Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)

Not Applicable

Completed

Conditions: Post Traumatic Stress Syndrome
Cardiac Arrest

Interventions: Behavioral: FAID Fear Intervention

Registration Number: NCT05144477

Lead Sponsor: Columbia University

Brief Summary: The present study will:

Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures.

Family members will be randomized to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge.

Aim 2: Obtain an estimate of the association of intervention v. control with (i) family member fear (operationalized as cardiac anxiety about the patients' cardiac condition) at hospital discharge and (ii) family member PTSS 30 days post-discharge.

Exploratory Aims: Obtain an estimate of the association of intervention v. control with family member aversive cognitions towards exercise at hospital discharge.

Detailed Description: A cardiac arrest (CA) is a terrifying experience for patients, but maybe even more so for their loved ones. CA patients often have little to no memory of the CA and are often unconscious for substantial parts of their hospitalization, particularly their time in the intensive care unit (ICU) . In contrast, family members often witness all of these things, resulting in high levels of fear and psychological distress in family members. This phenomenon is so prevalent that it has been termed Post-Intensive Care Syndrome - Family (PICS - Family).

Critically, emotions are socially transmitted and memories are socially constructed. In this manner, family members can transmit their distress onto patients. Prior research has suggested that patients experiencing CA will develop memories of the CA event over time - potentially because they are trying to "fill in the gaps" in their memory. As such, family members may play a critical role in creating and cementing fear-based memories and distress in patients experiencing a CA. CA patients often report cardiac fear and preoccupation. This is not without consequence: fear-based distress, particularly early anxiety related to symptoms (e.g., rapid heartbeat) and markers for PTSS in other patient populations predicts reduced engagement in behavior necessary for secondary prevention (e.g., reduced physical activity) and increased morbidity and mortality. Distress in family members can also have an adverse impact on patients by undermining the capacity of family members to provide effective social support that can buffer patient distress.

A prior clinical trial found that family-authored diaries significantly reduced PTSS in family members (26.3% lower in intervention v. control conditions, 95% CI 4.8, 52.2) and trended towards a reduction in PTSS for patients (11.2% lower, 95% CI 15.7, 46.8). However, mechanisms of these effects were not examined, and no dyadic effects were tested. Furthermore, these previous diary studies have been conducted with the intention of sharing diaries with patients.

The present study will test the feasibility involving a similar Family-Authored ICU-diary intervention to reduce a proximal, dyadic mechanism: fear of CA in patients' family members. The target audience of the diary is thus family members, and patients will not see the diary unless the family member individually chooses to share it. The feasibility of targeting family member well-being alone is untested. The long-term goal is conducting a large scale randomized clinical trial (RCT) that tests whether a family-authored ICU diary can reduce fear of cardiac arrest in family members, and in turn, improve patients' mental wellbeing, health behaviors, and, ultimately, health outcomes.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FAID Fear Intervention	FAID Fear Intervention	Family members of CA patients assigned to intervention will receive the ICU diary.

Primary Outcome Measures

Name	Time	Method
Proportion of Enrolled Family Members Who Complete the Pilot Study	30 days post-discharge	This is to estimate/assess retention. Family members who remain in the study at the final assessment will be tallied. Specifically, we divided the number of family member participants who completed the study by the number of potential participants who did not complete the study (completed/did not complete).
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study	Baseline (ICU admittance)	This is to assess feasibility of recruitment. Potential family member participants whom the study team approaches and agree/consent to take part in the study will be tallied. Specifically, we divided the number of family member participants who enrolled in the study by the number of potential participants referred to the study (enrolled/referred).

Secondary Outcome Measures

Name	Time	Method
Proportion of Family Members That Adhere to the Diary Intervention	Up to hospital discharge (approximately 21 days)	This is to assess acceptability of study procedures. Family members who report completing at least 2 diary entries/week will be tallied. Specifically, we divided the number of family member participants in the diary intervention who adhered to the intervention by the number of participants who did not adhere to the intervention (adhered/did not adhere).
Proportion of Family Members That Agree That the Intervention Was Appropriate	30 days post-discharge	As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was appropriate for reducing cardiac anxiety about the patient's heart using the 4-item Intervention Appropriateness Measure (score \>= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5. Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was appropriate by the number of family member participants in the diary intervention who did not agree that the intervention was appropriate (appropriate/not appropriate).
Proportion of Family Members That Complete the Majority of Survey Assessments	Up to 30 days post-discharge	This is to assess acceptability of study procedures. Family members who complete at least 90% of survey assessments will be tallied. Specifically, we divided the number of family member participants who completed at least 90% of survey assessments by the number of family member participants who completed less than 90% of survey assessments (completed/did not complete).
Proportion of Family Members That Agree That the Intervention Was Acceptable	30 days post-discharge	As a measure of intervention acceptability, study will assess the proportion of participants who agree that the intervention was acceptable for reducing cardiac anxiety about the patient's heart using mean of the 4-item Acceptability of Intervention Measure (score \>= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5. Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was acceptable by the number of family member participants in the diary intervention who did not agree that the intervention was acceptable (acceptable/not acceptable).
Proportion of Family Members That Agree That the Intervention Was Feasible	30 days post-discharge	As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was feasible using the mean of the 4-item Feasibility of Intervention Measure (score \>= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5. Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was feasible by the number of family member participants in the diary intervention who did not agree that the intervention was feasible (feasible/not feasible).