Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT00251875
Previous Study | Return to List | Next Study

Shared Online Health Records for Patient Safety and Care

The recruitment status of this study is unknown because the information has not been verified recently.
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
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

Contacts
Contact: Alexandra Businger abusinger@partners.org

Locations
United States, Massachusetts
Beacon Hill/Downtown Primary Care Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard Winickoff, MD         
Bulfinch Medical Group Recruiting
Boston, Massachusetts, United States, 02114
Contact: Charles Weiss, MD         
Massachusetts General Hospital Women's Health Associates Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Karen Carlson, MD         
Charlestown Health Center Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Michael Garrity, MD         
Brigham & Women's Physicians Group Not yet recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Jonathan Appelbaum, MD         
Brigham & Women's Hospital Women's Health Center Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Lori Farnan, MD         
Brigham Primary Physicians at Faulkner Not yet recruiting
Jamaica Plain, Massachusetts, United States, 02130
Contact: Michael Healey, MD         
Southern Jamaica Plain Health Center Not yet recruiting
Jamaica Plain, Massachusetts, United States, 02130
Contact: Michael Lambert, MD         
Brigham & Women's Hospital at Norwood Recruiting
Norwood, Massachusetts, United States, 02062
Contact: Louise Schneider, MD         
Revere Health Center Not yet recruiting
Revere, Massachusetts, United States, 02151
Contact: Eric Weil, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Blackford Middleton, MD, MPH, MSc Brigham & Women's Hospital, Partners HealthCare System, Inc.
  More Information

No publications provided by Agency for Healthcare Research and Quality (AHRQ)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00251875     History of Changes
Other Study ID Numbers: R01 HS13326
Study First Received: November 9, 2005
Last Updated: November 9, 2005
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
patient portals
electronic health records
family history
health maintenance
medications
diabetes

ClinicalTrials.gov processed this record on November 25, 2014