Collaborative Connected Health (CCH) for PCORI

NCT02358135 | Completed Results

• 1 other identifier: HS-15-00417
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Keywords

Pragmatic; Equivalency; Teledermatology

Outcome Measures

Primary Outcomes (1)

• Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI)

  Participants are asked to complete self-administered Psoriasis Area and Severity Index (SA-PASI). SA-PASI combines the assessment of lesion severity (erythema, induration, and scale) and the affected areas into a single score between 0 (no disease) to 72 (maximal disease). The primary outcome of the study was the mean percent improvement in SA-PASI averaged over three, six, nine, and 12 months. The percent improvement in SA-PASI was defined as the difference in SA-PASI scores between the baseline and each of the follow-up visits divided by the SA-PASI score from the baseline visit.

  12 months

Secondary Outcomes (5)

• Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments

  12 months

• Access to Care: Distance Traveled

  12 months.

• Depression Severity

  12 months

• Other Psoriasis Disease Severity Measures

  12 months

• Access to Care: Wait Time

  12 months

Study Arms (2)

Control

OTHER

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 psoriasis care from primary care practitioners or dermatologists, just as they would in the real world.

Other: Control

CCH Model

EXPERIMENTAL

The intervention arm will be the collaborative connected health (CCH) model, which purports to increase access to specialists and improve outcomes. Specifically, CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously. CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists.

Other: Collaborative Connected health, (CCH)

Interventions

Collaborative Connected health, (CCH) OTHER

CCH is an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. Likewise, practitioners can request and/or initiate dermatology consultations, assume longitudinal care or communicate with patients directly.

CCH Model

Control OTHER

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 UV 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 psoriasis care from PCPs or dermatologists, just as they would in the real world.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

University of Southern California

Los Angeles, California, 90089, United States

Location

University of California Davis School of Medicine

Sacramento, California, 95817, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 30646223 DERIVED

• 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.

  PMID: 30481495 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: April W. Armstrong, MD, MPH; Associate Dean of Clinical Research
• Organization: Keck School of Medicine of University of Southern California

april.armstrong@med.usc.edu

323-865-3871

Study Officials

• April Armstrong, MD MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean, Clinical Research

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: February 6, 2015
• Study Start: February 2, 2015
• Primary Completion: August 20, 2017
• Study Completion: August 20, 2017
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-07

Locations

US (3)