Improving the Design of Pragmatic Clinical Trials Using Data Collected from Electronic Medical Records

• Activity Number: 111 - Issues and Advances in Power Calculations for Mental Health Studies
• Type: Topic Contributed
• Date/Time: Monday, July 30, 2018 : 8:30 AM to 10:20 AM
• Sponsor: Mental Health Statistics Section
• Author(s): Susan Shortreed* and Carlyn M Rutter and Andrea J. Cook and Greg Simon
• Companies: Kaiser Permanente Washington Health Research Institute and RAND Corporation and Kaiser Permanente Washington Health Research Institute and Kaiser Permenete Washington Health Research Insitute
• Keywords: Pragmatic Randomized clinical trials; Suicide prevention; Study design; Electronic health records; Mental health; Power calculations

Abstract

Pragmatic randomized clinical trials (RCTs) have been proposed as an approach that takes advantage of the strengths of randomization, while leveraging electronic medical record (EMR) technology to address limitations to conducting RCTs. Traditionally, RCTs are limited in the number of participants that can be randomized due to the resources required to contact individuals to assess eligibility and collect outcome information, while pragmatic RCTs use EMR data to determine eligibility and assess outcomes. RCTs conducted within health systems are especially unique because EMR data on potential participants is available when investigators are making design decisions. We will outline how EMR data can be used to inform the selection of trial eligibility requirements, to estimate distribution of participant characteristics over the course of trial, and to conduct power or sample size calculations. Our work is motivated by a pragmatic RCT to evaluate the impact of suicide-prevention outreach interventions on fatal and non-fatal suicide attempts in the 18 months after randomization. We use EMR data from the Mental Health Research Network to illustrate our proposed approaches.