Dataset Information

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.

Purpose

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.

Lessons learned

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.

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:BackgroundAs consumer health information technology (IT) becomes more thoroughly integrated into patient care, it is critical that these tools are appropriate for the diverse patient populations whom they are intended to serve. Cultural differences associated with ethnicity are one aspect of diversity that may play a role in user-technology interactions.ObjectiveOur aim was to evaluate the current scope of consumer health IT interventions targeted to the US Spanish-speaking Latino population and to characterize these interventions in terms of technological attributes, health domains, cultural tailoring, and evaluation metrics.MethodsA narrative synthesis was conducted of existing Spanish-language consumer health IT interventions indexed within health and computer science databases. Database searches were limited to English-language articles published between January 1990 and September 2015. Studies were included if they detailed an assessment of a patient-centered electronic technology intervention targeting health within the US Spanish-speaking Latino population. Included studies were required to have a majority Latino population sample. The following were extracted from articles: first author's last name, publication year, population characteristics, journal domain, health domain, technology platform and functionality, available languages of intervention, US region, cultural tailoring, intervention delivery location, study design, and evaluation metrics.ResultsWe included 42 studies in the review. Most of the studies were published between 2009 and 2015 and had a majority percentage of female study participants. The mean age of participants ranged from 15 to 68. Interventions most commonly focused on urban population centers and within the western region of the United States. Of articles specifying a technology domain, computer was found to be most common; however, a fairly even distribution across all technologies was noted. Cancer, diabetes, and child, infant, or maternal health were the most common health domains targeted by consumer health IT interventions. More than half of the interventions were culturally tailored. The most frequently used evaluation metric was behavior/attitude change, followed by usability and knowledge retention.ConclusionsThis study characterizes the existing body of research exploring consumer health IT interventions for the US Spanish-speaking Latino population. In doing so, it reveals three primary needs within the field. First, while the increase in studies targeting the Latino population in the last decade is a promising advancement, future research is needed that focuses on Latino subpopulations previously overlooked. Second, preliminary steps have been taken to culturally tailor consumer health IT interventions for the US Spanish-speaking Latino population; however, focus must expand beyond intervention content. Finally, the field should work to promote long-term evaluation of technology efficacy, moving beyond intermediary measures toward measures of health outcomes.

Dataset Information

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

Background

Purpose

Methods

Lessons learned

Conclusions

Publications

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

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