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Post-ICU Palliative Care Intervention (PIPCI) Trial

13 juin 2019 mis à jour par: Matthew Baldwin, Columbia University

Post-ICU Palliative Care Consultation Intervention Pilot Trial in Older Survivors of Acute Respiratory Failure

This is a single center, pilot, randomized, single-blind, usual care controlled, pragmatic clinical trial of a post-ICU palliative care consultation intervention in older (age ≥50 years) survivors of acute respiratory failure.

Aim 1: To conduct a pilot post-ICU palliative care consultation intervention trial among frail older ICU survivors and their surrogates. Hypothesis:The Investigators can achieve an adequate enrollment rate, protocol adherence, and intervention fidelity.

Aim 2: To estimate effect sizes and variability for changes in symptoms at hospital discharge and 1 month, and to estimate hospice referral rates and acute-care readmission rates at 1 and 3 months. Hypothesis: Effect sizes and feasibility data will inform and support future post-ICU palliative care studies focused on improving ICU survivorship.

Exploratory Aim. To assess the use of methylphenidate that is recommended and dosed by the palliative care physician for the treatment of moderate-to-severe fatigue. Hypothesis: (1) Not all patients with moderate-to-severe fatigue will be recommended for methylphenidate therapy. (2) Patients prescribed methylphenidate for treatment of moderate-to-severe fatigue after critical illness will adhere to methylphenidate therapy.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

There is an urgent need for research to improve outcomes for the rapidly growing population of older survivors of critical illness. Most adults, including older adults, survive critical illness. While recovery with minimal sequelae occurs, a substantial proportion of survivors are left with physical disability and cognitive impairment, have an increased risk of death, and incur high health care costs after hospital discharge. In prior work the Investigators have shown that about 75% of older survivors of respiratory failure are phenotypically frail and that these frail ICU survivors have a high burden of uncontrolled symptoms at hospital discharge and 1-month later. Moderate to severe post-ICU fatigue is the most prevalent symptom and may interfere with functional recovery.

This study is designed to determine whether consultation with a palliative care team may help alleviate any physical symptoms or psychological distress that the patients and their caregivers (surrogates) have coming out of the ICU.

Type d'étude

Interventionnel

Inscription (Réel)

66

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New York
      • New York, New York, États-Unis, 10032
        • Columbia University Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age ≥ 50 years.
  • Acute respiratory failure requiring invasive mechanical ventilation, non-invasive mechanical ventilation (continuous or bi-level positive pressure), or high flow nasal cannula for greater than 24 hours in a Columbia University Medical Center medical or surgical ICU.

Exclusion Criteria:

