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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00296426
Collaborator
(none)
322
1
2
51
6.3

Study Details

Study Description

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
  • Procedure: New technology - PAML
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
322 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Implementation and Evaluation of a Medical Reconciliation Protocol
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual Care

control patients admitted to hospital floors received usual care

Experimental: Intervention

computerized medication reconciliation tool and process redesign involving physicians, nurses, and pharmacists

Procedure: New technology - PAML

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeffrey L. Schnipper, MD.,MPH., Jeffrey Schnipper, MD, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT00296426
    Other Study ID Numbers:
    • 2005-P-002458/1
    First Posted:
    Feb 27, 2006
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Jeffrey L. Schnipper, MD.,MPH., Jeffrey Schnipper, MD, Brigham and Women's Hospital

    Study Results

    No Results Posted as of Aug 13, 2019