- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alexandra Businger
- Correo electrónico: abusinger@partners.org
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Aún no reclutando
- Beacon Hill/Downtown Primary Care
-
Contacto:
- Richard Winickoff, MD
-
Boston, Massachusetts, Estados Unidos, 02114
- Reclutamiento
- Bulfinch Medical Group
-
Contacto:
- Charles Weiss, MD
-
Boston, Massachusetts, Estados Unidos, 02114
- Aún no reclutando
- Massachusetts General Hospital Women's Health Associates
-
Contacto:
- Karen Carlson, MD
-
Charlestown, Massachusetts, Estados Unidos, 02129
- Reclutamiento
- Charlestown Health Center
-
Contacto:
- Michael Garrity, MD
-
Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Reclutamiento
- Brigham & Women's Hospital Women's Health Center
-
Contacto:
- Lori Farnan, MD
-
Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Aún no reclutando
- Brigham & Women's Physicians Group
-
Contacto:
- Jonathan Appelbaum, MD
-
Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Aún no reclutando
- Brigham Primary Physicians at Faulkner
-
Contacto:
- Michael Healey, MD
-
Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Aún no reclutando
- Southern Jamaica Plain Health Center
-
Contacto:
- Michael Lambert, MD
-
Norwood, Massachusetts, Estados Unidos, 02062
- Reclutamiento
- Brigham & Women's Hospital at Norwood
-
Contacto:
- Louise Schneider, MD
-
Revere, Massachusetts, Estados Unidos, 02151
- Aún no reclutando
- Revere Health Center
-
Contacto:
- Eric Weil, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
1. ADEs
|
2. duration of ameliorable medication side effects
|
3. health goal adherence rates
|
4. diabetes outcomes
|
5. familial risk factor documentation rates
|
6. user satisfaction surveys
|
7. user metrics
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Blackford Middleton, MD, MPH, MSc, Brigham & Women's Hospital, Partners HealthCare System, Inc.
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- R01HS013326 (Subvención/Contrato de la AHRQ de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .