ICU Experience in Family Members

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-29

Study Completion Date

2021-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Post-Traumatic Growth, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Expressive writing intervention

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

Group Type EXPERIMENTAL

Expressive writing

Intervention Type BEHAVIORAL

Brief expressive writing intervention

Control writing intervention

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

Group Type OTHER

Control writing

Intervention Type BEHAVIORAL

Brief fact-based writing exercise.

Interventions

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Expressive writing

Brief expressive writing intervention

Intervention Type BEHAVIORAL

Control writing

Brief fact-based writing exercise.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes