Clincosm LogoSign in Get a demo

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

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06048068
Collaborator
National Institute on Aging (NIA) (NIH)
100
Enrollment
1
Location
2
Arms
8.7
Anticipated Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational Informational Platform
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Other
Official Title:
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study
Actual Study Start Date :
Sep 7, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    No Intervention: Control Arm

    Participants in this arm will receive usual care and no access to the informational intervention program.

    Outcome Measures

    Primary Outcome Measures

    1. Mishel Uncertainty in Illness Scale Score - Family Member Form [At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge]

      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.

    Secondary Outcome Measures

    1. Post-Traumatic Stress Disorder Checklist (PCL-5) Score [At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge]

      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.

    2. Cardiac Anxiety Questionnaire Score - fear subscale [At hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge]

      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.

    3. 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.

    Other Outcome Measures

    1. Intolerance of Uncertainty Scale Score [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.

    2. Threat Perception Scale Score [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.

    3. ENRICHD Social Support Instrument Score [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.

    4. Systems Usability Scale (SUS) Score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center/New York Presbyterian New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University
    • National Institute on Aging (NIA)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sachin Agarwal, Associate Professor of Neurology (Neurocritical Care), Columbia University
    ClinicalTrials.gov Identifier:
    NCT06048068
    Other Study ID Numbers:
    • AAAR8497
    • P30AG064198
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sachin Agarwal, Associate Professor of Neurology (Neurocritical Care), Columbia University
    cardiac arrest
    uncertainty
    cardiac anxiety
    acute stress disorder
    posttraumatic stress disorder
    sleep
    caregiver
    family
    surrogate
    information
    self care
    Additional relevant MeSH terms:
    Heart Arrest
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Sep 26, 2023