Medication Reconciliation Technology to Improve Quality of Transitional Care (MedMatch)

This study has been completed.
Sponsor:
Collaborators:
Regenstrief Institute, IU Center for Aging Research
Wishard Health Services
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01195051
First received: July 12, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Medication Reconciliation
Other: Electronic medication reconciliation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Medication Reconciliation Technology to Improve Quality of Transitional Care

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Reconciliation of outpatient medications [ Time Frame: Hospital admission, transfer, and discharge; 1 year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Measurement of potential for harm and potential severity of harm [ Time Frame: Hospital discharge; 1 year ] [ Designated as safety issue: Yes ]
    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).

  • Measurement and analysis of providers' perspectives [ Time Frame: Start and end of trial; 1 year ] [ Designated as safety issue: No ]
    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.

  • Measurement and analysis of patients' perspectives [ Time Frame: Hospital discharge; 1 year ] [ Designated as safety issue: No ]
    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.

  • Reportable financial and organizational dimensions [ Time Frame: Start of trial; time 0 and 1 year ] [ Designated as safety issue: No ]
    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.

  • Utilization of intervention [ Time Frame: Hospital admission, transfer, and discharge; 1 year ] [ Designated as safety issue: No ]
    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.

  • Measurement and analysis of drug-related medical errors [ Time Frame: Hospital discharge; 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Measurement of adverse drug events and near misses [ Time Frame: Hospital discharge; 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Medication discrepancies between pre-admission and ambulatory followup [ Time Frame: Ambulatory followup; 18 months ] [ Designated as safety issue: Yes ]
    Mean number of erroneous discrepancies between pre-admission and ambulatory followup


Enrollment: 4818
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electronic medication reconciliation
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
A new, computer-based application will be used to document and prescribe outpatient medications in the inpatient setting.
Other Name: MedMatch
No Intervention: Control

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195051

Locations
United States, Indiana
Wishard Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Regenstrief Institute, IU Center for Aging Research
Wishard Health Services
Investigators
Principal Investigator: Michael Weiner, MD, MPH Indiana University School of Medicine, Department of Medicine
  More Information

Publications:
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01195051     History of Changes
Other Study ID Numbers: 0910-19, R18HS018183
Study First Received: July 12, 2010
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Medication Reconciliation
Inpatient
Electronic Medical Records

ClinicalTrials.gov processed this record on October 20, 2014