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Trial record 3 of 3 for:    15755945 [PUBMED-IDS]

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Integrated Medication Manager   Standard EHR
STARTED   30   28 
COMPLETED   30   28 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Integration 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.
Total Total of all reporting groups

Baseline Measures
   Integration Medication Manager   Standard EHR   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   28   58 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   30   28   58 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   18   15   33 
Male   12   13   25 
Region of Enrollment 
[Units: Participants]
     
United States   30   28   58 


  Outcome Measures

1.  Primary:   Amount of Time to Complete Assessment and Plan   [ Time Frame: 10 minutes ]

2.  Primary:   Accuracy of Written Assessment and Plan in Terms of Control and Status   [ Time Frame: 10 minutes ]

3.  Secondary:   Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan   [ Time Frame: 10 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: Jonathan.Nebeker@hsc.utah.edu


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