Clinical trial NCT01337063: Multi-Center Medication Reconciliation Quality Improvement Study
Official title: Multi-Center Medication Reconciliation Quality Improvement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Events
Medication Administered in Error
Keywords: Adverse drug events
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Society of Hospital Medicine
name: Vanderbilt University
name: University of Wisconsin, Madison
name: University of California, San Francisco
name: Baystate Health
name: University of Chicago
name: Presbyterian Hospital, Charlotte
name: Sioux Falls VA Health Care System
name: Emory Johns Creek Hospital
First posted: 2011-04-18
Enrollment: 1836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Primary outcomes:
measure: The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm
timeFrame: 6 months prior to implementation of intervention to 21 months during intervention
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 months prior to implementation of intervention to 21 months during intervention
measure: Administrative outcomes
timeFrame: 6 months prior to implementation of intervention to 21 months during intervention
measure: Total medication discrepancies
timeFrame: 6 months prior to implementation of intervention to 21 months during intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Johns Creek
country: United States
facility: Emory Johns Creek Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospitals and Clinics
state: Illinois
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Sioux Falls
country: United States
facility: Sioux Falls VA Medical Center
state: South Dakota
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeffrey L Schnipper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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