Medication Reconciliation Technology to Improve Quality of Transitional Care

Medication Reconciliation Clinical Trial

— MedMatch  

Official title:

Medication Reconciliation Technology to Improve Quality of Transitional Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195051
• Other study ID #: 0910-19
• Secondary ID: R18HS018183
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2010
• Last updated: March 4, 2014
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4818
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medication Reconciliation

Intervention

Other:
• Electronic medication reconciliation
A new, computer-based application will be used to document and prescribe outpatient medications in the inpatient setting.

Locations

Country	Name	City	State
United States	Wishard Hospital	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Agency for Healthcare Research and Quality (AHRQ), Regenstrief Institute, Inc., Wishard Health Services

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Measurement of potential for harm and potential severity of harm	For each medication discrepancy, the study team will reach consensus about potential for harm and potential severity of harm. The study team will adopt the following framework: little or no confidence (e.g., omission of multivitamin); slight to modest confidence (e.g., docusate 200 mg every morning, instead of 100 mg twice daily); less than 50% chance but close call (e.g., omission of as-needed enema at discharge); more than 50% chance but close call (e.g., omission of fluticasone twice daily at discharge); or strong confidence (e.g., omission of as-needed haloperidol).	Hospital discharge; 1 year	Yes
Secondary	Measurement and analysis of providers' perspectives	We will conduct a before-and-after survey of providers. Providers will be surveyed about satisfaction with care, managing medications, and usefulness of local information systems in managing medications.	Start and end of trial; 1 year	No
Secondary	Measurement and analysis of patients' perspectives	The inpatient geriatrics consultation service has begun calling patients who received geriatrics consultation and were subsequently discharged to home. The calls are made by telephone within 72 hours of discharge. Patients are asked eight to ten questions, addressing satisfaction with care, receipt of information about medications, and adherence to medications.	Hospital discharge; 1 year	No
Secondary	Reportable financial and organizational dimensions	We will track and report hours required for several parts of the development and implementation, as follows: hours required for new technical development; and hours providers spend in learning about system and how to use it.	Start of trial; time 0 and 1 year	No
Secondary	Utilization of intervention	Fraction of intervention admissions for which Web-based medication list was reviewed or modified. Mean duration of use of Web-based application. Fraction of intervention admissions, transfers, and discharges for which new medication list was used to order medications. Fraction of medications on medication list that were ordered on admission, transfer, and discharge. Timing of when medication reconciliation occurred.	Hospital admission, transfer, and discharge; 1 year	No
Secondary	Measurement and analysis of drug-related medical errors	At discharge, we will assess for unintentional medication discrepancies at discharge. At ambulatory followup, we will assess whether the medications should have been prescribed at discharge. When a patient is discharged from the hospital and resumes ambulatory care, the patient is expected to adhere to the discharge prescriptions. Each discharge will be reviewed by members of the study team, to determine, for each medication listed on the pre-admission medication list but not prescribed at discharge, whether the discrepancy was intentional or unintentional.	Hospital discharge; 1 year	Yes
Secondary	Measurement of adverse drug events and near misses	We will count deaths and will identify and assess adverse drug events (ADEs). The following kinds of triggers will be used to identify encounters that might reflect ADEs: diagnostic codes for diagnoses associated with ADEs, potential ADEs, or medication errors; use of specific drugs suggesting that an ADE may have occurred; potentially dangerous drug combinations; combinations of drugs and symptoms (e.g., angiotensin converting enzyme inhibitor and cough); combinations of diagnoses and drugs; and combinations of drugs and miscellaneous.	Hospital discharge; 1 year	Yes
Secondary	Medication discrepancies between pre-admission and ambulatory followup	Mean number of erroneous discrepancies between pre-admission and ambulatory followup	Ambulatory followup; 18 months	Yes