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

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.

SUBMITTER: DeVito Dabbs A

PROVIDER: S-EPMC3808467 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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

DeVito Dabbs Annette A Song Mi-Kyung MK Myers Brad B Hawkins Robert P RP Aubrecht Jill J Begey Alex A Connolly Mary M Li Ruosha R Pilewski Joseph M JM Bermudez Christian A CA Dew Mary Amanda MA

Clinical trials (London, England) 20130718 6

<h4>Background</h4>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.<h4>Purpose</h4>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 ...[more]

PMID: 23867222

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Project description:BACKGROUND:Clinical trials are one of the most challenging and meaningful designs in medical research. One essential step before starting a clinical trial is screening, that is, to identify patients who fulfill the inclusion criteria and do not fulfill the exclusion criteria. The screening step for clinical trials might be supported by modern information technology (IT). OBJECTIVE:This explorative study aimed (1) to obtain insights into which tools for feasibility estimations and patient screening are actually used in clinical routine and (2) to determine which method and type of IT support could benefit clinical staff. METHODS:Semistandardized interviews were conducted in 5 wards (cardiology, gynecology, gastroenterology, nephrology, and palliative care) in a German university hospital. Of the 5 interviewees, 4 were directly involved in patient screening. Three of them were clinicians, 1 was a study nurse, and 1 was a research assistant. RESULTS:The existing state of study feasibility estimation and the screening procedure were dominated by human communication and estimations from memory, although there were many possibilities for IT support. Success mostly depended on the experience and personal motivation of the clinical staff. Electronic support has been used but with little importance so far. Searches in ward-specific patient registers (databases) and searches in clinical information systems were reported. Furthermore, free-text searches in medical reports were mentioned. For potential future applications, a preference for either proactive or passive systems was not expressed. Most of the interviewees saw the potential for the improvement of the actual systems, but they were also largely satisfied with the outcomes of the current approach. Most of the interviewees were interested in learning more about the various ways in which IT could support and relieve them in their clinical routine. CONCLUSIONS:Overall, IT support currently plays a minor role in the screening step for clinical trials. The lack of IT usage and the estimations made from memory reported by all the participants might constrain cognitive resources, which might distract from clinical routine. We conclude that electronic support for the screening step for clinical trials is still a challenge and that education of the staff about the possibilities for electronic support in clinical trials is necessary.

Project description:BACKGROUND:Caregivers of adolescents with mental health issues experience challenges that may result in the caregivers having a variety of unmet needs. There is a growing need to support these caregivers. Effective support to strengthen positive caregiving behavior in caregivers may address their challenges. Communication technologies offer novel opportunities to assist these caregivers and may contribute to strengthening caregiver behavior. However, little is known about the use of communication technologies among caregivers of adolescents with mental health issues. OBJECTIVE:The study aimed to answer the question: "What is the best evidence available to strengthen positive behavior of caregivers of adolescents with mental health issues using communication technology." METHODS:A systematic review of articles published between January 2007 and August 2018 was conducted. Searches included articles of multiple study designs from EBSCO Host and Scopus platforms with prespecified eligibility criteria. Methodological quality was evaluated using the applicable Critical Appraisal Skills Programme and Joanna Briggs Institute assessment tools. RESULTS:The search yielded 1746 articles. Altogether, 5 articles met the eligibility criteria and were included in the review for data synthesis. Data analysis and synthesis identified three thematic conclusions reflecting the types of communication technologies used, caregivers as the target population, and strengthening of positive behavior through determinants of the Integrated Model of Behavior Prediction. CONCLUSIONS:The review reported the usefulness of communication technology by caregivers. Caregivers also demonstrated improvement in self-efficacy, knowledge, parent-child communication, and parental skills reflecting positive behavior. Although the use of communication technology is expanding as a supportive intervention to address caregivers' needs, the evidence for usefulness among caregivers of adolescents with mental health issues is still scarce. More research and information related to preferred methods of communication delivery among caregivers of adolescents is still needed.

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

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

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