Shared Online Health Records for Patient Safety and Care
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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
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes | Device: online health information journal | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 5400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Shared Online Health Records for Patient Safety and Care |
Study Start Date : | July 2005 |
Study Completion Date : | September 2007 |

- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251875
Contact: Alexandra Businger | abusinger@partners.org |
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 Hospital Women's Health Center | Recruiting |
Chestnut Hill, Massachusetts, United States, 02467 | |
Contact: Lori Farnan, MD | |
Brigham & Women's Physicians Group | Not yet recruiting |
Chestnut Hill, Massachusetts, United States, 02467 | |
Contact: Jonathan Appelbaum, 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 |
Principal Investigator: | Blackford Middleton, MD, MPH, MSc | Brigham & Women's Hospital, Partners HealthCare System, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00251875 History of Changes |
Other Study ID Numbers: |
R01HS013326 ( U.S. AHRQ Grant/Contract ) |
First Posted: | November 11, 2005 Key Record Dates |
Last Update Posted: | November 11, 2005 |
Last Verified: | November 2005 |
Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
patient portals electronic health records family history |
health maintenance medications diabetes |