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A Palliative Care Model Impact on Knowledge and Attitudes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The controls will read written information of the same content shown on the video and will complete similar questionnaires."
  • "The investigators will also have an open-ended question for those subjects who change their preferences from the initial post-video or control survey ("Can patients tell us more about why they have changed their preference from the one stated before?")."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a short video with a written sheet about palliative care—care that supports people with serious illness alongside treatment. It tests how these tools affect patients’ knowledge, care choices, and readiness to make decisions. It is for adults ages 18–65 with MS, NMOSD, or anti-MOG, diseases that affect the brain, spinal cord, or nerves.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were diagnosed with MS, NMOSD, or anti-MOG at least 2 years ago.
  • Are 18–65 years old.
  • Speak English.

Who can't join

  • Have trouble seeing. Hearing loss does not exclude you because the video has captions.
  • Are not emotionally ready to discuss palliative care, based on the PHQ9 depression questionnaire.
  • Score 11 or higher on the PHQ9. You will be referred for care right away.
  • Have thinking problems that prevent you from discussing palliative care, based on a Processing Speed Test score below a Z score of -1.5.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosed with MS, NMOSD, or anti-MOG, at least 2 years after their diagnosis. * Aged 18-65 * Speak English since all instruments are available in English. Exclusion Criteria: * Visually impaired (note, hearing impaired is not an exclusion criterion as the video is closed captioned). * Psychological state not appropriate for PC discussions as determined by the Patient Health Questionnaire 9 (PHQ9). * A score of 11 or higher, indicative of major depressive disorder, will be referred to immediate management and excluded from the study. * Unable to participate in PC discussions due to cognitive impairment as determined by the Processing Speed Test (PST) score below -1.5 Z score.

Study sites (2)

NY