Clinical trial NCT04345393: Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
Official title: Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: IBD
Treat to target
Digital transformation network
Social determinants of health
e-PRO
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: Northwestern University
name: RxHealth
name: University of California, Davis
First posted: 2020-04-14
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 1. Smartphone, and inform them about the DTN program through a description and embedded video.
2. Including SDH, behavioral health, lack of knowledge of quality metrics, or lack of Smartphone access or connectivity.
3. The IBD home or to IBDTx care pathways. RxUniverse platform allows the creation of adaptive pathways based on feedback loops that provide relevant on-demand resources based on patient care touch-points.
4. Digitally enabled population, or an Interactive Voice Response \[IVR\] for those who are not
Primary purpose: PREVENTION

Brief summary: Delivery of healthcare has been traditionally limited to in-person visits or hospitalizations, while patients spend the majority of their time at home or work. Digital Medicine (e.g. apps, remote monitoring, telemedicine, patient reported outcomes) has the potential to bridge this gap, but the question remains as to how to translate it to mainstream practice while providing individualized recommendations to improve population health across organizations. Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), the study team plans to reduce digital disparities and scientifically test the impact of these technologies in a clinical trial in three CTSA sites catering to diverse populations and communities.

Detailed description: Delivery of healthcare has been traditionally limited to in-person office visits or hospitalizations, while patients spent the majority of their time at home or work. Digital Medicine (e.g. apps, remote monitoring, telemedicine, patient reported outcomes ePRO has the potential to bridge this gap, but it is unclear how to implement in a mainstream clinical practice that can lead to high-level patient and provider adoption. Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), the study team plans to reduce digital disparities and scientifically address the evidence gap of digital health interventions across populations and communities.

AIM I. Unify existing digital assets (mobile app, ePROs, assessment for digital disparities and behavioral health, referral to IBD home and health education) into an IBD Digital Therapeutics Toolkit and integrate with EHRs at 3 CTSA hubs. Hypothesis: Integration with EHRs will lead to higher adoption by providers and limit disruption of workflow.

AIM II: Establish baseline levels of digital connectivity, disease control, quality of life and care metrics in cohorts at the three IBD centers. Hypothesis: A multipronged approach of assessment through text, phone, an app, and in-person will yield higher adoption.

AIM III. Implement and evaluate precision-matched interventions (digital skills, social determinants, behavioral health, monitoring through apps, and referral to interdisciplinary care) among 1500 patients with IBD using a stepped-wedge, cluster- randomized trial. Hypothesis: Medical homes supported by a unified platform will translate to sustainable improvement in population health outcomes. Analyze the Impact of DTN interventions. The primary outcome will be the improvement of the percentage of patients in DTN in disease control and decrease in urgent care utilization (emergency department visits and hospitalization days) across the three CTSA sites.

AIM IV. Support sustainability and dissemination across CTSA sites. Hypothesis: The patient- centric DTN will be sustainable through alignment with value-based healthcare.

Anticipated Impact: About 2 million Americans suffer from IBD and many more with chronic inflammatory diseases. The study team hopes that this study will help the study team build an evidence-based approach to determine whether digital medicine can engage a diverse group of patients and improve outcomes; and if yes, how it can be reproduced and replicated across different settings to address theT3 and T4 translational gaps.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed Inflammatory Bowel Disease (IBD) will be enrolled into DTN in stepped-wedge cluster randomized trial
* Age greater than or equal to 18 years
* Ability to speak or understand English or Spanish Language.

Exclusion Criteria:

- Condition or disease that, in the opinion of the investigators, may make it exceedingly difficult for the patient to use DTN, including, but not limited to, advanced dementia.

Primary outcomes:
measure: Number of Participants in Disease Control
timeFrame: 1 year after enrollment
measure: Change in Number of Unplanned Acute Care
timeFrame: baseline
Secondary outcomes:
measure: Northstar Digital Literacy Assessment
timeFrame: 1 year after enrollment
measure: Digital Disparities Module
timeFrame: 1 year after enrollment
measure: Overall Health Numeric Rating Scale [OHNRS]
timeFrame: 1 year after enrollment
measure: PROMIS Global scales
timeFrame: 1 year after enrollment
measure: Patient Health Questionnaire (PHQ-4)
timeFrame: 1 year after enrollment
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 1 year after enrollment
measure: Generalized Anxiety Disorder scale (GAD-7)
timeFrame: 1 year after enrollment
measure: Number of participants with improvement in mucosal healing
timeFrame: 1 year after enrollment
measure: Visual Analog Scale (VAS)
timeFrame: 1 year after enrollment
measure: Proportion of patients meeting eligible quality metrics
timeFrame: 1 year after enrollment
measure: System Usability Scale (SUS)
timeFrame: 1 year after enrollment
measure: Net Promoter Score
timeFrame: 1 year after enrollment
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Secaucus
country: United States
facility: RxHealth
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Bruce Sands, MD
role: PRINCIPAL_INVESTIGATOR
References: