A Phase I Clinical Trial Evaluating the Impact of the Family Room App on Caregiver Well-being, Satisfaction, and Engagement in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool
研究概览
简要总结
Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. However, active involvement of family caregivers remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. This study will test and refine previously developed point-of-care application, Family Room, and determine its effectiveness by comparison with a control group. A series of surveys will be used to evaluate caregiver well-being, engagement and satisfaction.
详细描述
Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. However, active involvement of family caregivers remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. This study will test and refine previously developed point-of-care application, Family Room, and determine its effectiveness by comparison with a control group. A series of surveys will be used to evaluate caregiver well-being, engagement and satisfaction.
The investigators will recruit participants from 5 different intensive care units (ICU) to dampen any effects experienced within a single unit. During the first 8 months of recruitment, a convenience sample of up to 50 participants (25 paired caregiver - patient dyads) will be enrolled into the control group which consists of routine care and informational practices of the ICU team. The adult family caregiver participant must be at the patient participant's bedside during ICU admission.
During the last 10 months of recruitment, up to 50 participants (25 paired caregiver - patient dyads) participants will be enrolled into the intervention group where they will use the Family Room application on their personal devices. The Family Room is a point of care tool that guides families on how to contribute to patient care by providing real time education, a sense of connection, emotional support, and resources that enable meaningful caregiving. Caregiver participants will receive virtual training on comfort-focused care activities that can be done at the bedside, as well as a mechanism within the electronic health record (EHR) to measure and record the effectiveness of the care they provide.
Data will be collected at 2 timepoints: study enrollment and within 48 hours of patient participant ICU discharge. Caregiver well-being will be measured every 48 hours while the patient participant is admitted to the ICU. Caregiver participant data will be collected through structured interviews using pre-designed questionnaires which will include items related to demographic variables, caregiver participant psychological distress, engagement, and satisfaction. Trained research assistants will conduct either face to face, virtual (via Zoom), or phone interviews depending on the caregiver participant's preference and availability. Patient participant specific data will be extracted from the medical record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 years of age or older
- •Present at participant's bedside during the intensive care unit (ICU) admission
- •Participant's legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf
排除标准
- •Not legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf
研究组 & 干预措施
Control Group - No Intervention
During the first eight months, participants will be enrolled into the control group which consists of routine care and informational practices by the intensive care unit (ICU) team.
Intervention Group - Family Room Application
During the last 10 months, participants will be enrolled into the intervention group where they will use the Family Room application on their personal devices.
干预措施: Family Room Application (Device)
结局指标
主要结局
Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool
时间窗: At study enrollment and within 48 hours of patient participant ICU discharge
The FAMily Engagement (FAME) questionnaire is a self-rated instrument developed to assess current family engagement. Questions address key principles of family-centered care, such as dignity and respect, information sharing, participation, and collaboration. They also address family engagement domains, including family presence, family needs, communication and education, decision making, and direct care. A five-point Likert scale (1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree) is used for responses, which are transformed to a 0-100 scoring system by dividing the sum of the scores by the number of questions answered. Higher scores indicate greater engagement in care and lower scores indicating lesser engagement.
Daily Activity: Family Room Application
时间窗: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
The daily activity logged in the Family Room application at bedside is assessed (intervention group only).
Daily Patient Symptoms - Severity of Illness: Acute Physiology and Chronic Health Evaluation (Apache II)
时间窗: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system used in the ICU. An integer score is assessed by medical staff from 0 to 71 is computed based on several measurements. Higher scores correspond to more severe disease and a higher risk of death. Information is taken from the electronic health record.
Daily Patient Symptoms: Presence of Lines, Tubes and Equipment
时间窗: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
A daily count of number of lines, tubes and equipment present on ICU patient participant is taken. Information is taken from the electronic health record.
Daily Patient Symptoms: Glasgow Coma Scale (GCS)
时间窗: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
The Glasgow Coma Scale (GCS) is assessed by medical staff to describe the extent of impaired consciousness. Patient participants are assessed daily according to three aspects: eye-opening ("1" no response to "4" spontaneous eye opening), motor response ("1" no response to "5" oriented) and verbal response ("1" no response to "6" obeying commands). The total score ranges between 3 and 15. Higher scores indicate better responsiveness. Information is taken from the electronic health record.
Daily Patient Symptoms: Pain
时间窗: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
Pain scores are assessed by medical staff daily and range from "0" (no pain) to "10" (the worst pain). Information is taken from the electronic health record.
Daily Patient Symptoms: Richmond Agitation-Sedation Scale (RASS)
时间窗: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
The Richmond Agitation-Sedation Scale (RASS) is a nurse assessed 10 point scale, with -5 (unarousable) to +4 (combative). Information is taken from the electronic health record.
Daily Patient Symptoms: Confusion Assessment Method for the ICU
时间窗: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
The Confusion Assessment Method for the ICU (CAM-ICU) is a tool to assess the presence of delirium in ICU patient participant who are unable to talk. It involves a sedation assessment and a confusion assessment. The confusion assessment evaluates four features: acute onset or fluctuating course, inattention, disorganized thinking, and altered level of consciousness. A patient participant is considered to be confused if they have feature 1 plus 2 and either 3 or 4 present. The CAM-ICU score ranges from 0 to 4, with 4 being the most severe. Information is taken from the electronic health record.
次要结局
- Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D)(At study enrollment, every 48 hours while patient participant is in the ICU, and within 48 hours of patient participant ICU discharge)
- Caregiver Well-being: Caregiver Self-Assessment Questionnaire(At study enrollment and within 48 hours of patient participant ICU discharge)
- Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s)(At study enrollment and within 48 hours of patient participant ICU discharge)
- Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2)(At study enrollment)
- Caregiver Preparedness: Preparedness for Caregiving Scale(Within 48 hours of patient participant ICU discharge)