Ambulatory Medication Reconciliation Following Hospital Discharge

NCT ID: NCT00740675

Last Updated: 2011-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 912 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-02-28

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.

Conditions

Medication Administered in Error; Adverse Drug Events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Outpatient Medication Reconciliation

Intervention Type: OTHER

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).

Uusual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brigham and Women's Hospital

Principal Investigators

David W Bates, MD, MSc

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1U18 HS016790-01

Identifier Type: -

Identifier Source: org_study_id