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

November 4, 2025 updated by: Sachin Agarwal, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center/New York Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Participants in this arm will receive usual care and no access to the informational intervention program.
Experimental: 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.
Behavioral: 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.
Other Names:
  • Heartsight website, ourheartsight.com

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mishel Uncertainty in Illness Scale Score - Family Member Form
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
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Traumatic Stress Disorder Checklist (PCL-5) Score
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
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.
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
Cardiac Anxiety Questionnaire Score - Fear Subscale
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
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.
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
Zarit Burden Interview 12-item Short Form Score
Time Frame: 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.
At 3 months post-discharge.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intolerance of Uncertainty Scale Score
Time Frame: At study enrollment in the intensive care unit (baseline)
This 27-item metric measures surrogates' emotional, cognitive, and behavioral responses to ambiguity, uncertainty, and attempts to control the future. Participants will rank their response from a scale of 1 to 5, 1 being 'Strongly Disagree' and 5 being 'Strongly Agree.' The total score will be out of 135.
At study enrollment in the intensive care unit (baseline)
Threat Perception Scale Score
Time Frame: At study enrollment in the intensive care unit (baseline)
This 7-item scale measures surrogates' self-reported feelings of helplessness or lack of control related to their loved one's cardiac arrest. Participants choose from a range of 1 to 4, 1 being 'Not at all' and 4 being 'Extremely'. The total score is taken out of 28.
At study enrollment in the intensive care unit (baseline)
ENRICHD Social Support Instrument Score
Time Frame: At hospital discharge (approximately 21 days after baseline)
This metric is a 6-item self-reported measure of social support. Participants will be asked to score their answers from 1 to 5, 1 being "None of the time," and 5 being "All of the time." The total score is out of 30.
At hospital discharge (approximately 21 days after baseline)
Systems Usability Scale (SUS) Score
Time Frame: At 3 months post-discharge
This metric is a 10-item questionnaire measuring perceived usability of the online informational intervention platform by intervention group participants. Participants will be asked to score their answers from a range of 1 to 5, 1 being "Completely disagree," and 5 being "Completely Agree." The total score will be out of 50.
At 3 months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Sachin Agarwal, MD, MPH, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2023

Primary Completion (Actual)

October 14, 2024

Study Completion (Actual)

October 14, 2024

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR8497
  • P30AG064198 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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