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Clinical Trials/NCT01337063
NCT01337063
Completed
Not Applicable

Multi-Center Medication Reconciliation Quality Improvement Study

Brigham and Women's Hospital6 sites in 1 country1,836 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adverse Drug Events
Sponsor
Brigham and Women's Hospital
Enrollment
1836
Locations
6
Primary Endpoint
The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Patients often have problems after they leave the hospital, in part because errors are made in the medications they are prescribed. The goal of this project is to develop a more accurate and safe medication prescription process when patients enter and leave the hospital and implement this process at six U.S. hospitals. The investigators will measure the success of the project and develop lessons learned so this process can be applied to other hospitals.

Detailed Description

Unintentional medication discrepancies during transitions in care (such as hospitalization and subsequent discharge) are very common and represent a major threat to patient safety. One solution to this problem is medication reconciliation. In response to Joint Commission requirements, most hospitals have developed medication reconciliation processes, but some have been more successful than others, and there are reports of pro-forma compliance without substantial improvements in patient safety. There is now collective experience about effective approaches to medication reconciliation, but these have yet to be consolidated, evaluated rigorously, and disseminated effectively. This project's findings should provide valuable lessons to all hospitals regarding the best ways to design and implement medication reconciliation interventions to improve medication safety during transitions in care. SPECIFIC AIMS: Aim 1: Develop a toolkit consolidating the best practice recommendations for medication reconciliation Aim 2: Conduct a multi-center mentored quality improvement project in which each site adapts the tools for its own environment and implements them Aim 3: Assess the effects of a mentored medication reconciliation quality improvement intervention on unintentional medication discrepancies with potential for patient harm Aim 4: Conduct rigorous program evaluation to determine the most important components of a medication reconciliation program and how best to implement it

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey L. Schnipper, MD.,MPH.

Associate Professor of Medicine

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18 and over
  • Admitted to inpatient medical or surgical services

Exclusion Criteria

  • Vulnerable populations (pregnant women, prisoners, institutionalized individuals)
  • Under 18 years
  • Hospital staff subjects:
  • Personnel directly involved in the medication reconciliation process, which depending on the site might include residents, physician assistants, inpatient attending physicians, nurses, pharmacists, and pharmacy technicians.

Outcomes

Primary Outcomes

The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm

Time Frame: 6 months prior to implementation of intervention to 21 months during intervention

The primary outcome will be determined by a study pharmacist who will take a "gold standard" medication history on 5 patients per week, then compare that history to the medical team's medication history, to admission orders, and to discharge orders. Any unintentional medication discrepancies in orders will be recorded. A physician adjudicator will then make a final determination regarding whether an error occurred, the type of error, the potential for patient harm, and the potential severity.

Secondary Outcomes

  • Patient satisfaction(6 months prior to implementation of intervention to 21 months during intervention)
  • Total medication discrepancies(6 months prior to implementation of intervention to 21 months during intervention)
  • Administrative outcomes(6 months prior to implementation of intervention to 21 months during intervention)

Study Sites (6)

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