A Phase IV Open-Label Study of Clinical Outcome Assessments to Facilitate Patient–HCP Interaction in MS: Study Design and Rationale

Thursday, June 2, 2016
Exhibit Hall
Donald Barone, DO , Rowan University, Stratford, NJ
Mark Gudesblatt, MD , South Shore Neurologic Associates, Patchogue, NY
Susan E Bennett, PT, DPT, EdD, NCS, MSCS , State University of New York at Buffalo, Buffalo, NY
Megan Weigel, DNP, ARNP-C, MSCN , Baptist Neurology Beaches Division, South Jacksonville Beach, FL
Amy Perrin Ross, APN, MSN, CNRN, MSCN , Loyola University Chicago, Maywood, IL
Brooke Hayward, SM, MBA , EMD Serono, Inc., Rockland, MA
Frederick Munschauer, MD , EMD Serono, Inc., Rockland, MA
Michele Springer, BA , Caudex, New York, NY

Background: Better communication between patients and healthcare providers (HCPs) may improve the management of multiple sclerosis (MS). Additional patient-reported information should allow HCPs to develop more personalized disease management strategies, while effective communication with HCPs may help patients take a proactive role in managing their disease and improving their medication compliance. Novel technologies provide a possible mechanism to achieve these objectives.

Objectives: To report the design of, and rationale for, a new mobile- and web-based technology platform to enable completion of clinical outcome assessments (COAs) and facilitate patient–HCP communication.

Methods: This open-label clinical study will enroll patients with MS (aged 18–65 years) who are being treated with FDA-approved disease-modifying drugs as directed by their physician. Patients will use a newly developed web- and mobile phone-based technology platform to complete a panel of COAs, including MS-specific patient-reported assessments of quality of life (MusiQoL), fatigue (MFIS), mental health (MHI-5), social support (MSSS), cognition (PDQ-5), physical pain (PES), MS disability (PDDS), adherence behavior (MMAS-8), work productivity (WPAI-MS), and functional assessments of ambulation, upper-limb function, manual dexterity, cognition, and visual function. After a 24-week period including standard office-based consultations, patients will begin completing the COAs via the technology platform, and results will be incorporated into HCP–patient discussions during subsequent clinical visits at 24-week intervals. Perceived quality of interaction during standard consultations, and consultations incorporating COA results, will be assessed by patients and HCPs using a Likert scale questionnaire developed for this study. Patients and HCPs will report on the perceived utility of each individual COA, facilitating further development of the technology platform. 

Results: Final study results are expected in early 2019.

Conclusions: This study will evaluate the regular use of a mobile phone- and web-based platform, and incorporation of COAs into patient–HCP communication. Study results will help to define a minimal set of key platform features to improve communication without imposing additional burden on patients or HCPs. Maximizing the quality of communication between HCPs and patients has the potential to improve disease management, therapy compliance, and patient quality of life.