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

Cardiac Arrest Clinical Trial

— FAID Fear  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05144477
• Other study ID #: AAAT7681
• Secondary ID: P30AG064198
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Post Traumatic Stress Syndrome
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	CUIMC	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9. — View Citation

Edmondson D, Richardson S, Falzon L, Davidson KW, Mills MA, Neria Y. Posttraumatic stress disorder prevalence and risk of recurrence in acute coronary syndrome patients: a meta-analytic review. PLoS One. 2012;7(6):e38915. doi: 10.1371/journal.pone.0038915. Epub 2012 Jun 20. Erratum In: PLoS One. 2019 Mar 6;14(3):e0213635. — View Citation

French CC. Dying to know the truth: visions of a dying brain, or false memories? Lancet. 2001 Dec 15;358(9298):2010-1. doi: 10.1016/S0140-6736(01)07133-1. No abstract available. — View Citation

Gump BB, Kulik JA. Stress, affiliation, and emotional contagion. J Pers Soc Psychol. 1997 Feb;72(2):305-19. doi: 10.1037//0022-3514.72.2.305. — View Citation

Monane R, Sanchez GJ, Kronish IM, Edmondson D, Diaz KM. Post-traumatic stress disorder symptoms and aversive cognitions regarding physical activity in patients evaluated for acute coronary syndrome. Eur J Prev Cardiol. 2018 Mar;25(4):402-403. doi: 10.1177/2047487317746255. Epub 2017 Dec 4. No abstract available. — View Citation

Nielsen AH, Angel S, Egerod I, Hansen TB. The effect of diaries written by relatives for intensive care patients on posttraumatic stress (DRIP study): protocol for a randomized controlled trial and mixed methods study. BMC Nurs. 2018 Aug 16;17:37. doi: 10.1186/s12912-018-0306-y. eCollection 2018. — View Citation

Nielsen AH, Angel S, Egerod I, Lund TH, Renberg M, Hansen TB. The effect of family-authored diaries on posttraumatic stress disorder in intensive care unit patients and their relatives: A randomised controlled trial (DRIP-study). Aust Crit Care. 2020 Mar;33(2):123-129. doi: 10.1016/j.aucc.2019.01.004. Epub 2019 Feb 20. — View Citation

Rafaeli E, Gleason ME. Skilled support within intimate relationships. Journal of Family Theory & Review. 2009;1(1):20-37.

Rosman L, Whited A, Lampert R, Mosesso VN, Lawless C, Sears SF. Cardiac anxiety after sudden cardiac arrest: Severity, predictors and clinical implications. Int J Cardiol. 2015 Feb 15;181:73-6. doi: 10.1016/j.ijcard.2014.11.115. Epub 2014 Nov 18. — View Citation

Rossignac-Milon M, Higgins ET. Epistemic companions: shared reality development in close relationships. Curr Opin Psychol. 2018 Oct;23:66-71. doi: 10.1016/j.copsyc.2018.01.001. Epub 2018 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac Anxiety Questionnaire Fear Subscale Score	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). Possible mean scores range from 1 to 5.	Hospital discharge (approximately 21 days), 30 days post-discharge
Other	Cardiac Anxiety Questionnaire Avoidance Subscale Score	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). Possible mean scores range from 1 to 5.	Hospital discharge (approximately 21 days), 30 days post-discharge
Other	Posttraumatic Stress Disorder Checklist Score	This is to measure family members' posttraumatic stress symptoms in relation to the patients' cardiac arrest at discharge. Posttraumatic stress symptoms will be measured 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). Possible total scores range from 0 to 80.	30 days post-discharge
Primary	Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study	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).	Baseline (ICU admittance)
Primary	Proportion of Enrolled Family Members Who Complete the Pilot Study	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).	30 days post-discharge
Secondary	Proportion of Family Members That Adhere to the Diary Intervention	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).	Up to hospital discharge (approximately 21 days)
Secondary	Proportion of Family Members That Complete the Majority of Survey Assessments	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).	Up to 30 days post-discharge
Secondary	Proportion of Family Members That Agree That the Intervention Was Acceptable	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).	30 days post-discharge
Secondary	Proportion of Family Members That Agree That the Intervention Was Feasible	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).	30 days post-discharge
Secondary	Proportion of Family Members That Agree That the Intervention Was Appropriate	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).	30 days post-discharge