Clinical trial NCT06860932: A Palliative Care Model Impact on Knowledge and Attitudes
Official title: A Palliative Care Model Impact on Knowledge and Attitudes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Sclerosis, MS
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2025-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Guided by the Scott Murray's PC Transition Model, which integrates palliative services including decision making, communication, and coordinated care, the investigators will test the central hypothesis, and accomplish the objectives of this application by pursuing the following two specific aims in the pilot study:

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) 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Patients will be asked for their goals-of-care preferences at baseline, after watching the video or reading the information sheet and after three months. Patients will be asked for their goals-of-care preference (Life-prolonging, Limited/Blended, Comfort, or Unsure), cardiopulmonary resuscitation (CPR) preference (Yes, No, or Unsure), and ventilatory support (Yes, No, or Unsure) at baseline, and then again immediately after watching the video or reviewing the informational sheet, and then the investigators will contact all patients after 3 months by telephone to ask for their preferences again. 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?"). The primary outcome is patient treatment preferences (i.e., care considerations, discontinuation of care, versus continued full care) for neurological care (Aim 1). The preferences will be measured as a binary outcome based on our clinical experience. When a patient chooses "" as an option for any of the treatment outcomes, in clinical care that is equivalent to the default (i.e., full code or life-prolonging interventions). Secondary outcomes include knowledge, decisional conflict, and preparation for decision making (Aims 1). The investigators will also explore the stability of preferences and documentation after 3 months (Aim 2). In all of investigators' prior trials, 3 months has been the requisite amount of time needed for patients to contemplate their decisions regarding medical care.

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.

Primary outcomes:
measure: Palliative care preferences (i.e., care considerations, discontinuation of care, versus continued full care) for neurological care (Aim 1).
timeFrame: 3 months.
Secondary outcomes:
measure: Palliative care knowledge
timeFrame: 3 months
measure: Preparation for decision making
timeFrame: 3 months
measure: Decisional conflict
timeFrame: 3 months.
measure: Advance care planning engagement
timeFrame: 3 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: Judith Jaffe Multiple Sclerosis Center
state: New York
city: New York
country: United States
facility: Hunter College
state: New York
Study officials:
References:
citation: Ben-Zacharia AB, Bethoux FA, Volandes A. Self-Perceived Knowledge and Comfort Discussing Palliative Care and End-of-Life Issues among Professionals Managing Neuroinflammatory Diseases. J Palliat Med. 2021 May;24(5):725-735. doi: 10.1089/jpm.2020.0268. Epub 2020 Oct 16.
citation: Ben-Zacharia AB, Brugger HT, Carbone S, Malchiodi J, Wallace E, Bethoux F, Volandes A, Bartels A. Palliative Care Knowledge and Attitudes Among Patients With Neuroinflammatory Diseases. J Palliat Med. 2024 Jan;27(1):10-17. doi: 10.1089/jpm.2023.0224. Epub 2023 Aug 22.