J Am Med Inform Assoc - Implementation of the Department of Veterans Affairs' first point-of-care clinical trial.

Tópicos

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Resumo

JECTIVES: The Massachusetts Veterans Epidemiology Research and Information Center in collaboration with the Stanford Center for Innovative Study Design set out to test the feasibility of a new method of evidence generation. The first pilot of a point-of-care clinical trial (POCCT), adding randomization and other study processes to an electronic medical record (EMR) system, was launched to compare the effectiveness of two insulin regimens.MATERIALS AND METHODS: Existing functionalities of the Veterans Affairs (VA) computerized patient record system (CPRS)/veterans health information systems and technology architecture (VISTA) were modified to support the activities of a randomized controlled trial including enrolment, randomization, and longitudinal data collection.RESULTS: The VA's CPRS/VISTA was successfully adapted to support the processes of a clinical trial and longitudinal study data are being collected from the medical record automatically. As of 30 June 2011, 55 of the 67 eligible patients approached received a randomized intervention.DISCUSSION: The design of CPRS/VISTA made integration of study workflows and data collection possible. Institutions and investigators considering similar designs must carefully map clinical workflows and clinical trial workflows to EMR capabilities. POCCT study teams are necessarily interdisciplinary and interdepartmental. As a result, executive sponsorship is critical.CONCLUSION: POCCT represent a promising new method for conducting clinical science. Much work is needed to understand better the optimal uses and designs for this new approach. Next steps include focus groups to measure patient and clinician perceptions, multisite deployment of the current pilot, and implementation of additional studies.

Resumo Limpo

jectiv massachusett veteran epidemiolog research inform center collabor stanford center innov studi design set test feasibl new method evid generat first pilot pointofcar clinic trial pocct ad random studi process electron medic record emr system launch compar effect two insulin regimensmateri method exist function veteran affair va computer patient record system cprsveteran health inform system technolog architectur vista modifi support activ random control trial includ enrol random longitudin data collectionresult vas cprsvista success adapt support process clinic trial longitudin studi data collect medic record automat june elig patient approach receiv random interventiondiscuss design cprsvista made integr studi workflow data collect possibl institut investig consid similar design must care map clinic workflow clinic trial workflow emr capabl pocct studi team necessarili interdisciplinari interdepartment result execut sponsorship criticalconclus pocct repres promis new method conduct clinic scienc much work need understand better optim use design new approach next step includ focus group measur patient clinician percept multisit deploy current pilot implement addit studi

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