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Sponsored by: |
Agency for Healthcare Research and Quality (AHRQ) |
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Information provided by: | Agency for Healthcare Research and Quality (AHRQ) |
ClinicalTrials.gov Identifier: | NCT00251875 |
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 |
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Diabetes |
Device: online health information journal |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Shared Online Health Records for Patient Safety and Care |
Estimated Enrollment: | 5400 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexandra Businger | abusinger@partners.org |
United States, Massachusetts | |
Charlestown Health Center | Recruiting |
Charlestown, Massachusetts, United States, 02129 | |
Contact: Michael Garrity, MD | |
Bulfinch Medical Group | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Charles Weiss, MD | |
Brigham & Women's Hospital at Norwood | Recruiting |
Norwood, Massachusetts, United States, 02062 | |
Contact: Louise Schneider, 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 | |
Brigham & Women's Physicians Group | Not yet recruiting |
Chestnut Hill, Massachusetts, United States, 02467 | |
Contact: Jonathan Appelbaum, MD | |
Massachusetts General Hospital Women's Health Associates | Not yet recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Karen Carlson, MD | |
Revere Health Center | Not yet recruiting |
Revere, Massachusetts, United States, 02151 | |
Contact: Eric Weil, MD | |
Southern Jamaica Plain Health Center | Not yet recruiting |
Jamaica Plain, Massachusetts, United States, 02130 | |
Contact: Michael Lambert, MD | |
Beacon Hill/Downtown Primary Care | Not yet recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Richard Winickoff, MD |
Principal Investigator: | Blackford Middleton, MD, MPH, MSc | Brigham & Women's Hospital, Partners HealthCare System, Inc. |
Study ID Numbers: | R01 HS13326 |
Study First Received: | November 9, 2005 |
Last Updated: | November 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00251875 |
Health Authority: | United States: Federal Government |
patient portals electronic health records family history |
health maintenance medications diabetes |
Diabetes Mellitus |