Regional Data Exchange to Improve Medication Safety

NCT01239121 | Completed Results

• 1 other identifier: IIR 10-146
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Toxicity

Keywords

drug toxicity; drug interactions; electronic health records; medical errors

Outcome Measures

Primary Outcomes (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.

  During hospital stay and up to 1 month after hospital discharge

Secondary Outcomes (2)

• Adverse Drug Events

  During hospital stay and up to 1 month after hospital discharge

• Medication-related Symptoms

  Up to 1 month after hospital discharge

Study Arms (3)

HIE-Enhanced Medication Reconciliation

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)

Other: HIE-Enhanced Medication Reconciliation

Optimal Medication Reconciliation without HIE

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)

Other: Optimal Medication Reconciliation without HIE

Pilot HIE-Enhanced Outpatient Medication Reconciliation

OTHER

Health Information Exchange (HIE)-Enhanced Medication Reconciliation for Veterans seen as outpatients in Geriatrics Primary care clinic

Other: HIE-Enhanced Medication Reconciliation

Interventions

HIE-Enhanced Medication Reconciliation OTHER

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

HIE-Enhanced Medication Reconciliation; Pilot HIE-Enhanced Outpatient Medication Reconciliation

Optimal Medication Reconciliation without HIE OTHER

Medication reconciliation implemented by a pharmacist without regional health information exchange

Optimal Medication Reconciliation without HIE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Victoria: collaborator
• Weill Medical College of Cornell University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Limitations and Caveats

In the HIE-enhanced medication reconciliation intervention arm, the Health Information Exchange (HIE) capabilities were reduced from what was planned, limiting the potency of the intervention relative to control.

Results Point of Contact

• Title: Kenneth Boockvar
• Organization: James J. Peters VA Medical Center

kenneth.boockvar@va.gov

718-584-9000

Study Officials

• Kenneth S Boockvar, MD MS

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 11, 2010
• Study Start: February 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 15, 2016
• Results First Posted: April 21, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)