Shared Online Health Records for Patient Safety and Care

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 1. ADEs
2. 2. duration of ameliorable medication side effects
3. 3. health goal adherence rates
4. 4. diabetes outcomes
5. 5. familial risk factor documentation rates
6. 6. user satisfaction surveys
7. 7. user metrics

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

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.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schnipper JL, Gandhi TK, Wald JS, Grant RW, Poon EG, Volk LA, Businger A, Williams DH, Siteman E, Buckel L, Middleton B. Effects of an online personal health record on medication accuracy and safety: a cluster-randomized trial. J Am Med Inform Assoc. 2012 Sep-Oct;19(5):728-34. doi: 10.1136/amiajnl-2011-000723. Epub 2012 May 3.

Wright A, Poon EG, Wald J, Schnipper JL, Grant R, Gandhi TK, Volk LA, Bloom A, Williams DH, Gardner K, Epstein M, Nelson L, Businger A, Li Q, Bates DW, Middleton B. Effectiveness of health maintenance reminders provided directly to patients. AMIA Annu Symp Proc. 2008 Nov 6:1183.

Grant RW, Wald JS, Schnipper JL, Gandhi TK, Poon EG, Orav EJ, Williams DH, Volk LA, Middleton B. Practice-linked online personal health records for type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2008 Sep 8;168(16):1776-82. doi: 10.1001/archinte.168.16.1776.

ClinicalTrials.gov Identifier:	NCT00251875 History of Changes
Other Study ID Numbers:	R01HS013326 ( U.S. AHRQ Grant/Contract )
First Posted:	November 11, 2005
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