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Multi-Center Medication Reconciliation Quality Improvement Study

Not Applicable
Completed
Conditions
Medication Administered in Error
Adverse Drug Events
Interventions
Other: Mentored medication reconciliation quality improvement
Registration Number
NCT01337063
Lead Sponsor
Brigham and Women's Hospital
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1836
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
InterventionMentored medication reconciliation quality improvementImproved medication reconciliation process using continuous quality improvement methods, mentored implementation, and an implementation guide.
Primary Outcome Measures
NameTimeMethod
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 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.

Secondary Outcome Measures
NameTimeMethod
Patient satisfaction6 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.")

Total medication discrepancies6 months prior to implementation of intervention to 21 months during intervention

As with Outcome 1, but without adjudication for potential for harm

Administrative outcomes6 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.

Trial Locations

Locations (6)

Presbyterian Hospital

🇺🇸

Charlotte, North Carolina, United States

Emory Johns Creek Hospital

🇺🇸

Johns Creek, Georgia, United States

Baystate Health

🇺🇸

Springfield, Massachusetts, United States

University of Chicago Hospitals and Clinics

🇺🇸

Chicago, Illinois, United States

University of California, San Francisco

🇺🇸

San Francisco, California, United States

Sioux Falls VA Medical Center

🇺🇸

Sioux Falls, South Dakota, United States

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