Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes

Inflammatory Bowel Disease (IBD) Clinical Trial

Official title:

Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04345393
• Other study ID #: GCO 18-2481
• Secondary ID: STUDY-21-01875SS
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Drew Helmus, MPH, MA
• Phone: 212-824-7786
• Email: drew.helmus[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1578
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases

Intervention

Behavioral:
• Digital Transformation Network (DTN) Program
Patients will be screened based on ePRO and online assessment tool results to be identified to be eligible for enrollment into the DTN program. The results of ePROs and online assessments will be used to precision match patients to in-person care at 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. For example, a patient with mild depression or anxiety, maybe offered an online DTx and if not useful, link to telepsychiatry or in-person psychiatry consultation. Patients will transition into the intervention DTN arm at set intervals by site.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of California, Davis	Davis	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	RxHealth	Secaucus	New Jersey

Sponsors (5)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Northwestern University, RxHealth, The Cleveland Clinic, University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Disease Control	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.	1 year after enrollment
Primary	Change in Number of Unplanned Acute Care	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.	baseline
Secondary	Northstar Digital Literacy Assessment	Digital skills and connectivity will be assessed using the Northstar digital literacy assessment. A 17-item rating scale, with full score from 0 to 100, with score 85% or above achieve a passing score.	1 year after enrollment
Secondary	Digital Disparities Module	The digital disparities module is still in development through SBIR. The digital disparities module will assess the impact of digital disparities module in improving digital skills and access to Internet using previously developed digital disparities assessment instrument. The scale for the digital disparities assessment full scale from 0 - 100 where a higher score indicates the patient has a higher level of disparity in digital connectivity, digital skills and digital usage.	1 year after enrollment
Secondary	Overall Health Numeric Rating Scale [OHNRS]	Overall Health Numeric Rating Scale (OHNRS) - Full scale from 0 to 10, higher score indicates worse health outcomes	1 year after enrollment
Secondary	PROMIS Global scales	PROMIS Global scales is a 14-item measure that is part of the PROMIS Social Function. The measure refers to social roles, such as work and family responsibilities, and more discretionary social activities, such as leisure activity and relationships with friends. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	1 year after enrollment
Secondary	Patient Health Questionnaire (PHQ-4)	The Patient Health Questionnaire (PHQ)-4 s a 4 item inventory. Anxiety subscale from 0-6, depression subscale from 0-6, with full scale from 0-12, higher score indicates more symptoms.	1 year after enrollment
Secondary	Patient Health Questionnaire (PHQ-9)	The Questionnaire Type 9 for Depression (PHQ-9) is a self-administered instrument. Full scale from 0-27, with higher score indicating more severe symptoms. As needed.	1 year after enrollment
Secondary	Generalized Anxiety Disorder scale (GAD-7)	The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire. Full scale from 0-21, with higher score indicating more symptoms. As needed.	1 year after enrollment
Secondary	Number of participants with improvement in mucosal healing	This will be defined as the absence of inflammation on endoscopy (scoring systems) or imaging notes collected from EHR.	1 year after enrollment
Secondary	Visual Analog Scale (VAS)	The Visual Analog Scale (VAS) will be used to assess medication adherence using <80% cut-off to designate non-adherence. Full Scale from 0 to 100 with higher score indicating more adherence.	1 year after enrollment
Secondary	Proportion of patients meeting eligible quality metrics	Proportion of patients meeting eligible quality metrics confirmed through EHR. Composite score of metrics for skin care protection, flu vaccination, smoking cessation advice, pneumonia vaccination, bone density test, hepatitis B screen steroid sparing medication, TB test and TPMT test	1 year after enrollment
Secondary	System Usability Scale (SUS)	The system usability scale (SUS) is a 10-item Likert scale questionnaire. The range of scores is from 0 - 100 where a SUS score above 68 is considered average.	1 year after enrollment
Secondary	Net Promoter Score	The Net Promoter is a 10 point scale and the full score ranges from -100 to 100 where a higher score translates to higher satisfaction with a product.	1 year after enrollment