Clinical trial NCT02358135: Collaborative Connected Health (CCH) for PCORI
Official title: Collaborative Connected Health (CCH): A Pragmatic Trial Evaluating Effectiveness of CCH in Psoriasis Management Compared to In-person Visits.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Pragmatic
Equivalency
Teledermatology
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators propose to evaluate whether an innovative collaborative connected health (CCH) model increases access to specialists and improves patient outcomes. CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously to maximize effectiveness in a real-world setting. CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists. The specific aims of the proposal are to (1) determine whether the CCH model results in equivalent improvements in psoriasis disease severity compared to in-person care, (2) determine whether the CCH model results in equivalent improvements in quality of life and mental health compared to in-person care, and (3) assess whether the CCH model provides better access to care than in-person care.

Detailed description: The investigators propose to conduct a 12-month, pragmatic, randomized controlled trial to evaluate the impact of a collaborative connected health model for psoriasis management compared to inperson care. The pragmatic trial will compare psoriasis severity, quality-of-life, mental health, and access-to-care between the two models. We will enroll 300 psoriasis patients from Colorado and California. In addition to recruiting patients from the general population, we will place a specific emphasis on recruiting psoriasis patients living in rural and underserved communities. We will also recruit from the full disease spectrum of mild, moderate, and severe psoriasis patients. We will use an intention-to-treat approach to analyze outcomes and perform longitudinal data analysis using repeated measures approach to identify potential differences in the trend over time between the two arms. To evaluate the utility of CCH for increasing access from patients' and clinicians' perspective, the study team will conduct key informant interviews and use qualitative analytical techniques with investigator triangulation and member checking to enhance the validity of the conclusions.

Eligibility criteria: Inclusion Criteria:

* Be age 18 years and older
* Have physician-diagnosed plaque psoriasis
* Have access to internet and a digital camera or a mobile phone with camera features
* Have a primary care provider or the ability to establish primary care

Exclusion Criteria:

-

Primary outcomes:
measure: Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI)
timeFrame: 12 months
Secondary outcomes:
measure: Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments
timeFrame: 12 months
measure: Access to Care: Distance Traveled
timeFrame: 12 months.
measure: Depression Severity
timeFrame: 12 months
measure: Other Psoriasis Disease Severity Measures
timeFrame: 12 months
measure: Access to Care: Wait Time
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: University of California Davis School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Southern California
name: April Armstrong, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armstrong AW, Chambers CJ, Maverakis E, Cheng MY, Dunnick CA, Chren MM, Gelfand JM, Wong DJ, Gibbons BM, Gibbons CM, Torres J, Steel AC, Wang EA, Clark CM, Singh S, Kornmehl HA, Wilken R, Florek AG, Ford AR, Ma C, Ehsani-Chimeh N, Boddu S, Fujita M, Young PM, Rivas-Sanchez C, Cornejo BI, Serna LC, Carlson ER, Lane CJ. Effectiveness of Online vs In-Person Care for Adults With Psoriasis: A Randomized Clinical Trial. JAMA Netw Open. 2018 Oct 5;1(6):e183062. doi: 10.1001/jamanetworkopen.2018.3062.
citation: Armstrong AW, Ford AR, Chambers CJ, Maverakis E, Dunnick CA, Chren MM, Gelfand JM, Gibbons CM, Gibbons BM, Lane CJ. Online Care Versus In-Person Care for Improving Quality of Life in Psoriasis: A Randomized Controlled Equivalency Trial. J Invest Dermatol. 2019 May;139(5):1037-1044. doi: 10.1016/j.jid.2018.09.039. Epub 2018 Nov 24.