Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01337063
First received: April 15, 2011
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention
Adverse Drug Events
Medication Administered in Error
Other: Mentored medication reconciliation quality improvement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Multi-Center Medication Reconciliation Quality Improvement Study

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Patient satisfaction [ Time Frame: 6 months prior to implementation of intervention to 21 months during intervention ] [ Designated as safety issue: No ]
    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.")

  • Administrative outcomes [ Time Frame: 6 months prior to implementation of intervention to 21 months during intervention ] [ Designated as safety issue: No ]
    Emergency Department (ED) or hospital readmission to the same institution within 30 days of discharge, using computerized hospital records of all eligible patients.


Estimated Enrollment: 3600
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337063

Contacts
Contact: Nyryan V Nolido, MA 617-525-6653 nnolido@partners.org

Locations
United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Andrew Auerbach, MD, MPH    415-502-1412    ada@medicine.ucsf.edu   
United States, Georgia
Emory Johns Creek Hospital Recruiting
Johns Creek, Georgia, United States, 30097
Contact: Hasan Shabbir, MD    404-759-7099    hshabbi@emory.edu   
United States, Illinois
University of Chicago Hospitals and Clinics Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Sameer Badlani, MD, MBBS    773-702-5186    sbadlani@medicine.bsd.uchicago.edu   
United States, Massachusetts
Baystate Health Not yet recruiting
Springfield, Massachusetts, United States, 01199
Contact: Surinder Yadav, MD    413-794-4320    Surinder.Yadav@baystatehealth.org   
Contact: Randy Pato, MD    413-794-4285    RandolphMD.Peto@baystatehealth.org   
United States, North Carolina
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: John Gardella, MD    704-384-9378    jegardella@novanthealth.org   
United States, South Dakota
Sioux Falls VA Medical Center Not yet recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Justin Metzger, PharmD    605-336-3230    Justin.Metzger@va.gov   
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
Investigators
Principal Investigator: Jeffrey L Schnipper, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
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.
Strauss A, Corbin. Basics of qualitative research: grounded theory procedures and techniques. 2nd ed. Thousand Oaks, CA: Sage; 1998.

Additional 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
Study First Received: April 15, 2011
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Adverse drug events

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

ClinicalTrials.gov processed this record on October 16, 2014