Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events

Study Overview
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Brief Summary
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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
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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.

Official Title
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Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Behavioral: Educational Informational Platform


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Informational Intervention Arm<br>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. | Behavioral: Educational Informational Platform<br>* 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.<br>* Other names: Heartsight website, ourheartsight.com;|
| No Intervention: Control Arm<br>Participants in this arm will receive usual care and no access to the informational intervention program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge | 
| 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. | At hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge | 
| 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. | At 3 months post-discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, uncertainty, cardiac anxiety, acute stress disorder, posttraumatic stress disorder, sleep, caregiver, family, surrogate, information, self care