Trial Outcomes & Findings for Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear) (NCT NCT05144477)
NCT ID: NCT05144477
Last Updated: 2023-04-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline (ICU admittance)
Results posted on
2023-04-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
5
|
|
Overall Study
COMPLETED
|
10
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
This question was added partway through the study.
Baseline characteristics by cohort
| Measure |
FAID Fear Intervention
n=10 Participants
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
n=5 Participants
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Education
College Degree
|
3 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=15 Participants
|
|
Age, Continuous
|
51.50 years
STANDARD_DEVIATION 13.32 • n=10 Participants
|
49.20 years
STANDARD_DEVIATION 15.04 • n=5 Participants
|
50.73 years
STANDARD_DEVIATION 13.41 • n=15 Participants
|
|
Sex/Gender, Customized
Gender · Woman
|
9 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Gender · Man
|
1 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
5 participants
n=5 Participants
|
15 participants
n=15 Participants
|
|
Language
English
|
8 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=15 Participants
|
|
Language
Spanish
|
2 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
|
Health Insurance
Yes
|
8 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=15 Participants
|
|
Health Insurance
No
|
2 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=15 Participants
|
|
Education
No Formal Education
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Education
Less than High School
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Education
Some High School
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Education
High School/GED
|
2 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=15 Participants
|
|
Education
Trade/Vocational School
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Education
Some College
|
2 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
|
Education
Associate's Degree
|
1 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
|
Education
Graduate/ Professional Degree
|
2 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
|
Income
$0
|
0 Participants
n=6 Participants • This question was added partway through the study.
|
0 Participants
n=3 Participants • This question was added partway through the study.
|
0 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
$1 - $9,999
|
0 Participants
n=6 Participants • This question was added partway through the study.
|
0 Participants
n=3 Participants • This question was added partway through the study.
|
0 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
$10,000 - $24,999
|
2 Participants
n=6 Participants • This question was added partway through the study.
|
0 Participants
n=3 Participants • This question was added partway through the study.
|
2 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
$25,000 - $49,999
|
2 Participants
n=6 Participants • This question was added partway through the study.
|
1 Participants
n=3 Participants • This question was added partway through the study.
|
3 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
$50,000 - $74,999
|
0 Participants
n=6 Participants • This question was added partway through the study.
|
0 Participants
n=3 Participants • This question was added partway through the study.
|
0 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
$75,000 - $99,999
|
0 Participants
n=6 Participants • This question was added partway through the study.
|
0 Participants
n=3 Participants • This question was added partway through the study.
|
0 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
$100,000 - $149,999
|
1 Participants
n=6 Participants • This question was added partway through the study.
|
0 Participants
n=3 Participants • This question was added partway through the study.
|
1 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
$150,000 or more
|
1 Participants
n=6 Participants • This question was added partway through the study.
|
0 Participants
n=3 Participants • This question was added partway through the study.
|
1 Participants
n=9 Participants • This question was added partway through the study.
|
|
Income
Decline to Respond
|
0 Participants
n=6 Participants • This question was added partway through the study.
|
2 Participants
n=3 Participants • This question was added partway through the study.
|
2 Participants
n=9 Participants • This question was added partway through the study.
|
|
Relationship to Patient
Partner
|
7 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=15 Participants
|
|
Relationship to Patient
Child
|
2 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=15 Participants
|
|
Relationship to Patient
Parent
|
1 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
|
Relationship to Patient
Sibling
|
0 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
|
Live with Patient
Yes
|
9 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=15 Participants
|
|
Live with Patient
No
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=15 Participants
|
|
Relationship Length (Partners of Patients Only)
|
19.86 years
STANDARD_DEVIATION 11.77 • n=7 Participants • This was reported by partner of patients only.
|
22.67 years
STANDARD_DEVIATION 19.14 • n=3 Participants • This was reported by partner of patients only.
|
20.70 years
STANDARD_DEVIATION 13.25 • n=10 Participants • This was reported by partner of patients only.
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
All Referrals to FAID Fear
n=25 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study
Unable to Reach
|
5 Participants
|
—
|
|
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study
Agreed to Participate
|
16 Participants
|
—
|
|
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study
Declined to Participate
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days post-dischargePopulation: Proportion of enrolled participants who remained in the study 30 days after the end of hospital care was calculated.
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).
