Post Traumatic Stress Disorder Clinical Trial
Official title:
Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19
Verified date | July 2022 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 31, 2021 |
Est. primary completion date | April 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Central Michigan University |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial | Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress. | Measured once upon enrollment | |
Primary | Symptoms of Anxiety and Depression Initial | 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 upon enrollment | |
Secondary | Surrogate Satisfaction With the Patient's ICU Care: | 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 upon enrollment | |
Secondary | Symptoms of Post-Traumatic Stress Disorder (PTSD) Final | IES-R score before intervention
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD |
Measured before behavioral intervention (6-12 weeks after enrollment) | |
Secondary | Symptoms of Post-Traumatic Stress Disorder (PTSD) Final | IES-R after intervention
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD |
Measured after behavioral intervention (12-24 weeks after enrollment) | |
Secondary | Symptoms of Anxiety and Depression Final | 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 before behavioral intervention (6-12 weeks after enrollment) | |
Secondary | Symptoms of Anxiety and Depression Final | 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 after behavioral intervention (12-24 weeks after enrollment) | |
Secondary | Interview Initial | Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms | Measured once upon enrollment | |
Secondary | Interview Final | Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms | Measured after behavioral intervention (12-24 weeks after enrollment) |
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