Implementation and Evaluation of a Medical Reconciliation Protocol at Brigham and Women's Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296426
Recruitment Status : Unknown
Verified January 2010 by Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 27, 2006
Last Update Posted : January 14, 2010
Information provided by:
Brigham and Women's Hospital

Brief Summary:
An incomplete understanding of patients' preadmission medications and failure to reconcile these with medications ordered in the hospital and at discharge are major, previously unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation of Healthcare Organizations has now mandated a process for reconciling all medications at hospital admission and discharge. The best ways to implement medication reconciliation and the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's Hospital, will design and implement a medication reconciliation process with two major components: 1) information technology to integrate medication reconciliation into the current workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the effects of this new process on reducing medication reconciliation errors with the potential to cause patient harm (potential ADEs).

Condition or disease Intervention/treatment Phase
Medication Reconciliation Procedure: New technology - PAML Not Applicable

Detailed Description:
The primary outcome will be medication reconciliation errors with a potential for causing harm (potential ADEs). Secondary outcomes will include the different types of reconciliation errors, hospital length of stay, emergency department visits and hospital readmissions within 30 days of discharge, resident/nurse satisfaction, and compliance with the reconciliation process. To measure medication reconciliation errors, we will use a method similar to that suggested by the Massachusetts Coalition for the Prevention of Medical Errors. A study pharmacist, separate from the floor pharmacist, will determine each patient's preadmission medication regimen at the time of hospital discharge, using patient and family interviews and any additional information needed to validate the list. This list will then be compared with the preadmission medication list compiled by the intern to identify any errors in identifying preadmission medications. The list will also be compared with the admission and discharge medication orders in order to identify unexplained discrepancies. Questions will be resolved by communication between the study pharmacist and the ordering intern. Reports of all potential medication reconciliation errors will be presented in blinded fashion to two physician reviewers, who will judge whether a reconciliation error has taken place and its potential for harm. All medication reconciliation errors will be recorded, as well as each of the individual types: inaccuracies in the preadmission medication list, unexplained discrepancies with the admission medication orders, and unexplained discrepancies in the discharge orders. This methodology is similar to that used in other studies of medication errors conducted at BWH. This process will allow pharmacists to ethically report any problems to the medical team prior to discharge, while still allowing for a full measurement of medical errors. Hospital length of stay, emergency department visits, and hospital readmissions will be measured using hospital administrative data. Resident and nurse satisfaction and perceived quality of patient care will be measured using web-based surveys. Compliance with the reconciliation process will be measured by electronic tracking of the use and timing of: 1) PAML building and signing by the ordering intern, 2) reconciliation of all PAML medications within 24 hours of admission, and 3) reconciliation of the PAML and discharge medication orders by the ordering clinician at the time of discharge.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Implementation and Evaluation of a Medical Reconciliation Protocol
Study Start Date : May 2006
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be inpatients on the General Medical Service at Brigham and Women's Hospital

Exclusion Criteria:

  • Any other patients at BWH hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296426

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Jeffrey L Schnipper, MD, MPH Brigham and Women's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeffrey L. Schnipper, Brigham & Women's Hospital Identifier: NCT00296426     History of Changes
Other Study ID Numbers: 2005-P-002458/1
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Brigham and Women's Hospital:
Adverse Drug Event
Outcome assessment