Amyotrophic lateral sclerosis (ALS) is a fatal, rare neurodegenerative disease affecting 30,000 people in the United States. The gold standard of care for people with ALS is multidisciplinary clinics (MDC). In these multidisciplinary clinics, which occur every 3 to 4 months, people with ALS see up to 12 different healthcare providers (e.g., speech therapy, physical therapy, the ALS doctor). These clinics can last from three to five hours, and across these three to five hours people with ALS and their caregivers receive a lot of information that is critical to the care and quality of life for people with ALS. However, this information can be difficult to remember given the large amount of information that is conveyed. The current standard for providing take-home information about the visit is to provide patients with a written after-visit summary and access to their doctor's notes about the visit, typically through the patient portal. This study tests whether providing participants with video recordings of their MDC visits improves their quality of life and the quality of life of their caregivers. The study will enroll 400 pairs of people with ALS and their caregivers from eight different sites in the United States. Half of the participants in the study will receive their after-visit summary notes (the NOTES condition) and the other half of the participants will receive both their summary notes, but will also receive video recordings of their MDC visits that they can watch on their own at home (the VIDEO condition). The study will last for 12 months, with participants receiving NOTES or VIDEO at each of their regularly-scheduled MDCs during the 12 months. The study will test whether caregiver and patient participants in the VIDEO condition experience better quality of life than those in the NOTES condition at 1 month, 6 months, and 12 months from study enrollment. The results of this study will help determine what is the most effective approach to communicating MDC information to 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.

Inclusion Criteria for People with ALS:

• Diagnosis of ALS by either El- Escorial or Gold Coast Criteria
• ≥18 years of age
• Plan to attend MDC visits for 12 months
• Speak English or Spanish
• Presence of a caregiver (defined as someone who assists with care) who is also participating in the VITALS trial
• Projected life expectancy of at least 12 months as determined by the site investigator.

Exclusion Criteria for People with ALS:

• Unable or unwilling to provide informed consent or follow study procedures
• Significant cognitive impairment, clinical dementia, or unstable psychiatric illness (including, but not limited to, psychosis, active suicidal ideation, suicide attempt, or untreated major depression) as determined by the site investigator
• Current pregnancy based on participant self-report;
• Unable to access the internet;
• Do not have access to a personal or shared email and are not interested in creating a personal or shared email;
• Do not wish to create a patient portal account, if they do not already have one;
• Uncorrected hearing or visual impairment that would impair the ability to view video recordings;
• Incarcerated.

Inclusion Criteria for Caregivers:

• Agree to their identified role as a caregiver of a patient with ALS participating in the VITALS trial;
• Speak English or Spanish;
• ≥18 years of age.

Exclusion Criteria for Caregivers:

• Unable or unwilling to provide consent or follow study procedures;
• Unable to access the internet;
• Do not have access to a personal or shared email and are not interested in creating a personal or shared email;
• Uncorrected hearing or visual impairment;
• Professional caregiver for the patient;
• Incarcerated.

Deidentified non-video data that will be shared include demographic data (e.g., age, gender, language, race, ethnicity, income); information on use of the patient portal and video recordings; researcher field notes (e.g., if a caregiver is present at a visit, whether the visit was telehealth or in-person); participant-reported survey responses (e.g., assessments measuring cognitive function, health literacy, quality of life, adherence, self-management ability, caregiver burden, caregiver preparedness). We will also share raw video recordings of the participants' multidisciplinary clinic visits. Raw video recordings will not be accompanied by personal identifying information, but they will not be stripped of any visual or auditory features that could potentially identify an individual.

We anticipate IPD data being available for sharing within 1 year of the study close (September 2031) in perpetuity.

Data will be stored in a secured data archive. Access to the data will be restricted and available only upon request from researchers with a clear research plan for the data, whom have IRB approval, and the training and resources to carry out the research plan.