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Идёт набор NCT06118606

Pilot Study of a Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity

Без фазы С лечением Post-Intensive Care Syndrome Depressive Symptoms Anxiety Physical Disability

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: Case-manager led multidisciplinary follow-up after intensive care.
Кому может быть актуально
Состояния в реестре: Post-Intensive Care Syndrome, Depressive Symptoms, Anxiety, Physical Disability. 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Interventional Multidisciplinary Rehabilitation and Special Support; a Pilot Study of a Case Manager-led Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity -IMPRESS-ICU Pilot Study

Обзор

Pilot study of the feasibility and utility of an early, in-hospital multidisciplinary intervention in ICU survivors at risk for psychological and physical problems post-ICU stay

Подробное описание

60 adult patients at two hospitals in Region Stockholm (Karolinska University Hospital and Södersjukhuset) with an ICU stay ≥12 hours with increased risk for psychological/physical sequelae will be invited to participate.

Intervention: Early re-assessment and multidisciplinary follow-up, led by an ICU follow-up staff (Case Manager, CM). The CM will support the patient and coordinate the rehabilitation efforts from ICU discharge to primary care with a secondary, deepened assessment of symptoms in the ward, recapitulation and information about the time spent in the ICU, followed by a multidisciplinary discussion with concerned specialists and the set-up of an individual rehabilitation plan communicated to the patient and the informal caregivers. The CM will keep track of the patient during hospital stay and ensure that there is a plan for further primary care rehabilitation after hospital discharge. The CM will contact the patient weekly to follow up on wellbeing and planned primary care activities until 12 weeks. At twelve weeks, patients will be assessed with regards to psychological symptoms (HADS, PTSS-14) and physical disability (BI).

Outcome: The primary outcome is the feasibility of the intervention. Patients and informal caregivers will be invited to participate in semi-structured interviews that will deepen the knowledge about their views upon the intervention, needs and suggested measures to improve the patients' recovery. Resource utilisation will be documented by the CM and feedback collected from involved ICU staff and hospital clinicians. Secondary outcomes are patients' level of psychological and physical problems and health-related quality of life. The results from the pilot study will inform a subsequent randomized controlled trial of an early follow-up intervention.

Вмешательства

  • Другое Case-manager led multidisciplinary follow-up after intensive care
    Early in-hospital follow-up in survivors of intensive care with an increased risk of psychological/physical sequelae. The follow-up is led by a case-manager reassessing the patient after ICU discharge for psychological/physical rehabilitation needs. The CM will discuss patient needs with concerned specialists in a multidisciplinary team, leading to the establishment of a personal rehabilitation plan, communicated to the patient and next-of-kin. The CM will keep track of the patient during hospit

Первичные конечные точки

  • Feasibility of the intervention [Срок оценки: Outcome measured during and after termination of data collection and end of intervention]
  • Utility of the intervention [Срок оценки: Outcome measured three-four months after ICU discharge]
Вторичные конечные точки (5)
  • Depressive symptoms post-ICU [Срок оценки: Outcome measured three months after ICU discharge]
  • Anxiety symptoms post-ICU [Срок оценки: Outcome measured three months after ICU discharge]
  • Symptoms of post-traumatic stress post-ICU [Срок оценки: Outcome measured three months after ICU discharge]
  • Physical disability post-ICU [Срок оценки: Outcome measured three months after ICU discharge]
  • Health-related quality of life post-ICU [Срок оценки: Outcome measured three months after ICU discharge]

Критерии участия

Критерии включения

\- Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU/PREPICS instruments)

Критерии исключения

  • Dementia or other major cognitive problems
  • Structural brain or spinal cord injury
  • Multiple limitations of medical treatment
  • Insufficient language skills (Swedish)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Швеция · 2 центра
  • ICU Karolinska University Hospital — Stockholm
  • ICU Södersjukhuset — Stockholm

Идентификаторы

NCT: NCT06118606 · 2022-03436-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