NCT00296426

Brief Summary

An incomplete understanding of patients' preadmission medications and failure to reconcile these with medications ordered in the hospital and at discharge are major, previously unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation of Healthcare Organizations has now mandated a process for reconciling all medications at hospital admission and discharge. The best ways to implement medication reconciliation and the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's Hospital, will design and implement a medication reconciliation process with two major components: 1) information technology to integrate medication reconciliation into the current workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the effects of this new process on reducing medication reconciliation errors with the potential to cause patient harm (potential ADEs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

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

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

February 24, 2006

Last Update Submit

August 9, 2019

Conditions

Keywords

Adverse Drug EventInpatientsOutcome assessment

Study Arms (2)

Usual Care

NO INTERVENTION

control patients admitted to hospital floors received usual care

Intervention

EXPERIMENTAL

computerized medication reconciliation tool and process redesign involving physicians, nurses, and pharmacists

Procedure: New technology - PAML

Interventions

Intervention

Eligibility Criteria

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

You may qualify if:

  • Must be inpatients on the General Medical Service at Brigham and Women's Hospital

You may not qualify if:

  • Any other patients at BWH hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Schnipper JL, Hamann C, Ndumele CD, Liang CL, Carty MG, Karson AS, Bhan I, Coley CM, Poon E, Turchin A, Labonville SA, Diedrichsen EK, Lipsitz S, Broverman CA, McCarthy P, Gandhi TK. Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster-randomized trial. Arch Intern Med. 2009 Apr 27;169(8):771-80. doi: 10.1001/archinternmed.2009.51.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Jeffrey L Schnipper, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jeffrey Schnipper, MD

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations