ICU Experience in Family Members

NCT02940028 | Unknown

• 1 other identifier: 1050308
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The ICU is a stressful and challenging place for patients and their families. Many family members experience anxiety, depression, and post-traumatic stress disorder during and after their ICU experience. The investigators are studying post-traumatic growth in this study. Post-traumatic growth (PTG) is a set of positive changes that occurs after a challenging or difficult life experience. This study investigates the effects of expressive writing on positive changes that occur after a difficult experience. PTG will be compared between the intervention group receiving the expressive writing intervention and the control group (non-expressive or fact based writing).

Conditions

Post-Traumatic Growth, Psychological

Outcome Measures

Primary Outcomes (1)

• Posttraumatic Growth Inventory

  4 months

Secondary Outcomes (8)

• Hospital Depression and Anxiety Scale

  4 months

• Impact of Event Scale Revised (IES-R)

  4 months

• Perceived Stress Scale

  4 months

• Brief COPE

  4 months

• Physical Symptoms Scale

  4 months

Study Arms (2)

Expressive writing intervention

EXPERIMENTAL

The intervention group will participate in a brief expressive writing intervention.

Behavioral: Expressive writing

Control writing intervention

OTHER

The control group will receive a control writing condition (fact based writing).

Behavioral: Control writing

Interventions

Expressive writing BEHAVIORAL

Brief expressive writing intervention

Expressive writing intervention

Control writing BEHAVIORAL

Brief fact-based writing exercise.

Control writing intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant can be a family member of a patient admitted to a study ICU for \>24 hours and ≥1 of the following:
• mechanical ventilation via endotracheal tube for ≥ 12 hours
• non-invasive ventilation (CPAP, BiPAP) for \> 4 hours in a 24-hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
• high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours
• use of vasopressors for shock of any etiology for \>1 hour
• Both participant and ICU patient must be adult (age ≥18 years of age)
• Participant must be able to read, speak, and write in English
• Participant must be enrolled within 72 hours of the patient's meeting mechanical ventilation criteria
• Participants who live with the patient will be accorded higher priority than those who do not live with the patient because they are more likely to be involved as caregivers. The preference would be for the participant to be the designated power of attorney; if there is no designated power of attorney living with the patient, then the primary informal caregiver (identified either by the patient or by the family) would be enrolled; if either of these is not available, the default surrogate (defined in figure 1) would be enrolled. If no one living with the patient meets these criteria, then family members and informal caregivers not living with the patient will be screened for the study. The preference would again be for first, the designated power of attorney, then a primary caregiver and a default surrogate. An informal caregiver provides care without reimbursement.

You may not qualify if:

• Pregnant or breastfeeding females
• Prisoners
• Children (age \<18 years of age)
• Known history of PTSD, dementia, or schizophrenia. Presence of these illnesses will be per participant report of physician diagnosis and treatment
• If a patient has been transferred from another ICU after an ICU course greater than 24 hours, or if the patient has had a previous ICU or long term acute care (LTAC) admission in the last 90 days, the family member or caregiver will be excluded.
• Patients admitted for hospice
• Participants who live more than 200 miles away or who have no specified domicile
• Non-English speaking

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Study Officials

• Ramona Hopkins, PhD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mardee Merrill

CONTACT

801-507-4608; mardee.merrill@imail.org

Ramona Hopkins, PhD

CONTACT

(801) 507-4569; mona.hopkins@imail.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 20, 2016
• Study Start: April 29, 2017
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)