Multi-Center Medication Reconciliation Quality Improvement Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Multi-Center Medication Reconciliation Quality Improvement Study

Conditions
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Adverse Drug Events, Medication Administered in Error

Intervention / Treatment
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* Other: Mentored medication reconciliation quality improvement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-intervention<br>Usual care regarding medication reconciliation as currently practiced at each participating site. | |
| Experimental: Intervention<br>Improved medication reconciliation process using continuous quality improvement methods, mentored implementation, and an implementation guide. | Other: Mentored medication reconciliation quality improvement<br>* 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.<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | As with Outcome 1, but without adjudication for potential for harm | 6 months prior to implementation of intervention to 21 months during intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adverse drug events