CClinicalTrials.gg
Status unknownNCT00740675Updated Jan 6, 2011

Ambulatory Medication Reconciliation Following Hospital Discharge

An interventional study of Outpatient Medication Reconciliation in Medication Administered in Error and Adverse Drug Events, sponsored by Brigham and Women's Hospital. Status unknown at 2 sites in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-06.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jan 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
912
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Medication Administered in Error
  • Adverse Drug Events

Keywords

  • adverse drug events
  • outpatient
03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's planned enrollment of 912 is above the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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,
      1. be admitted to the participating delivery system's hospital during the study period for a non-psychiatric condition,
      1. have no plans to enter hospice,
      1. be discharged back to the community,
      1. 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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
912 participants (estimated)

Study arms

  • 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

  • No intervention
    Uusual care

    PCPs manage the patient's medications after hospital discharge as they normally would.

Interventions

  • OtherOutpatient 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).

06

What researchers measure

Primary outcomes

  1. presence of at least one serious medication error per patient

    Time frame: 30 days post-discharge

Secondary outcomes

  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

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham & Women's Hospital
    Boston, Massachusetts 02120, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00740675
Lead sponsor
Brigham and Women's Hospital
First posted
Aug 25, 2008
Start date
Apr 2008
Primary completion
Aug 2009
Completion
Feb 2011 (estimated)
Last update
Jan 6, 2011

Study contacts

David W Bates, MD, MSc
study director · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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