Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03749499
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2018-11-19
Brief Title:
Targeting of UnControlled Hypertension in Emergency Department
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Targeting of UnControlled Hypertension in Emergency Department TOUCHED
Status:
COMPLETED
Status Verified Date:
2023-11
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:
TOUCHED
Brief Summary:
The proposed project underscores the following 1 The prevalence of uncontrolledundiagnosed hypertension HTN in underrepresented groups presenting to the ED is alarmingly high and 2 ED engagement and early risk assessmentstratification is a cost-effective feasible innovation to help close health disparity gaps in HTN This proposal involves a two-arm randomized controlled trial of up to 770 patients from the Emergency Department at University of Illinois Hospital with elevated blood pressure BP The primary objective is to determine the effectiveness of an emergency department-initiated Educational and Empowerment E2 intervention with a Post Acute Care Hypertension Consultation PACHT-c intervention arm 2 on the primary outcome of mean systolic blood pressure SBP differences between the two trial arms at 6-months post intervention Secondary objectives include evaluating the effectiveness of this ED education and empowerment intervention on mean SBP and diastolic blood pressure DBP differences at 3-months and mean DBP differences at 6-months Additionally improvement in cardiovascular risk score as measured by the Atherosclerotic Cardiovascular Disease ASCVD Risk Score primary care engagement measured by compliance with outpatient follow-up appointments and HTN knowledge improvement as measured by a validated HTN knowledge survey
Detailed Description:
The study is a single-site randomized controlled trial RCT focused on a high-risk ED population with evidence of moderately elevated BP 14090 mmHg at discharge ED patients will be recruited and randomized into two arms 1 usual care preprinted discharge instructions and 48-72 hour referral to a federally qualified health center FQHC or assigned provider as appropriate 2 ED-initiated E2 intervention program followed by 48-72 hour referral to a FQHC or assigned health center Based on the ED population demographics 70 ethnic minorities the majority of participants will be underrepresented minorities NHB and Hispanic and low-income individuals The investigators propose the following specific aims and hypotheses
Aim 1 Evaluate the effectiveness of an ED-based E2 PACHT-c intervention arm 2 on the primary outcome of mean SBP difference at 6-months post-intervention compared to usual care arm 1
H1 The mean SBP difference from baseline will be significantly greater in the E2 PACHT-c group arm 2 compared to the usual care group arm 1 at 6- months post-randomization ie SBP change in arm 2 arm 1 at 6-months post-randomization
Aim 2 Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c on the secondary outcome of mean SBP and DBP differences at 3-months and mean DBP differences at 6 months post-intervention compared to usual care
H2 The mean SBP and DBP differences from baseline to 3- months post-intervention and mean DBP at 6-months post intervention will be significantly greater in the ED-based E2 intervention compared to the usual care group ie SBP and DBP change in arm 2 arm 1 at 3 -months post-intervention and DBP change in arm 2 arm 1 at 6 -months post-intervention
Aim 3 Examine if the E2 intervention reduces racial disparities Specifically if the intervention is as effective in racial minorities as non-minorities This will be an exploratory analysis and will primarily focus on changes in cardiovascular risk scoreprofile Also included will be an assessment of intervention mediators primary care engagement medication adherence and HTN knowledge in these same patients at 3 and 6-months post randomization-intervention
Aim 1 Evaluate the effectiveness of an ED-based E2 PACHT-c intervention arm 2 on the primary outcome of mean SBP difference at 6-months post-intervention compared to usual care arm 1
H1 The mean SBP difference from baseline will be significantly greater in the E2 PACHT-c group arm 2 compared to the usual care group arm 1 at 6- months post-randomization ie SBP change in arm 2 arm 1 at 6-months post-randomization
Aim 2 Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c on the secondary outcome of mean SBP and DBP differences at 3-months and mean DBP differences at 6 months post-intervention compared to usual care
H2 The mean SBP and DBP differences from baseline to 3- months post-intervention and mean DBP at 6-months post intervention will be significantly greater in the ED-based E2 intervention compared to the usual care group ie SBP and DBP change in arm 2 arm 1 at 3 -months post-intervention and DBP change in arm 2 arm 1 at 6 -months post-intervention
Aim 3 Examine if the E2 intervention reduces racial disparities Specifically if the intervention is as effective in racial minorities as non-minorities This will be an exploratory analysis and will primarily focus on changes in cardiovascular risk scoreprofile Also included will be an assessment of intervention mediators primary care engagement medication adherence and HTN knowledge in these same patients at 3 and 6-months post randomization-intervention
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R61HL139454-01A1 | NIH | None | httpsreporternihgovquickSearch1R61HL139454-01A1 |