Comparing the Impact of Video Integration to Traditional Amyotrophic Lateral Sclerosis Visit Communication on Patient and Caregiver Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 7
- 主要终点
- For Caregiver Participants: the total score on the PROMIS-10 self report survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
VIDEO
Participants in this arm of the study will have their multidisciplinary clinic visits video recorded and they will be able to access those video recordings on their own at home. They will also be able to access their doctor's notes and after visit summaries through their patient portal.
干预措施: Video recording (Behavioral)
VIDEO
Participants in this arm of the study will have their multidisciplinary clinic visits video recorded and they will be able to access those video recordings on their own at home. They will also be able to access their doctor's notes and after visit summaries through their patient portal.
干预措施: Notes Instruction (Behavioral)
NOTES
Participants in this arm of the study will have their standard access to their doctor's notes and after visit summaries through their patient portal. They will also be provided with training on how to access and share access to their patient portal notes.
干预措施: Notes Instruction (Behavioral)
结局指标
主要结局
For Caregiver Participants: the total score on the PROMIS-10 self report survey
时间窗: Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
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.
时间窗: Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
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.
次要结局
- Total Score on the Patient Activation Measure Short Form (PAM-SF)(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
- Total Score on the Exercise Adherence Rating Scale (EARS)(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
- Total Score on the Adherence to Refills and Medications Scale (ARMS)(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
- Total Score on the Adherence to Multidisciplinary Clinic Recommendations(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
- Total Score on the Interpersonal Processes of Care (IPC) Survey(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
- Total Score on the Caregiver Perceptions About Communication with Clinical Team (CAPACITY) Survey(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
- Total Score on the Preparedness for Caregiving Scale(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
- Total Score on the Burden Scale for Family Caregivers - Short Form (BSFC)(Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.)
研究者
Paul J. Barr
Professor
Trustees of Dartmouth College