Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Mishel Uncertainty in Illness Scale Score - Family Member Form
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mishel Uncertainty in Illness Scale Score - Family Member Form
时间窗: 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
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.
次要结局
- Post-Traumatic Stress Disorder Checklist (PCL-5) Score(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)
- Cardiac Anxiety Questionnaire Score - Fear Subscale(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)
- Zarit Burden Interview 12-item Short Form Score(At 3 months post-discharge.)
研究者
Sachin Agarwal
Associate Professor of Neurology (Neurocritical Care)
Columbia University