Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear): A Pilot Intervention Study
Phase: NA
Conditions: Cardiac Arrest, Post Traumatic Stress Syndrome
Sponsor: Columbia University

Revised 7/5/2022 
Page 1 of 8 
Protocol for Proposed Pilot Study: Family-Authored ICU Diaries to Reduce Fear in Patients 
Experiencing a Cardiac Arrest (FAID Fear) 
NCT Number: NCT05144477 
Document Date: 7/5/2022 
 
 

Revised 7/5/2022 
Page 2 of 8 
1. Study Purpose and Rationale 
A cardiac arrest (CA) is a terrifying experience for patients, but maybe even more so for their 
loved ones. Whereas patients are not conscious and often have little to no memory of the CA 
and associated stay in the hospital and the intensive care unit (ICU),1,2 families witness all of 
these things, resulting in high levels of fear and psychological distress. Indeed, ~1/3 of family 
members of ICU patients report clinically significant posttraumatic stress symptoms (PTSS).3 
This phenomenon is so prevalent that it has been termed Post-Intensive Care Syndrome – 
Family (PICS – Family).3-5 
Critically, emotions are socially transmitted,6-8 memories are socially constructed,9-13 and 
partner distress can undermine the provision of skilled social support that can buffer patient 
distress.14,15 Prior research has suggested that patients experiencing CA will develop memories 
of the CA event over time1,2 – potentially because they are trying to “fill in the gaps” in their 
memory.16 As such, partners or other close 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.17 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, medication avoidance) and increased 
morbidity and mortality.18-24  
The present study will test the feasibility of a Family-Authored ICU-diary intervention to 
reduce fear of CA in patients’ partners/family members, with the long-term goal of 
developing and implementing a large scale RCT to test whether fear reductions in family 
members improve patients’ mental wellbeing, health behaviors, and, ultimately, health 
outcomes. Following the methods of a RCT published in 2020,25,26 partners/family members will 
receive a bound diary from a trained research assistant and a brief explanation of how to use 
the diary, including recommended frequency for writing and tips on how to express 
themselves. This intervention 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).25,26 
Aim 1: Enroll 31 partners/family members of CA patients to (a) pilot recruitment 
procedures, (b) estimate retention, and (c) assess acceptability of study procedures.  
Partners/family members will be randomized to either complete an ICU diary25,26 or to a 
control condition, and will complete surveys in the ICU or hospital floor, at patient end 
of hospital care (contingent upon discharge status), and 30 days post-end of hospital 
care.  
Aim 2: Obtain an estimate of the association of intervention v. control with (i) 
partner/family member fear (operationalized as cardiac anxiety about the patients’ 
cardiac condition) at hospital discharge and (ii) partner/family member PTSS 30 days 
post-discharge. 
Exploratory Aims: Obtain an estimate of the association of intervention v. control with 
partner/family member aversive cognitions towards exercise at hospital discharge. 

Revised 7/5/2022 
Page 3 of 8 
 
2. Study Design and Statistical Analysis  
This is a randomized control study design using an intervention v. control condition. It is a pilot 
feasibility trial of up to 31 participants. 
Participants will be drawn from caregiver participants enrolled in the CANOE study (AAAR8497), 
who have indicated they are willing to hear about additional research opportunities and who 
meet initial study criteria.  
Eligibility 
1) the primary partner or 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 and indicated they were willing to hear about future 
research opportunities,  
5) willing to write in a journal about their experiences,  
6) available for follow-up, and 
7) does not have any medical or psychiatric impairment that would prevent them from 
complying with the research protocol. 
 
