NCT01195051

Brief Summary

This study addresses the problem of inadequate medication reconciliation as patients cross boundaries between inpatient and outpatient care (ambulatory care). The purpose of this study is to determine whether a new, computer-based application, integrated with electronic prescribing, improves erroneous discrepancies between pre-hospital medications and medications upon patients' return to ambulatory care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,818

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1.4 years

First QC Date

July 12, 2010

Last Update Submit

March 4, 2014

Conditions

Medication Reconciliation

Keywords

Medication ReconciliationInpatientElectronic Medical Records

Outcome Measures

Primary Outcomes (1)

  • Reconciliation of outpatient medications

    Number and fraction of outpatient medications prescribed or addressed as to why prescribing did not occur. Number and fraction of cases with MR by a pharmacist. Number and fraction of cases undergoing any MR. Number and fraction of cases where any outpatient medications were not prescribed or addressed as to why prescribing did not occur.

    Hospital admission, transfer, and discharge; 1 year

Secondary Outcomes (8)

  • Measurement of potential for harm and potential severity of harm

    Hospital discharge; 1 year

  • Measurement and analysis of providers' perspectives

    Start and end of trial; 1 year

  • Measurement and analysis of patients' perspectives

    Hospital discharge; 1 year

  • Reportable financial and organizational dimensions

    Start of trial; time 0 and 1 year

  • Utilization of intervention

    Hospital admission, transfer, and discharge; 1 year

  • +3 more secondary outcomes

Study Arms (2)

Electronic medication reconciliation

EXPERIMENTAL

Providers have access to a new, computer-based application to facilitate documentation and prescribing of outpatient medications in the inpatient setting.

Other: Electronic medication reconciliation

Control

NO INTERVENTION

Interventions

Electronic medication reconciliationOTHER

A new, computer-based application will be used to document and prescribe outpatient medications in the inpatient setting.

Also known as: MedMatch
Electronic medication reconciliation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the Medicine Service during a 12-month period
  • Physicians who provide inpatient or ambulatory care for participating patients.
  • Pharmacists who provide care for participating patients.

You may not qualify if:

  • Patients admitted but not seen in a primary-care clinic within the preceding 12 months
  • If an enrolled subject is determined to be a prisoner or pregnant woman, then the study will discontinue the subject for research purposes or will submit an amendment at that time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wishard Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Cadwallader J, Spry K, Morea J, Russ AL, Duke J, Weiner M. Design of a medication reconciliation application: facilitating clinician-focused decision making with data from multiple sources. Appl Clin Inform. 2013 Mar 13;4(1):110-25. doi: 10.4338/ACI-2012-12-RA-0057. Print 2013.

    PMID: 23650492BACKGROUND

Study Officials

  • Michael Weiner, MD, MPH

    Indiana University School of Medicine, Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

September 3, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

US(1)