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Ambulatory Medication Reconciliation Following Hospital Discharge

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ClinicalTrials.gov Identifier: NCT00740675
Recruitment Status : Unknown
Verified January 2011 by Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 25, 2008
Last Update Posted : January 6, 2011
Sponsor:
Information provided by:
Brigham and Women's Hospital

Brief Summary:
Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research study is see if we can design an electronic tool given to your primary care provider (PCP) that will reduce adverse drug events, hospital readmissions, and emergency department visits after you are discharged from the hospital.

Condition or disease Intervention/treatment Phase
Medication Administered in Error Adverse Drug Events Other: Outpatient Medication Reconciliation Not Applicable

Detailed Description:
The objective of this research is to reduce the incidence of post-discharge medication discrepancies, preventable and ameliorable ADEs, hospital readmissions, and ED visits through the use of HIT. The proposed tool will prompt primary care physicians to perform medication reconciliation at the first post-discharge outpatient visit, clearly display and organize preadmission and discharge medication regimens, and facilitate the creation of the new post-discharge medication list with just a few keystrokes. Using methodologies from prior studies at BWH, we will evaluate the intervention in a two-site RCT. The study will be conducted at Brigham and Women's Hospital and Massachusetts General Hospital, taking advantage of our rich experience with designing and testing new informatics applications, including one for inpatient medication reconciliation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 912 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Ambulatory Medication Reconciliation Following Hospital Discharge: Project 4 From "Center for Education and Research on Therapeutics (CERT) on Health Information Technology"
Study Start Date : April 2008
Actual Primary Completion Date : August 2009
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1

At post-discharge follow-up visit with PCP, PCP views:

  1. Discharge medication reconciliation screen.
  2. Prompts to perform post-discharge reconciliation at the first post-discharge visit.
Other: Outpatient Medication Reconciliation

The post-discharge medication reconciliation module has the following features:

  1. Presents the (preadmission) ambulatory medication list and the hospital discharge medication list side-by-side, sorted by class, with all identical medications lined up next to each other and all differences in the two regimens highlighted.
  2. Allows users to update the ambulatory medication list with a few keystrokes (i.e., to accept individual changes made during the hospitalization).
  3. Allows reconciliation to be performed in full (e.g., for PCPs who are responsible for the entire medication list) or in part (e.g., for specialists).
No Intervention: Uusual care
PCPs manage the patient's medications after hospital discharge as they normally would.



Primary Outcome Measures :
  1. presence of at least one serious medication error per patient [ Time Frame: 30 days post-discharge ]

Secondary Outcome Measures :
  1. ED visits and non-scheduled hospital readmissions and ED visits [ Time Frame: within 30 days of discharge ]
  2. Accuracy of medication list in ambulatory electronic medical record [ Time Frame: 30 days post discharge ]


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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients admitted to BWH or MGH who plan to follow up with a PCP in one of 12 primary care practices affiliated with BWH or MGH.
  • Patients will need to meet the following criteria:

    • 1) be 55 years or older,
    • 2) be admitted to the participating delivery system's hospital during the study period for a non-psychiatric condition,
    • 3) have no plans to enter hospice,
    • 4) be discharged back to the community,
    • 5) be prescribed 5 or more medications at discharge, including at least one of the following:

      • antibiotics,
      • insulin,
      • antihypertensives,
      • anti-rejection,
      • antiarrhythmics,
      • inhalers,
      • antiepileptics,
      • antianginals,
      • pain medications,
      • oral hypoglycemics,
      • steroids,
      • anticoagulants.
    • These drugs were selected because they require close monitoring, increase risk for drug-drug interactions, have a narrow therapeutic window, or are known to increase risk for ADEs in the older adult population

Exclusion Criteria:

Unable to provide informed consent and has no proxy who administers patient's medications and can provide informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740675


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Study Director: David W Bates, MD, MSc Brigham and Women's Hospital

Responsible Party: Jeffrey L. Schnipper, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00740675     History of Changes
Other Study ID Numbers: 1U18 HS016790-01
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Brigham and Women's Hospital:
adverse drug events
outpatient

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders