Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296426
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2006-02-24
Brief Title:
Implementation and Evaluation of a Medical Reconciliation Protocol at Brigham and Womens Hospital
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Implementation and Evaluation of a Medical Reconciliation Protocol
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Womens 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 Womens 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
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 residentnurse 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None