title: Clinical trials of health information technology interventions intended for patient use: unique issues and considerations.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: aSchool of Nursing, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Annette
authors.initials: A
authors.lastname: DeVito Dabbs
authors.forename: Mi-Kyung
authors.initials: MK
authors.lastname: Song
authors.forename: Brad
authors.initials: B
authors.lastname: Myers
authors.forename: Robert P
authors.initials: RP
authors.lastname: Hawkins
authors.forename: Jill
authors.initials: J
authors.lastname: Aubrecht
authors.forename: Alex
authors.initials: A
authors.lastname: Begey
authors.forename: Mary
authors.initials: M
authors.lastname: Connolly
authors.forename: Ruosha
authors.initials: R
authors.lastname: Li
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Pilewski
authors.forename: Christian A
authors.initials: CA
authors.lastname: Bermudez
authors.forename: Mary Amanda
authors.initials: MA
authors.lastname: Dew
mesh_terms: D001292:Attitude to Computers; D034201:Computers, Handheld; D006801:Humans; D016040:Lung Transplantation / Q000534:rehabilitation*; D008490:Medical Informatics / Q000295:instrumentation*; D063731:Mobile Applications; D010342:Patient Acceptance of Health Care; D016032:Randomized Controlled Trials as Topic; D012648:Self Care / Q000295:instrumentation*