Clinical trial NCT00251875: Shared Online Health Records for Patient Safety and Care
Official title: Shared Online Health Records for Patient Safety and Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: patient portals
electronic health records
family history
health maintenance
medications
diabetes
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2005-11-11
Enrollment: 5400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: 1. ADEs
measure: 2. duration of ameliorable medication side effects
measure: 3. health goal adherence rates
measure: 4. diabetes outcomes
measure: 5. familial risk factor documentation rates
measure: 6. user satisfaction surveys
measure: 7. user metrics
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beacon Hill/Downtown Primary Care
state: Massachusetts
city: Boston
country: United States
facility: Bulfinch Medical Group
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital Women's Health Associates
state: Massachusetts
city: Charlestown
country: United States
facility: Charlestown Health Center
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham & Women's Hospital Women's Health Center
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham & Women's Physicians Group
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Brigham Primary Physicians at Faulkner
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Southern Jamaica Plain Health Center
state: Massachusetts
city: Norwood
country: United States
facility: Brigham & Women's Hospital at Norwood
state: Massachusetts
city: Revere
country: United States
facility: Revere Health Center
state: Massachusetts
Study officials:
affiliation: Brigham & Women's Hospital, Partners HealthCare System, Inc.
name: Blackford Middleton, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.