Improving Specialty Care Delivery in Chronic Skin Disease April W. Armstrong, MD, MPH Associate Dean of Clinical Research Vice Chair and Professor of Dermatology University of Southern California Los Angeles, California November 1, 2018 #PCORI2018
No relevant conflict of interest specific to this presentation. Other disclosures: Research investigator and consultant to AbbVie, BMS, Janssen, Novartis, Lilly, Pfizer, Regeneron, Sanofi, Leo, Modernizing Medicine, Science 37, and/or Ortho Dermatologics. 2 • November 1, 2018
Outline • Discuss evidence gaps • Provide study overview • Highlight key study findings • Explore what is needed to change practice 3 • November 1, 2018
Evidence Gap 4 • November 1, 2018
Lack of regular access to specialists results in poor health care outcomes • Skin diseases account for 30% of all physician office visits. • Lack of regular access to dermatology providers results in poor healthcare outcomes • Many psoriasis patients have comorbidities that require management by specialists and PCPs. 5 • November 1, 2018
6 • November 1, 2018
Lack of validated instruments in teledermatology studies 7 • November 1, 2018
Study Design 8 • November 1, 2018
Intervention 9 • November 1, 2018
Example of an Online Encounter 10 • November 1, 2018
Specific Aims • Study Type: Pragmatic, randomized controlled equivalency trial • Specific aims : • To determine whether CCH results in equivalent improvements in psoriasis disease severity compared to in-person care • To determine whether CCH results in equivalent improvements in quality of life compared to in-person care • To determine whether CCH results in better access to specialists compared to in-person care 11 • November 1, 2018
Confirmation of Eligibility and Informed Consent Baseline demographic and clinical characteristics, psoriasis Trial Design Baseline Visit severity, quality-of-life, and mental health assessments Randomization In-Person Online, Collaborative Connected (Control) Health (Intervention) Patients undergo training on taking digital images of skin lesions and accessing online platform Month 3: Psoriasis severity, quality-of-life, mental Online visit In-person visit health, and access-to-care assessments. frequency frequency determined by determined by patient and patient and provider. Month 6: Psoriasis severity, quality-of-life, mental provider. health, and access-to-care assessments. Month 9: Psoriasis severity, quality-of-life, mental health, and access-to-care assessments. Month 12: Psoriasis severity, quality-of-life, mental health, and access-to-care assessments. Qualitative assessment of online intervention (online group only). 12 • November 1, 2018
Baseline Patient Demographics and Clinical Characteristics Online In-Person Total Characteristics n (%) n (%) n (%) Male 75 (50.7) 74 (50.0) 149 (50.3) Sex Female 73 (49.3) 74 (50.0) 147 (49.7) American Indian / Alaska Native 3 (2.0) 2 (1.4) 5 (1.7) Race Asian 13 (8.8) 6 (4.1) 19 (6.4) Black / African American 5 (3.4) 3 (2.0) 8 (2.7) Pacific Islander 3 (2.0) 2 (1.4) 5 (1.7) White 90 (60.8) 97 (65.5) 187 (63.2) Other 36 (24.3) 36 (24.3) 72 (24.3) Ethnicity Hispanic or Latino 46 (31.1) 54 (36.5) 100 (33.8) Topical Therapy 98 (66.2) 102 (68.9) 200 (67.6) Prior Psoriasis Light & Laser Therapy 52 (35.1) 53 (35.8) 105 (35.5) Treatment Non-Biologic Systemic Therapy 54 (36.5) 60 (40.5) 114 (38.5) Biologic Therapy 32 (21.6) 27 (18.2) 59 (19.9) PASI: mean [95% CI] 4.68 [3.96-5.41] 4.40 [3.80-5.00] blank Baseline Psoriasis BSA: mean [95% CI] 9.71% [7.35-12.07] 7.67% [6.14-9.21] blank Severity PtGA: mean [95% CI] 2.18 [2.00-2.35] 2.15 [1.98-2.32] blank 13 • November 1, 2018
Changes in Psoriasis Severity (PASI) over Time Changes in psoriasis severity (PASI) are equivalent between online and in-person groups -0.27 PASI: -0.27 (95% CI -0.85, 0.31) δ δ 0 PASI equivalence margin -6.5 6.5 Armstrong et al, JAMA Network Open 14 • November 1, 2018
Changes in Psoriasis Severity (BSA) over Time Changes in psoriasis severity (BSA) are equivalent between online and in-person groups -0.05 BSA: -0.05% (95% CI -1.58%, 1.48%) δ δ BSA equivalence margin 0 6.5 -6.5 Armstrong et al, JAMA Network Open 15 • November 1, 2018
Changes in Psoriasis Severity (Patient Global Assessment) over Time Comparison of Patient Global Assessment between online and in-person groups -0.11 PtGA: -0.11 (95% CI -0.32, 0.10) δ 0 δ PtGA equivalence margin -0.25 0.25 Armstrong et al, JAMA Network Open 16 • November 1, 2018
