Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
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.
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD
System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal
study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic
treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy
will be evaluated.
Not recruiting | High Blood Pressure / Hypertension | Site Unknown
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative
study. Subjects who sign informed consent will undergo study-specific screening assessments
within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization
will be stratified by upper arm or forearm placement based on the investigator's
determination of where the study access (SA) should be located. Subjects will be followed to
24 months post SA creation at routine study visits regardless of patency status. After 24
months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up
to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV
subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation
at routine study visits.
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