- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00251875
Shared Online Health Records for Patient Safety and Care
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Alexandra Businger
- E-mail: abusinger@partners.org
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Ikke rekrutterer endnu
- Beacon Hill/Downtown Primary Care
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Kontakt:
- Richard Winickoff, MD
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Bulfinch Medical Group
-
Kontakt:
- Charles Weiss, MD
-
Boston, Massachusetts, Forenede Stater, 02114
- Ikke rekrutterer endnu
- Massachusetts General Hospital Women's Health Associates
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Kontakt:
- Karen Carlson, MD
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Charlestown, Massachusetts, Forenede Stater, 02129
- Rekruttering
- Charlestown Health Center
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Kontakt:
- Michael Garrity, MD
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Chestnut Hill, Massachusetts, Forenede Stater, 02467
- Rekruttering
- Brigham & Women's Hospital Women's Health Center
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Kontakt:
- Lori Farnan, MD
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Chestnut Hill, Massachusetts, Forenede Stater, 02467
- Ikke rekrutterer endnu
- Brigham & Women's Physicians Group
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Kontakt:
- Jonathan Appelbaum, MD
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Ikke rekrutterer endnu
- Brigham Primary Physicians at Faulkner
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Kontakt:
- Michael Healey, MD
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Ikke rekrutterer endnu
- Southern Jamaica Plain Health Center
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Kontakt:
- Michael Lambert, MD
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Norwood, Massachusetts, Forenede Stater, 02062
- Rekruttering
- Brigham & Women's Hospital at Norwood
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Kontakt:
- Louise Schneider, MD
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Revere, Massachusetts, Forenede Stater, 02151
- Ikke rekrutterer endnu
- Revere Health Center
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Kontakt:
- Eric Weil, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
1. ADEs
|
2. duration of ameliorable medication side effects
|
3. health goal adherence rates
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4. diabetes outcomes
|
5. familial risk factor documentation rates
|
6. user satisfaction surveys
|
7. user metrics
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Blackford Middleton, MD, MPH, MSc, Brigham & Women's Hospital, Partners HealthCare System, Inc.
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- R01HS013326 (U.S.A. AHRQ bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med online health information journal
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-
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-
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-
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-
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-
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-
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-
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