Clinical trial NCT01195051: Medication Reconciliation Technology to Improve Quality of Transitional Care
Official title: Medication Reconciliation Technology to Improve Quality of Transitional Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Medication Reconciliation
Keywords: Medication Reconciliation
Inpatient
Electronic Medical Records
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Regenstrief Institute, Inc.
name: Wishard Health Services
First posted: 2010-09-03
Enrollment: 4818
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This project will test a systems-based intervention of the electronic medical records system. The specific aims of this study are to integrate a new electronic medication reconciliation (MR) system with an electronic prescribing system, conduct a randomized controlled trial of MR, and determine whether electronic facilitation of MR alters MR and the incidence of medication errors in ambulatory care. On a patient's hospital admission, a new Web-based MR module will receive an automatically compiled outpatient medication list. Following discussion with the patient, medical personnel will update the list, which will then be delivered to the computer-based provider order entry system and become actionable for prescribing. Main outcomes include adverse drug events and erroneous discrepancies between the pre-admission medication list and the medication list upon the patient's return to ambulatory care. We hypothesize that electronic facilitation of inpatient MR will improve completion of MR and will decrease the incidence of drug-related medical errors.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reconciliation of outpatient medications
timeFrame: Hospital admission, transfer, and discharge; 1 year
Secondary outcomes:
measure: Measurement of potential for harm and potential severity of harm
timeFrame: Hospital discharge; 1 year
measure: Measurement and analysis of providers' perspectives
timeFrame: Start and end of trial; 1 year
measure: Measurement and analysis of patients' perspectives
timeFrame: Hospital discharge; 1 year
measure: Reportable financial and organizational dimensions
timeFrame: Start of trial; time 0 and 1 year
measure: Utilization of intervention
timeFrame: Hospital admission, transfer, and discharge; 1 year
measure: Measurement and analysis of drug-related medical errors
timeFrame: Hospital discharge; 1 year
measure: Measurement of adverse drug events and near misses
timeFrame: Hospital discharge; 1 year
measure: Medication discrepancies between pre-admission and ambulatory followup
timeFrame: Ambulatory followup; 18 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Wishard Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine, Department of Medicine
name: Michael Weiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.