VA Integrated Medication Manager (IMM)

May 17, 2016 updated by: University of Utah

Veterans Affairs Integrated Medication Manager

The purpose of this study is to advance the science of healthcare informatics and to improve medication management through the development of a new approach to the electronic medical record called the Integrated Medication Manager (IMM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In an attempt to address problems patient non-compliance with quality goals barriers to access and integration of health information that impede achievement of treatment goals, the VA is developing a new approach to the electronic medical record. The VA is moving away from the paper-chart metaphor and towards an integrated representation of the patient's status and care process across time. One of the first steps in the development phase has been to explicitly relate patient conditions, therapies, and goals in the domain of pharmacotherapy. This is called Integrated Medication Management and draws on Hollnagel's Contextual Control Model. Providers will be able to plan care and create orders directly in the context of these explicit relationships. This application will be implemented nationwide through a web interface embedded within the existing Computerized Patient Record System (CPRS), the graphical user interface to VA Information Systems (VistA).

Aim 1: Identify cognitive components of providers' therapeutic decision making in the field.

Aim 2. Refine and evaluate the Integrated Medication Manager using simulation studies.

  • Aim 2.a. Refine interfaces and logic of the Integrated Medication Manager.
  • Aim 2.b. Compare the performance of the Integrated Medication Manager and usual CPRS.

All hypotheses (below) test the use of IMM versus usual electronic medical record (EMR).

  • Speed of decision-making will be faster.
  • Accuracy of data interpretation (clinical assessment) will be higher.
  • Appropriateness of therapeutic plans will be higher.
  • Efficiency of gathering information will be higher.
  • Common ground measures will be higher.
  • Appropriateness of therapeutic plans will be higher when relevant data is outside the usual time horizon.
  • Appropriateness of therapeutic plans will be higher when complex associations among patient therapies and goals exist.
  • Appropriateness of therapeutic plans will be no lower when relevant data is not captured by the displays of the IMM.
  • Appropriateness of therapeutic plans will be higher when highly salient data is not germane to the most important problem.
  • Appropriateness of therapeutic plans will be higher when cognitive load is high due to interruptions.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA SLC Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Practiced in primary care for at least two years
  • Third year residents with two years of residency in internal medicine or family practice
  • Do not have to be currently practicing

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Medication Manager
Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
Other: Integrated Medication Manager
A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use.
Other Names:
  • IMM
No Intervention: Standard EHR
Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Time to Complete Assessment and Plan
Time Frame: 10 minutes
Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.
10 minutes
Accuracy of Written Assessment and Plan in Terms of Control and Status
Time Frame: 10 minutes
Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. The primary outcome evaluated participants' recommendations for treatment of patient conditions. Participants reviewed a total of 10 patient cases and received a score between 0 and 3 points for each issue within each patient case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent greater accuracy of the written assessment and plan.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan
Time Frame: 10 minutes
Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. . The secondary outcome evaluated participants' recommendation about future monitoring of patient conditions. Participants reviewed a total of 10 patient cases and received a score of 0 or 1 point for each issue within each case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent a greater proportion of appropriate monitoring recommendations made.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Jonathan Nebeker, MD, MS, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5R18HS017186-03 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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