Adverse Drug Events | Multi-Center Medication Reconciliation Quality Improvement Study

Adverse Drug Events research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Adverse Drug Events

Medication Administered in Error

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Mentored medication reconciliation quality improvementBased 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pre-interventionUsual care regarding medication reconciliation as currently practiced at each participating site.

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

Study Status


Start Date: March 2011

Completed Date: September 2014

Phase: N/A

Type: Interventional


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

Secondary Outcome: Patient satisfaction

Study sponsors, principal investigator, and references

Principal Investigator: Jeffrey L Schnipper, MD, MPH

Lead Sponsor: Brigham and Women's Hospital

Collaborator: Society of Hospital Medicine

More information:

Coleman EA, Smith JD, Raha D, Min SJ. Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med. 2005 Sep 12;165(16):1842-7.

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