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Clinical Reminders in Test Reports to Improve Guideline Compliance

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: NCT01792544
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Paul Heidenreich, VA Palo Alto Health Care System

Tracking Information
First Submitted Date  ICMJE February 12, 2013
First Posted Date  ICMJE February 15, 2013
Last Update Posted Date April 28, 2016
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
Inappropriate follow-up [ Time Frame: 1 year ]
Performance of a follow-up echocardiogram when it was not indicated or not performing for a follow-up echocardiogram when it was indicated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Reminders in Test Reports to Improve Guideline Compliance
Official Title  ICMJE Not Provided
Brief Summary This study examines the impact of adding a statement to the echocardiography report that advises anyone reading the report regarding if and when a follow-up study is recommended.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Echocardiography
Intervention  ICMJE
  • Other: Statement
  • Other: No Statement
Study Arms  ICMJE
  • Experimental: Statement
    A statement is added to the echocardiography report describing if and when a follow-up echocardiogram is recommended. The statement may be positive (e.g. follow-up recommended in 6 months) or negative (e.g. no follow-up recommended).
    Intervention: Other: Statement
  • Experimental: No Statement
    No statement is added to the echocardiography report
    Intervention: Other: No Statement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
1706
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2013)
2000
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

All patients undergoing echocardiography where the physician creating the report feels a comment is appropriate regarding when follow-up should or should not occur.

Exclusion Criteria:

None.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01792544
Other Study ID Numbers  ICMJE SUIRB-021780
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Heidenreich, VA Palo Alto Health Care System
Study Sponsor  ICMJE VA Palo Alto Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VA Palo Alto Health Care System
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP