Clinical trial NCT00740675: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Administered in Error
Adverse Drug Events
Keywords: adverse drug events
outpatient
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 912
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: presence of at least one serious medication error per patient
timeFrame: 30 days post-discharge
Secondary outcomes:
measure: ED visits and non-scheduled hospital readmissions and ED visits
timeFrame: within 30 days of discharge
measure: Accuracy of medication list in ambulatory electronic medical record
timeFrame: 30 days post discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David W Bates, MD, MSc
role: STUDY_DIRECTOR
References: