NCT01065675

Brief Summary

Up to 50% of medication errors and 20% of adverse drug reactions (ADRs) in the hospital setting are estimated to be related to communication issues regarding patient medications at various transition points of care from admission to discharge. The Joint Commission (TJC) requires accurate and complete medication reconciliation occur at each transition point throughout hospitalization. Evidence from NQF demonstrates pharmacists (RPh) are the most effective medication management team leaders in the implementation of medication management practices and design of medication error reduction strategies; medication reconciliation is one of the five safety objectives pharmacists are recommended to lead. In addition, the Massachusetts Coalition for the Prevention of Medical Errors states strong evidence supports the use of pharmacy technicians (CPhT) in conjunction with pharmacists in completing accurate medication histories. WMC nurses (RN) currently are involved in the medication reconciliation process. In 2009, a Medication Use Evaluation (MUE) of Medication Reconciliation Accuracy found a 67% medication error rate on admission determined by comparing the nurse-obtained medication history to the pharmacist-obtained medication history. The number of home medications identified by the pharmacist compared to the nurse was 411 versus 312 (p\<0.0001). The total percentage of medication errors prevented by the pharmacist was 66.2. Using the VA Healthcare Failure Mode Effects Analysis - HFMEA™ Hazard Scoring Matrix, 3 independent pharmacist reviewers found that 18% of patients interviewed had a score greater than 7, and 3 patients had a score of 12 (major/probable), if the discrepancies would not have been identified and corrected by the pharmacist conducting the admission medication reconciliation audit. The same patients' discharge medication reconciliation and discharge medication lists were retrospectively reviewed for the MUE, and the total percentage of patients with medication errors on discharge was 43%.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

December 28, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

February 3, 2010

Last Update Submit

December 26, 2012

Conditions

Keywords

Medication ReconciliationEmergency DepartmentNursePharmacistCertified Pharmacy TechnicianMedication reconciliation: inpatients admitted from the ED

Outcome Measures

Primary Outcomes (1)

  • To determine which patients benefit most from medication histories obtained by the RN, CPhT, or RPh based on accuracy (% complete disease states, allergy documentation and description, vaccination documentation, medication documentation)

    5 months

Interventions

To determine which patients benefit the most from medication histories obtained by the RN, CPhT, or RPh. Patients will be admitted as inpatients through the ED with medication histories finalized electronically by the RN at the admitting unit.

Also known as: Medication Reconciliation, Pharmacist, Nurse, Certified Pharmacy Technician, Emergency Department, ED

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted as inpatients from the Emergency Department

You may not qualify if:

  • Prisoners (because the IRB does not have a prisoner representative)
  • Patients not admitted as inpatients through the Emergency Department
  • Patients admitted more than once during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Emergencies

Interventions

Medication ReconciliationPharmacistsNursesEmergency Service, Hospital

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medication ErrorsDrug TherapyTherapeuticsMedical ErrorsHealth ServicesHealth Care Facilities Workforce and ServicesMedication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care ManagementHealth PersonnelHospital DepartmentsHospital AdministrationHealth Facility AdministrationHealth FacilitiesEmergency Medical Services

Study Officials

  • Joan S Kramer, PharmD

    Wesley Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Pharmacist

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 9, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2010

Study Completion

May 1, 2011

Last Updated

December 28, 2012

Record last verified: 2012-12

Locations