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Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01337063
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : November 13, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Adverse Drug Events Medication Administered in Error Other: Mentored medication reconciliation quality improvement

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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1836 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Multi-Center Medication Reconciliation Quality Improvement Study
Study Start Date : March 2011
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Pre-intervention
Usual care regarding medication reconciliation as currently practiced at each participating site.
Experimental: Intervention
Improved medication reconciliation process using continuous quality improvement methods, mentored implementation, and an implementation guide.
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Patient satisfaction [ Time Frame: 6 months prior to implementation of intervention to 21 months during intervention ]
    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.")

  2. Administrative outcomes [ Time Frame: 6 months prior to implementation of intervention to 21 months during intervention ]
    Emergency Department (ED) or hospital readmission to the same institution within 30 days of discharge, using computerized hospital records of all eligible patients.

  3. Total medication discrepancies [ Time Frame: 6 months prior to implementation of intervention to 21 months during intervention ]
    As with Outcome 1, but without adjudication for potential for harm

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337063

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097
United States, Illinois
University of Chicago Hospitals and Clinics
Chicago, Illinois, United States, 60637
United States, Massachusetts
Baystate Health
Springfield, Massachusetts, United States, 01199
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
United States, South Dakota
Sioux Falls VA Medical Center
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Brigham and Women's Hospital
Society of Hospital Medicine
Vanderbilt University
University of Wisconsin, Madison
University of California, San Francisco
Baystate Health
University of Chicago
Presbyterian Hospital, Charlotte
Sioux Falls VA Medical Center
Emory Johns Creek Hospital
Principal Investigator: Jeffrey L Schnipper, MD, MPH Brigham and Women's Hospital
More Information

Institute for Healthcare Improvement. Medication Reconciliation Review. 2007; http://www.ihi.org/IHI/Topics/PatientSafety/MedicationSystems/Tools/Medication+Reconciliation+Review.htm. Accessed January 7, 2010.
Doyle E. Medication reconciliation done right. Today's Hospitalist. September 2009.
Agency for Healthcare Research and Quality. CAHPS Hospital Survey (H-CAHPS) 2009; https://www.cahps.ahrq.gov/content/products/HOSP/PROD_HOSP_Intro.asp?p=1022&s=221. Accessed January 15, 2010.
Kivimaki M, Elovainio M. A short version of the Team Climate Inventory: development and psychometric properties. Journal of Occupational and Organizational Psychology. 1999;72:241-246.
Cochrane Collaboration. Effective Practice and Organization of Care (EPOC) Methods Paper: Including interrupted time series (ITS) designs in a EPOC review. 1998.
Bazeley P. Computerized data analysis for mixed methods research. In: Tashakkori A, Teddlie C, eds. Mixed methodology: combining qualitative and quantitative approaches. Thousand Oaks, CA: Sage; 2003.
Glasser B, Strauss A. Discovery of grounded theory: strategies for qualitative research. Chicago: Adeline; 1967.
Strauss A, Corbin. Basics of qualitative research: grounded theory procedures and techniques. 2nd ed. Thousand Oaks, CA: Sage; 1998.
Patton MQ. Qualitative research & evaluation methods. 3rd ed. Thousand Oaks, CA: Sage; 2002.
Miles M, Huberman AM. Qualitative data analysis: an expanded sourcebook. 2nd ed. Newbury Park, CA: Sage; 1994.
Joint Commission on Accreditation of Healthcare Organizations. Joint Commission Fact Sheets: Facts about the tracer methodology. 2006; http://www.jointcommission.org/AboutUs/Fact_Sheets/Tracer_Methodology.htm. Accessed January 15, 2010.
Agency for Healthcare Research and Quality. Hospital Survey on Patient Safety Culture. 2009; http://www.ahrq.gov/qual/patientsafetyculture/hospsurvindex.htm. Accessed January 10, 2010.
Joint Commission on Accreditation of Healthcare Organizations. Accreditation Program: Hospital 2011 National Patient Safety Goals; http://www.jointcommission.org/assets/1/6/2011_NPSGs_HAP.pdf. Accessed April 12, 2011.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey L. Schnipper, MD.,MPH., Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01337063     History of Changes
Other Study ID Numbers: 2010P001814
1R18HS019598 ( U.S. AHRQ Grant/Contract )
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital:
Adverse drug events

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders