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Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS)

Primary Purpose

Adverse Drug Events, Medication Administered in Error

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentored medication reconciliation quality improvement
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Drug Events focused on measuring Adverse drug events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco
  • Emory Johns Creek Hospital
  • University of Chicago Hospitals and Clinics
  • Baystate Health
  • Presbyterian Hospital
  • Sioux Falls VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-intervention

Intervention

Arm Description

Usual care regarding medication reconciliation as currently practiced at each participating site.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient satisfaction
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
Emergency Department (ED) or hospital readmission to the same institution within 30 days of discharge, using computerized hospital records of all eligible patients.
Total medication discrepancies
As with Outcome 1, but without adjudication for potential for harm

Full Information

First Posted
April 15, 2011
Last Updated
November 11, 2015
Sponsor
Brigham and Women's Hospital
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 Health Care System, Emory Johns Creek Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01337063
Brief Title
Multi-Center Medication Reconciliation Quality Improvement Study
Acronym
MARQUIS
Official Title
Multi-Center Medication Reconciliation Quality Improvement Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
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 Health Care System, Emory Johns Creek Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events, Medication Administered in Error
Keywords
Adverse drug events

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1836 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention
Arm Type
No Intervention
Arm Description
Usual care regarding medication reconciliation as currently practiced at each participating site.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Improved medication reconciliation process using continuous quality improvement methods, mentored implementation, and an implementation guide.
Intervention Type
Other
Intervention Name(s)
Mentored medication reconciliation quality improvement
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm
Description
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.
Time Frame
6 months prior to implementation of intervention to 21 months during intervention
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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.")
Time Frame
6 months prior to implementation of intervention to 21 months during intervention
Title
Administrative outcomes
Description
Emergency Department (ED) or hospital readmission to the same institution within 30 days of discharge, using computerized hospital records of all eligible patients.
Time Frame
6 months prior to implementation of intervention to 21 months during intervention
Title
Total medication discrepancies
Description
As with Outcome 1, but without adjudication for potential for harm
Time Frame
6 months prior to implementation of intervention to 21 months during intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Schnipper, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Emory Johns Creek Hospital
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
University of Chicago Hospitals and Clinics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Baystate Health
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Sioux Falls VA Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

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Multi-Center Medication Reconciliation Quality Improvement Study

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