Specific Aims • To determine whether CCH results in equivalent improvements in psoriasis disease severity compared to in-person care • To determine whether CCH results in equivalent improvements in quality of life compared to in-person care • To determine whether CCH results in better access to specialists compared to in-person care 17 • November 1, 2018
Changes in Quality of Life (Skindex-16) over Time Changes in quality of life (Skindex-16) are equivalent between online and in-person groups -0.83 Skindex-16: -0.83 (95% CI -5.18, 3.51) δ δ 0 Skindex-16 equivalence margin -7.0 7.0 Armstrong et al, Journal of Investigative Dermatology 18 • November 1, 2018
Changes in Quality of Life (DLQI) over Time Changes in quality of life (DLQI) are equivalent between online and in-person groups -0.45 DLQI: -0.45 (95% CI -1.29, 0.38) δ δ 0 DLQI equivalence margin -2.5 2.5 Armstrong et al, Journal of Investigative Dermatology 19 • November 1, 2018
Specific Aims • To determine whether CCH results in equivalent improvements in psoriasis disease severity compared to in-person care • To determine whether CCH results in equivalent improvements in quality of life compared to in-person care • To determine whether CCH results in better access to specialists compared to in-person care 20 • November 1, 2018
Differences in access to care between online and in-person groups: Average total distance traveled and waiting time per person during the year Ford et al, Telemedicine and e-Health 21 • November 1, 2018
“Yes [online visits] are efficient because they are on the spot. “That was, for me, very They are there when one most easy. I’m very comfortable needs them. For me this is what being online, and it was matters. The service is fast and well designed –so easy to accessible. When one needs use. I think it was fairly them, they are there fast.” intuitive.” Patient Perspectives “[Online care] has actually “It was almost no difference, helped me out a lot, so it’s particularly with these skin conditions. kind of cool. I’m glad I found If the physician is capable of making an your study. It’s been assessment online, the treatment is working really well. I notice going to be the same regardless. I don’t significant improvement. It’s see a problem with it.” awesome.” 22 • November 1, 2018
Considerations for implementation Telehealth technology Reimbursement Medicolegal considerations Workforce considerations 23 • November 1, 2018
Conclusions • Online model produced equivalent outcomes in disease severity and quality of life and superior access to care. • Patient-centeredness: increased patient engagement and comprehensive specialist support. • Transformative and applicable to other chronic diseases. 24 • November 1, 2018
Learn More • www.pcori.org • info@pcori.org • #PCORI2018 • https://armstronglab.usc.edu/ 25 • November 1, 2018
It takes a village! • April W. Armstrong, MD, MPH • Caitlin M. Gibbons, MSSW • Nazanin Ehsani-Chimeh, MD • Paulina M. Young, BS • Josefina Torres, MD • Sucharita Boddu, MD • Cindy J. Chambers, MD, MAS, • Andrea C. Steel, MD • Mayumi Fujita, MD, PhD MPH • Elizabeth A. Wang, BA, BS • Cesar Rivas-Sanchez • Emanual Maverakis, MD • Caitlin M. Clark, BS • Brenda I. Cornejo, BA • Michelle Y. Cheng, MD • Sanminder Singh, BS • Laura C. Serna, BA • Cory A. Dunnick, MD • Heather A. Kornmehl, BS • Eric R. Carlson MS • Mary-Margaret Chren, MD • Reason Wilken, MD • Christianne J. Lane, PhD • Joel M. Gelfand, MD, MSCE • Aleksandra G. Florek, MD • David J. Wong, MD, PhD • Adam R. Ford, BS • Brittany M. Gibbons, MPH • Chelsea Ma, MD 26 • November 1, 2018
Patient-Centered Outcomes Research Institute (PCORI) Award (IHS-071502-IC) Jason Kao, BS Soneet Dhillon, BS National Psoriasis Foundation State Network of Colorado Ambulatory Practices and Partners High Plains Research Network California Association of Rural Health Clinics Los Angeles Network California Primary Care Association Psoriasis Patient Advocacy Council American Telemedicine Association Group for Research and Assessment of Psoriasis and Psoriatic Arthritis American Academy of Dermatology 27 • November 1, 2018
Thank you April W. Armstrong, MD, MPH Associate Dean of Clinical Research Vice Chair and Professor of Dermatology University of Southern California Los Angeles, California
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