Cardiac Arrest, Post Traumatic Stress Syndrome
Conditions
Keywords
Family Members, Couples, Partners, Fear, Fear of Exercise, Physical Activity
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.
Interventions
BEHAVIORALFAID 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.
Sponsors
National Institute on Aging (NIA)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Enrolled Family Members Who Complete the Pilot Study | 30 days post-discharge | 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). |
| 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. 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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). |
| 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). 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). |
| 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. 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). |
| 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). 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). |
| 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). 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). Possible mean scores range from 1 to 5. |
| 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). Possible mean scores range from 1 to 5. |
| 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 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. |
Countries
United States
Participant flow
Recruitment details
The first participant enrolled on November 29, 2021, and the last enrolled on September 30, 2022. Follow-up sessions occurred between January 21, 2022-November 30, 2022.
Pre-assignment details
The baseline/pre-intervention session was conducted in person or over the telephone. During the baseline/pre-intervention session, participants (1) provided verbal consent, (2) were randomized, and (3) completed baseline assessments.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Control Condition - Usual Care Family members of CA patients assigned to usual care will not receive the ICU diary. | 5 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Control Condition - Usual Care | Total | FAID Fear Intervention |
|---|---|---|---|
| Age, Continuous | 49.20 years STANDARD_DEVIATION 15.04 | 50.73 years STANDARD_DEVIATION 13.41 | 51.50 years STANDARD_DEVIATION 13.32 |
| Education Associate's Degree | 0 Participants | 1 Participants | 1 Participants |
| Education College Degree | 1 Participants | 4 Participants | 3 Participants |
| Education Graduate/ Professional Degree | 1 Participants | 3 Participants | 2 Participants |
| Education High School/GED | 2 Participants | 4 Participants | 2 Participants |
| Education Less than High School | 0 Participants | 0 Participants | 0 Participants |
| Education No Formal Education | 0 Participants | 0 Participants | 0 Participants |
| Education Some College | 1 Participants | 3 Participants | 2 Participants |
| Education Some High School | 0 Participants | 0 Participants | 0 Participants |
| Education Trade/Vocational School | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance No | 0 Participants | 2 Participants | 2 Participants |
| Health Insurance Yes | 5 Participants | 13 Participants | 8 Participants |
| Income $0 | 0 Participants | 0 Participants | 0 Participants |
| Income $100,000 - $149,999 | 0 Participants | 1 Participants | 1 Participants |
| Income $10,000 - $24,999 | 0 Participants | 2 Participants | 2 Participants |
| Income $150,000 or more | 0 Participants | 1 Participants | 1 Participants |
| Income $1 - $9,999 | 0 Participants | 0 Participants | 0 Participants |
| Income $25,000 - $49,999 | 1 Participants | 3 Participants | 2 Participants |
| Income $50,000 - $74,999 | 0 Participants | 0 Participants | 0 Participants |
| Income $75,000 - $99,999 | 0 Participants | 0 Participants | 0 Participants |
| Income Decline to Respond | 2 Participants | 2 Participants | 0 Participants |
| Language English | 4 Participants | 12 Participants | 8 Participants |
| Language Spanish | 1 Participants | 3 Participants | 2 Participants |
| Live with Patient No | 1 Participants | 2 Participants | 1 Participants |
| Live with Patient Yes | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 6 Participants |
| Region of Enrollment United States | 5 participants | 15 participants | 10 participants |
| Relationship Length (Partners of Patients Only) | 22.67 years STANDARD_DEVIATION 19.14 | 20.70 years STANDARD_DEVIATION 13.25 | 19.86 years STANDARD_DEVIATION 11.77 |
| Relationship to Patient Child | 1 Participants | 3 Participants | 2 Participants |
| Relationship to Patient Parent | 0 Participants | 1 Participants | 1 Participants |
| Relationship to Patient Partner | 3 Participants | 10 Participants | 7 Participants |
| Relationship to Patient Sibling | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 12 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
| Sex/Gender, Customized Gender Man | 2 Participants | 3 Participants | 1 Participants |
| Sex/Gender, Customized Gender Woman | 3 Participants | 12 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
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).
Time frame: Baseline (ICU admittance)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Referrals to FAID Fear | Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study | Agreed to Participate | 16 Participants |
| All Referrals to FAID Fear | Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study | Declined to Participate | 4 Participants |
| All Referrals to FAID Fear | Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study | Unable to Reach | 5 Participants |
95% CI: [0.425, 0.82]
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).
Time frame: 30 days post-discharge
Population: Proportion of enrolled participants who remained in the study 30 days after the end of hospital care was calculated.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Referrals to FAID Fear | Proportion of Enrolled Family Members Who Complete the Pilot Study | Remained in FAID Fear | 14 Participants |
| All Referrals to FAID Fear | Proportion of Enrolled Family Members Who Complete the Pilot Study | Withdrew from FAID Fear | 2 Participants |
95% CI: [0.617, 0.985]
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).
