Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS)

November 11, 2015 updated by: Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1836

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Georgia
      • Johns Creek, Georgia, United States, 30097
        • Emory Johns Creek Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals and Clinics
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sioux Falls VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months prior to implementation of intervention to 21 months during intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.")
6 months prior to implementation of intervention to 21 months during intervention
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.
6 months prior to implementation of intervention to 21 months during intervention
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
6 months prior to implementation of intervention to 21 months during intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

University of Chicago
University of Wisconsin, Madison
University of California, San Francisco
Vanderbilt University
Baystate Health
Society of Hospital Medicine
Presbyterian Hospital, Charlotte
Sioux Falls VA Health Care System
Emory Johns Creek Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P001814
  • 1R18HS019598 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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