Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598436
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
ACCTiVATE
Brief Summary:
This study examines the impact of a multi-level intervention aiming to improve telehealth access for low-income patients managing chronic health conditions such as hypertension and diabetes The multi-level intervention includes clinic-level practice facilitation and patient-level digital health coaching
Detailed Description:
ACCTIVATE is a multi-level intervention including practice facilitation and patient digital coaching that aims to tackle patient-level and clinic-level barriers to increase the equitable use of telehealth tools for chronic disease management Direct patient support via digital coaching can meet the needs of patients who have been left behind in the digital divide For those with reduced digital literacy and low access to smartphones and broadband this resource can increase their confidence in using digital technologies and engaging in virtual care Additionally primary care clinic support through practice facilitation can empower team members to address racialethnic disparities in telehealth use through equitable screeningoffering of digital technologies resources to prepare patients for virtual chronic disease management and consistent review of telehealth equity data The investigators hypothesize that this multi-level intervention will improve patient control of chronic health conditions ie glycosylated hemoglobin as well as digital literacy while also increasing patient and clinician engagement with patient portals telehealth video visits and remote monitoring
Aim 1 Assess the impact of the multi-level intervention on clinical outcomes at 3 6 12 and 24 months Our working hypotheses are that patients randomized to receive digital coaching vs usual care will experience a greater change in mean glycosylated hemoglobin A1C both overall and among Black and Latinx patients Clinics randomized to practice facilitation vs usual care will experience a greater clinic-level change in mean glycosylated hemoglobin A1C both overall and among their Black and Latinx populations
Aim 2 Assess the impact of the multi-level intervention on process outcomes related to digital literacy engagement in care and health IT utilization at 3 6 12 and 24 months The investigators hypothesize that randomization to digital coaching vs usual care will increase patient portal use digital literacy and visit show rate overall and among Black and Latinx patients Randomization to practice facilitation vs usual care will increase clinic-level use of telehealth video visits and patient-portal communication overall and with Black and Latinx patients
Aim 3 Conduct a mixed methods evaluation of intervention implementation outcomes Quantitative engagement data direct observations of intervention sessions and stakeholder interviews will characterize implementation outcomes and factors necessary to integrate the multi-level intervention into clinical operations applying the RE-AIM implementation science framework
Aim 1 Assess the impact of the multi-level intervention on clinical outcomes at 3 6 12 and 24 months Our working hypotheses are that patients randomized to receive digital coaching vs usual care will experience a greater change in mean glycosylated hemoglobin A1C both overall and among Black and Latinx patients Clinics randomized to practice facilitation vs usual care will experience a greater clinic-level change in mean glycosylated hemoglobin A1C both overall and among their Black and Latinx populations
Aim 2 Assess the impact of the multi-level intervention on process outcomes related to digital literacy engagement in care and health IT utilization at 3 6 12 and 24 months The investigators hypothesize that randomization to digital coaching vs usual care will increase patient portal use digital literacy and visit show rate overall and among Black and Latinx patients Randomization to practice facilitation vs usual care will increase clinic-level use of telehealth video visits and patient-portal communication overall and with Black and Latinx patients
Aim 3 Conduct a mixed methods evaluation of intervention implementation outcomes Quantitative engagement data direct observations of intervention sessions and stakeholder interviews will characterize implementation outcomes and factors necessary to integrate the multi-level intervention into clinical operations applying the RE-AIM implementation science framework
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