Overview

This trial is active, not recruiting.

Condition drug toxicity
Treatments hie-enhanced medication reconciliation, optimal medication reconciliation without hie
Sponsor VA Office of Research and Development
Collaborator University of Victoria
Start date February 2012
End date June 2015
Trial size 400 participants
Trial identifier NCT01239121, IIR 10-146

Summary

Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and harm. The aims of this study are: 1) To adapt medication reconciliation to include information from a computerized regional health information exchange (RHIO) in the Bronx, 2) To conduct a trial of the adapted medication reconciliation process and examine effects on medication errors, harm, and hospital costs, and 3) To identify factors that are barriers to adoption of the RHIO tool by James J. Peters (Bronx) VA providers. Findings from this project will provide an understanding of the effect of the RHIO tool on reducing harmful VA and non-VA medication use. It will also provide information on the feasibility of incorporating RHIO tool use into every day work flow for pharmacists and physicians.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
hie-enhanced medication reconciliation
Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist
(Active Comparator)
Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)
optimal medication reconciliation without hie
Medication reconciliation implemented by a pharmacist without regional health information exchange
(Other)
Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic
hie-enhanced medication reconciliation
Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist

Primary Outcomes

Measure
Transition drug risk
time frame: During hospital stay and up to 1 month after hospital discharge

Secondary Outcomes

Measure
Adverse drug events
time frame: During hospital stay and up to 1 month after hospital discharge
Medication-related symptoms
time frame: Up to 1 month after hospital discharge

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Veterans admitted to James J. Peters VA hospital units 6B, 7B, 7C, or 8B or seen as outpatients in the Geriatrics Primary care clinic, who have an identity match in the Bronx RHIO, who consent to participate in the Bronx RHIO, and who stay on the unit at least 24 hours Exclusion Criteria: - Cannot be transferred from another James J. Peters VA hospital unit

Additional Information

Official title Implementing a Regional Data Exchange Tool to Improve Medication Use and Safety
Principal investigator Kenneth S Boockvar, MD MS
Description Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and harm. The most important barrier to effective medication reconciliation is the unreliability of patients' own reports about their medication use and incomplete provider history-taking. The James J. Peters VA (JJP VA) participates in the Bronx RHIO, a New York State-funded health information exchange organization that in October 2008 implemented clinical data information exchange among the largest healthcare providers in the Bronx. JJP VA providers can now access clinical data, including medication use, from non-VA facilities with patients' consent. The aims of this study are: 1) To adapt a medication reconciliation process to include information from a regional health information exchange (RHIO), 2) To conduct a controlled trial of a medication reconciliation process at the time of hospital admission either enhanced or not enhanced with data from a regional health information exchange, and examine effects on transition drug risk, adverse drug events, and total inpatient costs, and 3) To identify system and provider factors that impede and facilitate adoption of the information exchange tool for routine use by VA providers. The investigators plan to conduct qualitative and quantitative studies. First the investigators will perform cognitive task analysis (CTA) to examine providers' decision-making and to map RHIO tool functions while providers interface with the tool, with interview questions to identify factors that facilitate or hinder use. Second, the investigators will enroll patients admitted to 2 inpatient units at the JJP VA, and assign them to receive usual medication reconciliation or RHIO-enhanced medication reconciliation with a notification to physicians about the patient's non-VA services that can be viewed in the RHIO. The investigators will measure transition drug risk and ADEs by medical record review and patient interview, and measure inpatient costs with administrative cost data from national VA datasets. Third, the investigators will conduct CTA with pharmacists and physicians at the end of the quantitative study who are expert in use of the tool to characterize differences in cognitive processes from prior to the quantitative study. This will supply information on system and provider factors that impede and facilitate adoption of the tool for routine use, and on potential improvements in the tool. Findings from this project will provide an understanding of the effect of real-time review of Veteran's non-VA medication use -- enabled by a Regional Health Information Organization (RHIO) tool -- on reducing duplicative VA and non-VA medication use and adverse drug events in Veterans. It will also provide information on the feasibility and effectiveness of incorporating RHIO tool access and use into every day work flow for VA pharmacist and physician providers.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.