AzTrials
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Cardiac ArrestRESURFACENCT06048068

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

A study testing Educational Informational Platform in people with Cardiac Arrest, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest
What is being tested?
Educational Informational Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
7 Sep 2023to 14 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Columbia University Medical Center/New York Presbyterian

    New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Cardiac Arrest
Being tested
Educational Informational Platform
Keywords
cardiac arrest, uncertainty, cardiac anxiety, acute stress disorder, posttraumatic stress disorder, sleep, caregiver, family, surrogate, information, self care
Medical subject headings
Heart Arrest, Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational Informational PlatformBehavioural

    Also called Heartsight website, ourheartsight.com

    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.

Study groups in NCT06048068
Study groupRoleWhat they receive
Informational Intervention ArmExperimentalParticipants 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.
Receives: Behavioral: Educational Informational Platform
Control ArmNo interventionParticipants in this arm will receive usual care and no access to the informational intervention program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (3)
  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: At 3 months post-discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start7 Sep 2023
  3. Primary completion14 Oct 2024
  4. Study completion14 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06048068
Sponsor's protocol ID
AAAR8497
Other IDs
P30AG064198
Acronym
RESURFACE
Status last verified
Nov 2025
First submitted
15 Sep 2023
Last updated
18 Nov 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sawyer KN, Camp-Rogers TR, Kotini-Shah P, Del Rios M, Gossip MR, Moitra VK, Haywood KL, Dougherty CM, Lubitz SA, Rabinstein AA, Rittenberger JC, Callaway CW, Abella BS, Geocadin RG, Kurz MC; American Heart Association Emergency Cardiovascular Care Committee; Council on Cardiovascular and Stroke Nursing; Council on Genomic and Precision Medicine; Council on Quality of Care and Outcomes Research; and Stroke Council. Sudden Cardiac Arrest Survivorship: A Scientific Statement From the American Heart Association. Circulation. 2020 Mar 24;141(12):e654-e685. doi: 10.1161/CIR.0000000000000747. Epub 2020 Feb 12.

    PubMed 32078390
  • Parnia S, Waller DG, Yeates R, Fenwick P. A qualitative and quantitative study of the incidence, features and aetiology of near death experiences in cardiac arrest survivors. Resuscitation. 2001 Feb;48(2):149-56. doi: 10.1016/s0300-9572(00)00328-2.

    PubMed 11426476
  • van Lommel P, van Wees R, Meyers V, Elfferich I. Near-death experience in survivors of cardiac arrest: a prospective study in the Netherlands. Lancet. 2001 Dec 15;358(9298):2039-45. doi: 10.1016/S0140-6736(01)07100-8.

    PubMed 11755611
  • Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.

    PubMed 15665319
  • Ann-Britt T, Ella D, Johan H, Asa AB. Spouses' experiences of a cardiac arrest at home: an interview study. Eur J Cardiovasc Nurs. 2010 Sep;9(3):161-7. doi: 10.1016/j.ejcnurse.2009.12.005. Epub 2010 Jan 13.

    PubMed 20071240
  • Grunau B, Dainty K, MacRedmond R, McDonald K, Sasaki A, Sarti AJ, Shemie SD, Cheung A, Gill J. A qualitative exploratory case series of patient and family experiences with ECPR for out-of-hospital cardiac arrest. Resusc Plus. 2021 Apr 28;6:100129. doi: 10.1016/j.resplu.2021.100129. eCollection 2021 Jun.

    PubMed 34223386
  • De Stefano C, Normand D, Jabre P, Azoulay E, Kentish-Barnes N, Lapostolle F, Baubet T, Reuter PG, Javaud N, Borron SW, Vicaut E, Adnet F. Family Presence during Resuscitation: A Qualitative Analysis from a National Multicenter Randomized Clinical Trial. PLoS One. 2016 Jun 2;11(6):e0156100. doi: 10.1371/journal.pone.0156100. eCollection 2016.

    PubMed 27253993
  • Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.

    PubMed 22080636
  • van Wijnen HG, Rasquin SM, van Heugten CM, Verbunt JA, Moulaert VR. The impact of cardiac arrest on the long-term wellbeing and caregiver burden of family caregivers: a prospective cohort study. Clin Rehabil. 2017 Sep;31(9):1267-1275. doi: 10.1177/0269215516686155. Epub 2017 Jan 9.

    PubMed 28068794
  • Wachelder EM, Moulaert VR, van Heugten C, Verbunt JA, Bekkers SC, Wade DT. Life after survival: long-term daily functioning and quality of life after an out-of-hospital cardiac arrest. Resuscitation. 2009 May;80(5):517-22. doi: 10.1016/j.resuscitation.2009.01.020. Epub 2009 Mar 17.

    PubMed 19282084
  • Douma MJ, Graham TAD, Ali S, Dainty KN, Bone A, Smith KE, Dennet L, Brindley PG, Kroll T, Frazer K. What are the care needs of families experiencing cardiac arrest?: A survivor and family led scoping review. Resuscitation. 2021 Nov;168:119-141. doi: 10.1016/j.resuscitation.2021.09.019. Epub 2021 Sep 27.

    PubMed 34592400
  • Rojas DA, DeForge CE, Abukhadra SL, Farrell L, George M, Agarwal S. Family experiences and health outcomes following a loved ones' hospital discharge or death after cardiac arrest: A scoping review. Resusc Plus. 2023 Mar 3;14:100370. doi: 10.1016/j.resplu.2023.100370. eCollection 2023 Jun.

    PubMed 36909925
  • Bremer A, Dahlberg K, Sandman L. Experiencing out-of-hospital cardiac arrest: significant others' lifeworld perspective. Qual Health Res. 2009 Oct;19(10):1407-20. doi: 10.1177/1049732309348369.

    PubMed 19805803
  • Case R, Stub D, Mazzagatti E, Pryor H, Mion M, Ball J, Cartledge S, Keeble TR, Bray JE, Smith K. The second year of a second chance: Long-term psychosocial outcomes of cardiac arrest survivors and their family. Resuscitation. 2021 Oct;167:274-281. doi: 10.1016/j.resuscitation.2021.06.018. Epub 2021 Jul 6.

    PubMed 34242735
  • Muehlschlegel S, Perman SM, Elmer J, Haggins A, Teixeira Bailey ND, Huang J, Jansky L, Kirchner J, Kasperek-Wynn R, Lipman PD, Yeatts SD, Fetters MD, Dickert NW, Silbergleit R. The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health-Funded Workshop. Crit Care Explor. 2022 Mar 4;4(3):e0648. doi: 10.1097/CCE.0000000000000648. eCollection 2022 Mar.

    PubMed 35265851

Questions about this trial

What is this clinical trial studying?

A study testing Educational Informational Platform in people with Cardiac Arrest, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06048068, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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