Intervention Development in Elderly Adults (IDEA) Duke Pepper Center, Fall 2017 Cathleen Colon-Emeric, MD, MHS colon001@mc.duke.edu Kimbery Johnson, MD, MHS Kimberly.Johnson@duke.edu

What makes an intervention complex? Number of intervention components (and interactions between them!) Older Population Considerations Multifactorial geriatric syndromes Interactions with comorbidities Medical-Social-Psychological- Environmental

What makes an intervention complex? Number and difficulty of behaviors required by those delivering or receiving the intervention Older Population Considerations Adherence… usually better! Feasibility of behavior change Cognitive impairment Health literacy Mobility Transportation Use of technology

What makes an intervention complex? Number of groups or organizational levels targeted Older Population Considerations Patients Caregivers/Family Providers Nursing Homes, CCRCs, ALFs Community agencies Hospitals

What makes an intervention complex? Number and variability of outcomes Older Population Considerations Mortality, utilization difficult to move Typically function, QOL, cognition, other PROs Ceiling/floor effects High variability, sample sizes Patient priorities different than payer priorities

What makes an intervention complex? Degree of flexibility or tailoring of the intervention permitted Older Population Considerations Heterogeneity!

Why is it harder to develop and evaluate complex interventions? Good theoretical understanding of how the intervention causes change is needed so that weak links can be identified and strengthened Lack of impact may reflect implementation failure (or teething problems) rather than genuine ineffectiveness (require process evaluations) Sample sizes larger to take account of the extra variability, and cluster- randomized designs considered. Range of outcome measures usually needed Unintended consequences must be sought Ensuring strict fidelity to a protocol may be inappropriate; the intervention may work better if adaptation to local setting is allowed. Ethical/political constraints to withholding or delaying intervention

Problems with Complex Interventions Standardizing design and delivery Sensitivity to local context Logistical barriers to applying experimental methods to health service or policy changes Complexity of causal chain linking interventions to outcomes Identifying the “active ingredients”

Questions for Intervention Development Phase What are you trying to do? What outcome you are aiming for, and how you will bring about change? Does your intervention have a coherent theoretical basis? Have you used this theory systematically to develop the intervention? Can you describe the intervention fully? (replication) Does the existing evidence – ideally collated in a systematic review – suggest that it is likely to be effective/cost effective? Is it likely to be widely implementable if the results are favorable?

Questions for Piloting and Feasibility Phase Have you done enough piloting and feasibility work to be confident that the intervention can be delivered as intended? Can you make safe assumptions needed to design an effectiveness study? effect sizes Variability rates of recruitment and retention

Questions for Evaluation Phase What design are you going to use, and why? Is an experimental design feasible? (e.g., parallel group randomized controlled trial) Cluster randomization or a stepped wedge design needed? Is an observational design appropriate? (large rapid effects, little potential for selection bias). Have you set up procedures for monitoring delivery of the intervention, and overseeing the conduct of the evaluation? Are you including a process evaluation to explain discrepancies between expected and observed outcomes, to understand how context influences outcomes, and to provide insights to aid implementation? Should you include an economic evaluation ?

Workshop Goals and Process 9/22 (3-4:30) Pre-Clinical or Theoretical Phase (Crowley, Zullig) 10/20 Phase I: Defining components of the intervention (Whitson, Steinhauser) 11/10 Phase II: Exploratory Trial – Optimize intervention (Schmader, Pieper) 11/17 Phase II: Exploratory Trial – Optimize evaluation (Morey, Fillenbaum) 12/1 Phase III: Pragmatic Trial Design (Colón-Emeric, Pendergast) 12/15 Scholar presentations, Course Evaluation and Celebration Come ready to discuss your intervention and seek input and feedback!

Resources Course materials, articles, resources posted on Pepper REC website https://sites.duke.edu/centerforaging/claude-d-pepper-older- americans-independence-center/cores/research-education- component-rec/ Course faculty and participants

Pepper Center RFAs