Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588556
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Improving Needs Among Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Needs Among Older Adults the ICUconnect 2 Primary Palliative Care RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICUconnect 2
Brief Summary:
Millions of older adults receive care in intensive care units ICUs annually However the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians due in part to specialists limited workforce and geographic inconsistency To address these gaps the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect ICUconnect facilitates families and patients self-report of actual palliative care needs across all core domains of palliative care quality provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care and provides a variety of informational supports relevant to each users role In this RCT the investigators will test ICUconnect vs usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population Duke Medical University of South Carolina University of Alabama at Birmingham Columbia
The specific aims are to 1 Test the efficacy of ICUconnect vs usual care control in improving palliative care needs and other person-centered outcomes including psychological distress 2 Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach and 3 Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data
The specific aims are to 1 Test the efficacy of ICUconnect vs usual care control in improving palliative care needs and other person-centered outcomes including psychological distress 2 Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach and 3 Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data
Detailed Description:
Millions of older adults receive care in intensive care units ICUs annually However the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians due in part to specialists limited workforce and geographic inconsistency Furthermore there are few evidence-based interventions designed to help ICU clinicians provide primary palliative care themselves-and even fewer interventions tested among participants who adequately reflect the racial and ethnic diversity of the US
To address these gaps the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect ICUconnect facilitates families and patients self-report of actual palliative care needs across all core domains of palliative care quality provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care and provides a variety of informational supports relevant to each users role In a recent single-center cluster RCT with 111 patient-family member dyads U54 MD012530 42 of whom were Black ICUconnect significantly improved unmet needs and goal concordance of care compared to usual care control The investigators have since linguistically and culturally adapted the intervention to Latin American Spanish
What is now needed is a multicenter RCT to test the interventions efficacy in a population diverse in race ethnicity and geography that reflects the real-world experience of patients and family members Therefore the investigators will test ICUconnect vs usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population Duke Medical University of South Carolina University of Alabama at Birmingham Columbia
The specific aims are to 1 Test the efficacy of ICUconnect vs usual care control in improving palliative care needs and other person-centered outcomes including psychological distress 2 Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach and 3 Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data
To address these gaps the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect ICUconnect facilitates families and patients self-report of actual palliative care needs across all core domains of palliative care quality provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care and provides a variety of informational supports relevant to each users role In a recent single-center cluster RCT with 111 patient-family member dyads U54 MD012530 42 of whom were Black ICUconnect significantly improved unmet needs and goal concordance of care compared to usual care control The investigators have since linguistically and culturally adapted the intervention to Latin American Spanish
What is now needed is a multicenter RCT to test the interventions efficacy in a population diverse in race ethnicity and geography that reflects the real-world experience of patients and family members Therefore the investigators will test ICUconnect vs usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population Duke Medical University of South Carolina University of Alabama at Birmingham Columbia
The specific aims are to 1 Test the efficacy of ICUconnect vs usual care control in improving palliative care needs and other person-centered outcomes including psychological distress 2 Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach and 3 Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None