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Clinical Trials/NCT01337063
NCT01337063CompletedNot Applicable

Multi-Center Medication Reconciliation Quality Improvement Study

Brigham and Women's Hospital6 sites in 1 country1,836 target enrollmentStarted: March 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,836
Locations
6
Primary Endpoint
The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm

Study 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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Pre-intervention

No Intervention

Usual care regarding medication reconciliation as currently practiced at each participating site.

Intervention

Experimental

Improved medication reconciliation process using continuous quality improvement methods, mentored implementation, and an implementation guide.

Intervention: Mentored medication reconciliation quality improvement (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey L. Schnipper, MD.,MPH.

Associate Professor of Medicine

Brigham and Women's Hospital

Study Sites (6)

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