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Ambulatory Medication Reconciliation Following Hospital Discharge

Primary Purpose

Medication Administered in Error, Adverse Drug Events

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient Medication Reconciliation
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medication Administered in Error focused on measuring adverse drug events, outpatient

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Brigham & Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

Uusual care

Arm Description

At post-discharge follow-up visit with PCP, PCP views: Discharge medication reconciliation screen. Prompts to perform post-discharge reconciliation at the first post-discharge visit.

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

Outcomes

Primary Outcome Measures

presence of at least one serious medication error per patient

Secondary Outcome Measures

ED visits and non-scheduled hospital readmissions and ED visits
Accuracy of medication list in ambulatory electronic medical record

Full Information

First Posted
December 28, 2007
Last Updated
January 5, 2011
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00740675
Brief Title
Ambulatory Medication Reconciliation Following Hospital Discharge
Official Title
Ambulatory Medication Reconciliation Following Hospital Discharge: Project 4 From "Center for Education and Research on Therapeutics (CERT) on Health Information Technology"
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Administered in Error, Adverse Drug Events
Keywords
adverse drug events, outpatient

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
912 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
At post-discharge follow-up visit with PCP, PCP views: Discharge medication reconciliation screen. Prompts to perform post-discharge reconciliation at the first post-discharge visit.
Arm Title
Uusual care
Arm Type
No Intervention
Arm Description
PCPs manage the patient's medications after hospital discharge as they normally would.
Intervention Type
Other
Intervention Name(s)
Outpatient Medication Reconciliation
Intervention Description
The post-discharge medication reconciliation module has the following features: 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. Allows users to update the ambulatory medication list with a few keystrokes (i.e., to accept individual changes made during the hospitalization). 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).
Primary Outcome Measure Information:
Title
presence of at least one serious medication error per patient
Time Frame
30 days post-discharge
Secondary Outcome Measure Information:
Title
ED visits and non-scheduled hospital readmissions and ED visits
Time Frame
within 30 days of discharge
Title
Accuracy of medication list in ambulatory electronic medical record
Time Frame
30 days post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Bates, MD, MSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ambulatory Medication Reconciliation Following Hospital Discharge

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