Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)
NCT ID: NCT05144477
Last Updated: 2023-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2021-11-29
2022-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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FAID Fear Intervention
Family members of CA patients assigned to intervention will receive the ICU diary.
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.
Control condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Medical or psychiatric impairment that would prevent them from complying with the research protocol
18 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Columbia University
OTHER
Responsible Party
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Talea M. Cornelius
Assistant Professor of Medicine
Principal Investigators
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Talea Cornelius, PhD, MSW, MS
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Medicine
Locations
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CUIMC
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Rafaeli E, Gleason ME. Skilled support within intimate relationships. Journal of Family Theory & Review. 2009;1(1):20-37.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AAAT7681
Identifier Type: -
Identifier Source: org_study_id
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