ICU Experience in Family Members

Sponsor
Intermountain Health Care, Inc. (Other)
Overall Status
Unknown status
CT.gov ID
NCT02940028
Collaborator
(none)
130
1
2
47.1
2.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Expressive writing
  • Behavioral: Control writing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
ICU Experience Among Family Members of ICU Patients
Actual Study Start Date :
Apr 29, 2017
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Expressive writing intervention

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

Behavioral: Expressive writing
Brief expressive writing intervention

Other: Control writing intervention

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

Behavioral: Control writing
Brief fact-based writing exercise.

Outcome Measures

Primary Outcome Measures

  1. Posttraumatic Growth Inventory [4 months]

Secondary Outcome Measures

  1. Hospital Depression and Anxiety Scale [4 months]

  2. Impact of Event Scale Revised (IES-R) [4 months]

  3. Perceived Stress Scale [4 months]

  4. Brief COPE [4 months]

  5. Physical Symptoms Scale [4 months]

  6. Groningen Activity Restriction Scale (GARS) [4 months]

  7. Activity Restriction Scale [4 months]

  8. Essay Evaluation Measure [4 months]

    The essay evaluation measure assesses if the writing sample (essay) was personal, meaningful and reveals emotions. This measure has 3 items that are scored 0 to 6 for a total score of 0 to 18.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Family members of ICU patients are eligible for the study. We will enroll one study participant per patient admitted to a study ICU (Shock Trauma or Respiratory ICU at

Intermountain Medical Center) who meets the following 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Intermountain Medical Center Murray Utah United States 84107

Sponsors and Collaborators

  • Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: Ramona Hopkins, PhD, Intermountain Health Care, Inc.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT02940028
Other Study ID Numbers:
  • 1050308
First Posted:
Oct 20, 2016
Last Update Posted:
Jun 18, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 18, 2020