The Impact of the Family Room App on Caregivers
- Conditions
- EngagementSatisfaction, ConsumerWell-Being, Psychological
- Interventions
- Device: Family Room App
- Registration Number
- NCT06463158
- Lead Sponsor
- University of Nebraska
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
• Not legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention Group- Family Room Application Family Room App During the last 10 months of recruitment, participants will be enrolled into the experimental group where they will receive the Family Room application on their personal devices.
- Primary Outcome Measures
Name Time Method Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool 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 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) 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 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) 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 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) 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 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.
- Secondary Outcome Measures
Name Time Method 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 This is a self-rated 5 item instrument which provides severity scores for each of the common psychosocial problem areas: depression, anxiety, stress, anger, and low social support. Scoring is "0" (not at all) to "9" (severely). The higher the score the greater the psychological distress.
Caregiver Well-being: Caregiver Self-Assessment Questionnaire At study enrollment and within 48 hours of patient participant ICU discharge This is a self-rated 18-item instrument devised by the American Medical Association for physicians to assess the stress-levels of family caregivers. Caregivers are asked to respond either "Yes" or "No" to a series of statements, simple scoring system allows family caregiver themselves to score their results and to determine whether or not they are highly stressed. Points are added for each 'yes' answer for 16 questions plus a 1 to 10 score for a question of current stress levels and for a question on comparing perceived current health compared to a year ago. A higher number means more stress.
Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s) At study enrollment and within 48 hours of patient participant ICU discharge This is a self-rated 7 item multidimensional instrument to evaluate the impact of burden on different aspects of a caregiver's life. Caregivers respond to a series of statements, indicating their level of agreement or disagreement. The CHE is scored based on a Likert-type scale. The total score reflects the caregiver's overall engagement in healthcare. Higher scores indicate greater engagement.
Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2) At study enrollment This is a self-rated 2 item instrument that measures resilience as it relates to ability to thrive in the face of adversity. Answers are on a 5-point scale, not true at all=0, rarely true=1, sometimes true=2, often true=3, and true nearly all of the time=4. Higher scores indicating greater perceived resilience.
Caregiver Preparedness: Preparedness for Caregiving Scale Within 48 hours of patient participant ICU discharge The Preparedness for Caregiving Scale is a self-rated 10 item instrument that asks caregivers how well prepared they believe they are for multiple domains of care giving. Preparedness is defined as perceived readiness for multiple domains of the care giving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of care giving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score the less prepared the caregiver feels.
Trial Locations
- Locations (2)
Nebraska Medicine
🇺🇸Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States