Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 543
- Locations
- 4
- Primary Endpoint
- Number of Participants in Disease Control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Digital Transformation Network (DTN) Program
IBD patients at the 3 sites will be sent a message to their Smartphone
Intervention: Digital Transformation Network (DTN) Program (Behavioral)
Control Arm
Patients will enter the control group once they initially complete the ePRO and online assessment tools. They will remain in the control group, and then at set intervals each site will transition these patients into the DTN intervention arm.
Intervention: Digital Transformation Network (DTN) Program (Behavioral)
Outcomes
Primary Outcomes
Number of Participants in Disease Control
Time Frame: 1 year after enrollment
Number of participants in disease control. Disease control is defined by normalization of inflammatory markers and ePROs (PRO2\<8 and PRO3\<13). PRO2 measures stool frequency and bleeding while PRO3 measures the number of liquid or soft stools, abdominal pain and general well-being. Inflammatory markers including Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP) and Fecal Calprotectin will be dichotomized using cut-offs of \<30mm/hr, \<5mg/L and \<50 μg/g respectively for normal values.
Change in Number of Unplanned Acute Care
Time Frame: baseline
Change in number of unplanned acute care 1 year after enrollment as compared to baseline. Unplanned acute care is defined as the number of ED visits and hospitalizations days 12 months before the intervention and the last 12 months of DTN intervention.
Secondary Outcomes
- Northstar Digital Literacy Assessment(1 year after enrollment)
- PROMIS Global scales(1 year after enrollment)
- Generalized Anxiety Disorder scale (GAD-7)(1 year after enrollment)
- Number of participants with improvement in mucosal healing(1 year after enrollment)
- Visual Analog Scale (VAS)(1 year after enrollment)
- Patient Health Questionnaire (PHQ-4)(1 year after enrollment)
- Proportion of patients meeting eligible quality metrics(1 year after enrollment)
- System Usability Scale (SUS)(1 year after enrollment)
- Net Promoter Score(1 year after enrollment)
- Digital Disparities Module(1 year after enrollment)
- Overall Health Numeric Rating Scale [OHNRS](1 year after enrollment)
- Patient Health Questionnaire (PHQ-9)(1 year after enrollment)
Investigators
Bruce E. Sands
Professor
Icahn School of Medicine at Mount Sinai