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Post-ICU Palliative Care Intervention (PIPCI) Trial

13 juni 2019 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

66

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 10032
        • Columbia University Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Andra namn:
  • PIPCI
Placebo-jämförare: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Annual enrollment rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Edmonton Symptom Assessment System (ESAS) scores
Tidsram: 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
Tidsram: 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.

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of patients with moderate-to-severe fatigue who are recommended for and receive methylphenidate treatment.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Columbia University

Samarbetspartners

National Institute on Aging (NIA)

Utredare

  • Huvudutredare: Matthew R Baldwin, MD, MS, Columbia University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 mars 2018

Primärt slutförande (Faktisk)

31 maj 2019

Avslutad studie (Förväntat)

31 augusti 2019

Studieregistreringsdatum

Först inskickad

22 februari 2018

Först inskickad som uppfyllde QC-kriterierna

28 februari 2018

Första postat (Faktisk)

7 mars 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juni 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2019

Senast verifierad

1 juni 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AAAR3202
  • K23AG045560 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

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NEJ

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