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VA Integrated Medication Manager (IMM)

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ClinicalTrials.gov Identifier: NCT01787175
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Electronic Health Records
Intervention Other: Integrated Medication Manager
Enrollment 58

Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Integrated Medication Manager Standard EHR
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 30 28
Completed 30 28
Not Completed 0 0
Arm/Group Title Integration Medication Manager Standard EHR Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 30 28 58
Hide Baseline Analysis Population Description
Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned to use VA's CPRS (standard EHR). Providers were randomly assigned which system to use.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 28 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
28
 100.0%
58
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 28 participants 58 participants
Female
18
  60.0%
15
  53.6%
33
  56.9%
Male
12
  40.0%
13
  46.4%
25
  43.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 28 participants 58 participants
30 28 58
1.Primary Outcome
Title Amount of Time to Complete Assessment and Plan
Hide Description Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
58 providers were enrolled
Arm/Group Title Integrated Medication Manager Standard EHR
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 28
Mean (Standard Deviation)
Unit of Measure: minutes
8.5  (1.9) 8.7  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Integrated Medication Manager
Comments Null hypothesis: Participants will require the same amount of time to complete assessments and plans using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Mixed-effects linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in time to complete A&P
Estimated Value -17.73
Confidence Interval (2-Sided) 95%
-35.24 to -0.23
Estimation Comments [Not Specified]
2.Primary Outcome
Title Accuracy of Written Assessment and Plan in Terms of Control and Status
Hide Description 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.
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Integrated Medication Manager Standard EHR
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 28
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.609
(0.581 to 0.637)
0.569
(0.535 to 0.604)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Integrated Medication Manager
Comments Null hypothesis: Participants will receive the same scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Mixed-effects linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Value of problem scores for A&P complete
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.01 to 0.09
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan
Hide Description 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.
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Integrated Medication Manager Standard EHR
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 28
Mean (95% Confidence Interval)
Unit of Measure: proportion
0.505
(0.459 to 0.551)
0.477
(0.430 to 0.525)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Integrated Medication Manager
Comments Null hypothesis: Participants will receive the same proportion of acceptable scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.90
Confidence Interval (2-Sided) 95%
1.22 to 2.98
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Integrated Medication Manager Standard EHR
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Integrated Medication Manager Standard EHR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Integrated Medication Manager Standard EHR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Integrated Medication Manager Standard EHR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/28 (0.00%) 
We were not able to evaluate a system-wide deployment of the resulting graphical user interface (GUI) (IMM) in terms of patient outcomes (Aim 3). We were unable to conduct Aim 3, which would have evaluated IMM in a cluster-randomized trial.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jonathan Nebeker
Organization: University of Utah Health Care System
Phone: 801-582-1565 ext 2458
Publications:
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01787175     History of Changes
Other Study ID Numbers: 5R18HS017186-03 ( U.S. AHRQ Grant/Contract )
First Submitted: January 22, 2013
First Posted: February 8, 2013
Results First Submitted: January 3, 2014
Results First Posted: June 23, 2016
Last Update Posted: June 23, 2016