Time frame: Up to hospital discharge (approximately 21 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Referrals to FAID Fear | Proportion of Family Members That Adhere to the Diary Intervention | Adherent to Diary Intervention | 7 Participants |
| All Referrals to FAID Fear | Proportion of Family Members That Adhere to the Diary Intervention | Not Adherent to Diary Intervention | 4 Participants |
95% CI: [0.308, 0.891]
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).
Time frame: 30 days post-discharge
Population: Excludes participant who withdrew immediately following randomization.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Referrals to FAID Fear | Proportion of Family Members That Agree That the Intervention Was Acceptable | Acceptable | 8 Participants |
| All Referrals to FAID Fear | Proportion of Family Members That Agree That the Intervention Was Acceptable | Not Acceptable | 2 Participants |
95% CI: [0.444, 0.975]
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).
Time frame: 30 days post-discharge
Population: Excludes one participant who withdrew immediately following randomization.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Referrals to FAID Fear | Proportion of Family Members That Agree That the Intervention Was Appropriate | Appropriate | 7 Participants |
| All Referrals to FAID Fear | Proportion of Family Members That Agree That the Intervention Was Appropriate | Not Appropriate | 3 Participants |
95% CI: [0.348, 0.933]
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).
Time frame: 30 days post-discharge
Population: Excludes one participant who withdrew immediately after randomization.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Referrals to FAID Fear | Proportion of Family Members That Agree That the Intervention Was Feasible | Feasible | 9 Participants |
| All Referrals to FAID Fear | Proportion of Family Members That Agree That the Intervention Was Feasible | Not Feasible | 1 Participants |
95% CI: [0.555, 0.998]
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).
Time frame: Up to 30 days post-discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Referrals to FAID Fear | Proportion of Family Members That Complete the Majority of Survey Assessments | Provided Data for >= 90% of Assessments | 14 Participants |
| All Referrals to FAID Fear | Proportion of Family Members That Complete the Majority of Survey Assessments | Provided Data for < 90% of Assessments | 2 Participants |
95% CI: [0.617, 0.985]
Other Pre-specified
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.
Time frame: Hospital discharge (approximately 21 days), 30 days post-discharge
Population: Excludes two participants who did not provide data for these assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Referrals to FAID Fear | Cardiac Anxiety Questionnaire Avoidance Subscale Score | End of Hospital Care | 3.56 score on a scale | Standard Deviation 1.14 |
| All Referrals to FAID Fear | Cardiac Anxiety Questionnaire Avoidance Subscale Score | 30 Days After End of Hospital Care | 3.16 score on a scale | Standard Deviation 1.07 |
| Control Condition - Usual Care | Cardiac Anxiety Questionnaire Avoidance Subscale Score | End of Hospital Care | 3.45 score on a scale | Standard Deviation 0.53 |
| Control Condition - Usual Care | Cardiac Anxiety Questionnaire Avoidance Subscale Score | 30 Days After End of Hospital Care | 3.35 score on a scale | Standard Deviation 0.72 |
Comparison: Outcome analysis for the end of hospital care.p-value: 0.8695% CI: [-1.43, 1.21]t-test, 2 sided
Comparison: Outcome analysis for 30 days after the end of hospital care.p-value: 0.7595% CI: [-1.1, 1.58]t-test, 2 sided
Other Pre-specified
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.
Time frame: Hospital discharge (approximately 21 days), 30 days post-discharge
Population: Excludes two participants who withdrew before completing assessments at the end of hospital care.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Referrals to FAID Fear | Cardiac Anxiety Questionnaire Fear Subscale Score | End of Hospital Care | 3.35 score on a scale | Standard Deviation 0.9 |
| All Referrals to FAID Fear | Cardiac Anxiety Questionnaire Fear Subscale Score | 30 Days After End of Hospital Care | 3.33 score on a scale | Standard Deviation 0.88 |
| Control Condition - Usual Care | Cardiac Anxiety Questionnaire Fear Subscale Score | End of Hospital Care | 3.59 score on a scale | Standard Deviation 0.61 |
| Control Condition - Usual Care | Cardiac Anxiety Questionnaire Fear Subscale Score | 30 Days After End of Hospital Care | 3.41 score on a scale | Standard Deviation 0.33 |
Comparison: Outcome analysis at the end of hospital care.p-value: 0.6395% CI: [-0.83, 1.32]t-test, 2 sided
Comparison: Outcome analysis for 30 days after the end of hospital care.p-value: 0.8695% CI: [-0.92, 1.08]t-test, 2 sided
Other Pre-specified
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.
Time frame: 30 days post-discharge
Population: Excludes two participants who did not provide data for this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Referrals to FAID Fear | Posttraumatic Stress Disorder Checklist Score | 19.70 score on a scale | Standard Deviation 12.83 |
| Control Condition - Usual Care | Posttraumatic Stress Disorder Checklist Score | 11.00 score on a scale | Standard Deviation 4.08 |
p-value: 0.2295% CI: [-23.26, 5.86]t-test, 2 sided
p-value: 0.26Wilcoxon (Mann-Whitney)
Comparison: A Fisher's Exact Test was conducted to compare the number of participants with a positive screen for PTSD symptoms (score \>=33) to those who did not have a positive screen for PTSD symptoms (score \< 33).p-value: 1Fisher Exact