Ambulatory Medication Reconciliation Following Hospital Discharge

Adverse Drug Events Clinical Trial

Official title:

Ambulatory Medication Reconciliation Following Hospital Discharge: Project 4 From "Center for Education and Research on Therapeutics (CERT) on Health Information Technology"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00740675
• Other study ID #: 1U18 HS016790-01
• Status: Active, not recruiting
• Phase: N/A
• First received: December 28, 2007
• Last updated: January 5, 2011
• Start date: April 2008
• Est. completion date: February 2011

Study information

• Verified date: January 2011
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 912
• Est. completion date: February 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adverse Drug Events
• Drug-Related Side Effects and Adverse Reactions
• Medication Administered in Error

Intervention

Other:
• Outpatient Medication Reconciliation
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).

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of at least one serious medication error per patient		30 days post-discharge	Yes
Secondary	ED visits and non-scheduled hospital readmissions and ED visits		within 30 days of discharge	No
Secondary	Accuracy of medication list in ambulatory electronic medical record		30 days post discharge	Yes