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Rounding Summaries for Families of Critically Ill Patients

8 marca 2021 zaktualizowane przez: Jared Greenberg, Rush University Medical Center

Many patients in intensive care units (ICUs) rely on family members or surrogates to make medical decisions on their behalf. One of the recommended ways to improve a surrogate's experience is to invite him or her to participate in daily, multidisciplinary ICU rounds. In practice, this is often a challenging way for clinicians to engage with the patient's surrogates.

Surrogates of non-decisional ICU patients will be randomized to receive a written rounding summary every day or every other day that the patient is in the ICU. The summary will be organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.

The investigators hypothesize that surrogates who receive written rounding summaries will be more satisfied with ICU care than surrogates who receive usual care. Satisfaction will be measured by the Critical Care Family Needs Inventory (CCFNI) questionnaire.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

252

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60612
        • Rush University Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Patients in the adult Medical and Cardiac ICUs at Rush University Medical Center will be prospectively screened.

Inclusion criteria (Patient characteristics required for surrogate inclusion) At least one of the following

  • The patient has required invasive or non-invasive mechanical ventilation for at least three consecutive days.
  • The patient has an expected in-hospital mortality rate of at least 25% according to the primary ICU physician.

Exclusion criteria (Patient characteristics that will exclude surrogates from study enrollment):

  • The patient possesses decisional capacity at the time of enrollment.
  • The patient has required invasive or non-invasive mechanical ventilation for more than the previous 14 days
  • The patient is expected to die or transition to comfort care within the next 48 hours based on ICU physician estimate.
  • The patient is expected to be liberated from mechanical ventilation (if applicable) or discharged from the ICU within the next 24 hours.
  • There is no identifiable surrogate.
  • The patient is member of a vulnerable population i.e. pregnant, prisoner.
  • The ICU physician refuses permission to approach surrogates for consent

The investigators will hand out fliers that describe the study to surrogates of patients who are expected to meet the above criteria. Surrogates can ask the nurse to contact the lead investigator if they are interested in learning more about the study. If no surrogate is present prior to the patient meeting the inclusion criteria, the investigators will attempt to contact the surrogate by phone to provide information on the study.

One surrogate will be approached for informed consent and enrolled based on the following criteria.

Inclusion criteria for surrogate decision maker:

  • Age ≥ 18 years old
  • Self-identified as participating directly in health care decision making for the incapable patient

Exclusion criteria for surrogate decision makers:

  • The surrogate does not agree to participate in study procedures (surveys, interviews)
  • The surrogate needs translation assistance because of poor English fluency
  • The surrogate has history of a clinically important neurological disorder (e.g., dementia)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Rounding Summary

Surrogates who are assigned to the intervention group will receive a written rounding summary every day or every other day that the patient is in the ICU. The summary will be organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.

For patients assigned to the intervention group, the investigators will forward the previous day's summary to the ICU nurse at the beginning of each day shift. After participating in morning rounds, ICU nurses will be asked to modify the summary based on the plan for the day. Nurses will be asked to use the written summary to guide communication with surrogates that day.
Behawioralne: Rounding Summary
Written summary of rounds
Brak interwencji: Usual Care
Usual ICU care

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Ramy czasowe: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Surrogate Anxiety and Depression
Ramy czasowe: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Ramy czasowe: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Surrogate and physician agreement regarding the patient's condition
Ramy czasowe: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses. Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient. When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided. Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same." Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Change in Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Ramy czasowe: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Change in Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Change in Surrogate Anxiety and Depression
Ramy czasowe: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Change in Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Change in Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Ramy czasowe: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
Change in score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Qualitative feedback from participating surrogates
Ramy czasowe: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
All surrogates will be asked to participate in a 10-15 minute phone or in-person interview. This interview will deal with their satisfaction with the patient's care and communication with the ICU staff.
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
Feedback from participating nurses
Ramy czasowe: Daily while patient is in the ICU
Nurses of enrolled patients/surrogates will be asked to complete an online survey regarding communication with the patient and/or surrogates that day. Nurses will also be invited to participate in focus groups to provide feedback.
Daily while patient is in the ICU
Surrogate Satisfaction with Patient Care
Ramy czasowe: Measured once 10-14 days after enrollment if patient still in ICU
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
Measured once 10-14 days after enrollment if patient still in ICU
Surrogate Anxiety and Depression
Ramy czasowe: Measured once 10-14 days after enrollment if patient still in ICU
Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
Measured once 10-14 days after enrollment if patient still in ICU
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Ramy czasowe: Measured once 10-14 days after enrollment if patient still in ICU
Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
Measured once 10-14 days after enrollment if patient still in ICU
Surrogate and physician agreement regarding the patient's condition
Ramy czasowe: Measured once 10-14 days after enrollment if patient still in ICU
Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses. Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient. When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided. Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same." Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.
Measured once 10-14 days after enrollment if patient still in ICU
Patient length of mechanical ventilation (if applicable)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Patient length of mechanical ventilation (if applicable)
Measured during hospitalization, up to 90 days after enrollment.
Patient failed extubation attempt (yes/no) (if applicable)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Failed extubation attempt (yes/no) (if applicable)
Measured during hospitalization, up to 90 days after enrollment.
Tracheostomy placement during ICU admission (yes/no)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Tracheostomy placement during ICU admission (yes/no)
Measured during hospitalization, up to 90 days after enrollment.
Days from intubation to tracheostomy placement (if applicable)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Days from intubation to tracheostomy placement (if applicable)
Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring invasive mechanical ventilation (yes/no)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring invasive mechanical ventilation (yes/no)
Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring new artificial nutritional supplementation (yes/no)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring new artificial nutritional supplementation (yes/no)
Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring new renal replacement therapy (yes/no)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
ICU discharge requiring new renal replacement therapy (yes/no)
Measured during hospitalization, up to 90 days after enrollment.
Change in code status or limitations to care during ICU stay (yes/no)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Change in code status or limitations to care during ICU stay (yes/no)
Measured during hospitalization, up to 90 days after enrollment.
Days from ICU admission to change in code status or new limitations to care (if applicable)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Days from ICU admission to change in code status or new limitations to care (if applicable)
Measured during hospitalization, up to 90 days after enrollment.
ICU length of stay (days)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
ICU length of stay (days)
Measured during hospitalization, up to 90 days after enrollment.
Hospital length of stay (days)
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Hospital length of stay (days)
Measured during hospitalization, up to 90 days after enrollment.
Hospital disposition
Ramy czasowe: Measured during hospitalization, up to 90 days after enrollment.
Hospital disposition
Measured during hospitalization, up to 90 days after enrollment.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Rush University Medical Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2019

Zakończenie podstawowe (Rzeczywisty)

11 stycznia 2021

Ukończenie studiów (Rzeczywisty)

12 lutego 2021

Daty rejestracji na studia

Pierwszy przesłany

10 maja 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2019

Pierwszy wysłany (Rzeczywisty)

31 maja 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 marca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 19042604

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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