  • Hospital discharge directly from ICU.
  • Already received palliative care consultation during the hospitalization.
  • Planned discharge to hospice or home hospice. These patients do not need further palliative care consultation since they have already decided on prioritizing palliative care over life-sustaining treatment.
  • Respiratory failure due to neurologic diagnosis (intracranial hemorrhage, stroke, or coma). These patients are unlikely to be able to participate in any frailty measurements, and may have difficulty with communicating their symptom burden.
  • Pre-existing neurologic disease or stroke with motor deficits. Older adults with motor diseases (e.g Parkinson's disease) will be excluded from frailty measurements because they could present with frailty characteristics from a single disease. This criterion was used to exclude subjects in the original Cardiovascular Health Study from which the Fried frailty phenotype was first assessed.
  • Psychiatric history of Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia.
  • Current Alcoholism or drug abuse.
  • Not English or Spanish speaking. Many surveys are not validated in other languages besides English or Spanish. Obtaining interpreters in other languages for palliative care assessments and intervention can be challenging. We expect < 3% of all potentially eligible patients/surrogates to not have English or Spanish speaking ability.
  • No healthcare proxy or surrogate also consenting to participate.
  • Expected to be discharged to a location >20 miles from Columbia University Medical Center. This discharge radius will make in-person 1-month follow-up feasible.
  • Status post heart, lung, or liver transplantation. These patients are not representative of the larger population of older adult survivors of acute respiratory failure.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Palliative Care Consultation
After enrollment the palliative care consultation team will meet with the patient-surrogate pair one or more times to (1) assess symptoms, (2) provide supportive counseling, (3) make symptom treatment recommendations to the primary team of physicians, and (4) will address goals of care.
Comportemental: Palliative Care Consultation
The palliative care consultation team will be led by one of the board-certified palliative care physicians at Columbia University Medical Center. Over one or more visits, the palliative care consultation team will first review intervention participants' medical records and baseline Edmonton Symptom Assessment System (ESAS) scores. They will also directly assess participants' physical and psychological symptoms. They will provide supportive counseling, make treatment recommendations for burdensome symptoms to the primary team of physicians, and will address goals of care. They will document these activities in structured electronic medical record consultation notes.
Autres noms:
  • PIPCI
Comparateur placebo: Usual Care
Patient-surrogate pairs randomized to usual care will continue to receive care by their primary physicians without having a palliative care consultation intervention offered.
Autre: Usual Care
Patient-surrogate pairs randomized to usual care will not have a palliative care consultation intervention offered, and will receive care by their primary physicians. However, if a palliative care consultation is requested after randomization to usual care by the primary team of physicians and/or the patient/surrogate, it will be provided.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Annual enrollment rate
Délai: 1 year
The number of patients who enroll compared to the number of patients who enroll and decline enrolling over 1 year
1 year
Adherence to the palliative care consultation intervention
Délai: From date of Randomization until the date of hospital discharge or 28 days later.
Proportion of patient-surrogate pairs randomized to a palliative care consultation who actually agree to have the palliative care consultation prior to hospital discharge.
From date of Randomization until the date of hospital discharge or 28 days later.
Crossover from usual care to post-ICU palliative care
Délai: From date of Randomization until the date of hospital discharge or 28 days later.
Proportion of patient-surrogate pairs randomized to usual care who end up receiving a post-ICU palliative care consultation prior to hospital discharge.
From date of Randomization until the date of hospital discharge or 28 days later.
Fidelity of the palliative care intervention
Délai: From date of Randomization until the date of hospital discharge or 28 days later.
Documentation in electronic medical record consultation notes of (a) burdensome symptoms, (b) supportive counseling, (c) symptom treatment recommendations, and (d) addressing goals-of-care.
From date of Randomization until the date of hospital discharge or 28 days later.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Edmonton Symptom Assessment System (ESAS) scores
Délai: Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.
Changes in patients' ESAS symptoms (best(0) to worse(10)) from randomization to hospital discharge, and from hospital discharge to 1-month follow-up. ESAS symptoms are: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing.
Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.
Change in Hospital Anxiety and Depression Scores (HADS) for surrogates
Délai: Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.
Changes in surrogates' HADS scores (best(0) to worst(42)) from randomization to hospital discharge, and from hospital discharge to 1-month follow-up.
Pre-randomization baseline until the date of hospital discharge or 28 days later, and 1-month follow-up after hospital discharge.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Number of patients with moderate-to-severe fatigue who are recommended for and receive methylphenidate treatment.
Délai: Randomization until 1-month follow-up after hospital discharge.
Number of patients with ESAS fatigue scores greater than or equal to 4 at baseline who are recommended for and receive methylphenidate treatment.
Randomization until 1-month follow-up after hospital discharge.
New limitation of life-sustaining therapy
Délai: Day of hospital discharge until 3-month follow-up after hospital discharge.
Number of patients who elect DNR after randomization
Day of hospital discharge until 3-month follow-up after hospital discharge.
Enrollment in Hospice
Délai: Day of hospital discharge until 3-month follow-up after hospital discharge.
Number of patients who enroll in-patient hospice or home hospice.
Day of hospital discharge until 3-month follow-up after hospital discharge.
Acute-care readmissions
Délai: Day of hospital discharge until 3-month follow-up after hospital discharge.
Number of patients who are re-admitted to an acute care hospital within 1-month and 3-months.
Day of hospital discharge until 3-month follow-up after hospital discharge.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Columbia University

Collaborateurs

National Institute on Aging (NIA)

Les enquêteurs

  • Chercheur principal: Matthew R Baldwin, MD, MS, Columbia University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 mars 2018

Achèvement primaire (Réel)

31 mai 2019

Achèvement de l'étude (Anticipé)

31 août 2019

Dates d'inscription aux études

Première soumission

22 février 2018

Première soumission répondant aux critères de contrôle qualité

28 février 2018

Première publication (Réel)

7 mars 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 juin 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juin 2019

Dernière vérification

1 juin 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AAAR3202
  • K23AG045560 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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