Sample size and power estimates are based on Aim 1. Although some have used pilot studies 
to estimates effect sizes on primary outcomes, we agree with leaders in our field who argue 
that effect size estimates from small pilot studies are too imprecise to meaningfully inform 
effect size assumptions of power analyses for larger, later stage studies. Therefore, we do not 
provide power calculations for the effects of our intervention on fear-based mechanisms or 
behavioral outcomes. We will, however, use estimates from these studies (e.g., standard 
deviations, attrition rates) to help determine appropriate sample sizes for a subsequent study 
that is powered to detect meaningful reductions in measures of cardiac anxiety.  
As this is a pilot study, our sample size was guided by the need to enroll enough participants – 
specifically, family members or partners of patients who recently survived CA – to examine the 
feasibility of conducting a larger stage II or III randomized clinical trial of our FAID-Fear 
intervention in this population. In particular, we will determine whether we are capable of 
recruiting, retaining, and assessing participants, and of implementing the proposed intervention 
with good compliance.  
 
3. Study Procedures 
IRB-approved personnel from the CANOE (AAAR8497) research team will identify participants 
enrolled in the CANOE study as part of the caregiver cohort who have indicated they are willing 
to hear about additional research opportunities and who meet initial study criteria. Members of 
the CANOE research team will generate a list that includes the CANOE caregiver participant 

Revised 7/5/2022 
Page 4 of 8 
name, CANOE patient participant MRN, patient location, caregiver relationship to the patient, 
and caregiver contact information. The list will be sent to a member of the FAID Fear study 
team via encrypted email. Using the list, the FAID Fear study coordinator will either approach 
potentially eligible partners/family members in the ICU/hospital or contact them via telephone. 
A verbal information sheet that explains overall study participation will be used to complete the 
consent process.  
Partners/family members who undergo informed consent and agree to participate will be 
randomized 2:1 to either the ICU diary (intervention) or the control condition. Randomization 
will occur using opaque sealed envelopes to be opened by the study coordinator after consent 
is provided/documented. The partner/family member participant will be informed of the 
randomization assignment and a baseline assessment will also occur.  
Randomized to ICU Diary Condition 
These partners/family members will receive standard contact and communication from 
ICU/hospital doctors. 
Following the design of Nielsen et al.,25 partners/family members will be provided with a 
hard-cover diary containing written instructions (diary instructions included in RASCAL 
attachments) and a pen. If consent and randomization occur in person, the diary will be 
handed to the participant. If consent and randomization occur by phone, the diary will 
either be mailed to the participant or the coordinator will arrange for a time to meet the 
participant in the hospital or at the CBCH offices to provide the diary. A trained research 
assistant will explain how to use the diary, and instructions will include recommended 
frequency for writing and tips on how to express themselves. The hard copy of the diary will 
remain with the partner/family member participant and they will be asked to continue 
writing in the diary until patient end of hospital care (e.g. ICU). The diary will not be 
collected at the conclusion of the study. Research assistants will check in with participants 
via weekly telephone calls to provide support, as needed, if the partner/family member 
reports difficulty in writing diary entries (e.g., suggesting the partner/family member write 
at home rather than in the hospital, encouraging use of key words or focusing on the 
present if events are hard to summarize). 
We confirm that the hard-copy diary that is provided to subjects will not reference any 
identifiers or codes and the diary will NOT be collected back from participants as part of the 
study (once the blank diary is given to the participant, it is theirs to keep). 
Randomized to Control Condition 
These partners/family members will receive standard contact and communication from 
ICU/hospital doctors. 
The CANOE patient MRN will be used to access the patient EHR to view/document the date of 
discharge or death. All FAID Fear study participants (both intervention and control) will 
complete 1) a survey upon end of hospital care (contingent upon discharge status; specifically, 
if a patient dies, then we will not contact family members at this time but will wait to contact 
them until one month has passed in accordance with the procedures of the CANOE-F team in 

