Clinical trial NCT05144477: Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)
Official title: Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear): A Pilot Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Post Traumatic Stress Syndrome
Keywords: Family Members
Couples
Partners
Fear
Fear of Exercise
Physical Activity
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-12-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria

1. The family member of a patient who has experienced a cardiac arrest
2. Age 18 years and over
3. Able to speak, read, and write in English or Spanish
4. Participating in the CANOE study (AAAR8497) and indicated they were willing to hear about future research opportunities
5. Willing to write in a journal about their experiences

Exclusion Criteria

1. Unavailable for follow-up
2. Medical or psychiatric impairment that would prevent them from complying with the research protocol

Primary outcomes:
measure: Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study
timeFrame: Baseline (ICU admittance)
measure: Proportion of Enrolled Family Members Who Complete the Pilot Study
timeFrame: 30 days post-discharge
Secondary outcomes:
measure: Proportion of Family Members That Adhere to the Diary Intervention
timeFrame: Up to hospital discharge (approximately 21 days)
measure: Proportion of Family Members That Complete the Majority of Survey Assessments
timeFrame: Up to 30 days post-discharge
measure: Proportion of Family Members That Agree That the Intervention Was Acceptable
timeFrame: 30 days post-discharge
measure: Proportion of Family Members That Agree That the Intervention Was Feasible
timeFrame: 30 days post-discharge
measure: Proportion of Family Members That Agree That the Intervention Was Appropriate
timeFrame: 30 days post-discharge
Other outcomes:
measure: Cardiac Anxiety Questionnaire Fear Subscale Score
timeFrame: Hospital discharge (approximately 21 days), 30 days post-discharge
measure: Cardiac Anxiety Questionnaire Avoidance Subscale Score
timeFrame: Hospital discharge (approximately 21 days), 30 days post-discharge
measure: Posttraumatic Stress Disorder Checklist Score
timeFrame: 30 days post-discharge
Locations:
city: New York
country: United States
facility: CUIMC
state: New York
Study officials:
affiliation: Assistant Professor of Medicine
name: Talea Cornelius, PhD, MSW, MS
role: PRINCIPAL_INVESTIGATOR
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