N/A
N=90
Psychological Symptoms and Families of COVID-19 Patients
Family Members · Post Intensive Care Unit Syndrome · Post Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04501445 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial — 27.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Written Summary of Rounds (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial |
27.9 | — |
| PRIMARY Symptoms of Anxiety and Depression Initial |
12.8 | — |
| SECONDARY Surrogate Satisfaction With the Patient's ICU Care: |
16.8 | — |
| SECONDARY Symptoms of Post-Traumatic Stress Disorder (PTSD) Final |
24.1 | — |
| SECONDARY Symptoms of Post-Traumatic Stress Disorder (PTSD) Final |
24.1 | — |
| SECONDARY Symptoms of Anxiety and Depression Final |
11.7 | — |
| SECONDARY Symptoms of Anxiety and Depression Final |
11.7 | — |
| SECONDARY Interview Initial |
— | — |
| SECONDARY Interview Final |
— | — |
Summary
Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life.
The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care.
The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals.
Eligibility Criteria
Inclusion Criteria
- The patient's surrogate was enrolled in "ICU Rounding Summaries for Families of Critically Ill Patients" (NCT03969810) and the patient had COVID-19
- The patient has been discharged from the hospital
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04501445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.