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

Not Applicable

Completed

Conditions: Atopic Dermatitis
Atopic Dermatitis Eczema
Eczema

Interventions: Other: Team-Based Connected Health (TCH)

Registration Number: NCT03981926

Lead Sponsor: University of Southern California

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Team-Based Connected Health (TCH)	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.

Primary Outcome Measures

Name	Time	Method
Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI)	12 months	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 improvement in EASI.

Secondary Outcome Measures

Name	Time	Method
Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA)	12 months	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.
Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization	12 months	We will compare differences in healthcare utilization by using the Cornell Services Index (CSI). The CSI is a validated method to assess health service use. Mean time per medical, psychological, and professional visits will be calculated.
Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM).	12 months	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. Scores range from 0 (clear) to 28 (very severe). 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.
Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI)	12 months	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. Scores range from 0 to 30, with higher scores indicating more severe impact on quality of life. 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.
Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y	12 months	EQ-5D-5L and EQ-5D-Y are validated measures of health status. The EQ-5D-5L and the EQ-5D-Y provide an index value that can be used for quality of life and economic evaluations. An index value of 0 represents a health state equivalent to death and an index value of 1 represents full health. The EQ-5D-5L and the EQ-5D-Y also provide a Visual Analogue Score (VAS) where respondents rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health). The overall change in quality of life for this outcome is measured by calculating the change in utility index and VAS from baseline averaged across 12 months.
Access to Care: Transportation	12 months	Access-to-care measures include mode of transportation.
Access to Care: Wait Time	12 months	Access-to-care measures include time needed for evaluation.
Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs	12 months	We will compare differences in healthcare costs by using the Cornell Services Index (CSI). The CSI is a validated method to assess health service use. Mean out-of-pocket costs across medical, psychological, and professional visits will be calculated.

Trial Locations

Locations (2): University of California, Los Angeles
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Los Angeles, California, United States
University of Southern California
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Los Angeles, California, United States