Multi-Center Medication Reconciliation Quality Improvement Study

NCT01337063 | Completed

• 2 other identifiers: 2010P0018141R18HS019598
• Study Type: interventional
• Target: 1,836
• Locations: 1 country
• Sites: 6

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.

Conditions

Adverse Drug Events; Medication Administered in Error

Keywords

Adverse drug events

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Patient satisfaction

  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

• Total medication discrepancies

  6 months prior to implementation of intervention to 21 months during intervention

Study Arms (2)

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.

Other: Mentored medication reconciliation quality improvement

Interventions

Mentored medication reconciliation quality improvement OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Society of Hospital Medicine: collaborator
• Vanderbilt University: collaborator
• University of Wisconsin, Madison: collaborator
• University of California, San Francisco: collaborator
• Baystate Health: collaborator
• University of Chicago: collaborator
• Presbyterian Hospital, Charlotte: collaborator
• Sioux Falls VA Health Care System: collaborator
• Emory Johns Creek Hospital: collaborator

Study Sites (6)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

University of Chicago Hospitals and Clinics

Chicago, Illinois, 60637, United States

Location

Baystate Health

Springfield, Massachusetts, 01199, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Sioux Falls VA Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (32)

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• Mixon AS, Kripalani S, Stein J, Wetterneck TB, Kaboli P, Mueller S, Burdick E, Nolido NV, Labonville S, Minahan JA, Orav EJ, Goldstein J, Schnipper JL. An On-Treatment Analysis of the MARQUIS Study: Interventions to Improve Inpatient Medication Reconciliation. J Hosp Med. 2019 Oct 1;14(10):614-617. doi: 10.12788/jhm.3308. Epub 2019 Aug 16.

  PMID: 31433768 DERIVED

• Schnipper JL, Mixon A, Stein J, Wetterneck TB, Kaboli PJ, Mueller S, Labonville S, Minahan JA, Burdick E, Orav EJ, Goldstein J, Nolido NV, Kripalani S. Effects of a multifaceted medication reconciliation quality improvement intervention on patient safety: final results of the MARQUIS study. BMJ Qual Saf. 2018 Dec;27(12):954-964. doi: 10.1136/bmjqs-2018-008233. Epub 2018 Aug 20.

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• Salanitro AH, Kripalani S, Resnic J, Mueller SK, Wetterneck TB, Haynes KT, Stein J, Kaboli PJ, Labonville S, Etchells E, Cobaugh DJ, Hanson D, Greenwald JL, Williams MV, Schnipper JL. Rationale and design of the Multicenter Medication Reconciliation Quality Improvement Study (MARQUIS). BMC Health Serv Res. 2013 Jun 25;13:230. doi: 10.1186/1472-6963-13-230.

  PMID: 23800355 DERIVED

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: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

US (6)