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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00296426
First received: February 24, 2006
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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 Intervention
Medication Reconciliation
Procedure: New technology - PAML

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Implementation and Evaluation of a Medical Reconciliation Protocol

Further study details as provided by Brigham and Women's Hospital:

Estimated Enrollment: 500
Study Start Date: May 2006
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any other patients at BWH hospital
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00296426

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

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey L. Schnipper, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00296426     History of Changes
Other Study ID Numbers: 2005-P-002458/1
Study First Received: February 24, 2006
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014