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Drug ToxicityNCT01239121

Regional Data Exchange to Improve Medication Safety

A study testing HIE-Enhanced Medication Reconciliation and Optimal Medication Reconciliation without HIE in people with Drug Toxicity, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Drug Toxicity
What is being tested?
HIE-Enhanced Medication Reconciliation and Optimal Medication Reconciliation without HIE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
1 siteUnited States
Study dates
Feb 2012to Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Cannot be transferred from another James J. Peters VA hospital unit

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468

Other trials in United States

About this study

Official title: Implementing a Regional Data Exchange Tool to Improve Medication Use and Safety

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.

Read the detailed 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.

Conditions
Drug Toxicity
Being tested
HIE-Enhanced Medication Reconciliation, Optimal Medication Reconciliation without HIE
Keywords
drug toxicity, drug interactions, electronic health records, medical errors
Medical subject headings
Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIE-Enhanced Medication ReconciliationOther

    Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist

  • Optimal Medication Reconciliation without HIEOther

    Medication reconciliation implemented by a pharmacist without regional health information exchange

Study groups in NCT01239121
Study groupRoleWhat they receive
HIE-Enhanced Medication ReconciliationExperimentalHealth 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)
Receives: Other: HIE-Enhanced Medication Reconciliation
Optimal Medication Reconciliation without HIEActive comparatorOptimal 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)
Receives: Other: Optimal Medication Reconciliation without HIE
Pilot HIE-Enhanced Outpatient Medication ReconciliationOtherHealth Information Exchange (HIE)-Enhanced Medication Reconciliation for Veterans seen as outpatients in Geriatrics Primary care clinic
Receives: Other: HIE-Enhanced Medication Reconciliation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transition Drug Risk

    Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.

    Measured: During hospital stay and up to 1 month after hospital discharge

Secondary outcomes (2)
  1. Adverse Drug Events

    Actual harm to patient from hospital medication discrepancies by record review

    Measured: During hospital stay and up to 1 month after hospital discharge

  2. Medication-related Symptoms

    Patient's self-report of medication-related symptoms by telephone questionnaire

    Measured: Up to 1 month after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2010 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2015
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239121
Sponsor's protocol ID
IIR 10-146
Status last verified
Jul 2016
First submitted
9 Nov 2010
Last updated
15 Aug 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hung WW, Morano B, Moodhe N, Boockvar K. Regional Health Information Organization (RHIO): its potential uses to improve veteran health care. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2011 Jan 1; 28(3):33-36.

Questions about this trial

What is this clinical trial studying?

A study testing HIE-Enhanced Medication Reconciliation and Optimal Medication Reconciliation without HIE in people with Drug Toxicity, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transition Drug Risk (time frame: During hospital stay and up to 1 month after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239121, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.

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