Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis (TCH in AD)

• ClinicalTrials.gov Identifier: NCT03981926
• Recruitment Status: Completed
• First Posted: June 11, 2019
• Last Update Posted: February 21, 2023
• Sponsor: University of Southern California
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): April Armstrong, University of Southern California

Study Description

Brief Summary:

This is a pragmatic, randomized, controlled, equivalency trial. This 12-month trial will evaluate the impact of an online, team-based connected health (TCH) model for management of atopic dermatitis (AD) as compared to in-person care. 300 patients will be randomly assigned to the online TCH model or the in-person control arm. This pragmatic, randomized trial will compare AD disease severity (Aim 1), quality-of-life and access-to-care measures (Aim 2), and costs (Aim 3) between the two models.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis Eczema; Atopic Dermatitis; Eczema	Other: Team-Based Connected Health (TCH)	Not Applicable

Detailed Description:

Skin diseases account for 30% of all physician office visits. In the United States, access to dermatologists remains a significant challenge for those in underserved or rural communities. To increase access to specialists and improve patient outcomes, we will evaluate a team-based connected health (TCH) model that enables structured asynchronous online interactions among patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable effective management of chronic skin diseases via high-quality and efficient online care between providers and patients. TCH purports to bring direct and expedient specialist care to patients and PCPs in a location-independent and asynchronous manner.

Specifically, TCH offers several ways that patients and providers can communicate online asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and (3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access dermatologists online asynchronously for consultations or to request a dermatologist to assume care of patient's skin disease. With patient-dermatologist interactions, patients can upload clinical images and history online and obtain asynchronous evaluation and recommendations from dermatologists directly. Finally, PCPs have the option of managing their patients' skin diseases online. Importantly, TCH applies efficient workflow that maximally supports providers and fosters multi-directional, informed communication among patients, PCPs, and dermatologists.

To evaluate the impact of TCH, we use atopic dermatitis (AD) as a disease model. AD is a common, relapsing inflammatory skin disease affecting 32 million individuals in the U.S. AD is characterized by intense itching and red, scaly patches. It incurs significant morbidities and high healthcare costs. To address skin inflammation, itch, and psychosocial consequences, PCPs and dermatologists need to adopt a team-based approach to effectively manage all aspects of AD.

The primary goal of the proposed research is to test whether the online TCH model results in equivalent improvements in disease severity and quality of life, provides better access to specialist care, and is cost- saving as compared to usual in-person care in pediatric and adult patients with AD. Specifically, we will conduct a pragmatic, cluster-randomized controlled equivalency trial and use validated measures to compare AD disease severity, health-related quality of life, and access to care between TCH and in-person care. We will also compare costs of the two healthcare delivery models from a societal perspective by conducting cost- minimization and sensitivity analyses.

This proposal evaluates a significant innovation in specialty-care delivery that will likely result in improved patient outcomes, greater access to specialists, and cost savings. The study findings will be highly impactful and have immense dissemination potential to the management of many other chronic diseases.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a pragmatic, randomized, controlled, equivalency trial.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
• Actual Study Start Date: August 27, 2019
• Actual Primary Completion Date: February 1, 2023
• Actual Study Completion Date: February 1, 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: In-Person; In-person care is the control group because it is currently considered the standard of care in delivering dermatologic services. The intervention includes regular visits to a physician, and may include such treatments as ointments, steroids or ultraviolet therapy at the discretion of a physician. In-person care is the major healthcare-delivery model for managing chronic skin diseases and a realistic, primary option that patients face. The patients in the in-person arm can seek atopic dermatitis care from primary care practitioners or dermatologists, just as they would in the real world.
Experimental: Team-Based Connected Health (TCH); The intervention arm is the team-based connected health (TCH) model, which purports to increase access to specialists and improve outcomes. Specifically, TCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously. TCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists.	Other: Team-Based Connected Health (TCH); TCH is an asynchronous, secure online platform where patients can upload images of atopic dermatitis disease and submit assessments. Likewise, practitioners can request and/or initiate dermatology consultations, assume longitudinal care or communicate with patients directly.; Other Names: Online healthcare; Teledermatology

Outcome Measures

Primary Outcome Measures :

1. Change in disease severity as measured by the Eczema Area and Severity Index (EASI) [ Time Frame: 12 months ]
   Participants are asked to complete the Eczema Area and Severity Index (EASI) at baseline, month 3, month 6, month 9, and month 12. EASI combines the assessment of disease severity (erythema, induration, excoriation, and lichenification) and the affected area into a single score between 0 (no disease) to 72 (maximal disease). The primary outcome of the study is the mean percent improvement in EASI averaged over three, six, nine, and 12 months. The percent improvement in EASI is defined as the difference in EASI scores between the baseline and each of the follow-up visits divided by the EASI score from the baseline visit. By using EASI, we will be able to compare the results of this study with other studies in AD patients.

