Do Video Recordings of Multidisciplinary Clinics Improve Quality of Life for People With ALS and Their Caregivers?

BACKGROUND AND SIGNIFICANCE Amyotrophic lateral sclerosis (ALS) is a fatal, rare neurodegenerative disease affecting 30,000 people in the United States. People with ALS (pwALS) and their caregivers, attend 3 - 5 hour long multidisciplinary clinics (MDC) every 3 months where they meet with up to 12 specialists. The goal of treatment is to maintain pwALS quality of life (QOL). Optimal information from MDCs is necessary for the intensive at-home management which gets more complex as ALS progresses. Yet 40% of recommendations are forgotten by pwALS negatively impacting QOL, while caregivers report information deficits increasing caregiving burden. Patient portal access to MDC notes is standard, and can improve recall and health outcomes, yet concerns exist about their layout, comprehensiveness and challenges for people with low health literacy. An underutilized strategy to share MDC information is video recording. Systematic reviews find recordings improve health outcomes, and the use of video in an ALS context may be particularly helpful given complicated at-home management. The study will determine what is the most effective approach to communicating MDC information to facilitate optimal delivery of care for pwALS and their caregivers STUDY AIMS Aim 1. Assess the comparative effectiveness of written MDC visit information provided to pwALS and their caregivers via the patient portal (NOTES) versus NOTES plus visit video recording (VIDEO) on patient and caregiver quality of life. Aim 2. Determine whether patient and caregiver health literacy and rapid ALS disease progression are modifying factors on the comparative effectiveness of NOTES versus VIDEO on primary outcomes. Aim 3. Identify system and patient-level factors that impact the implementation and use of multimodal strategies of MDC information exchange by a diverse sample of pwALS, caregivers, clinicians and health system leaders. Hypothesis (Main Effect): Compared to those receiving NOTES, pwALS randomized to also receive routine VIDEO recordings of their MDC visit will report better QOL via improved care-management (i.e., treatment adherence), self-management ability, satisfaction with communication and reduced healthcare utilization at 12 months; there will be larger relative benefits for pwALS, and caregivers, with low health literacy and rapid disease progression. The investigators also hypothesize that compared to NOTES alone, caregivers in the VIDEO arm will report better QOL, improved preparedness and less burden at 12 months. STUDY DESCRIPTION Overall study design This study is a multisite, two-arm, parallel group, patient-randomized, controlled, comparative effectiveness trial with 12-month follow-up. Adopting a Hybrid Type 1 design, the investigators will also examine implementation barriers and facilitators using interviews guided by the Consolidated Framework for Implementation Research Framework 2.0. Comparators Comparator 1 (NOTES): After the initial MDC study staff will provide a 15-minute training to orient participants to the portal and how to access visit notes. Comparator 2 (VIDEO): All MDC visits will be video-recorded over 12 months, using HealthPAL, an NIH-funded HIPAA-compliant personal health library developed by PI Barr. Participants in the VIDEO arm will receive orientation to the patient portal and HealthPAL. Following each scheduled MDC, pwALS and caregivers in both groups will receive emails reminding them to watch the visit video recording and/or review their note: 1) within 48 hours of the visit to remind them of the visit discussion and self-management tasks they may have; and 2) 3 days before their next MDC visit to prepare for their next MDC visit. Study Population The study recruit 400 patient and caregiver pairs (400 pwALS and their 400 caregivers) from eight MDC sites (∼50 pairs per site): Dartmouth Health (Lebanon, NH), Massachusetts General Hospital (Boston, MA), Mayo Clinics (Scottsdale, AZ, and Jacksonville, FL), Penn State Health (Hershey, PA), University of Pittsburgh Medical Center (Pittsburgh, PA), University of Wisconsin (Madison, WI) and Virginia Commonwealth University (Richmond, VA). The study will include pwALS, age ≥18 years, who plan to attend MDC visits for 12-months, speak English or Spanish, have ≥12 months projected survival, and internet access and their primary caregivers (family member or friend), ≥18 years who attends MDC visits or assist with their care. Outcomes Primary outcomes: For people with ALS, the total score on the ALSAQ-40 (a self report survey measure of quality of life for people with ALS) is the primary outcome. For caregivers, the total score on the PROMIS-10 (a self report survey measure of quality of life); Secondary outcomes include exercise adherence, medication adherence, adherence to MDC recommendations, self-management ability, patient satisfaction with communication, caregiver visit engagement, preparedness for caregiving, and caregiver burden. Exploratory outcomes include healthcare utilization. Timeframe Twelve-month follow-up for all outcomes.