Outcome measures
| Measure |
All Referrals to FAID Fear
n=16 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Proportion of Enrolled Family Members Who Complete the Pilot Study
Withdrew from FAID Fear
|
2 Participants
|
—
|
|
Proportion of Enrolled Family Members Who Complete the Pilot Study
Remained in FAID Fear
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
All Referrals to FAID Fear
n=11 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Proportion of Family Members That Adhere to the Diary Intervention
Adherent to Diary Intervention
|
7 Participants
|
—
|
|
Proportion of Family Members That Adhere to the Diary Intervention
Not Adherent to Diary Intervention
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days post-dischargeThis 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).
Outcome measures
| Measure |
All Referrals to FAID Fear
n=16 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Proportion of Family Members That Complete the Majority of Survey Assessments
Provided Data for >= 90% of Assessments
|
14 Participants
|
—
|
|
Proportion of Family Members That Complete the Majority of Survey Assessments
Provided Data for < 90% of Assessments
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-dischargePopulation: Excludes participant who withdrew immediately following randomization.
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).
Outcome measures
| Measure |
All Referrals to FAID Fear
n=10 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Proportion of Family Members That Agree That the Intervention Was Acceptable
Acceptable
|
8 Participants
|
—
|
|
Proportion of Family Members That Agree That the Intervention Was Acceptable
Not Acceptable
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-dischargePopulation: Excludes one participant who withdrew immediately after randomization.
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).
Outcome measures
| Measure |
All Referrals to FAID Fear
n=10 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Proportion of Family Members That Agree That the Intervention Was Feasible
Feasible
|
9 Participants
|
—
|
|
Proportion of Family Members That Agree That the Intervention Was Feasible
Not Feasible
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-dischargePopulation: Excludes one participant who withdrew immediately following randomization.
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).
Outcome measures
| Measure |
All Referrals to FAID Fear
n=10 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Proportion of Family Members That Agree That the Intervention Was Appropriate
Appropriate
|
7 Participants
|
—
|
|
Proportion of Family Members That Agree That the Intervention Was Appropriate
Not Appropriate
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Hospital discharge (approximately 21 days), 30 days post-dischargePopulation: Excludes two participants who withdrew before completing assessments at the end of hospital care.
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.
Outcome measures
| Measure |
All Referrals to FAID Fear
n=10 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
n=4 Participants
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Cardiac Anxiety Questionnaire Fear Subscale Score
End of Hospital Care
|
3.35 score on a scale
Standard Deviation 0.90
|
3.59 score on a scale
Standard Deviation 0.61
|
|
Cardiac Anxiety Questionnaire Fear Subscale Score
30 Days After End of Hospital Care
|
3.33 score on a scale
Standard Deviation 0.88
|
3.41 score on a scale
Standard Deviation 0.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Hospital discharge (approximately 21 days), 30 days post-dischargePopulation: Excludes two participants who did not provide data for these assessments.
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.
Outcome measures
| Measure |
All Referrals to FAID Fear
n=10 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
n=4 Participants
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Cardiac Anxiety Questionnaire Avoidance Subscale Score
30 Days After End of Hospital Care
|
3.16 score on a scale
Standard Deviation 1.07
|
3.35 score on a scale
Standard Deviation 0.72
|
|
Cardiac Anxiety Questionnaire Avoidance Subscale Score
End of Hospital Care
|
3.56 score on a scale
Standard Deviation 1.14
|
3.45 score on a scale
Standard Deviation 0.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-dischargePopulation: Excludes two participants who did not provide data for this assessment.
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.
Outcome measures
| Measure |
All Referrals to FAID Fear
n=10 Participants
25 potential participants met preliminary eligibility and were referred to study staff for recruitment.
Participants were recruited from among those who were enrolled in the Cardiac Neuropsychosocial Outcomes Evaluation - Family (CANOE-F; R01 HL153311; PI Agarwal) substudy, an observational cohort study of family members of CA patients within CUIMC/NewYork-Presbyterian Hospital (NYPH). Only CANOE-F participants who enrolled while the patient was still in the ICU and who agreed to be contacted about future research opportunities were approached for participation in this study.
Participant eligibility criteria additionally included (1) primary partner or family member of a patient who was hospitalized at CUIMC for a CA, (2) age 18 years or over, (3) able to speak, read, and write in English or Spanish, (4) willing to write in a journal about their experiences, and (5) available for follow-up. Participants were excluded if they presented any medical or psychiatric impairment that would have prevented them from complying with the research protocol.
|
Control Condition - Usual Care
n=4 Participants
Family members of CA patients assigned to usual care will not receive the ICU diary.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist Score
|
19.70 score on a scale
Standard Deviation 12.83
|
11.00 score on a scale
Standard Deviation 4.08
|
Adverse Events
FAID Fear Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition - Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Talea Cornelius
Columbia University Irving Medical Center
Phone: (212) 342-5503
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place