Palliative Care Information for Multiple Sclerosis
Trial Summary
What is the purpose of this trial?
This study is using a central, computer-generated simple randomization technique. Participants will be randomly assigned to groups within the constraints of ensuring balanced representation of gender, ethnicity, and race. One-half of the patients are randomized to the decision aid video model, and one-half will serve as controls and receive a palliative care (PC) informational sheet. Sessions are designed to be consistent with PC principles of care using constructs from the Murray's transition theory including knowledge development coupled with advanced care planning (ACP)-to drive palliative care alongside curative treatment, and to support people with chronic progressive illnesses. The 2 groups will complete the demographic forms, and pre- and post-tests, at baseline and after three months. The intervention group will view the video decision aid, which takes 10 minutes, during their follow up appointment. The controls will read written information of the same content shown on the video and will complete similar questionnaires. The video opens with empathic statements regarding the situation in which patients may find themselves, including an introduction about medical decisions, and statements regarding values and spiritual beliefs and their impact on decision-making. The video translates the information into actionable medical orders using a three-goal framework: life-prolonging care, limited/blended care, and comfort care. The video describes the features of each of the goals of care and the risks and benefits of each option using visual images that illustrate the interventions. Patients will review the video using iPads and will be able to review the video again as needed. The Flesch-Kincaid ease score for the video narration is 71.6; for the "Conversation" piece, it is 65.9. These indicate that the passages require approximately a 7th or 8th grade reading level, which Flesch suggests makes them "easy to read" and "plain English," respectively. The goal of the video intervention is to help patients express their values and health goals, while achieving their life and core values. The intervention group will view the video which includes modules to teach patients strategies for expressing their concerns and enhance their self-efficacy, helping them overcome any barriers. To enhance intervention fidelity, an ACP facilitator guide will be developed as reference for the intervention implementation. It will detail the key topics and purposes of each session of the intervention, the guiding questions, and the facilitation skills. Aim 1: To explore the preferences of patients with neuroinflammatory diseases, PC knowledge, decisional conflict, and preparation for decision making among 50 adult (18-65 years old) patients randomly assigned to one of two PC modalities: 1. a video depicting PC goals of care (intervention group, n=25), or 2. standard usual care using PC written information (control group, n=25). H1a: Patients randomized to the video will have higher documented preferences and fewer preferences for life-prolonging interventions (primary outcome) than the control group. The intervention group will have greater knowledge, lower decisional conflict, and greater preparation for decision making than those randomized to the control group. Aim 2: To compare PC conversations and documentation at 3 months among patients with neuroinflammatory diseases. H2: Patients randomized to the video will have more PC conversations and higher rates of PC documentation after 3 months.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing information and support for decision-making in palliative care, so it's unlikely that medication changes are required.
What data supports the effectiveness of the treatment Palliative Care Model for Multiple Sclerosis?
Preliminary evidence suggests that palliative care may be beneficial for people with severe multiple sclerosis, as it addresses complex physical and emotional needs. A pilot study also indicates that patients and caregivers can benefit from palliative care services, such as counseling hotlines, which help connect them to necessary support.12345
How does the Palliative Care Model treatment differ from other treatments for multiple sclerosis?
The Palliative Care Model for multiple sclerosis focuses on improving quality of life through symptom management, psychosocial support, and rehabilitation, rather than trying to prevent or delay disease progression. This approach is unique because it addresses the complex physical and emotional needs of patients with severe, progressive MS, which are often not the primary focus of standard disease-modifying treatments.23456
Eligibility Criteria
This trial is for adults aged 18-65 with neuroinflammatory diseases like Multiple Sclerosis. Participants should be able to understand content at a 7th or 8th grade reading level. The study aims to include a balanced representation of gender, ethnicity, and race.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete demographic forms and pre-tests
Intervention
Participants are randomized to either view a palliative care video or read written information, followed by post-tests
Follow-up
Participants are contacted by telephone to reassess goals-of-care preferences and complete post-tests
Treatment Details
Interventions
- Palliative Care Model
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hunter College of City University of New York
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator