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Набор по приглашению NCT07224594

Comparing Optimized Models of Primary And Specialist Services for Palliative Care

Без фазы С лечением Seriously Ill Hospitalized Patients

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Default Order, Accountable Justification, Standardized Usual Care.
Кому может быть актуально
Состояния в реестре: Seriously Ill Hospitalized Patients. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This pragmatic clinical trial will be conducted with 48 hospitals at two large U.S. health systems and enroll more than 78,000 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 70% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. The 48 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalist clinicians are trained using the Center to Advance Palliative Care (CAPC) online trainings. This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures, and follows a pilot feasibility study. We will collect Patient-Reported Outcomes (PROs) surveys from a random subset of enrolled patients.

Вмешательства

  • Поведенческое Default Order
    A specialist PC consult is automatically ordered for patients meeting a certain threshold of 1-year mortality risk (dependent on arm). An EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.
  • Поведенческое Accountable Justification
    An EHR-based Our Practice Advisory alert asks generalist clinicians to self-report whether they have provided primary PC by clicking which of 4 key PC domains they have addressed or to provide a brief justification as to why not.
  • Поведенческое Standardized Usual Care
    High-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. For very high-risk patients (i.e., with a 1-year mortality risk of ≥ 95%), an EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.

Первичные конечные точки

  • Hospital free days [Срок оценки: Enrollment- 182 days.]
Вторичные конечные точки (12)
  • Patient quality of life [Срок оценки: 1-month, 3-months, and 6-months post-enrollment]
  • Clinician communication [Срок оценки: 1-month post-enrollment]
  • Pain management [Срок оценки: 1-month post-enrollment]
  • Goal concordant care [Срок оценки: 1-month post-enrollment]
  • Social interaction [Срок оценки: 1-month post-enrollment]
  • Loneliness [Срок оценки: 1-month post-enrollment]
  • Hospital free days at 3 months [Срок оценки: Enrollment - 3-months post-enrollment]
  • Institution free days at 3 months [Срок оценки: Enrollment - 3-months post-enrollment]
  • Institution free days at 6 months [Срок оценки: Enrollment - 6-months post-enrollment]
  • 30-day hospital readmissions [Срок оценки: Enrollment - 30 days post-enrollment]
  • 90-day hospital readmissions [Срок оценки: Enrollment - 90 days post-enrollment]
  • Community-based palliative care use [Срок оценки: Enrollment - 6-months post-enrollment]

Критерии участия

Критерии включения

  • Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% or greater; AND Admitted to a study hospital.

Критерии исключения

  • Patients who die or have an active or completed discharge order prior to enrollment time OR
  • Readmission within 182 days of an eligible encounter OR
  • Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics

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
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 2 центра
  • Kaiser Permanente Southern California — Pasadena
  • Trinity Health — Livonia

Идентификаторы

NCT: NCT07224594 · 855378 · PLACER-2022C3-30553

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