NCT00251875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,400

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable diabetes

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 11, 2005

Status Verified

November 1, 2005

First QC Date

November 9, 2005

Last Update Submit

November 9, 2005

Conditions

Diabetes

Keywords

patient portalselectronic health recordsfamily historyhealth maintenancemedicationsdiabetes

Outcome Measures

Primary Outcomes (7)

  • 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

Interventions

online health information journalDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients, who are enrolled in Patient Gateway, of physicians and practices participating in the study.

You may not qualify if:

  • Any patients who are not enrolled in Patient Gateway or do not belong to a participating practice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Beacon Hill/Downtown Primary Care

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Bulfinch Medical Group

Boston, Massachusetts, 02114, United States

RECRUITING

Massachusetts General Hospital Women's Health Associates

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Charlestown Health Center

Charlestown, Massachusetts, 02129, United States

RECRUITING

Brigham & Women's Hospital Women's Health Center

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

Brigham & Women's Physicians Group

Chestnut Hill, Massachusetts, 02467, United States

NOT YET RECRUITING

Brigham Primary Physicians at Faulkner

Jamaica Plain, Massachusetts, 02130, United States

NOT YET RECRUITING

Southern Jamaica Plain Health Center

Jamaica Plain, Massachusetts, 02130, United States

NOT YET RECRUITING

Brigham & Women's Hospital at Norwood

Norwood, Massachusetts, 02062, United States

RECRUITING

Revere Health Center

Revere, Massachusetts, 02151, United States

NOT YET RECRUITING

Related Publications (3)

  • 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.

    PMID: 22556186DERIVED

  • 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.

    PMID: 18999087DERIVED

  • 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.

    PMID: 18779465DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Blackford Middleton, MD, MPH, MSc

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Businger

CONTACT

abusinger@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

July 1, 2005

Study Completion

September 1, 2007

Last Updated

November 11, 2005

Record last verified: 2005-11

Locations

US(10)