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Rounding Summaries for Families of Critically Ill Patients

8 de março de 2021 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

252

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Rush University Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: Rounding Summary
Written summary of rounds
Sem intervenção: Usual Care
Usual ICU care

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Surrogate Anxiety and Depression
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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).

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Qualitative feedback from participating surrogates
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: Measured during hospitalization, up to 90 days after enrollment.
Hospital disposition
Measured during hospitalization, up to 90 days after enrollment.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Rush University Medical Center

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2019

Conclusão Primária (Real)

11 de janeiro de 2021

Conclusão do estudo (Real)

12 de fevereiro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

10 de maio de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de maio de 2019

Primeira postagem (Real)

31 de maio de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de março de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de março de 2021

Última verificação

1 de março de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 19042604

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INDECISO

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Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

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