Trial Outcomes & Findings for VA Integrated Medication Manager (NCT NCT01787175)

NCT ID: NCT01787175

Last Updated: 2016-06-23

Results Overview

Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

10 minutes

Results posted on

2016-06-23

Participant Flow

Recruitment 12/2010 to 3/2011 at the Salt Lake City VA and University of Utah health care systems. Simulations took place at either of these locations.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
30
28
Overall Study
COMPLETED
30
28
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VA Integrated Medication Manager

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Integration Medication Manager
n=30 Participants
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.
Standard EHR
n=28 Participants
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.
Total
n=58 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
n=5 Participants
28 Participants
n=7 Participants
58 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
15 Participants
n=7 Participants
33 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
13 Participants
n=7 Participants
25 Participants
n=5 Participants
Region of Enrollment
United States
30 participants
n=5 Participants
28 participants
n=7 Participants
58 participants
n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes

Population: 58 providers were enrolled

Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.

Outcome measures

Outcome measures
Measure
Integrated Medication Manager
n=30 Participants
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.
Standard EHR
n=28 Participants
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.
Amount of Time to Complete Assessment and Plan
8.5 minutes
Standard Deviation 1.9
8.7 minutes
Standard Deviation 1.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Integrated Medication Manager
n=30 Participants
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.
Standard EHR
n=28 Participants
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.
Accuracy of Written Assessment and Plan in Terms of Control and Status
0.609 units on a scale
Interval 0.581 to 0.637
0.569 units on a scale
Interval 0.535 to 0.604

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Integrated Medication Manager
n=30 Participants
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.
Standard EHR
n=28 Participants
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.
Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan
0.505 proportion
Interval 0.459 to 0.551
0.477 proportion
Interval 0.43 to 0.525

Adverse Events

Integrated Medication Manager

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard EHR

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Nebeker

University of Utah Health Care System

Phone: 801-582-1565

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place