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Shared Online Health Records for Patient Safety and Care

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00251875
First received: November 9, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes
Device: online health information journal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Shared Online Health Records for Patient Safety and Care

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 5400
Study Start Date: July 2005
Estimated Study Completion Date: September 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251875

Locations
United States, Massachusetts
Beacon Hill/Downtown Primary Care
Boston, Massachusetts, United States, 02114
Bulfinch Medical Group
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital Women's Health Associates
Boston, Massachusetts, United States, 02114
Charlestown Health Center
Charlestown, Massachusetts, United States, 02129
Brigham & Women's Hospital Women's Health Center
Chestnut Hill, Massachusetts, United States, 02467
Brigham & Women's Physicians Group
Chestnut Hill, Massachusetts, United States, 02467
Brigham Primary Physicians at Faulkner
Jamaica Plain, Massachusetts, United States, 02130
Southern Jamaica Plain Health Center
Jamaica Plain, Massachusetts, United States, 02130
Brigham & Women's Hospital at Norwood
Norwood, Massachusetts, United States, 02062
Revere Health Center
Revere, Massachusetts, United States, 02151
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Blackford Middleton, MD, MPH, MSc Brigham & Women's Hospital, Partners HealthCare System, Inc.