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NCT06860932Recruiting

A Palliative Care Model Impact on Knowledge and Attitudes

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
5 Feb 2025
Start date
1 Feb 2025
Primary completion date
1 Jun 2026
Lead sponsor
Hunter College of City University of New York
NCT number
NCT06860932

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Feb 2025 to the primary completion date, 1 Jun 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hunter College
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Judith Jaffe Multiple Sclerosis Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.