Cardiac Arrest
Conditions
Keywords
cardiac arrest, uncertainty, cardiac anxiety, acute stress disorder, posttraumatic stress disorder, sleep, caregiver, family, surrogate, information, self care
Brief summary
The goal of this study is to test the feasibility and acceptability of an informational website to reduce uncertainty, psychological distress, and caregiver burden among close family members of cardiac arrest patients. The investigators hypothesize that participants who receive access to the website will have lower rates of uncertainty, psychological distress, and caregiver burden at 3 months post-hospital discharge compared to participants who receive usual care.
Detailed description
This study will be an unblinded, two-arm randomized controlled trial that enrolls up to 100 adult surrogates of living cardiac arrest patients hospitalized in the New York Presbyterian hospital system. Participants must be English- or Spanish-speaking and have a device with internet access. Participants will be randomized 2:1 to receive the informational intervention program or usual care (control). Intervention arm participants will receive the informational intervention in three discrete packages upon study enrollment, movement to the general medical floor, and at one month post-discharge. All participants will be assessed at study enrollment, hospital discharge, and 3 months post-discharge for their illness uncertainty, psychological distress, and caregiver burden. All participants will also wear a GENEActiv sleep monitor to track their sleep for one week following hospital discharge.
Interventions
BEHAVIORALEducational Informational Platform
This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.
Sponsors
National Institute on Aging (NIA)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized 2:1 to the informational intervention group or the control group (care as usual). Participants will remain in their assigned arm for the entirety of their study participation. Randomization will be performed using the REDCap randomization module by a study coordinator. This study will be unblinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Surrogate of a living NewYork Presbyterian Hospital cardiac arrest patient * English- or Spanish-speaking * Has a working smartphone, tablet, laptop, or other device with internet access
Exclusion criteria
* Any medical and/or psychiatric impairment precluding them from complying with the protocol * Non-English and non-Spanish speaking * Lack of internet/device access * Surrogate of an adult CA patient who passed away * Cannot be reached for initial contact (3 unsuccessful attempts made in ICU) * Moved to the in-patient floor before initial contact can be established
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mishel Uncertainty in Illness Scale Score - Family Member Form | Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported | This metric is a 31-item scale measuring surrogates' self-reported uncertainty related to their loved one's cardiac arrest. Participants will be asked to answer from a scale of 1 to 5, 1 being 'Strongly Disagree' and 5 being 'Strongly Agree.' The scale will be scored out of 155. A higher score indicates a greater level of uncertainty. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Traumatic Stress Disorder Checklist (PCL-5) Score | Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported | This metric is a 20-item measure of self-reported post-traumatic stress symptoms as defined by the DSM-5. Participants will be asked to score their answer from 0 to 4, 0 being 'Not at all,' and 4 being 'Extremely.' The total score will be out of 80. A higher score indicates more severe PTSD symptoms. |
| Cardiac Anxiety Questionnaire Score - Fear Subscale | Data was collected at hospital discharge (approximately 21 days after baseline) and 3 months post-hospital discharge. The data at 3 months post-discharge is reported | This 8-item metric measures surrogates' self-reported fear of their loved one's cardiac-related stimuli and sensations due to perceived negative consequences. Participants will be asked to rank answers from 1 to 5, 1 being 'Never' and 5 being 'Always.' The total will be out of 40. A higher score indicates more fear and worry related to the heart. |
| Zarit Burden Interview 12-item Short Form Score | At 3 months post-discharge. | This 12-item metric measures surrogates' self-reported caregiver burden. Participants will be asked to score their answers from 0 to 4, 0 being Never, and 4 being Always. The total score is taken out of 48. A higher total score indicates a greater degree of caregiver burden. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Informational Intervention Arm Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.
Educational Informational Platform: This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish. | 36 |
| Control Arm Participants in this arm will receive usual care and no access to the informational intervention program. | 17 |
| Total | 53 |
Baseline characteristics
| Characteristic | Informational Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 2 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 15 Participants | 45 Participants |
| Age, Continuous | 48.2 years STANDARD_DEVIATION 16 | 48.0 years STANDARD_DEVIATION 12.6 | 48.2 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 12 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 10 Participants | 30 Participants |
| Region of Enrollment United States | 36 participants | 17 participants | 53 participants |
| Sex: Female, Male Female | 26 Participants | 12 Participants | 38 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 36 | 5 / 17 |
| other Total, other adverse events | 0 / 36 | 0 / 17 |
| serious Total, serious adverse events | 0 / 36 | 0 / 17 |
Outcome results
Primary
Mishel Uncertainty in Illness Scale Score - Family Member Form
This metric is a 31-item scale measuring surrogates' self-reported uncertainty related to their loved one's cardiac arrest. Participants will be asked to answer from a scale of 1 to 5, 1 being 'Strongly Disagree' and 5 being 'Strongly Agree.' The scale will be scored out of 155. A higher score indicates a greater level of uncertainty.
Time frame: Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Informational Intervention Arm | Mishel Uncertainty in Illness Scale Score - Family Member Form | 82.67 score on a scale |
| Control Arm | Mishel Uncertainty in Illness Scale Score - Family Member Form | 88.18 score on a scale |
Secondary
Cardiac Anxiety Questionnaire Score - Fear Subscale
This 8-item metric measures surrogates' self-reported fear of their loved one's cardiac-related stimuli and sensations due to perceived negative consequences. Participants will be asked to rank answers from 1 to 5, 1 being 'Never' and 5 being 'Always.' The total will be out of 40. A higher score indicates more fear and worry related to the heart.
Time frame: Data was collected at hospital discharge (approximately 21 days after baseline) and 3 months post-hospital discharge. The data at 3 months post-discharge is reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Informational Intervention Arm | Cardiac Anxiety Questionnaire Score - Fear Subscale | 18.3 score on a scale | Standard Deviation 3.8 |
| Control Arm | Cardiac Anxiety Questionnaire Score - Fear Subscale | 18.9 score on a scale | Standard Deviation 7.7 |
Secondary
Post-Traumatic Stress Disorder Checklist (PCL-5) Score
This metric is a 20-item measure of self-reported post-traumatic stress symptoms as defined by the DSM-5. Participants will be asked to score their answer from 0 to 4, 0 being 'Not at all,' and 4 being 'Extremely.' The total score will be out of 80. A higher score indicates more severe PTSD symptoms.
Time frame: Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Informational Intervention Arm | Post-Traumatic Stress Disorder Checklist (PCL-5) Score | 22.1 score on a scale | Standard Deviation 13.3 |
| Control Arm | Post-Traumatic Stress Disorder Checklist (PCL-5) Score | 32.7 score on a scale | Standard Deviation 12.65 |
Secondary
Zarit Burden Interview 12-item Short Form Score
This 12-item metric measures surrogates' self-reported caregiver burden. Participants will be asked to score their answers from 0 to 4, 0 being Never, and 4 being Always. The total score is taken out of 48. A higher total score indicates a greater degree of caregiver burden.
Time frame: At 3 months post-discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Informational Intervention Arm | Zarit Burden Interview 12-item Short Form Score | 12.5 score on a scale | Standard Deviation 6.75 |
| Control Arm | Zarit Burden Interview 12-item Short Form Score | 18.6 score on a scale | Standard Deviation 8.3 |