NCT00370916

Brief Summary

Patient transfer between sites of care is regular practice during an episode of care in our current health care system. Yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will evaluate a medication reconciliation tool developed to help providers make effective prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in reducing transition drug risk and ADEs. We additionally will conduct focus group discussions and cognitive task analysis among end-users to better understand how providers make drug-prescribing decisions at the time of transfer and to assess factors influencing effective use of the tool.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 7, 2015

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

August 30, 2006

Last Update Submit

April 6, 2015

Conditions

Hospitalization

Keywords

Clinical Decision Support SystemsContinuity of Patient CareMedication ErrorsDrug Adverse Effects

Outcome Measures

Primary Outcomes (1)

  • High risk drug discrepancies

    After hospital admission and discharge

Secondary Outcomes (1)

  • Drug discrepancy adverse events

    During the hospital stay and 1 month after hospital discharge

Study Arms (3)

Arm 1

EXPERIMENTAL

Physician-initiated medication reconciliation

Behavioral: Physician-initiated medication reconciliation

Arm 2

EXPERIMENTAL

Pharmacist-initiated medication reconciliation

Behavioral: Pharmacist-initiated medication reconciliation

Arm 3

NO INTERVENTION

No formal medication reconciliation

Interventions

Physician-initiated medication reconciliationBEHAVIORAL

Physician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template

Arm 1
Pharmacist-initiated medication reconciliationBEHAVIORAL

Pharmacist performed and documented medication reconciliation

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who were admitted to the JJ Peters (Bronx) VA Hospital general medical wards (units 7A and 7B) between 10/05-2/06 and stayed least 24 hours

You may not qualify if:

  • Patients who were transferred to one of the study units wards (units 7A and 7B) from another JJ Peters (Bronx) VA Hospital acute care unit (e.g., an intensive care unit), or who stayed in the hospital less than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (4)

  • Boockvar KS, Santos SL, Kushniruk A, Johnson C, Nebeker JR. Medication reconciliation: barriers and facilitators from the perspectives of resident physicians and pharmacists. J Hosp Med. 2011 Jul-Aug;6(6):329-37. doi: 10.1002/jhm.891.

    PMID: 21834114RESULT

  • Kushniruk AW, Santos SL, Pourakis G, Nebeker JR, Boockvar KS. Cognitive analysis of a medication reconciliation tool: applying laboratory and naturalistic approaches to system evaluation. Stud Health Technol Inform. 2011;164:203-7.

    PMID: 21335711RESULT

  • Boockvar KS, Blum S, Kugler A, Livote E, Mergenhagen KA, Nebeker JR, Signor D, Sung S, Yeh J. Effect of admission medication reconciliation on adverse drug events from admission medication changes. Arch Intern Med. 2011 May 9;171(9):860-1. doi: 10.1001/archinternmed.2011.163. No abstract available.

    PMID: 21555668RESULT

  • Mergenhagen KA, Blum SS, Kugler A, Livote EE, Nebeker JR, Ott MC, Signor D, Sung S, Yeh J, Boockvar KS. Pharmacist- versus physician-initiated admission medication reconciliation: impact on adverse drug events. Am J Geriatr Pharmacother. 2012 Aug;10(4):242-50. doi: 10.1016/j.amjopharm.2012.06.001. Epub 2012 Jul 20.

    PMID: 22819386DERIVED

Study Officials

  • Kenneth S Boockvar, MD MS

    James J. Peters Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

October 1, 2005

Primary Completion

March 1, 2006

Study Completion

September 1, 2010

Last Updated

April 7, 2015

Record last verified: 2010-12

Locations

US(1)