Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema
Conditions
Keywords
Telemedicine, Pragmatic, Equivalency, Skin diseases
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.
Interventions
OTHERTeam-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.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a pragmatic, randomized, controlled, equivalency trial.
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Access to Care: Wait Time | 12 months | Access-to-care measures include time needed for evaluation. |
| 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 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. |
| Access to Care: Transportation | 12 months | Access-to-care measures include mode of transportation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 151 |
| 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.
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. | 149 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 9 |
Baseline characteristics
| Characteristic | In-Person | Total | Team-Based Connected Health (TCH) |
|---|---|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 16.6 | 34.6 years STANDARD_DEVIATION 17.7 | 37.2 years STANDARD_DEVIATION 18.2 |
| Education College Degree | 49 Participants | 103 Participants | 54 Participants |
| Education Grades 1-8 (Grade School) | 10 Participants | 21 Participants | 11 Participants |
| Education Graduate or Doctoral Degree | 35 Participants | 67 Participants | 32 Participants |
| Education High School Diploma or Equivalent (GED) | 7 Participants | 15 Participants | 8 Participants |
| Education Not Applicable | 18 Participants | 24 Participants | 6 Participants |
| Education Some College, No Degree | 26 Participants | 59 Participants | 33 Participants |
| Education Some High School | 5 Participants | 10 Participants | 5 Participants |
| Education Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 86 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants | 212 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Insurance Type Medicaid | 20 Participants | 42 Participants | 22 Participants |
| Insurance Type Medicare | 12 Participants | 32 Participants | 20 Participants |
| Insurance Type No Insurance | 5 Participants | 12 Participants | 7 Participants |
| Insurance Type Private or Health Maintenance Organization (HMO) | 111 Participants | 210 Participants | 99 Participants |
| Insurance Type Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 65 Participants | 112 Participants | 47 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 27 Participants | 15 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 43 Participants | 23 Participants |
| Race/Ethnicity, Customized White | 53 Participants | 116 Participants | 63 Participants |
| Sex: Female, Male Female | 106 Participants | 211 Participants | 105 Participants |
| Sex: Female, Male Male | 45 Participants | 89 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 149 |
| other Total, other adverse events | 0 / 151 | 0 / 149 |
| serious Total, serious adverse events | 2 / 151 | 1 / 149 |
Outcome results
Primary
Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI)
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| In-Person | Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI) | Baseline | 4.81 score on a scale |
| In-Person | Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI) | Month 12 | 2.70 score on a scale |
| Team-Based Connected Health (TCH) | Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI) | Baseline | 4.93 score on a scale |
| Team-Based Connected Health (TCH) | Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI) | Month 12 | 2.76 score on a scale |
Secondary
Access to Care: Transportation
Access-to-care measures include mode of transportation.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| In-Person | Access to Care: Transportation | Walking | 7 Participants |
| In-Person | Access to Care: Transportation | Car | 131 Participants |
| In-Person | Access to Care: Transportation | Unknown or Not Reported | 1 Participants |
| In-Person | Access to Care: Transportation | Bus or Train | 12 Participants |
| Team-Based Connected Health (TCH) | Access to Care: Transportation | Unknown or Not Reported | 0 Participants |
| Team-Based Connected Health (TCH) | Access to Care: Transportation | Car | 139 Participants |
| Team-Based Connected Health (TCH) | Access to Care: Transportation | Walking | 1 Participants |
| Team-Based Connected Health (TCH) | Access to Care: Transportation | Bus or Train | 9 Participants |
Secondary
Access to Care: Wait Time
Access-to-care measures include time needed for evaluation.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-Person | Access to Care: Wait Time | Baseline | 65.9 minutes | Standard Deviation 46.1 |
| In-Person | Access to Care: Wait Time | Month 12 | 30.1 minutes | Standard Deviation 33.1 |
| Team-Based Connected Health (TCH) | Access to Care: Wait Time | Baseline | 51.6 minutes | Standard Deviation 39.4 |
| Team-Based Connected Health (TCH) | Access to Care: Wait Time | Month 12 | 29.1 minutes | Standard Deviation 30 |
Secondary
Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM).
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| In-Person | Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM). | Baseline | 11.7 score on a scale |
| In-Person | Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM). | Month 12 | 8.57 score on a scale |
| Team-Based Connected Health (TCH) | Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM). | Baseline | 11.6 score on a scale |
| Team-Based Connected Health (TCH) | Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM). | Month 12 | 7.70 score on a scale |
Secondary
Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA)
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| In-Person | Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA) | Baseline | 2.28 score on a scale |
| In-Person | Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA) | Month 12 | 1.71 score on a scale |
| Team-Based Connected Health (TCH) | Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA) | Baseline | 2.48 score on a scale |
| Team-Based Connected Health (TCH) | Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA) | Month 12 | 1.56 score on a scale |
Secondary
Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person | Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs | 201.7 dollars | Standard Deviation 701 |
| Team-Based Connected Health (TCH) | Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs | 48.3 dollars | Standard Deviation 45 |
Secondary
Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-Person | Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization | Time per Medical Visit | 44.6 minutes | Standard Deviation 45.2 |
| In-Person | Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization | Time per Psychological Visit | 51.1 minutes | Standard Deviation 13.3 |
| In-Person | Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization | Time per Professional Visit | 38.1 minutes | Standard Deviation 22.4 |
| Team-Based Connected Health (TCH) | Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization | Time per Medical Visit | 46.0 minutes | Standard Deviation 38.1 |
| Team-Based Connected Health (TCH) | Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization | Time per Psychological Visit | 45.5 minutes | Standard Deviation 14.5 |
| Team-Based Connected Health (TCH) | Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization | Time per Professional Visit | 36.7 minutes | Standard Deviation 20.8 |
Secondary
Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (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. 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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| In-Person | Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI) | Baseline | 7.73 score on a scale |
| In-Person | Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI) | Month 12 | 6.52 score on a scale |
| Team-Based Connected Health (TCH) | Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI) | Baseline | 8.04 score on a scale |
| Team-Based Connected Health (TCH) | Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI) | Month 12 | 6.10 score on a scale |
Secondary
Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| In-Person | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | Utility Index Baseline | 0.86 score on a scale |
| In-Person | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | Utility Index Month 12 | 0.87 score on a scale |
| In-Person | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | VAS Baseline | 82.6 score on a scale |
| In-Person | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | VAS Month 12 | 84.2 score on a scale |
| Team-Based Connected Health (TCH) | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | VAS Month 12 | 84.4 score on a scale |
| Team-Based Connected Health (TCH) | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | Utility Index Baseline | 0.85 score on a scale |
| Team-Based Connected Health (TCH) | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | VAS Baseline | 82.0 score on a scale |
| Team-Based Connected Health (TCH) | Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y | Utility Index Month 12 | 0.87 score on a scale |