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DiabetesNCT00251875

Shared Online Health Records for Patient Safety and Care

A study testing online health information journal in people with Diabetes, run by Agency for Healthcare Research and Quality (AHRQ) at 10 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
online health information journal
Type of treatment
Medical device
How many people
5,400 participants
Where
10 sitesUnited States
Study dates
Jul 2005to Sep 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

Alexandra Businger contact

abusinger@partners.org

10 sites in 1 country

United States10 sites, 10 recruiting

  • Beacon Hill/Downtown Primary Care

    Boston, Massachusetts, 02114

    Richard Winickoff, MD

    Not yet recruiting

  • Bulfinch Medical Group

    Boston, Massachusetts, 02114

    Charles Weiss, MD

    Recruiting

  • Massachusetts General Hospital Women's Health Associates

    Boston, Massachusetts, 02114

    Karen Carlson, MD

    Not yet recruiting

  • Charlestown Health Center

    Charlestown, Massachusetts, 02129

    Michael Garrity, MD

    Recruiting

  • Brigham & Women's Hospital Women's Health Center

    Chestnut Hill, Massachusetts, 02467

    Lori Farnan, MD

    Recruiting

  • Brigham & Women's Physicians Group

    Chestnut Hill, Massachusetts, 02467

    Jonathan Appelbaum, MD

    Not yet recruiting

  • Brigham Primary Physicians at Faulkner

    Jamaica Plain, Massachusetts, 02130

    Michael Healey, MD

    Not yet recruiting

  • Southern Jamaica Plain Health Center

    Jamaica Plain, Massachusetts, 02130

    Michael Lambert, MD

    Not yet recruiting

  • Brigham & Women's Hospital at Norwood

    Norwood, Massachusetts, 02062

    Louise Schneider, MD

    Recruiting

  • Revere Health Center

    Revere, Massachusetts, 02151

    Eric Weil, MD

    Not yet recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Diabetes
Being tested
online health information journal
Keywords
patient portals, electronic health records, family history, health maintenance, medications, diabetes
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • online health information journalDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2005 (estimated)
  2. Study startJul 2005
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251875
Sponsor's protocol ID
R01HS013326
Status last verified
Nov 2005
First submitted
9 Nov 2005
Last updated
11 Nov 2005
Results posted
No

Publications

  • 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.

    PubMed 22556186

  • 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.

    PubMed 18999087

  • 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.

    PubMed 18779465

Questions about this trial

What is this clinical trial studying?

A study testing online health information journal in people with Diabetes, run by Agency for Healthcare Research and Quality (AHRQ) at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexandra Businger (abusinger@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. ADEs. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251875, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2005.

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