Psychological Symptoms and Families of COVID-19 Patients

NCT04501445 | Completed Results

• 1 other identifier: 20071101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Family Members; Post Intensive Care Unit Syndrome; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Surrogate Satisfaction With the Patient's ICU Care:

  Measured once upon enrollment

• Symptoms of Post-Traumatic Stress Disorder (PTSD) Final

  Measured before behavioral intervention (6-12 weeks after enrollment)

• Symptoms of Post-Traumatic Stress Disorder (PTSD) Final

  Measured after behavioral intervention (12-24 weeks after enrollment)

• Symptoms of Anxiety and Depression Final

  Measured before behavioral intervention (6-12 weeks after enrollment)

• Symptoms of Anxiety and Depression Final

  Measured after behavioral intervention (12-24 weeks after enrollment)

Study Arms (2)

Rounding Summary

EXPERIMENTAL

Surrogates who were assigned to the intervention group received a written rounding summary every day or every other day that the patient is in the ICU.

Behavioral: Written Summary of Rounds

Usual Care

NO INTERVENTION

Interventions

Written Summary of Rounds BEHAVIORAL

The summary was 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.

Rounding Summary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Rush University Medical Center: lead
• Central Michigan University: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

• 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.

  PMID: 22080636 BACKGROUND

• 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.

  PMID: 28387538 BACKGROUND

• 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.

  PMID: 27984278 BACKGROUND

• White KR, Lee JJ, Sarigiannis KA, Tringali JJ, Vu J, Eaton England A, Lietzau S, Hebert C, Banayan D, Basapur S, Glover CM, Shah RC, Gerhart J, Greenberg JA. Restrictive Visitation Policies and Related Post-Traumatic Stress Among Families of Critically Ill Patients With COVID-19. Chest. 2023 Dec;164(6):1462-1465. doi: 10.1016/j.chest.2023.06.021. Epub 2023 Jun 24. No abstract available.

  PMID: 37356707 DERIVED

• Sarigiannis KA, Tringali JJ, Vu J, Eaton England A, Lietzau S, Hebert C, Banayan D, Basapur S, Glover CM, Shah RC, Gerhart J, Greenberg JA. Symptoms of Anxiety, Depression, and Stress among Families of Critically Ill Patients with COVID-19: A Longitudinal Clinical Trial. Ann Am Thorac Soc. 2023 May;20(5):705-712. doi: 10.1513/AnnalsATS.202209-797OC.

  PMID: 36603135 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

small sample size, single center

Results Point of Contact

• Title: Jared A Greenberg
• Organization: Rush University Medical Center

jared_greenberg@rush.edu

312-942-6744

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: September 14, 2020
• Primary Completion: April 8, 2021
• Study Completion: July 31, 2021
• Last Updated: April 27, 2023
• Results First Posted: April 27, 2023

Record last verified: 2022-07

Locations

US (1)