Secondary Outcome Measures :

1. Change in disease severity as measured by the validated Investigator Global Assessment (vIGA) [ Time Frame: 12 months ]
   Participants are asked to complete a validated Investigator Global Assessment (vIGA) at baseline, month 3, month 6, month 9, and month 12. vIGA is an ordinal scale that provides a global assessment of the patient's AD disease severity. vIGA is scored on a 5-point ordinal scale ranging from 0 (clear) to 4 (severe). The overall change in disease severity for this outcome is measured by calculating the change in vIGA score from baseline averaged across 12 months.
2. Change in disease severity as measured by the Patient-Oriented Eczema Measure (POEM). [ Time Frame: 12 months ]
   Participants are asked to complete the POEM at baseline, month 3, month 6, month 9, and month 12. POEM is a 7-item tool for patient and/or proxy self-completion used to monitor atopic dermatitis severity, focusing on the illness as experienced by the patient. The overall change in disease severity for this outcome will be measured by calculating the change in POEM score from baseline averaged across 12 months.
3. Change in quality of life as measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI) [ Time Frame: 12 months ]
   Participants will complete the DLQI or CDLQI at baseline, month 3, month 6, month 9, and month 12. The DLQI and the CDLQI The DLQI and the CDLQI are validated, 10-question questionnaires that can be used to assess dermatology-specific quality of life in adults and children with atopic dermatitis. The overall change in quality of life for this outcome is measured by calculating the change in DLQI / CDLQI from baseline averaged across 12 months.
4. Change in quality of life as measured by the EQ-5D-5L and the EQ-5D-Y [ Time Frame: 12 months. ]
   Participants will complete the EQ-5D-5L or th EQ-5D-Y at baseline, month 3, month 6, month 9, and month 12. EQ-5D-5L and EQ-5D-Y are validated measures of health status. The EQ-5D-5L and the EQ-5D-Y provide a single index value that can be used for quality of life and economic evaluations. The overall change in quality of life for this outcome is measured by calculating the change in EQ-5D-5L/EQ-5D-Y from baseline averaged across 12 months.
5. Change in access to care [ Time Frame: 12 months ]
   Access to care is an overall term to capture the following information: distance travelled to obtain in-person provider evaluation and the transportation and in-office waiting time to see a provider. Transportation and in-office waiting time is defined as round trip transportation time plus in-office waiting time multiplied by the number of in-person visits during the study period. Access to care measures will be collected at baseline, month 3, month 6, month 9, and month 12.
6. Change in healthcare utilization and healthcare costs [ Time Frame: 12 months ]
   We will compare differences in healthcare utilization and healthcare costs by using the Cornell Services Index (CSI). The CSI is a validated method to assess health service use. The measure provides a reliable snapshot of service use patterns across types, providers, and sites of service among adults who seek medical care. Self-reported healthcare service utilization, time spent, and caregiver support burden will be captured at baseline and 12 months using the Cornell Services Index. All costs will be modeled over a 20-year time horizon utilizing 3% constant rate discounting.

Eligibility Criteria

• Ages Eligible for Study: 1 Year and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age 1 year or older
• Physician-diagnosed atopic dermatitis (AD)
• Access to a digital-photo capturing device (mobile phone or camera) capable of capturing images with a minimum resolution of 1024x768 pixels
• Access to internet
• Able to establish care or have established care with providers
• Provision of signed and dated informed consent and youth assent form

Exclusion Criteria:

• Unable to fulfill study-related tasks by adult AD patients or parents or guardians of pediatric AD patients

Contacts and Locations

Locations

United States, California

University of Southern California

Los Angeles, California, United States, 90089

Sponsors and Collaborators

University of Southern California

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

More Information

• Responsible Party: April Armstrong, Associate Dean of Clinical Research, Professor of Dermatology, University of Southern California
• ClinicalTrials.gov Identifier: NCT03981926
• Other Study ID Numbers: HS-16-00914; 1R01AR073486-01A1 ( U.S. NIH Grant/Contract )
• First Posted: June 11, 2019
• Last Update Posted: February 21, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by April Armstrong, University of Southern California:

Telemedicine; Pragmatic; Equivalency; Skin diseases

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases