Ambulatory Medication Reconciliation Following Hospital Discharge

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

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.

Study Overview

• Status: Unknown
• Conditions: Medication Administered in Error; Adverse Drug Events
• Intervention / Treatment: Other: Outpatient Medication Reconciliation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 912
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02120
      • Brigham & Women'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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.	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).
No Intervention: Uusual care; PCPs manage the patient's medications after hospital discharge as they normally would.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
presence of at least one serious medication error per patient	30 days post-discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Study Director: David W Bates, MD, MSc, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: August 22, 2008
• First Posted (Estimate): August 25, 2008

Study Record Updates

• Last Update Posted (Estimate): January 6, 2011
• Last Update Submitted That Met QC Criteria: January 5, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: outpatient; adverse drug events
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 1U18 HS016790-01