Prohaska has more than 30 years experience in gerontological public health research, education, and practice. Prior to joining George Mason University, Dr. Prohaska was a professor of Public Health at the School of Public Health and Co-Director of the Center for Research on Health and Aging at the University of Illinois at Chicago where he is an emeritus professor of public health. He has been the principal investigator of federally funded research studies and co-investigator on many others and has over one hundred publications and government documents in gerontological health and behavioral health risk factors in older populations. He was an editor, along with Tom Hickey and Marjorie Speers, of the first volume of the book, Public Health and Aging as well as the second volume, with Lynda Anderson and Robert Binstock, (2012) Public Health for an Aging Society. His research interests focus on gerontological public health including physical activity, health behavior, illness behavior in older adults, self-care and chronic disease management in older populations, and the translation and dissemination of evidence-based research and health innovations in older populations. He is on the editorial board of The Gerontologist, the Journal of Gerontology Social Sciences and the Journal of Health and Aging. Dr. Prohaska research funding sources have included the Administration on Aging, the Robert Wood Johnson Foundation, and the National Institute on Aging, the Retirement Research Foundation, and Easter Seals. He has served on numerous regional and national advisory panels including the Centers for Disease Control and Prevention (CDC) Expert Panel on Nutrition, Physical Activity and Obesity-Related Health Disparities as well as the CDC Healthy Aging research Network (CDC-HAN). He is also currently on the Board of Trustees of the Retirement Research Foundation. Dr. Prohaska received his PhD in Experimental Psychology at Virginia Commonwealth University, Medical College of Virginia and his Post-doctoral training in Health Psychology and Gerontology at the University of Wisconsin Madison. Barbara Resnick PhD, RN, CRNO, FAAN, FAANP, University of Maryland School of Nursing Professor, Organizational Systems and Adult Health Sonya Ziporkin Gershowitz Chair in Gerontology 655 W. Lombard St. 390D Baltimore, MD resnick@son.maryland.edu Dr. Barbara Resnick is a Professor in the Department of Organizational Systems and Adult Health at the University of Maryland School of Nursing, co-directs the Adult/Gerontological nurse Practitioner Program, Co-Directs the Biology and Behavior Across the Lifespan Research Center of Excellence, holds the Sonya Ziporkin Gershowitz Chair in Gerontology at the School of Nursing, and does clinical work at Roland Park Place, a Lifecare community. In addition to clinical work and teaching, her research program is focused on optimizing function, physical activity and overall health among older adults, exploring the impact of resilience and genetics on function and physical activity, and tests methods of dissemination and implementation of established interventions in real world settings. Dr. Resnick has approximately 200 published articles, numerous chapters in nursing and medical textbooks, and books on Restorative

6 Care, Assisted Living Nursing and Resilience in Older adults. She has held leadership positions in multiple organizations including the American Academy of Nurse Practitioners, Gerontological Advanced Practice Nurses Association, the Society of Behavioral Medicine, Gerontological Society of American and the American Geriatric Society. Dr. Resnick has been recognized through receipt of numerous awards such as the Doris Schwartz award in 2008, the 2009 Nurse Leader in Gerontology award, and multiple mentoring awards. She has also been honored with Fellowships in the American Academy of Nursing, the American Academy of Nurse Practitioners, the National Gerontological Nurses Association, the American Geriatrics Society and the Gerontological Society of America. David L. Roth, PhD, Johns Hopkins University Professor Director, Center on Aging and Health (COAH) 2024 E. Monument St. Suite Baltimore, Maryland Dr. David L. Roth has over 25 years of experience as an investigator in the areas of gerontology, behavioral research, and applied statistical modeling. He was recently appointed as the Director of the Center on Aging and Health and a Professor in the Division of Geriatric Medicine and Gerontology at Johns Hopkins University. A secondary appointment in the Department of Biostatistics of the Bloomberg School of Public Health is also anticipated. Prior to joining the faculty at Johns Hopkins, Dr. Roth was a Professor of Biostatistics in the School of Public Health at the University of Alabama at Birmingham. Dr. Roth has specific interests in the psychosocial aspects of chronic health conditions, both for patients and their family caregivers. This includes considerable research on the effects of caregiving for disorders such as Alzheimer s disease and stroke-related disabilities. Areas of analytic expertise include longitudinal analysis approaches, structural equation modeling, latent variable analyses, mediation modeling, and causal inferences. In addition to directing his own research on caregiving and the social support resources of older adults, Dr. Roth also contributes to many funded research programs as a senior biostatistician and methodological expert.

