ClinicalTrials.gov
ClinicalTrials.gov Menu

VISN Collaborative for Improving Hypertension Management With ATHENA-HTN (HTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374452
Recruitment Status : Completed
First Posted : September 11, 2006
Results First Posted : December 18, 2017
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Hypertension
Interventions: Other: ATHENA-CDS-HTN plus Guideline Link
Other: Guideline Link Only

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study initially involved 5 medical centers with 103 participants across the medical centers. One of the 5 medical centers completed installation of ATHENA-HTN system, but did not continue with the intervention period, so the intervention included 4 medical centers with 82 participants.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (Clinic sites within medical centers)

Reporting Groups
  Description
Guideline Link Only

Link to The Seventh Report of the Joint National Committee on Prevention Detection Evaluation and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines

Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA-DoD and JNC7 hypertension guidelines.

ATHENA-CDS-HTN

ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.

ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.


Participant Flow:   Overall Study
    Guideline Link Only   ATHENA-CDS-HTN
Participants Units (Clinic sites within medical centers) Participants Units (Clinic sites within medical centers)
STARTED [1]   34   10   48   10 
Intervention Started   30   10   46   10 
COMPLETED   29   10   43   10 
NOT COMPLETED   5      5    
Left clinic before intervention started                4                                1                 
Change in job role before intervention                0                                1                 
Left clinic after intervention started                1                                1                 
Withdrawal by Subject                0                                2                 
[1] Randomization of the clinic sites.



  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.
Baseline characteristics of primary care providers who started intervention period

Reporting Groups
  Description
Guideline Link Only

Link to JNC7 and to VA-DoD hypertension guidelines

Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.

ATHENA-CDS-HTN

ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.

ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.

Total Total of all reporting groups

Baseline Measures
   Guideline Link Only   ATHENA-CDS-HTN   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   46   76 
Overall Units Analyzed (Clinics) 
[Units: Clinics]
 10   10   20 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age >= 18 years   30   46   76 
Sex/Gender, Customized [1] 
[Units: Percentage of male participants]
     
Mean percentage male participants per clinic   35.5   24.6   30.1 
[1] Measured percentage of male participants per clinic site, then mean of these percentages for study arm.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   30   46   76 


  Outcome Measures

1.  Primary:   Mean Percentages of Events After Index Visit to Primary Care by Patient   [ Time Frame: up to one year after index visit ]


  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
The study has originally planned to include 5 large medical centers. One of the medical centers dropped out before the intervention started. This lowered the number of clinic sites and of participants (clinicians).


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mary K. Goldstein, MD
Organization: VA Palo Alto Health Care System
phone: 650-493-5000 ext 1,1,62105
e-mail: mary.goldstein@va.gov


Publications of Results:


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00374452     History of Changes
Other Study ID Numbers: IMV 04-062
First Submitted: September 8, 2006
First Posted: September 11, 2006
Results First Submitted: October 19, 2017
Results First Posted: December 18, 2017
Last Update Posted: March 29, 2018