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Rounding Summaries for Families of Critically Ill Patients

8 mars 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

252

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
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
        • Rush 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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 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: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Rounding Summary
Written summary of rounds
Aucune intervention: Usual Care
Usual ICU care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Surrogate Anxiety and Depression
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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).

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Qualitative feedback from participating surrogates
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: Measured during hospitalization, up to 90 days after enrollment.
Hospital disposition
Measured during hospitalization, up to 90 days after enrollment.

Collaborateurs et enquêteurs

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

Parrainer

Rush University Medical Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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)

1 juin 2019

Achèvement primaire (Réel)

11 janvier 2021

Achèvement de l'étude (Réel)

12 février 2021

Dates d'inscription aux études

Première soumission

10 mai 2019

Première soumission répondant aux critères de contrôle qualité

29 mai 2019

Première publication (Réel)

31 mai 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 mars 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 19042604

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INDÉCIS

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

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