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Shared Online Health Records for Patient Safety and Care

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: NCT00251875
Recruitment Status : Unknown
Verified November 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was:  Recruiting
First Posted : November 11, 2005
Last Update Posted : November 11, 2005
Information provided by:

November 9, 2005
November 11, 2005
November 11, 2005
July 2005
Not Provided
  • 1. ADEs
  • 2. duration of ameliorable medication side effects
  • 3. health goal adherence rates
  • 4. diabetes outcomes
  • 5. familial risk factor documentation rates
  • 6. user satisfaction surveys
  • 7. user metrics
Same as current
No Changes Posted
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Shared Online Health Records for Patient Safety and Care
Shared Online Health Records for Patient Safety and Care

The study uses a randomized, prospective cohort design to assess the impact of shared online health records on 1) patient safety, 2) health goal adherence and outcomes, 3) documentation of family history, and 4) barriers to the adoption of patient-physician communication technology.

Hypothesis: the respective interventions will result in 1) improved patient safety 2) greater adherence to health care maintenance and chronic disease guidelines 3) more accurate documentation of family history 4) the identification of technology adoption enablers and barriers.

During the first phase of the study, primary care practice patients continue to receive “usual care” while their physician’s offices are using Patient Gateway, an Internet portal offering secure messaging, common requests, chart information, and health information that has already been developed. Also in this first phase, all patients using Patient Gateway will receive an electronic letter explaining the research study and a link to an electronic consent form. In addition to recruitment of subjects, phase 1 allows for baseline data to be collected.

In the second phase, study clinics will be randomized into one of two intervention “arms”. Study subjects whose clinics are randomized into Arm 1 will be invited to review and comment on their medication, allergy, and diabetes information through Patient Gateway; they can then submit this information to their primary care physician for review. Those randomized into Arm 2 will report on their health maintenance status and family history and submit this information to their primary care physician through Patient Gateway prior to a scheduled visit. Chart reviews performed at the end of Phase 1 and Phase 2 will be conducted to identify differences in process measures and outcome measures between intervention and control groups.

In addition, a medication phone survey sub-study will be conducted to evaluate the effect of the new Patient Gateway features on medication management.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Device: online health information journal
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2007
Not Provided

Inclusion Criteria:

  • All patients, who are enrolled in Patient Gateway, of physicians and practices participating in the study.

Exclusion Criteria:

  • Any patients who are not enrolled in Patient Gateway or do not belong to a participating practice.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01HS013326( U.S. AHRQ Grant/Contract )
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Agency for Healthcare Research and Quality (AHRQ)
Not Provided
Principal Investigator: Blackford Middleton, MD, MPH, MSc Brigham & Women's Hospital, Partners HealthCare System, Inc.
Agency for Healthcare Research and Quality (AHRQ)
November 2005

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