7 Select Readings: Sara Czaja, PhD Challenges and Strategies for Implementing Randomized Clinical Trials in Community Settings Czaja, S. J., Schulz, R., Lee, C. C., Belle, S. H., & REACH Investigators. (2003). A methodology for describing and decomposing complex psychosocial and behavioral interventions. Psychology and Aging, 18(3), doi: / Finkel, S., Czaja, S. J., Schulz, R., Martinovich, Z., Harris, C., & Pezzuto, D. (2007). E-care: A telecommunications technology intervention for family caregivers of dementia patients. The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, 15(5), doi: /jgp.0b013e d87 Schulz, R., Lustig, A., Handler, S., & Martire, L. M. (2002). Technology-based caregiver intervention research: Current status and future directions. Gerontechnology, 2(1), Laura Gitlin, PhD - From Randomized Trial to Practice Contexts: What are the pipelines that can shorten the research-practice gap Burke, J.P., Gitlin, L.N., (2012). The Issue is.how do we change practice when we have the evidence? American Journal of Occupational Therapy. American Journal of Occupational Therapy, 66(5), 885-e88. Doi /ajot Curran, G.M., Bauer, M., Mittman, B., Pyne, J.M., & Stetler, C. (2012). Effectiveness- Implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact. Medical Care, 2, Gitlin, L.N. (in press). Introducing a New Intervention: An Overview of Research Phases and Common Challenges. American Journal of Occupational Therapy Glasgow, R. E., Lichtenstein, E., & Marcus, A. C. (2003). Why don't we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. American Journal of Public Health, 9, Murray, E., Treweek, S., Pope, C., MacFarlane, A., Ballini, L., Dowrick, C.,... May, C. (2010). Normalisation process theory: A framework for developing, evaluation and implementing complex interventions. BMC Medicine, 8, 63. Thomas Prohaska, PhD- Translation and Implementation Challenges in Community based Behavioral Interventions Prohaska, T. & Peters, K. (2007). Physical activity and cognitive functioning: Translating research to practice using a public health approach. Alzheimer s & Dementia, 3, S58-S64.

8 Satariano WA, Guralnik JM, Jackson RJ, Marottoli RA, Phelan EA, & Prohaska TR. (2012). Mobility and aging: New directions for public health action. Am J Public Health, 102(8), Prohaska, T., Renae-Smith Ray & Russell Glasgow (2012). Translation dissemination and implementation issues. In Thomas Prohaska, Lynda Anderson and Robert Binstock (eds.) Public Health for and Aging Society. Johns Hopkins University press. Barbara Resnick, PhD, RN CRNP, FAAN, FAANP Translating RCT Evidence for Implementation Bellg, A. J., Borrelli, B., Resnick, B., Hecht, J., Minicucci, D. S., Ory, M. Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. (2004). Enhancing treatment fidelity in health behavior change studies: Best practices and recommendations from the NIH behavior change consortium. Health Psychology : Official Journal of the Division of Health Psychology, American Psychological Association, 23(5), doi: / Breitenstein, S. M., Fogg, L., Garvey, C., Hill, C., Resnick, B., & Gross, D. (2010). Measuring implementation fidelity in a community-based parenting intervention. Nursing Research, 59(3), doi: /nnr.0b013e3181dbb2e2 Song, M. K., Happ, M. B., & Sandelowski, M. (2010). Development of a tool to assess fidelity to a psycho-educational intervention. Journal of Advanced Nursing, 66(3), doi: /j x David Roth, PhD Analytic Strategies that Strengthen Population Impact Little, R. J., & Yau, L. H. Y. (1998). Statistical techniques for analyzing data from prevention trials: Treatment of no-shows using Rubin s casual model. Psychological Methods, 3(2), Roth, D. L., & MacKinnon, D. P. (2012). Mediation analysis with longitudinal data. In J. T. Newsom, R. N. Jones, & S. M. Hofer (Eds). Longitudinal data analysis: A practical guide for researchers in aging, health, and social sciences (pp ). New York: Routledge. Tucker, J. A., Roth, D. L., Huang, J., Crawford, M. S., & Simpson, C. A. (2012). Effects of interactive voice response self-monitoring on natural resolutions of drinking problems: Utilization and behavioral economic factors. Journal of Studies on Alcohol and Drugs, 73,

