NCT00740675

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
912

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

1.3 years

First QC Date

December 28, 2007

Last Update Submit

January 5, 2011

Conditions

Keywords

adverse drug eventsoutpatient

Outcome Measures

Primary Outcomes (1)

  • presence of at least one serious medication error per patient

    30 days post-discharge

Secondary Outcomes (2)

  • ED visits and non-scheduled hospital readmissions and ED visits

    within 30 days of discharge

  • Accuracy of medication list in ambulatory electronic medical record

    30 days post discharge

Study Arms (2)

1

EXPERIMENTAL

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

Uusual care

NO INTERVENTION

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

Interventions

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).

1

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • \) be 55 years or older,
  • \) be admitted to the participating delivery system's hospital during the study period for a non-psychiatric condition,
  • \) have no plans to enter hospice,
  • \) be discharged back to the community,
  • \) be prescribed 5 or more medications at discharge, including at least one of the following:
  • antibiotics,
  • insulin,
  • antihypertensives,
  • anti-rejection,
  • antiarrhythmics,
  • inhalers,
  • antiepileptics,
  • antianginals,
  • +5 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • David W Bates, MD, MSc

    Brigham and Women's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2007

First Posted

August 25, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2009

Study Completion

February 1, 2011

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations