Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents
12 de mayo de 2016 actualizado por: University of California, San Francisco
Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents: A Pilot Study
This project leverages digital health technology to support patient engagement and shared decision-making between families, patients, and providers.
The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1).
The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2).
The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3).
The hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Hospitals are not consistently patient centered, contributing to worse outcomes and a sense of loss of control.
Prior interventions that promote patient-centered care focused on provider and hospital factors vs. engaging patients directly.
No project to date has capitalized on digital health technology to engage families in shared decision-making and patient engagement.
The goal of the proposed randomized controlled trial is to test the impact of an evidence-based educational module delivered using an interactive patient-facing IT platform, on measures of patient engagement and shared decision-making.
The platform was developed for the UCSF Benioff Children's Hospital by OneView, Inc. and includes an educational module that promotes shared decision-making through orientation to the hospital and evidence-based teaching on engaging with providers.
This study will provide pilot data for a large-scale trial measuring the impact of the system on patient engagement.
The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1).
The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2).
The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3).
Our hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience.
The eligible study population is all pediatric and newborn inpatients and their caregivers from June 2015 - August 2015.
The investigators anticipate needing a sample size of 100, 50 in each arm.
This pilot will generate key information on the platform's feasibility and acceptability and initial data on effect sizes to power future large-scale grants.
Tipo de estudio
Intervencionista
Inscripción (Actual)
58
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 95 años (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- An admitted patient (up to age 22) or caregiver (up to 95) of an admitted patient at Benioff Children's Hospital in the acute care units, the pediatric hematology-oncology units, or the transitional care units, admitted to the hospital within the past 72 hours.
Exclusion Criteria:
- Was already admitted and discharged during the study period.
- Not an English speaker.
- Not having a parent or legal guardian present or available by phone to give consent for those <18 years of age.
- Patient is in foster care.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Treatment
Empower educational module: After the patient activation measure/s are collected, for parents or patients assigned to the intervention arm, they will be given an opportunity to launch the EMPOWER video and interactive powerpoint.
They will be able to pause on reviewing the educational material and come back to it, as with other assigned education, and they will be able to review it again if they would like.
Discharge surveys will be assigned 24 hours prior to the estimated discharge time in Apex.
Oneview will display notifications that the surveys have been assigned.
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Evidence-based video module delivering content of the Right Question intervention from Deen et al. (2011)
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Sin intervención: Control
Standard care: Those who opt to participate in the study will be randomly assigned to receive standard features of the media center (control group), or standard features plus the educational module intervention.
They will complete online (1) a baseline patient activation survey (for patients old enough to complete and for caregivers) at the start of their participation, and (2) an end-of-study survey pre-discharge or at the end of the study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in activation as measured with the Parent Patient Activation Measure (PPAM)
Periodo de tiempo: Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.
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Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Shared Decision-Making measured using the CollaboRATE 3-item scale
Periodo de tiempo: Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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Quality of Shared Decision-Making measured using M-PICS scores
Periodo de tiempo: Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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Length of Stay obtained from the Epic electronic health record
Periodo de tiempo: Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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30-day readmission obtained from the Epic electronic health record
Periodo de tiempo: Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
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This is a binary measure assessing whether the patient was readmitted to the hospital (Benioff Children' Hospital) within 30 days after discharge date.
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Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
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Study Recruitment Rate
Periodo de tiempo: Baseline
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Number of patients with at least one person agreeing to participate (either a family member or a child) / Number of eligible patients who were assigned the study introduction materials in the hospital electronic educational center
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Baseline
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Study Retention
Periodo de tiempo: Measured at discharge, an average of 3 days after study enrollment
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Number of participants who complete the survey capturing the second patient activation measure prior to hospital discharge / Number of participants who completed the first Patient Activation Measure
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Measured at discharge, an average of 3 days after study enrollment
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Engagement with the Educational Module
Periodo de tiempo: Duration of the hospital stay, an average of 3 days
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Number of participants viewing the EMPOWER educational module (intervention) at least once / Number of patients assigned the module.
Data from the OneView system
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Duration of the hospital stay, an average of 3 days
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Repeated Engagement with the Education Module
Periodo de tiempo: Duration of the hospital stay, an average of 3 days
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Number of views of the educational module for participants who viewed it at least once
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Duration of the hospital stay, an average of 3 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Naomi S. Bardach, MD, MAS, University of California, San Francisco
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. Erratum In: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32.
- Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
- Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Alegria M, Polo A, Gao S, Santana L, Rothstein D, Jimenez A, Hunter ML, Mendieta F, Oddo V, Normand SL. Evaluation of a patient activation and empowerment intervention in mental health care. Med Care. 2008 Mar;46(3):247-56. doi: 10.1097/MLR.0b013e318158af52.
- Pennarola BW, Rodday AM, Mayer DK, Ratichek SJ, Davies SM, Syrjala KL, Patel S, Bingen K, Kupst MJ, Schwartz L, Guinan EC, Hibbard JH, Parsons SK; HSCT-CHESS Study. Factors associated with parental activation in pediatric hematopoietic stem cell transplant. Med Care Res Rev. 2012 Apr;69(2):194-214. doi: 10.1177/1077558711431460. Epub 2011 Dec 26.
- Deen D, Lu WH, Rothstein D, Santana L, Gold MR. Asking questions: the effect of a brief intervention in community health centers on patient activation. Patient Educ Couns. 2011 Aug;84(2):257-60. doi: 10.1016/j.pec.2010.07.026. Epub 2010 Aug 25.
- Smith MY, Winkel G, Egert J, Diaz-Wionczek M, DuHamel KN. Patient-physician communication in the context of persistent pain: validation of a modified version of the patients' Perceived Involvement in Care Scale. J Pain Symptom Manage. 2006 Jul;32(1):71-81. doi: 10.1016/j.jpainsymman.2006.01.007.
- Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.
- Bardach NS, Lam R, Jasik CB. Assessment of automated clinical trial recruitment and enrolment using patient-facing technology. BMJ Health Care Inform. 2021 Jan;28(1):e100076. doi: 10.1136/bmjhci-2019-100076.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2015
Finalización primaria (Actual)
1 de enero de 2016
Finalización del estudio (Actual)
1 de marzo de 2016
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2015
Publicado por primera vez (Estimar)
7 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
12 de mayo de 2016
Última verificación
1 de mayo de 2016
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 15-16151
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .
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