- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Non ancora reclutamento
- Beacon Hill/Downtown Primary Care
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Contatto:
- Richard Winickoff, MD
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Boston, Massachusetts, Stati Uniti, 02114
- Reclutamento
- Bulfinch Medical Group
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Contatto:
- Charles Weiss, MD
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Boston, Massachusetts, Stati Uniti, 02114
- Non ancora reclutamento
- Massachusetts General Hospital Women's Health Associates
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Contatto:
- Karen Carlson, MD
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Charlestown, Massachusetts, Stati Uniti, 02129
- Reclutamento
- Charlestown Health Center
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Contatto:
- Michael Garrity, MD
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Chestnut Hill, Massachusetts, Stati Uniti, 02467
- Reclutamento
- Brigham & Women's Hospital Women's Health Center
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Contatto:
- Lori Farnan, MD
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Chestnut Hill, Massachusetts, Stati Uniti, 02467
- Non ancora reclutamento
- Brigham & Women's Physicians Group
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Contatto:
- Jonathan Appelbaum, MD
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Jamaica Plain, Massachusetts, Stati Uniti, 02130
- Non ancora reclutamento
- Brigham Primary Physicians at Faulkner
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Contatto:
- Michael Healey, MD
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Jamaica Plain, Massachusetts, Stati Uniti, 02130
- Non ancora reclutamento
- Southern Jamaica Plain Health Center
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Contatto:
- Michael Lambert, MD
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Norwood, Massachusetts, Stati Uniti, 02062
- Reclutamento
- Brigham & Women's Hospital at Norwood
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Contatto:
- Louise Schneider, MD
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Revere, Massachusetts, Stati Uniti, 02151
- Non ancora reclutamento
- Revere Health Center
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Contatto:
- Eric Weil, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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1. ADEs
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2. duration of ameliorable medication side effects
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3. health goal adherence rates
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4. diabetes outcomes
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5. familial risk factor documentation rates
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6. user satisfaction surveys
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7. user metrics
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Blackford Middleton, MD, MPH, MSc, Brigham & Women's Hospital, Partners HealthCare System, Inc.
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- R01HS013326 (Sovvenzione/contratto AHRQ degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .