Supporting Families in the ICU

Официальное название

Supporting Families in the ICU: The Chaplain Family Project Multicenter RCT

Обзор

The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.

Подробное описание

To prepare for a fully powered, multi-center study, we propose a 2-arm, attention controlled, randomized pilot trial of high-quality spiritual care for 64 surrogates at 2 additional US medical centers.

Specific Aims are:

1. To determine the feasibility and acceptability of all aspects of the study, including enrollment, randomization, delivery of the SCAI framework (e.g., chaplain intervention) and attention control conditions, acceptability, and outcome assessments, in preparation for a larger, Stage III effectiveness trial. 2. To test the effects of spiritual care on the primary outcome of anxiety (GAD-7) and the secondary outcomes of surrogate spiritual well-being and satisfaction with spiritual care (FACIT-Sp-non-illness version, Satisfaction with Care-Chaplain), and decision making for the patient, including the process of decision making and the medical care received by the patient. 3. To study the experience of spiritual care from the perspective of surrogates who are religious and those who are not, those of different faiths, and those who describe themselves as spiritual but not religious.

Because chaplains are common in the ICU this intervention is highly scalable. Results will guide hospital leaders, policy makers and the healthcare team regarding how to deploy chaplains to improve surrogates' psychological and spiritual health and the quality of decisions for critically ill patients.

Вмешательства

• Поведенческое Spiritual Care Assessment and Intervention (SCAI) Framework
  The SCAI intervention includes three visits generally scheduled 48-72 hours apart. After three visits, the chaplain will contact the surrogate at least weekly for the remainder of the hospitalization. If the patient dies, the chaplain will conduct a bereavement visit. The SCAI framework addresses four dimensions of spirituality. If all four dimensions are not addressed, they may be assessed during follow-up visits. If all four dimensions are addressed during the initial visit, other visits incl
• Поведенческое ICU Guide
  The ICU Guide intervention will include three visits with the site RA that are similar in duration to the chaplain visits (based on the single center study, first visit median of 23 minutes, follow-up visit median 12 minutes), with review of a brochure introducing the family member to the ICU including staff, policies and procedures that will be helpful to the family member.

Первичные конечные точки

• Effect of the intervention on surrogate anxiety (GAD-7) [Срок оценки: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital]

Вторичные конечные точки (3)

• Effect of the intervention on surrogate spiritual well-being (FACIT-Sp) [Срок оценки: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital]
• Decision making quality (FS-ICU) [Срок оценки: Assessed 6-8 weeks after the patient has discharged from the hospital]
• Satisfaction with Spiritual Care (PSI-C) [Срок оценки: Assessed 6-8 weeks after the patient has discharged from the hospital]

Критерии участия

We will enroll patient/surrogate dyads.

Patients will be eligible if:

• They are age 18 or older at the time of screening.
• They are judged to lack decisional capacity based on either:

a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9-13 with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians to be unresponsive, comatose or unable to follow commands).

\* They have an eligible surrogate willing to participate.

Surrogates will be eligible if:

• They are age 18 or older,
• They are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law.

Patient/surrogate dyads will be ineligible if:

\* They are unable to complete enrollment activities within 96 hours of admission to the ICU.

Patients will be ineligible if:

• They are being discharged from the ICU within 24 hours.
• They are intubated for surgery but expected to be extubated soon (typically within 24 hours).
• They are imminently dying or have a planned terminal wean.

Surrogates will be ineligible if:

\*They are unable to complete study procedures in English.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• University of California- San Francisco — San Francisco
• Wake Forest University — Winston-Salem

Идентификаторы

NCT: NCT07228299 · 27922 · R56AG086388

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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