Revised 7/5/2022 
Page 5 of 8 
order to be respectful of, and sensitive to, the needs of participants for space and time), and 2) 
a final survey at 30 days post-end of hospital care (participants randomized to the control 
condition will not be asked questions about intervention appropriateness, feasibility, and 
acceptability, but will be asked if they kept a diary. If yes, they will be asked questions about 
diary usage). Upon completion of the 30-day survey, study participation is complete.  
For analysis purposes, the data collected as part of this study will be shared with CANOE study 
(AAAR8497) researchers. The patient MRN number will be used to link partner/family member 
participant data from this study with data from the CANOE study.  
In addition, identifiable data from the PACE study (AAAT4053) will be accessed and used as part 
of our analysis.   
Compensation: Participants will be provided with compensation to acknowledge the time and 
effort put into study participation as follows: 
• Payment for randomization - $25.  
• Payment for survey completion at baseline - $25 
• Payment for survey completion at 30-days post-end of hospital care - $50 
Total compensation for the completion of all study activity is $100. Payments will be distributed 
in the form of Bank of America PayCards.  
 
4. Risks 
Study procedures (i.e., completing questionnaires and, as applicable, writing in an ICU diary) 
present minimal risk. The questions asked and the thoughts evoked during the course of this 
research study pose minimal risk of psychological discomfort, and participants may wish to skip 
any question or questionnaire that they choose. Participants will be made aware of these risks 
and will be assured they can terminate their participation in the study at any time without 
penalty. A mental health referral plan is outlined in the Data Safety and Monitoring section of 
this protocol. 
Study participation also involves the possibility of a loss of confidentiality.  The study team has 
outlined plans to protect participant confidentiality in the Privacy and Data Security section of 
RASCAL. 
 
5. Benefits  
There is no direct benefit to subjects who participate in this study. Results may be used to 
design future adequately powered RCTs to refine and develop ICU-based diary interventions. 
The information obtained as a result of this study may thus help future family members cope 
with the distressing experience of a loved one experiencing a cardiac arrest, and surviving 
patients may also benefit. 

Revised 7/5/2022 
Page 6 of 8 
 
6. Alternatives 
The alternative is not to participate.   
 
7. Data and Safety Monitoring 
As this study presents minimal risk to participants, data and safety monitoring will be 
conducted by the study staff as directed by the principal investigator. Thus, there is no plan for 
a Data Safety and Monitoring Board (DSMB).  
Mental Health Referral Plan: To support subject well-being, all subjects will be asked if they 
would like to be provided with a mental health resource sheet (which reflects referral to 
General Psychiatry at Columbia University Irving Medical Center) at the 30-day contact.  
If a participant expresses immediate risk of self-harm during study participation, we will follow 
mandated reporting requirements, which may include emergency room evaluation and/or 
psychiatric services. These safety procedures will be overseen by Dr. Talea Cornelius, who also 
holds a master’s degree in Clinical Social Work, and has previous experience with counseling, 
care coordination, patient referrals, and client services.  
Study Team Meetings: Investigators and research assistants will meet weekly to discuss any 
issues or concerns with the study, in particular, whether there were any unexpected complaints 
about the study procedures or questionnaires, or whether there were any breaches in data 
confidentiality (which will be reported to the IRB as required by policy). If unexpected 
complaints about the study tasks or questionnaires are generated, then the study may be 
stopped or altered prior to recruiting the full sample.  
 
References 
1. 
Parnia S, Waller DG, Yeates R, Fenwick P. A qualitative and quantitative study of the incidence, 
features and aetiology of near death experiences in cardiac arrest survivors. Resuscitation. 
2001;48(2):149-156. 
2. 
Van Lommel P, Van Wees R, Meyers V, Elfferich I. Near-death experience in survivors of cardiac 
arrest: a prospective study in the Netherlands. The Lancet. 2001;358(9298):2039-2045. 
3. 
Azoulay E, Pochard F, Kentish-Barnes N, et al. Risk of post-traumatic stress symptoms in family 
members of intensive care unit patients. American journal of respiratory and critical care 
medicine. 2005;171(9):987-994. 
4. 
Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: Postintensive care 
syndrome–family. Critical care medicine. 2012;40(2):618-624. 
5. 
Zante B, Camenisch SA, Schefold JC. Interventions in Post-Intensive Care Syndrome-Family: A 
Systematic Literature Review. Critical care medicine. 2020;48(9):e835-e840. 
6. 
Rose AJ. Co–rumination in the friendships of girls and boys. Child development. 2002;73(6):1830-
1843. 

