Clinical trial NCT06048068: Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events
Official title: Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: cardiac arrest
uncertainty
cardiac anxiety
acute stress disorder
posttraumatic stress disorder
sleep
caregiver
family
surrogate
information
self care
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-09-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mishel Uncertainty in Illness Scale Score - Family Member Form
timeFrame: At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
Secondary outcomes:
measure: Post-Traumatic Stress Disorder Checklist (PCL-5) Score
timeFrame: At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
measure: Cardiac Anxiety Questionnaire Score - fear subscale
timeFrame: At hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
measure: Zarit Burden Interview 12-item short form score
timeFrame: At 3 months post-discharge.
Other outcomes:
measure: Intolerance of Uncertainty Scale Score
timeFrame: At study enrollment in the intensive care unit (baseline)
measure: Threat Perception Scale Score
timeFrame: At study enrollment in the intensive care unit (baseline)
measure: ENRICHD Social Support Instrument Score
timeFrame: At hospital discharge (approximately 21 days after baseline)
measure: Systems Usability Scale (SUS) Score
timeFrame: At 3 months post-discharge
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian
state: New York
Study officials:
affiliation: Columbia University
name: Sachin Agarwal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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