Well-Being, Psychological Clinical Trial
Official title:
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
BACKGROUND/PURPOSE: Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. Active involvement of family caregivers in patient care remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. Therefore, the purpose of this study is to conduct a clinical trial that includes information developed while engaged in previous work related to the development and testing of a point-of-care technology that operationalizes caregiver involvement during acute hospitalization The investigators engaged in hypothesis driven customer discovery, then performed an iterative user centered design development and testing process, and now conclude with a clinical trial in the inpatient environment.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | October 31, 2025 |
| Est. primary completion date | October 31, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | Inclusion Criteria: - Participants will be eligible if they are age 19 or older - At the patient's bedside during the patient's intensive care unit (ICU) admission and are considered the patient's legally authorized representative (LAR) or designated caregiver who is able to make medical decisions on their behalf. Exclusion Criteria: -Located at the patient's bedside but is not their legally authorized representative (LAR) or designated caregiver who is able to make medical decisions on their behalf |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nebraska | Gordon and Betty Moore Foundation |
United States,
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* Note: There are 40 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Caregiver Engagement-Practical Aspects-FAMily Engagement (FAME) Tool | The FAMily Engagement (FAME) questionnaire is an instrument developed to assess current family engagement practice. Items 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 then transformed to a 0-100 scoring system, with higher scores indicating greater engagement in care and lower scores indicating lesser engagement in care. The overall engagement score is calculated by dividing the sum of the scores by the number of questions answered, with the result ranging from 0-100. The FAME tool has high construct validity and can be completed in 3.33 minutes by family members. | Taken at study enrollment and within 48 hours of ICU discharge | |
| Primary | Daily activity within the Family Room App | Measuring the daily activity logged within the application at the bedside. Only being measured in the experimental group. | Daily from enrollment in study until ICU discharge, assessed up to 16 months | |
| Primary | Daily Patient Symptoms- Severity of Illness- Apache II | Taken from the electronic health record. APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system used in the ICU. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. | Daily from enrollment in the study until ICU discharge, assessed up to 16 months | |
| Primary | Daily Patient Symptoms- Presence of lines, tubes, equipment | Taken from the electronic health record. Count of number of lines, tubes, equipment present on ICU patient | Daily from enrollment in the study until ICU discharge, assessed up to 16 months | |
| Primary | Daily Patient Symptoms- Glasgow Coma Scale (GCS) | Nurse documentation of level of consciousness in the electronic health record. The Glasgow Coma Scale (GCS) is used to objectively describe the extent of impaired consciousness. The scale assesses patients according to three aspects of responsiveness: eye-opening, motor, and verbal responses.The total score ranges between 3 and 15, with 3 being the worst and 15 being the highest. | Daily from enrollment in the study until ICU discharge, assessed up to 16 months | |
| Primary | Daily Patient Symptoms- Pain | Nurse documentation of patient pain in the electronic health record. Pain scores can range for 0 being no pain to 10 being the worst pain. | Daily from enrollment in the study until ICU discharge, assessed up to 16 months | |
| Primary | Daily Patient Symptoms- Richmond Agitation-Sedation Scale (RASS) | Nurse documentation of patient agitation in the electronic health record. Documented with a RASS score (richmond agitation-sedation scale). Range of scale is a ten point scale, with -5 (being unarousable) to +4 (being combative). | Daily from enrollment in the study until ICU discharge, assessed up to 16 months | |
| Primary | Daily Patient Symptoms- CAM-ICU | Confusion Assessment Method for the ICU (CAM-ICU). Taken from the electric health record. CAM-ICU is a valid and reliable delirium assessment tool. CAM-ICU is a tool to assess for the presence of delirium in ICU patients 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 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. | Daily from enrollment in the study until ICU discharge, assessed up to 16 months | |
| Secondary | Caregiver well-being- Screening Tool for Psychological Distress (STOP-D) | 5 item screening tool which provides severity scores for each of the common psychosocial problem areas: depression, anxiety, stress, anger, and low social support. A recent study showed that the STOP-D is a valid screening tool for depression and anxiety when used in inpatient settings. | Taken at study enrollment, then every 48 hours while patient is admitted to the ICU, and within 48 hours of ICU discharge, up to study completion or about 16 months | |
| Secondary | Caregiver well-being- Caregiver Self-Assessment Questionnaire | 18-item, caregiver self-report measure was devised by the American Medical Association as a means of helping physicians 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. Scores between 0-16 for "yes" responses, with a higher number meaning more stress. The questionnaire was normed on a small national sample of family caregivers (n=60); the reliability coefficient alpha was .78. Specific items were found to be predictive of caregiver stress. | Taken at study enrollment and within 48 hours of ICU discharge | |
| Secondary | Caregiver Engagement -Psychological Experience- Caregiving Health Engagement Scale (CHE-s) | 7 item multidimensional scale proposed to evaluate the impact of burden on different aspects of a caregivers life. A recent validation study showed solid evidence for the internal consistency and concurrent validity of the CHE-s. The CHE is scored based on a Likert-type scale. Caregivers respond to a series of statements, indicating their level of agreement or disagreement. The total score reflects the caregiver's overall engagement in healthcare. Higher scores indicate greater engagement. | Taken at study enrollment and within 48 hours of ICU discharge | |
| Secondary | Caregiver Resilience- Connor-Davidson Resilience Scale (CD-RISC2) | 2 item instrument that measures resilience, specifically as it relates to bounce back and adaptability. Good test-retest reliability, convergent validity, and divergent validity. Answers are on a 5-point scale response, 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. | Taken at study enrollment | |
| Secondary | Caregiver Preparedness-Preparedness for Caregiving Scale | The Preparedness for Caregiving Scale is a caregiver self-rated instrument that consists of ten items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving. 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. | Taken within 48 hours of ICU discharge |