- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01195051
Medication Reconciliation Technology to Improve Quality of Transitional Care (MedMatch)
March 4, 2014 updated by: Indiana University
This study addresses the problem of inadequate medication reconciliation as patients cross boundaries between inpatient and outpatient care (ambulatory care).
The purpose of this study is to determine whether a new, computer-based application, integrated with electronic prescribing, improves erroneous discrepancies between pre-hospital medications and medications upon patients' return to ambulatory care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project will test a systems-based intervention of the electronic medical records system.
The specific aims of this study are to integrate a new electronic medication reconciliation (MR) system with an electronic prescribing system, conduct a randomized controlled trial of MR, and determine whether electronic facilitation of MR alters MR and the incidence of medication errors in ambulatory care.
On a patient's hospital admission, a new Web-based MR module will receive an automatically compiled outpatient medication list.
Following discussion with the patient, medical personnel will update the list, which will then be delivered to the computer-based provider order entry system and become actionable for prescribing.
Main outcomes include adverse drug events and erroneous discrepancies between the pre-admission medication list and the medication list upon the patient's return to ambulatory care.
We hypothesize that electronic facilitation of inpatient MR will improve completion of MR and will decrease the incidence of drug-related medical errors.
Study Type
Interventional
Enrollment (Actual)
4818
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Wishard Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients admitted to the Medicine Service during a 12-month period
- Physicians who provide inpatient or ambulatory care for participating patients.
- Pharmacists who provide care for participating patients.
Exclusion Criteria:
- Patients admitted but not seen in a primary-care clinic within the preceding 12 months
- If an enrolled subject is determined to be a prisoner or pregnant woman, then the study will discontinue the subject for research purposes or will submit an amendment at that time.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
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Experimental: Electronic medication reconciliation
Providers have access to a new, computer-based application to facilitate documentation and prescribing of outpatient medications in the inpatient setting.
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A new, computer-based application will be used to document and prescribe outpatient medications in the inpatient setting.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reconciliation of outpatient medications
Time Frame: Hospital admission, transfer, and discharge; 1 year
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Number and fraction of outpatient medications prescribed or addressed as to why prescribing did not occur.
Number and fraction of cases with MR by a pharmacist.
Number and fraction of cases undergoing any MR.
Number and fraction of cases where any outpatient medications were not prescribed or addressed as to why prescribing did not occur.
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Hospital admission, transfer, and discharge; 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measurement of potential for harm and potential severity of harm
Time Frame: Hospital discharge; 1 year
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For each medication discrepancy, the study team will reach consensus about potential for harm and potential severity of harm.
The study team will adopt the following framework: little or no confidence (e.g., omission of multivitamin); slight to modest confidence (e.g., docusate 200 mg every morning, instead of 100 mg twice daily); less than 50% chance but close call (e.g., omission of as-needed enema at discharge); more than 50% chance but close call (e.g., omission of fluticasone twice daily at discharge); or strong confidence (e.g., omission of as-needed haloperidol).
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Hospital discharge; 1 year
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Measurement and analysis of providers' perspectives
Time Frame: Start and end of trial; 1 year
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We will conduct a before-and-after survey of providers.
Providers will be surveyed about satisfaction with care, managing medications, and usefulness of local information systems in managing medications.
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Start and end of trial; 1 year
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Measurement and analysis of patients' perspectives
Time Frame: Hospital discharge; 1 year
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The inpatient geriatrics consultation service has begun calling patients who received geriatrics consultation and were subsequently discharged to home.
The calls are made by telephone within 72 hours of discharge.
Patients are asked eight to ten questions, addressing satisfaction with care, receipt of information about medications, and adherence to medications.
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Hospital discharge; 1 year
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Reportable financial and organizational dimensions
Time Frame: Start of trial; time 0 and 1 year
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We will track and report hours required for several parts of the development and implementation, as follows: hours required for new technical development; and hours providers spend in learning about system and how to use it.
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Start of trial; time 0 and 1 year
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Utilization of intervention
Time Frame: Hospital admission, transfer, and discharge; 1 year
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Fraction of intervention admissions for which Web-based medication list was reviewed or modified.
Mean duration of use of Web-based application.
Fraction of intervention admissions, transfers, and discharges for which new medication list was used to order medications.
Fraction of medications on medication list that were ordered on admission, transfer, and discharge.
Timing of when medication reconciliation occurred.
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Hospital admission, transfer, and discharge; 1 year
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Measurement and analysis of drug-related medical errors
Time Frame: Hospital discharge; 1 year
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At discharge, we will assess for unintentional medication discrepancies at discharge.
At ambulatory followup, we will assess whether the medications should have been prescribed at discharge.
When a patient is discharged from the hospital and resumes ambulatory care, the patient is expected to adhere to the discharge prescriptions.
Each discharge will be reviewed by members of the study team, to determine, for each medication listed on the pre-admission medication list but not prescribed at discharge, whether the discrepancy was intentional or unintentional.
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Hospital discharge; 1 year
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Measurement of adverse drug events and near misses
Time Frame: Hospital discharge; 1 year
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We will count deaths and will identify and assess adverse drug events (ADEs).
The following kinds of triggers will be used to identify encounters that might reflect ADEs: diagnostic codes for diagnoses associated with ADEs, potential ADEs, or medication errors; use of specific drugs suggesting that an ADE may have occurred; potentially dangerous drug combinations; combinations of drugs and symptoms (e.g., angiotensin converting enzyme inhibitor and cough); combinations of diagnoses and drugs; and combinations of drugs and miscellaneous.
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Hospital discharge; 1 year
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Medication discrepancies between pre-admission and ambulatory followup
Time Frame: Ambulatory followup; 18 months
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Mean number of erroneous discrepancies between pre-admission and ambulatory followup
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Ambulatory followup; 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Weiner, MD, MPH, Indiana University School of Medicine, Department of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
September 2, 2010
First Posted (Estimate)
September 3, 2010
Study Record Updates
Last Update Posted (Estimate)
March 5, 2014
Last Update Submitted That Met QC Criteria
March 4, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 0910-19
- R18HS018183 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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