Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463158
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-04
Brief Title:
The Impact of the Family Room App on Caregivers
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BACKGROUNDPURPOSE 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
Detailed Description:
For this phase 1 clinical trial the investigators will use a 2-stage sequential cohort design with repeated measures The investigators will recruit a total of 100 family caregivers of ICU patients from 5 ICUs at a single tertiary medical center over an 18-month period A convenience sampling technique will be used to recruit participants in the control group n50 followed by participants in the experimental group n 50 Participants will be eligible if they are age 19 or older and at the patients bedside during the patients ICU admission Data will be measured at 2 timepoints study enrollment T1 and within 48 hours of ICU discharge T2 with the primary endpoint caregiver well-being being measured more frequently every 48 hours while the patient is admitted to the ICU Data will be collected through structured interviews using pre-designed questionnaires Patient specific data will be extracted via chart review from the medical record The questionnaires will include items related to demographic variables caregiver psychological distress engagement and satisfaction Trained research assistants will conduct either face to face virtual via Zoom or phone depending on the participants preference and availability
During the first 8 months of recruitment participants will be enrolled into the control group which consists of routine care and informational practices of the ICU team 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 Conditions will be implemented in sequential order not concurrently This is a practical approach because it is reasonable to expect that only slight variations will exist between the demographics of the initial cohort control condition The investigators will test differential selection post hoc to identify whether the caregivers differentiated in any systematic way on variables that might be related to the intervention outcomes professional caregiving experience confidence in caregiving ability patients severity of illness etc In addition the use of 5 different ICUs is intended to dampen any historical effects experienced within a single unit
Intervention Details Family Room App The Family Room is a dynamic point of care tool that holds the power to profoundly change family caregiver involvement It guides families on how best to contribute to patient care by providing real time education a sense of connection emotional support and resources that enable meaningful caregiving Importantly family caregivers 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 The app has been developed in partnership with nurses and family caregivers and will be connected with the EHR to ensure family caregivers contributions are visible to all members of the health care team
During the first 8 months of recruitment participants will be enrolled into the control group which consists of routine care and informational practices of the ICU team 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 Conditions will be implemented in sequential order not concurrently This is a practical approach because it is reasonable to expect that only slight variations will exist between the demographics of the initial cohort control condition The investigators will test differential selection post hoc to identify whether the caregivers differentiated in any systematic way on variables that might be related to the intervention outcomes professional caregiving experience confidence in caregiving ability patients severity of illness etc In addition the use of 5 different ICUs is intended to dampen any historical effects experienced within a single unit
Intervention Details Family Room App The Family Room is a dynamic point of care tool that holds the power to profoundly change family caregiver involvement It guides families on how best to contribute to patient care by providing real time education a sense of connection emotional support and resources that enable meaningful caregiving Importantly family caregivers 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 The app has been developed in partnership with nurses and family caregivers and will be connected with the EHR to ensure family caregivers contributions are visible to all members of the health care team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None