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Rounding Summaries for Families of Critically Ill Patients

8. März 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

252

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Rush University Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Rounding Summary
Written summary of rounds
Kein Eingriff: Usual Care
Usual ICU care

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Surrogate Anxiety and Depression
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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).

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Qualitative feedback from participating surrogates
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Measured during hospitalization, up to 90 days after enrollment.
Hospital disposition
Measured during hospitalization, up to 90 days after enrollment.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rush University Medical Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2019

Primärer Abschluss (Tatsächlich)

11. Januar 2021

Studienabschluss (Tatsächlich)

12. Februar 2021

Studienanmeldedaten

Zuerst eingereicht

10. Mai 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Mai 2019

Zuerst gepostet (Tatsächlich)

31. Mai 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 19042604

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

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Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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