Reducing Transition Drug Risk

NCT ID: NCT00370916

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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This is a 2-phase study in which we will employ mixed quantitative and qualitative methods to conduct an evaluation of the IPT tool while improving our understanding of provider prescribing decisions at the time of patient transfer. In Phase 1 we will conduct a 5-month controlled trial among all admissions to 2 units at J.J. Peters (Bronx) VA Medical Center. We will compare IPT with usual care, and compare physician and pharmacist forms of IPT implementation with regard to, as primary outcome, transition drug risk, and, as secondary outcomes, ADEs, provider prescribing-decisions, and hospital utilization. In Phase 2, which will run concurrently with Phase 1, we will perform cognitive task analysis to examine providers' decision-making and to map IPT tool functions while providers interface with the tool, and perform focus group interviews with representative IPT users to identify factors that facilitate or hinder adoption. Results of cognitive analysis and focus groups will be used to identify tool deficiencies to consider for redesign.

Conditions

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Hospitalization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Physician-initiated medication reconciliation

Group Type EXPERIMENTAL

Physician-initiated medication reconciliation

Intervention Type BEHAVIORAL

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

Arm 2

Pharmacist-initiated medication reconciliation

Group Type EXPERIMENTAL

Pharmacist-initiated medication reconciliation

Intervention Type BEHAVIORAL

Pharmacist performed and documented medication reconciliation

Arm 3

No formal medication reconciliation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physician-initiated medication reconciliation

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

Intervention Type BEHAVIORAL

Pharmacist-initiated medication reconciliation

Pharmacist performed and documented medication reconciliation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Victoria

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth S Boockvar, MD MS

Role: PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Locations

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James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21834114 (View on PubMed)

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.

Reference Type RESULT
PMID: 21335711 (View on PubMed)

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.

Reference Type RESULT
PMID: 21555668 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22819386 (View on PubMed)

Other Identifiers

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IAB 05-204

Identifier Type: -

Identifier Source: org_study_id

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