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Multi-Center Medication Reconciliation Quality Improvement Study

Multi-Center Medication Reconciliation Quality Improvement Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01337063
Acronym
MARQUIS
Enrollment
1836
Registered
2011-04-18
Start date
2011-03-31
Completion date
2014-09-30
Last updated
2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Events, Medication Administered in Error

Keywords

Adverse drug events

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

Interventions

OTHERMentored 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.

Sponsors

Society of Hospital Medicine
CollaboratorOTHER
Vanderbilt University
CollaboratorOTHER
University of Wisconsin, Madison
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
Baystate Health
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Presbyterian Hospital, Charlotte
CollaboratorUNKNOWN
Sioux Falls VA Health Care System
CollaboratorFED
Emory Johns Creek Hospital
CollaboratorUNKNOWN
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm6 months prior to implementation of intervention to 21 months during interventionThe 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

MeasureTime frameDescription
Patient satisfaction6 months prior to implementation of intervention to 21 months during interventionPatient 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 outcomes6 months prior to implementation of intervention to 21 months during interventionEmergency Department (ED) or hospital readmission to the same institution within 30 days of discharge, using computerized hospital records of all eligible patients.
Total medication discrepancies6 months prior to implementation of intervention to 21 months during interventionAs with Outcome 1, but without adjudication for potential for harm

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026