My Own Health Report: Case Study for Pragmatic Research Marcia Ory Texas A&M Health Science Center Presentation at: CPRRN Annual Grantee Meeting October 2013

Pragmatic Research: Theory & Practice Trial Definitions: Contrasts A pragmatic trial is a real- world test in a real-world population An explanatory trial is a specialized experiment in a specialized population and often optimal setting Practical Example The MOHR study is designed to develop rapid, actionable evidence around the use of patient-reported outcomes in patient care.

‣ Diverse populations ‣ Questions from and important to stakeholders ‣ Multiple, heterogeneous settings ‣ Comparison conditions are real-world alternatives ‣ Multiple outcomes important to decision and policy makers Pragmatic Study Methods: Key Characteristics

Pragmatic Features of MOHR Relevant Diverse, real-world primary care settings; Embed MOHR into ongoing clinical processes Rigorous Cluster randomized, delayed intervention design Rapid Eighteen months from concept, planning, and execution Resource Informative Low cost; studying costs and cost-effectiveness under different delivery conditions Transparent Report on adaptations, failures, variation across sites and implementation models, lessons learned Riley WT, et al. Rapid, responsive, relevant (R3) research… Clin Transl Med 2013;2(1):10

Rapid Timeline: Four Research Stages

Designing a Pragmatic Trial: Balancing Rigor and Pragmatic Approaches Common features Randomization of immediate & delayed groups within pairs Study wide participant outcome goal (~150 outcome surveys per clinic setting) MOHR tool assessments Contextual and cost assessment Site specific features Selected practice sites purposively Different recruitment strategies—evolving over time Could vary how collected General guidance of data to be gathered

Key Features: Choice of Study Population Desire to have as broad as a population as possible Key factor: Avoid having staff select the “most responsive patients” Strategies: Recruit by type of patient visit (wellness or chronic care visits) By time of recruitment (e.g., Tuesdays and Thursdays) Indicate number of refusals

Diversity in Practice Partners: Early Intervention Sites

Key Features: Tailor Implementation Involvement of research and clinical stakeholder- circles of teams Discussions regarding what is possible regarding assessment and intervention Example: Changed implementation—from incorporation of MOHR into electronic health records to figuring out what would work best in each setting

Practice MOHR Implementation

Key Features: Choice of Measures Rapid decisions were facilitated by prior work identifying patient reported outcomes Still needed to discuss pros/cons of different decisions Couldn’t fully reflect 5 A framework How to fit all the essential behaviors into assessment Streamline to focus on patient behaviors and goal setting, practice behaviors not clinical outcomes

Pragmatic Research Trials: Conclusions Pragmatic design do not mean “lack of rigor” Pragmatic designs require an understanding of the context in which research is being conducted Important to understand common and flexible elements of PRTs Pragmatic designs can result in more rapid research translation

Revisiting Rapid Timeline  What is the ideal amount of time for a multi-center project such as MOHR?  What do you gain and lose from an accelerated time frame?  Are there settings where acceleration is likely to be more or less successful?