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Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468675
First Posted: November 9, 2011
Last Update Posted: April 28, 2017
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.
Information provided by (Responsible Party):
Jennifer S. Haas, MD, Brigham and Women's Hospital
Results First Submitted: December 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Colorectal Cancer
Breast Cancer
Coronary Heart Disease
Diabetes
Intervention: Other: Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Risk Assessment and Prevention Recommendations
Control Control - Usual Care

Participant Flow:   Overall Study
    Intervention   Control
STARTED   2699   3376 
COMPLETED   1699   2004 
NOT COMPLETED   1000   1372 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Intervention Risk Assessment and Prevention Recommendations provided to subjects
Control Usual Care
Total Total of all reporting groups

Baseline Measures
   Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 1699   2004   3703 
Age 
[Units: Years]
Median (Full Range)
 55 
 (18 to 75) 
 56 
 (18 to 75) 
 55 
 (18 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1338  78.8%      1415  70.6%      2753  74.3% 
Male      361  21.2%      589  29.4%      950  25.7% 
Race/Ethnicity, Customized 
[Units: Participants]
     
white   1418   1675   3093 
black   79   82   161 
Latino   91   105   196 
Other/ unknown   111   142   253 
Region of Enrollment 
[Units: Participants]
     
United States   1699   2004   3703 


  Outcome Measures

1.  Primary:   Number of Subjects Who Discussed Disease Risk With Primary Care Provider   [ Time Frame: 3 months following primary care visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jennifer Haas, M.D.
Organization: Brigham and Women's Hospital
phone: 617-525-6652
e-mail: jhaas@partners.org



Responsible Party: Jennifer S. Haas, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01468675     History of Changes
Other Study ID Numbers: 2009P002762
First Submitted: November 4, 2011
First Posted: November 9, 2011
Results First Submitted: December 21, 2016
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017