Clinical trials of health information technology interventions intended for patient use: Unique issues and considerations

Annette Devito Dabbs,Alex Begey,Ruosha Li,Robert P Hawkins,Brad Myers,Joseph M Pilewski,Mary Amanda Dew,Mary Connolly,Mi-Kyung Song,Jill Aubrecht,Christian A Bermudez

doi:10.1177/1740774513493149

Abstract

Despite the proliferation of health information technology (IT) interventions, descriptions of the unique considerations for conducting randomized trials of health IT interventions intended for patient use are lacking. Our purpose is to describe the protocol to evaluate Pocket PATH (Personal Assistant for Tracking Health), a novel health IT intervention, as an exemplar of how to address issues that may be unique to a randomized controlled trial (RCT) to evaluate health IT intended for patient use. An overview of the study protocol is presented. Unique considerations for health IT intervention trials and strategies are described to maintain equipoise, to monitor data safety and intervention fidelity, and to keep pace with changing technology during such trials. The sovereignty granted to technology, the rapid pace of changes in technology, ubiquitous use in health care, and obligation to maintain the safety of research participants challenge researchers to address these issues in ways that maintain the integrity of intervention trials designed to evaluate the impact of health IT interventions intended for patient use. Our experience evaluating the efficacy of Pocket PATH may provide practical guidance to investigators about how to comply with established procedures for conducting RCTs and include strategies to address the unique issues associated with the evaluation of health IT for patient use.

Highlights

Health information technology (IT) represents one of the ‘transforming’ advancements that impact the way patients manage their health information, communicate with healthcare providers, and support the goal for patients to be informed, active participants in their health care [1,2,3]
We describe a randomized controlled trial (RCT) designed to evaluate the effects of Pocket PATH® (Personal Assistant for Tracking Health), a novel health IT intervention to promote self-care agency, the performance of self-care behaviors and transplant-related health outcomes among patients with chronic illness to illustrate how we addressed the issues unique to trials of health IT intended for patient use
We intentionally referred to the trial as The Study Comparing Methods for Tracking Health at Home when communicating with the transplant clinicians, potential study participants, and the Institutional Review Board

Summary

Introduction

Health information technology (IT) represents one of the ‘transforming’ advancements that impact the way patients manage their health information, communicate with healthcare providers, and support the goal for patients to be informed, active participants in their health care [1,2,3]. A description of the unique considerations for conducting randomized trials of health IT interventions intended for patient use is warranted and timely. The ethical basis for medical research involving assignment of participants to different interventions requires investigators to maintain equipoise during the conduct of the trial [5,6]. I c) Assess barriers to performing self-care (medication timing, effects, symptoms, motor skills). Despite the proliferation of health information technology (IT) interventions, descriptions of the unique considerations for conducting randomized trials of health IT interventions intended for patient use are lacking. Purpose—Our purpose is to evaluate Pocket PATH® (Personal Assistant for Tracking Health), a novel health IT intervention, as an exemplar of how to address issues that may be unique to a randomized controlled trial to evaluate health IT intended for patient use

Methods

Results

Discussion

Conclusion