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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01337063
Other study ID # 2010P001814
Secondary ID 1R18HS019598
Status Completed
Phase N/A
First received April 15, 2011
Last updated November 11, 2015
Start date March 2011
Est. completion date September 2014

Study information

Verified date November 2015
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Mentored medication reconciliation quality improvement
Based on expert recommendations from a recent conference on medication reconciliation sponsored by the Society of Hospital Medicine and funded by AHRQ, investigators will engage a steering committee and conduct a second conference to operationalize these recommendations into a set of "best practice" guidelines, standards, and tools to be adapted by each of 6 participating sites. After training mentors and developing data collection tools, a mentored quality improvement project will be conducted for 21 months, in which each site works to improve medication reconciliation using the toolkit and with mentorship in the form of two site visits and monthly phone calls.

Locations

Country Name City State
United States Presbyterian Hospital Charlotte North Carolina
United States University of Chicago Hospitals and Clinics Chicago Illinois
United States Emory Johns Creek Hospital Johns Creek Georgia
United States University of California, San Francisco San Francisco California
United States Sioux Falls VA Medical Center Sioux Falls South Dakota
United States Baystate Health Springfield Massachusetts

Sponsors (10)

Lead Sponsor Collaborator
Brigham and Women's Hospital Baystate Health, Emory Johns Creek Hospital, Presbyterian Hospital, Charlotte, Sioux Falls VA Medical Center, Society of Hospital Medicine, University of California, San Francisco, University of Chicago, University of Wisconsin, Madison, Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (29)

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Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm 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. 6 months prior to implementation of intervention to 21 months during intervention Yes
Secondary Patient satisfaction Patient Satisfaction will be assessed using data from the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey. This survey is already administered to a sample of patients from all hospitals; we will measure both global satisfaction and questions related to medications (e.g., "before giving you any new medications, how often did hospital staff tell you what the medicine was for," and "before giving you any new medications, how often did hospital staff describe possible site effects in a way you could understand.") 6 months prior to implementation of intervention to 21 months during intervention No
Secondary Administrative outcomes Emergency Department (ED) or hospital readmission to the same institution within 30 days of discharge, using computerized hospital records of all eligible patients. 6 months prior to implementation of intervention to 21 months during intervention No
Secondary Total medication discrepancies As with Outcome 1, but without adjudication for potential for harm 6 months prior to implementation of intervention to 21 months during intervention Yes
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