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

Primary Purpose

Cardiac Arrest

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Informational Platform
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrest focused on measuring cardiac arrest, uncertainty, cardiac anxiety, acute stress disorder, posttraumatic stress disorder, sleep, caregiver, family, surrogate, information, self care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center/New York PresbyterianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Informational Intervention Arm

Control Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 15, 2023
Last Updated
September 22, 2023
Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT06048068
Brief Title
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events
Acronym
RESURFACE
Official Title
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, uncertainty, cardiac anxiety, acute stress disorder, posttraumatic stress disorder, sleep, caregiver, family, surrogate, information, self care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Informational Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants in this arm will receive usual care and no access to the informational intervention program.
Intervention Type
Behavioral
Intervention Name(s)
Educational Informational Platform
Other Intervention Name(s)
Heartsight website, ourheartsight.com
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mishel Uncertainty in Illness Scale Score - Family Member Form
Description
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.
Time Frame
At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
Secondary Outcome Measure Information:
Title
Post-Traumatic Stress Disorder Checklist (PCL-5) Score
Description
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.
Time Frame
At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
Title
Cardiac Anxiety Questionnaire Score - fear subscale
Description
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.
Time Frame
At hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
Title
Zarit Burden Interview 12-item short form score
Description
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.
Time Frame
At 3 months post-discharge.
Other Pre-specified Outcome Measures:
Title
Intolerance of Uncertainty Scale Score
Description
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.
Time Frame
At study enrollment in the intensive care unit (baseline)
Title
Threat Perception Scale Score
Description
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.
Time Frame
At study enrollment in the intensive care unit (baseline)
Title
ENRICHD Social Support Instrument Score
Description
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.
Time Frame
At hospital discharge (approximately 21 days after baseline)
Title
Systems Usability Scale (SUS) Score
Description
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.
Time Frame
At 3 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin Agarwal, MD, MPH
Phone
212-305-7236
Email
sa2512@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Isabella M Tincher, BA
Phone
212-305-4234
Email
imt2114@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sachin Agarwal, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center/New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Agarwal, MD, MPH
Phone
212-305-7236
Email
sa2512@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Isabella M Tincher, BA
Phone
212-305-4234
Email
imt2114@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Sachin Agarwal, MD, MPH
First Name & Middle Initial & Last Name & Degree
Talea Cornelius, PhD, MSW, MA
First Name & Middle Initial & Last Name & Degree
Jeffery Birk, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events

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