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

Primary Purpose

Inflammatory Bowel Disease (IBD)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Transformation Network (DTN) Program
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Disease (IBD) focused on measuring IBD, Treat to target, Digital transformation network, Social determinants of health, e-PRO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis
  • Northwestern University
  • RxHealth
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Transformation Network (DTN) Program

Control Arm

Arm Description

IBD patients at the 3 sites will be sent a message to their Smartphone

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Overall Health Numeric Rating Scale [OHNRS]
Overall Health Numeric Rating Scale (OHNRS) - Full scale from 0 to 10, higher score indicates worse health outcomes
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.
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.
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.
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.
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.
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.
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
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.
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.

Full Information

First Posted
March 20, 2020
Last Updated
September 17, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
The Cleveland Clinic, Northwestern University, RxHealth, University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04345393
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
The Cleveland Clinic, Northwestern University, RxHealth, University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease (IBD)
Keywords
IBD, Treat to target, Digital transformation network, Social determinants of health, e-PRO

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Smartphone, and inform them about the DTN program through a description and embedded video. Including SDH, behavioral health, lack of knowledge of quality metrics, or lack of Smartphone access or connectivity. 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. Digitally enabled population, or an Interactive Voice Response [IVR] for those who are not
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1578 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Transformation Network (DTN) Program
Arm Type
Experimental
Arm Description
IBD patients at the 3 sites will be sent a message to their Smartphone
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Digital Transformation Network (DTN) Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants in Disease Control
Description
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.
Time Frame
1 year after enrollment
Title
Change in Number of Unplanned Acute Care
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Northstar Digital Literacy Assessment
Description
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.
Time Frame
1 year after enrollment
Title
Digital Disparities Module
Description
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.
Time Frame
1 year after enrollment
Title
Overall Health Numeric Rating Scale [OHNRS]
Description
Overall Health Numeric Rating Scale (OHNRS) - Full scale from 0 to 10, higher score indicates worse health outcomes
Time Frame
1 year after enrollment
Title
PROMIS Global scales
Description
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.
Time Frame
1 year after enrollment
Title
Patient Health Questionnaire (PHQ-4)
Description
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.
Time Frame
1 year after enrollment
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
1 year after enrollment
Title
Generalized Anxiety Disorder scale (GAD-7)
Description
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.
Time Frame
1 year after enrollment
Title
Number of participants with improvement in mucosal healing
Description
This will be defined as the absence of inflammation on endoscopy (scoring systems) or imaging notes collected from EHR.
Time Frame
1 year after enrollment
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
1 year after enrollment
Title
Proportion of patients meeting eligible quality metrics
Description
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
Time Frame
1 year after enrollment
Title
System Usability Scale (SUS)
Description
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.
Time Frame
1 year after enrollment
Title
Net Promoter Score
Description
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.
Time Frame
1 year after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Drew Helmus, MPH, MA
Phone
212-824-7786
Email
drew.helmus@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Sands, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Nelson
Phone
216-444-5868
Email
c-ebert@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Emanuelle Bellaguarda
Facility Name
RxHealth
City
Secaucus
State/Province
New Jersey
ZIP/Postal Code
07094
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaurav Narang
Email
Gaurav@rx.health
First Name & Middle Initial & Last Name & Degree
Gaurav Narang
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Sands, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Smith
Phone
312-503-0942
Email
smithk24@ccf.org
First Name & Middle Initial & Last Name & Degree
Maged Rizk

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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