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

Cardiac Arrest Clinical Trial

— RESURFACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048068
• Other study ID #: AAAR8497
• Secondary ID: P30AG064198
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: September 2023
• Source: Columbia University
• Contact: Sachin Agarwal, MD, MPH
• Phone: 212-305-7236
• Email: sa2512[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiovascular Diseases
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center/New York Presbyterian	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (62)

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intolerance of Uncertainty Scale Score	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)
Other	Threat Perception Scale Score	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)
Other	ENRICHD Social Support Instrument Score	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)
Other	Systems Usability Scale (SUS) Score	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
Primary	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.	At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
Secondary	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.	At study enrollment in the intensive care unit (baseline), at hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
Secondary	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.	At hospital discharge (approximately 21 days after baseline), 3 months post-hospital discharge
Secondary	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.	At 3 months post-discharge.