Revised 7/5/2022 
Page 7 of 8 
7. 
Gump BB, Kulik JA. Stress, affiliation, and emotional contagion. Journal of personality and social 
psychology. 1997;72(2):305. 
8. 
Butler EA. Interpersonal affect dynamics: It takes two (and time) to tango. Emotion Review. 
2015;7(4):336-341. 
9. 
French L, Garry M, Mori K. You say tomato? Collaborative remembering leads to more false 
memories for intimate couples than for strangers. Memory. 2008;16(3):262-273. 
10. 
Condon CE, Ritchie TD, Igou ER. How dyads reminiscence moderates the relations between 
familiarity, trust, and memory conformity. Social Psychology. 2015;46(2):65. 
11. 
Hirst W, Echterhoff G. Remembering in conversations: The social sharing and reshaping of 
memories. Annual review of psychology. 2012;63. 
12. 
Rossignac-Milon M, Higgins ET. Epistemic companions: Shared reality development in close 
relationships. Current opinion in psychology. 2018;23:66-71. 
13. 
Hardin CD, Higgins ET. Shared reality: How social verification makes the subjective objective. 
1996. 
14. 
Uchino BN. Understanding the links between social support and physical health: A life-span 
perspective with emphasis on the separability of perceived and received support. Perspectives 
on psychological science. 2009;4(3):236-255. 
15. 
Rafaeli E, Gleason ME. Skilled support within intimate relationships. Journal of Family Theory & 
Review. 2009;1(1):20-37. 
16. 
French CC. Dying to know the truth: visions of a dying brain, or false memories? The Lancet. 
2001;358(9298):2010-2011. 
17. 
Rosman L, Whited A, Lampert R, Mosesso VN, Lawless C, Sears SF. Cardiac anxiety after sudden 
cardiac arrest: Severity, predictors and clinical implications. International journal of cardiology. 
2015;181:73-76. 
18. 
Edmondson D, Horowitz CR, Goldfinger JZ, Fei K, Kronish IM. Concerns about medications 
mediate the association of posttraumatic stress disorder with adherence to medication in stroke 
survivors. British journal of health psychology. 2013;18(4):799-813. 
19. 
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. 
20. 
Husain SA, Edmondson D, Kautz M, Umland R, Kronish IM. Posttraumatic stress disorder due to 
acute cardiac events and aversive cognitions towards cardiovascular medications. Journal of 
behavioral medicine. 2018;41(2):261-268. 
21. 
Kronish IM, Cornelius T, Schwartz JE, et al. Posttraumatic Stress Disorder and Electronically 
Measured Medication Adherence After Suspected Acute Coronary Syndromes. Circulation. 
2020;142(8):817-819. 
22. 
Kronish IM, Edmondson D, Goldfinger JZ, Fei K, Horowitz CR. Posttraumatic stress disorder and 
adherence to medications in survivors of strokes and transient ischemic attacks. Stroke. 
2012;43(8):2192-2197. 
23. 
Kronish IM, Edmondson D, Li Y, Cohen BE. Post-traumatic stress disorder and medication 
adherence: results from the Mind Your Heart study. Journal of psychiatric research. 
2012;46(12):1595-1599. 
24. 
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. European journal of preventive cardiology. 2018;25(4):402-403. 
25. 
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 nursing. 2018;17(1):1-10. 

Revised 7/5/2022 
Page 8 of 8 
26. 
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). Australian Critical Care. 2020;33(2):123-129. 
27. 
National Center for PTSD. PTSD Checklist for DSM-5 (PCL-5). 
https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp. Published 
February 22, 2018. Accessed2018. 
28. 
Eifert GH, Thompson RN, Zvolensky MJ, et al. The cardiac anxiety questionnaire: development 
and preliminary validity. Behaviour research and therapy. 2000;38(10):1039-1053.