Clinical trial NCT03981926: Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
Official title: Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis Eczema
Atopic Dermatitis
Eczema
Keywords: Telemedicine
Pragmatic
Equivalency
Skin diseases
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-06-11
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pragmatic, randomized, controlled, equivalency trial.
Primary purpose: TREATMENT

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.

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 the 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.

Eligibility 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

Primary outcomes:
measure: Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA)
timeFrame: 12 months
measure: Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM).
timeFrame: 12 months
measure: Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI)
timeFrame: 12 months
measure: Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y
timeFrame: 12 months
measure: Access to Care: Transportation
timeFrame: 12 months
measure: Access to Care: Wait Time
timeFrame: 12 months
measure: Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization
timeFrame: 12 months
measure: Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: April W Armstrong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: