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.
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
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;
Parallel
Video recording
BehavioralWe will video record participants' multidisciplinary clinic (MDC) visits for 12 months. Participants will access the videos in HealthPAL, an NIH-funded, HIPAA-compliant personal health library developed with older adults and caregivers, available in Spanish and English. Each specialist visited with during the MDC will have a 'chapter' in HealthPAL that can be reviewed online at home by participants. Participants will receive orientation and training on both their patient portal and HealthPAL, including how to review and share their recordings using a take-home manual (an instructions video is also available in HealthPAL).
Notes Instruction
BehavioralParticipants will be given instruction on how to view their after-visit summaries and doctors' notes in their patient portal, as well as how to give other trusted family members or friends access to their visit notes.
For Caregiver Participants: the total score on the PROMIS-10 self report survey
The Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) is a self-report measure of quality of life. The PROMIS-10 will be administered to caregivers via a secure online survey. We will analyze the total score on the PROMIS-10 as the primary outcome for caregiver participants.
For Patient Participants: The total score on the ALSAQ-40 self report survey.
The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) is a self-report measure of quality of life for people with ALS. The ALSAQ-40 will be administered via a secure online survey.
Total Score on the Patient Activation Measure Short Form (PAM-SF)
The PAM-SF is a self-reported measure of self-management ability. It will be administered to participants with ALS via a secure online survey.
Total Score on the Exercise Adherence Rating Scale (EARS)
The EARS is a self-report measure of exercise adherence. It will be administered to participants with ALS via a secure online survey.
Total Score on the Adherence to Refills and Medications Scale (ARMS)
The ARMS is a self-report measure of medication adherence. It will be administered to participants with ALS via a secure online survey.
Total Score on the Adherence to Multidisciplinary Clinic Recommendations
Using a secure online survey, participants with ALS will indicate which of a list of possible clinic recommendations they received and the extent to which they adhered to those recommendations.
Total number of patient phone calls and patient portal messages to the clinical care team.
Collected using the participant with ALS's electronic medical record.
Total number of emergency room visits and hospitalizations.
Collected from the participant with ALS's electronic medical record.
Click on the lead sponsor to view all of their trials.
Trustees of Dartmouth College
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Massachusetts General Hospital
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
University of Pittsburgh Medical Center
Collaborator
Penn State Health Milton S Hershey Medical Center
Collaborator
University of Wisconsin, Madison
Collaborator
Mayo Clinic
Collaborator
