Trial Outcomes & Findings for Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (NCT NCT06048068)

Last Updated: 2025-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

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

Results posted on

2025-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	Control Arm Participants in this arm will receive usual care and no access to the informational intervention program.
Overall Study STARTED	36	17
Overall Study COMPLETED	21	11
Overall Study NOT COMPLETED	15	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Informational Intervention Arm n=36 Participants 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. 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.	Control Arm n=17 Participants Participants in this arm will receive usual care and no access to the informational intervention program.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=29 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=39 Participants	15 Participants n=29 Participants	45 Participants n=60 Participants
Age, Categorical >=65 years	6 Participants n=39 Participants	2 Participants n=29 Participants	8 Participants n=60 Participants
Age, Continuous	48.2 years STANDARD_DEVIATION 16.0 • n=39 Participants	48.0 years STANDARD_DEVIATION 12.6 • n=29 Participants	48.2 years STANDARD_DEVIATION 14.9 • n=60 Participants
Sex: Female, Male Female	26 Participants n=39 Participants	12 Participants n=29 Participants	38 Participants n=60 Participants
Sex: Female, Male Male	10 Participants n=39 Participants	5 Participants n=29 Participants	15 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=39 Participants	4 Participants n=29 Participants	12 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=39 Participants	12 Participants n=29 Participants	40 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	1 Participants n=29 Participants	1 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=39 Participants	0 Participants n=29 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	2 Participants n=29 Participants	3 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=29 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	8 Participants n=39 Participants	1 Participants n=29 Participants	9 Participants n=60 Participants
Race (NIH/OMB) White	20 Participants n=39 Participants	10 Participants n=29 Participants	30 Participants n=60 Participants
Race (NIH/OMB) More than one race	6 Participants n=39 Participants	2 Participants n=29 Participants	8 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	2 Participants n=29 Participants	2 Participants n=60 Participants
Region of Enrollment United States	36 participants n=39 Participants	17 participants n=29 Participants	53 participants n=60 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Informational Intervention Arm n=21 Participants 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. 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.	Control Arm n=11 Participants Participants in this arm will receive usual care and no access to the informational intervention program.
Mishel Uncertainty in Illness Scale Score - Family Member Form	82.67 score on a scale Interval 78.31 to 87.02	88.18 score on a scale Interval 83.04 to 93.32

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Informational Intervention Arm n=21 Participants 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. 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.	Control Arm n=11 Participants Participants in this arm will receive usual care and no access to the informational intervention program.
Post-Traumatic Stress Disorder Checklist (PCL-5) Score	22.1 score on a scale Standard Deviation 13.3	32.7 score on a scale Standard Deviation 12.65

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Informational Intervention Arm n=22 Participants 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. 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.	Control Arm n=11 Participants Participants in this arm will receive usual care and no access to the informational intervention program.
Cardiac Anxiety Questionnaire Score - Fear Subscale	18.3 score on a scale Standard Deviation 3.8	18.9 score on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Informational Intervention Arm n=22 Participants 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. 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.	Control Arm n=11 Participants Participants in this arm will receive usual care and no access to the informational intervention program.
Zarit Burden Interview 12-item Short Form Score	12.5 score on a scale Standard Deviation 6.75	18.6 score on a scale Standard Deviation 8.3

Adverse Events

Informational Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sachin Agarwal, MD MPH

Columbia University Irving Medical Center

Phone: 212-305-7236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place