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Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents

12 maggio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

58

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 95 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: EMPOWER Educational Module
Evidence-based video module delivering content of the Right Question intervention from Deen et al. (2011)
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Change in activation as measured with the Parent Patient Activation Measure (PPAM)
Lasso di tempo: Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.
Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Shared Decision-Making measured using the CollaboRATE 3-item scale
Lasso di tempo: Measured at discharge, an average of 3 days after study enrollment
Measured at discharge, an average of 3 days after study enrollment
Quality of Shared Decision-Making measured using M-PICS scores
Lasso di tempo: Measured at discharge, an average of 3 days after study enrollment
Measured at discharge, an average of 3 days after study enrollment
Length of Stay obtained from the Epic electronic health record
Lasso di tempo: Measured at discharge, an average of 3 days after study enrollment
Measured at discharge, an average of 3 days after study enrollment
30-day readmission obtained from the Epic electronic health record
Lasso di tempo: Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
This is a binary measure assessing whether the patient was readmitted to the hospital (Benioff Children' Hospital) within 30 days after discharge date.
Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
Study Recruitment Rate
Lasso di tempo: Baseline
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
Baseline
Study Retention
Lasso di tempo: Measured at discharge, an average of 3 days after study enrollment
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
Measured at discharge, an average of 3 days after study enrollment
Engagement with the Educational Module
Lasso di tempo: Duration of the hospital stay, an average of 3 days
Number of participants viewing the EMPOWER educational module (intervention) at least once / Number of patients assigned the module. Data from the OneView system
Duration of the hospital stay, an average of 3 days
Repeated Engagement with the Education Module
Lasso di tempo: Duration of the hospital stay, an average of 3 days
Number of views of the educational module for participants who viewed it at least once
Duration of the hospital stay, an average of 3 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Francisco

Investigatori

  • Investigatore principale: Naomi S. Bardach, MD, MAS, University of California, San Francisco

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2015

Completamento primario (Effettivo)

1 gennaio 2016

Completamento dello studio (Effettivo)

1 marzo 2016

Date di iscrizione allo studio

Primo inviato

26 giugno 2015

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2015

Primo Inserito (Stima)

7 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 15-16151

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

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