Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)

Study Overview
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Brief Summary
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Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience.

Official Title
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Pilot Evaluation of FAMCOPE-ICU

Conditions
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Emotion Regulation, Coping Skills

Intervention / Treatment
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* Behavioral: FAMCOPE-ICU


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: 18-89 years old Intensive Care Unit (ICU) length of stay (LOS) >= 48 hours No anticipated ICU LOS for next 24 hours Unable to make healthcare decisions Family Inclusion Criteria Identified by critical care team as legally authorized representative (LAR) Able to speak or comprehend English >= 18 years old Patient Exclusion Criteria: Less than 18 years or older than 89 years ICU LOS < 48 hours Anticipated ICU discharge within next 24 hours Able to make healthcare decisions Family Exclusion Criteria Not identified by critical care team as the LAR Unable to speak or comprehend English < 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAMCOPE-ICU<br>A digital eHealth emotion regulation and coping intervention. | Behavioral: FAMCOPE-ICU<br>* (1) FAMCOPE-ICU is a digital eHealth emotion regulation and coping intervention. FAMCOPE-ICU contains three digital modules representing the three interventional doses. Corresponding with Gross's Extended Process Model of Emotion Regulation, the three respective doses entail assessments, adaptive feedback, and interactive activities pertaining to understanding their affective experiences, learning strategies to regulate emotions and stress, and practicing these skills in a virtual decision-making task. Each dose of the intervention is expected to last 10-15 minutes<br>|
| No Intervention: Usual Care<br>The care and support routinely provided to SDMs of critically ill patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention Measure | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) | After dose 1, 5 minutes | 
| Acceptability of Intervention Measure | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) | After dose 2, 5 minutes | 
| Acceptability of Intervention Measure | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) | After dose 3, 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety as measured by PROMIS Anxiety Short Form | Four item self-report survey; item responses range from 1 (Never) to 5 (Always) | Baseline (enrollment), one week. | 
| Change in Depression as measured by PROMIS Depression Short Form | Four item self-report survey; item responses range from 1 (Never) to 5 (Always) | Baseline (enrollment), one week. | 
| Change in Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form | Eight item self-report survey; item responses range from 1 (Not at all) to 5 (Very much) | Baseline (enrollment), one week. | 
| Decision Fatigue Scale | Nine item self-report survey; item responses range from 0 (Strongly Disagree) to 3 (Strongly Agree) | One week post-enrollment | 
| Decisional Conflict Scale | 10 item self-report survey; item responses are yes, unsure, and no. | One week post-enrollment | 
| Satisfaction as measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R | Four item self-report survey; item responses range from 1 (Very dissatisfied) to 5 (Completely satisfied) | One week post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Care, Informal Caregiving, Surrogate Decision-Making, Self-Regulation