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Shared Online Health Records for Patient Safety and Care

NCT ID: NCT00251875

Last Updated: 2005-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes

Keywords

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patient portals electronic health records family history health maintenance medications diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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online health information journal

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role lead

Principal Investigators

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Blackford Middleton, MD, MPH, MSc

Role: PRINCIPAL_INVESTIGATOR

Brigham & Women's Hospital, Partners HealthCare System, Inc.

Locations

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Beacon Hill/Downtown Primary Care

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Bulfinch Medical Group

Boston, Massachusetts, United States

Site Status RECRUITING

Massachusetts General Hospital Women's Health Associates

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Charlestown Health Center

Charlestown, Massachusetts, United States

Site Status RECRUITING

Brigham & Women's Hospital Women's Health Center

Chestnut Hill, Massachusetts, United States

Site Status RECRUITING

Brigham & Women's Physicians Group

Chestnut Hill, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Brigham Primary Physicians at Faulkner

Jamaica Plain, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Southern Jamaica Plain Health Center

Jamaica Plain, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Brigham & Women's Hospital at Norwood

Norwood, Massachusetts, United States

Site Status RECRUITING

Revere Health Center

Revere, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Alexandra Businger

Role: CONTACT

Email: [email protected]

Facility Contacts

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Richard Winickoff, MD

Role: primary

Charles Weiss, MD

Role: primary

Karen Carlson, MD

Role: primary

Michael Garrity, MD

Role: primary

Lori Farnan, MD

Role: primary

Jonathan Appelbaum, MD

Role: primary

Michael Healey, MD

Role: primary

Michael Lambert, MD

Role: primary

Louise Schneider, MD

Role: primary

Eric Weil, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22556186 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18999087 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18779465 (View on PubMed)

Other Identifiers

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R01HS013326

Identifier Type: AHRQ

Identifier Source: org_study_id

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