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

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05144477

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest Post Traumatic Stress Syndrome	Behavioral: FAID Fear Intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear): A Pilot Intervention Study

Actual Study Start Date :

Nov 29, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FAID Fear Intervention Family members of CA patients assigned to intervention will receive the ICU diary.	Behavioral: FAID Fear Intervention Participants will receive a hard-cover diary, written instructions on diary completion, and a pen. A trained research assistant will meet with the participant face to face or via telephone and explain how to use the diary. Instructions will include recommended frequency for writing (at least twice a week) and tips on how to express themselves. Potential topics will also be addressed, including what to write about in the beginning, during the ICU, and after ICU discharge. The hard copy of the diary will remain with the family member participant, and they will be asked to continue writing in the diary at least until patient discharge from the hospital. Research assistants will check in with participants via weekly telephone calls to provide prompts to remind them to use the diary and support, as needed, if the participant reports difficulty in writing diary entries. These calls will last approximately 1-5 minutes and will continue until patient discharge from the hospital. Other Names: Family-Authored ICU Diaries to Reduce Fear
No Intervention: Control condition - Usual Care Family members of CA patients assigned to usual care will not receive the ICU diary.

Arm

Intervention/Treatment

Experimental: FAID Fear Intervention

Family members of CA patients assigned to intervention will receive the ICU diary.

Behavioral: FAID Fear Intervention

Participants will receive a hard-cover diary, written instructions on diary completion, and a pen. A trained research assistant will meet with the participant face to face or via telephone and explain how to use the diary. Instructions will include recommended frequency for writing (at least twice a week) and tips on how to express themselves. Potential topics will also be addressed, including what to write about in the beginning, during the ICU, and after ICU discharge. The hard copy of the diary will remain with the family member participant, and they will be asked to continue writing in the diary at least until patient discharge from the hospital. Research assistants will check in with participants via weekly telephone calls to provide prompts to remind them to use the diary and support, as needed, if the participant reports difficulty in writing diary entries. These calls will last approximately 1-5 minutes and will continue until patient discharge from the hospital.

Other Names:

Family-Authored ICU Diaries to Reduce Fear

No Intervention: Control condition - Usual Care

Family members of CA patients assigned to usual care will not receive the ICU diary.

Outcome Measures

Primary Outcome Measures

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.
Proportion of enrolled family members who complete the pilot study [30 days post-discharge]
This is to estimate/assess retention. Family members who continue writing in the diary as instructed at the recommended frequency until patient discharge from the ICU will be tallied.

Secondary Outcome Measures

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.
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.
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).
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).
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).

Other Outcome Measures

Cardiac Anxiety Questionnaire Fear Subscale Score [Hospital discharge (approximately 21 days), 30 days post-discharge]
This is to measure family members' cardiac anxiety about the patients' heart. Cardiac anxiety will be measured using the 8-item fear subscale of the Cardiac Anxiety Questionnaire and compared between intervention and control participants (higher scores indicate greater fear; 1 = never, 5 = always).
Cardiac Anxiety Questionnaire Avoidance Subscale Score [Hospital discharge (approximately 21 days), 30 days post-discharge]
This is to measure family members' aversive cognitions towards patients' exercise. Aversive cognitions towards exercise will be measured using the 5-item avoidance subscale of the Cardiac Anxiety Questionnaire and compared between intervention and control participants (higher scores indicate greater aversive cognitions; 1 = never, 5 = always).
Posttraumatic Stress Disorder Checklist Score [30 days post-discharge]
This is to measure family members' posttraumatic stress symptoms in relation to the patients' cardiac arrest at discharge. Posttraumatic stress symptoms will be measuring using the sum of the 20-item Posttraumatic Stress Disorder Checklist cued to the CA-event and related hospitalization and compared between intervention and control participants. A score >=33 is considered a positive screen for PTSD (higher scores indicate greater PTSD symptoms; 0 = not at all, 4 = extremely).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

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

Exclusion Criteria