9 Where Does Your Intervention Fit Along the Pipeline? Discovery Phase I Feasibility Phase II Efficacy Phase III Effectiveness IV Implementation Phase V Sustainability Phase VI Discovery -Clinical problem -Public health problem -Relevant theory to ensure best choice of intervention and hypothesis and predict major confounds and design elements Phase I -Identify components of the intervention --Identify underlying mechanisms by which they will influence outcomes -Safety and protocol development Proof of concept, Safety Preliminary test of feasibility of the intervention protocol Identification and test of a comparison group or appropriate alternative -Refinements in all design elements -Identification of outcome measures - Compare a fully defined intervention to an appropriate alternative using a protocol that is theory based, reproducible, adequately controlled and with sufficient power -Replicate trial in a setting and/or with other others study populations Tasks may differ than in previous phases and involve translational activity: -Site preparation -Identification of financial structure - Manual/toolkit refinement, -Training & certification of interventionists -Pilot testing of mechanisms, materials, training -Evaluation of translational activities -Cost analyses -Determine whether others can reliably replicate the intervention -Evaluate adoption, scalability, fidelity to intervention -Training and monitoring for widespread adoption -Identify strategies to enhance uptake of intervention Determine maintenance strategies Develop train the trainer program On-going planning for infrastructure support Strategies for assuring volume of referrals and marketing strategies

10 What Theory are You Using? Discovery Phase I Feasibility Phase II Efficacy Phase III Effectiveness IV Implementation Phase V Sustainability Phase VI SHOULD IT WORK? Use theory to choose treatment elements and approach to delivery Social ecological framework of depression Behavioral activation Transtheoretical model of behavior change WHY DOES IT WORK? Use theory to understand & identify mechanisms of action and who benefits EXAMPLE Behavioral activation as mediator of treatment effect HOW DOES IT WORK IN REAL SETTINGS? Use theory to understand implementation EXAMPLE Normalization Process Theory to identify factors promoting or deterring integration in practice

11 Designing Behavioral Interventions Delivery Considerations Domain Elements Proposed Intervention 1. Target of intervention Individual Family/social network Physical environment Community Agency personnel Provider System of care Policy 2. Area targeted Behavior Affect Knowledge Skills Social environment Physical environment Organizational/policy environment 3. Stage of intervening Prevention Specific disease stage Treatment Disease management 4. Modality Face-to-face Group Telephone Mail Technology-assisted devices (computers, smart phones, Wii) 5. Dose and intensity Frequency of contact Length of time of contact 6. Duration Length of time of intervention 7. Delivery approach Tailored Prescriptive (one size fits all) Risk assessment driven Phases (active, maintenance, boosters) Stepped approach 11

12 8. Delivery setting Home Community Agency Clinic/medical office Legislative Virtual Web-based computer technology Telephone 9. Characteristics of interventionists 10. Potential funding streams to support sustainability of intervention if proven effective Professional background Level of education/previous training Level of exposure to target population/setting Cost of intervention Cost of training interventionists Identification of setting of delivery Cost mechanisms for sustainability

13 Fidelity Considerations Component DELIVERY Is intervention delivered as intended? Identify Enhancement Strategies Monitoring Procedures Measurement RECEIPT Did participant receive intervention? ENACTMENT individual enacts the cognitive or behavioral skills imparted

14