Rounding Summaries for Families of Critically Ill Patients
8 de marzo de 2021 actualizado 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
252
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
Written summary of rounds
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|
Sin intervención: Usual Care
Usual ICU care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Surrogate Anxiety and Depression
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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).
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Qualitative feedback from participating surrogates
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
|
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Patient failed extubation attempt (yes/no) (if applicable)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
|
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ICU discharge requiring new artificial nutritional supplementation (yes/no)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
|
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Days from ICU admission to change in code status or new limitations to care (if applicable)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Measured during hospitalization, up to 90 days after enrollment.
|
Hospital disposition
|
Measured during hospitalization, up to 90 days after enrollment.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Brown SM, Rozenblum R, Aboumatar H, Fagan MB, Milic M, Lee BS, Turner K, Frosch DL. Defining patient and family engagement in the intensive care unit. Am J Respir Crit Care Med. 2015 Feb 1;191(3):358-60. doi: 10.1164/rccm.201410-1936LE. No abstract available.
- Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
- Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
- Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
- Greenberg JA, Basapur S, Quinn TV, Bulger JL, Schwartz NH, Oh SK, Shah RC, Glover CM. Challenges faced by families of critically ill patients during the first wave of the COVID-19 pandemic. Patient Educ Couns. 2022 Feb;105(2):297-303. doi: 10.1016/j.pec.2021.08.029. Epub 2021 Aug 27.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2019
Finalización primaria (Actual)
11 de enero de 2021
Finalización del estudio (Actual)
12 de febrero de 2021
Fechas de registro del estudio
Enviado por primera vez
10 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2019
Publicado por primera vez (Actual)
31 de mayo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
8 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 19042604
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .