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The National Heart, Lung, and Blood Institute (NHLBI) convened a working group meeting consisting of experts in multi-level intervention research on September 15 and 16, 2015. The purpose of the meeting was to provide recommendations that would be useful for designing and implementing multi-level interventions that target hard-to-reach, high risk or vulnerable populations and communities. The recommendations are intended to guide the design and implementation of research in multi-level and systems based interventions. The NIH Office of Disease Prevention and the NIH Office of Behavioral and Social Science Research co-sponsored the meeting.
Multilevel interventions address more than one level of influence in the social-ecological model (Figure). Interventions that have multiple components that address only one level of influence are multi-component but not multi-level. Interventions that have multiple components that address a given level, but that also address two or more levels of the socio-ecological model are both multi-component and multi-level.
Multi-level intervention research and systems-based interventions in hard-to-reach or high-risk communities and populations (e.g., rural/urban low socio-economic status populations, elderly, underserved communities, minority populations including American Indians/Alaskan Natives) present unique challenges, including issues related to intervention design, blinding of study staff, recruitment and retention, culturally and linguistically appropriate intervention approaches, built environmental factors, and intervention dose, reach and fidelity at multiple levels of implementation.
Workshop participants consisted of experts in multi-level and systems-oriented intervention research, obesity, health promotion and health behavior, nursing, nutrition and physical activity and included pediatricians, family medicine and community health educators, senior research scientists, epidemiologists, biostatisticians, and project coordinators.
The meeting began after a brief overview and introduction and was followed by opening remarks by the Director, NIH Office of Disease Prevention (ODP), who emphasized the importance of Prevention at the NIH, and noted that the workshop supports ODP’s strategic priority III, which is to promote the “use of the best available methods in prevention research and to support the development of better methods.” Multilevel intervention research is relevant to many areas in prevention, including research targeting hard-to-reach, high-risk, or vulnerable populations and communities.
The ODP director’s remarks were followed by presentations and discussions including solution-oriented research approaches to health that emphasize “what works, how and to whom.” Major elements of this approach include the need to address interventions holistically and dynamically, and attend to the interactions, feedback loops, non-linear changes and multiple causal pathways. Further presentations and discussions included multi-level and systems-based intervention implementation (i.e., multiple systems within the ecological framework [see Figure]), including case examples, cultural tailoring of interventions, and approaches for engaging community health workers in multi-level interventions. Multi-level intervention design and challenges, adaptive research designs and their applications in multi-level interventions, statistical approaches, and recruitment and retention issues were emphasized. Perspectives from project coordinators and agency contacts regarding recruitment of study subjects and coordination of multi-level intervention activities were also discussed. In addition, perspectives were provided on implementation strategies for multi-level interventions that would engage community health workers to prevent cardiovascular disease (Community Preventive Services Task Force recommendations http://www.thecommunityguide.org/cvd/CHW.html). Each presenter provided recommendations for advancing multi-level and systems-oriented interventions in clinical and community trials.
Consistent with established conceptual models of causes and solutions, participants acknowledged that interventions should embrace complexity and systematically apply systems thinking (i.e., Implementation of interventions at multiple levels and systems). Modeling and simulations are useful in understanding the complexities in multi-level interventions, but directly testing and replicating “solutions” or intervention models will likely be most informative. To move the field of multi-level and systems-oriented interventions forward, and with particular attention to vulnerable populations, the following recommendations were proposed and organized under six research headings:
1. Study design and statistical approaches
Account for all sources of variation in design and analysis, some interactions within and between levels and the limited degrees of freedom in GRTs.
Randomize with stratification on the baseline value of the primary outcome and group size.
Blind evaluation staff to the extent possible.
2. Intervention implementation
3. Cultural adaptations of interventions
4. Use of community health workers
5. Recruitment and Retention
6. Intervention staff training
Coday M, Boutin-Foster C, Goldman Sher T, et al. Strategies for retaining study participants in behavioral intervention trials: retention experiences of the NIH Behavior Change Consortium. Ann Behav Med 2005;29 Suppl:55-65.
Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of minority research participants. Annu Rev Public Health 2006;27:1-28.
Dr. Charlotte Pratt, NHLBI
Dr. June Stevens, Professor of Nutrition, Workshop Chair
Dr. David Murray, Director, Office of Disease Prevention
Definitions and discussions on multilevel interventions and system science approaches to intervention implementation at multiple levels (e.g., individual, family, school, community). Discussions on how to create synergies among the levels when implementing interventions at multiple levels, and recommendations.
Dr. Thomas Robinson, Professor of Pediatrics and Medicine, Stanford University
Dr. Ying Kuen Cheung, Professor of Biostatistics, Columbia University
Dr. Lu Wang, Professor of Biostatistics, University of Michigan
Dr. Shirley Moore, Professor of Nursing and Associate Dean of Research, Case Western University
Dr. David Murray, Director, Office of Disease Prevention, NIH
Dr. Henry Feldman, Biostatistician, Boston Children’s Hospital
Strategies (e.g., incentives, community engagement, and trained community members as recruiters) and case examples and lessons learned. Recommendations.
Dr. Dianne Ward, Professor of Nutrition, University of North Carolina Chapel Hill.
Strategies (e.g., incentives, community engagement, and trained community members as recruiters) and case examples and lessons learned. Recommendations.
Dr. Thomas Robinson, Professor of Pediatrics and Medicine, Stanford University
Describe previous experiences, challenges and proposed solutions in implementing interventions and creating synergies among multiple levels (e.g., individual, family, school, community). Recommendations.
Dr. Nancy Sherwood, Senior Investigator and Director of Scientific Development,
HealthPartners Institute for Education and Research
Describe previous experiences, challenges and proposed solutions in implementing interventions and creating synergies among multiple levels (e.g., individual, family, school, community). Recommendations.
Dr. Leslie Lytle, Professor of Health Behavior , UNC
Dr. June Stevens, Professor, Workshop Chair
Dr. June Stevens, Professor, UNC-Chapel Hill. Workshop Chair
Dr. Michael Lauer, Director, Division of Cardiovascular Sciences, NHLBI
Dr. Lawrence Green, Professor of Epidemiology and Biostatistics, University of California at San Francisco
Dr. Dana Sampson, NIH/OBSSR
Dr. Shari Barkin, Professor of Pediatrics, Vanderbilt University
Dr. Donna Antoine Lavigne, Principal Investigator, JHS, Jackson State University
Dr. Clifton Addison, Jackson Heart Study Community Outreach
Sarah Jones, Intervention Coordinator, Case Western Reserve University
Cross cutting recommendations on above (i.e., definitions, design, interim assessments and preservation of blinding, statistical approaches, recruitment and retention, intervention, measurement and training)
ALL
Dr. June Stevens, Workshop Chair
Dr. Charlotte A. Pratt, Adjourn