Shared Online Health Records for Patient Safety and Care

Diabetes Clinical Trial

Official title:

Shared Online Health Records for Patient Safety and Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00251875
• Other study ID #: R01HS013326
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2005
• Last updated: November 9, 2005
• Start date: July 2005
• Est. completion date: September 2007

Study information

• Verified date: November 2005
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: Alexandra Businger
• Email: abusinger[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5400
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• online health information journal

Locations

Country	Name	City	State
United States	Beacon Hill/Downtown Primary Care	Boston	Massachusetts
United States	Bulfinch Medical Group	Boston	Massachusetts
United States	Massachusetts General Hospital Women's Health Associates	Boston	Massachusetts
United States	Charlestown Health Center	Charlestown	Massachusetts
United States	Brigham & Women's Hospital Women's Health Center	Chestnut Hill	Massachusetts
United States	Brigham & Women's Physicians Group	Chestnut Hill	Massachusetts
United States	Brigham Primary Physicians at Faulkner	Jamaica Plain	Massachusetts
United States	Southern Jamaica Plain Health Center	Jamaica Plain	Massachusetts
United States	Brigham & Women's Hospital at Norwood	Norwood	Massachusetts
United States	Revere Health Center	Revere	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. ADEs
Primary	2. duration of ameliorable medication side effects
Primary	3. health goal adherence rates
Primary	4. diabetes outcomes
Primary	5. familial risk factor documentation rates
Primary	6. user satisfaction surveys
Primary	7. user metrics