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Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)

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ClinicalTrials.gov Identifier: NCT03749499
Recruitment Status : Suspended (The Emergency Department has temporarily suspended research activities due to COVID19.)
First Posted : November 21, 2018
Last Update Posted : April 8, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Heather Prendergast, University of Illinois at Chicago

Brief Summary:
The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed hypertension (HTN) in underrepresented groups presenting to the ED is alarmingly high, and 2) ED engagement and early risk assessment/stratification 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), medication adherence (as measured by the Modified Morisky Scale), primary care engagement (measured by compliance with outpatient follow-up appointments), and HTN knowledge improvement (as measured by a validated HTN knowledge survey).

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Vascular Diseases Other: HTN Educational Video Other: Visual Echocardiogram Image Clips Other: Mobile Health and Remote BP monitoring Other: Post-Acute Care HTN Transition consultation (PACHT-c) Not Applicable

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 (≥140/90 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, i.e., 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, i.e., 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 score/profile. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures.
Primary Purpose: Screening
Official Title: Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Participants randomized to usual care will receive preprinted discharge instructions on HTN and a 48-72-hour referral to our FQHC (or other community health center if pre-assigned though Illinois Medicaid) to schedule their follow-up appointment (current standard of care)
Active Comparator: Educational and Empowerment Intervention

Participants receive:

  1. HTN Educational Video about high BP, how it is diagnosed, and importance of treatment to prevent secondary complications.
  2. Visual Echocardiogram Image Clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change behavior and improve their BP.
  3. Mobile Health and Remote BP monitoring- participants receive an FDA-approved home blood pressure monitoring (HBPM) kit that includes the Nokia wireless BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.
  4. A Post-Acute Care HTN Transition consultation (PACHT-c) with a clinical pharmacist or advanced practice nurse (APN).
Other: HTN Educational Video
The video will educate participants in arm 2 about high BP, how it is diagnosed, and the importance of treating it to prevent secondary complications.

Other: Visual Echocardiogram Image Clips
Visual clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change their behavior and improve their BP. We have found that real time visualization of cardiac ultrasound images with active discussion of findings is a significant patient motivator and empowerment tool, and was a significant factor in the success of our previous pilot study.

Other: Mobile Health and Remote BP monitoring
All participants randomized to the intervention group will receive an FDA-approved HBPM kit that includes the Nokia wireless (self-inflating) BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff and turns on the monitor to measure his/her BP. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.

Other: Post-Acute Care HTN Transition consultation (PACHT-c)
All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate.




Primary Outcome Measures :
  1. Mean systolic blood pressure (SBP) difference at 6 months post-intervention compared to usual care. [ Time Frame: Baseline, 6 months after baseline ]
    Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.


Secondary Outcome Measures :
  1. Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) differences at 3 months post-intervention compared to usual care. [ Time Frame: Baseline, 3 months after baseline ]
    Blood pressure will be collected at two time points (baseline and 3 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.

  2. Diastolic blood pressure (DBP) difference at 6 months post-intervention compared to usual care. [ Time Frame: Baseline, 6 months after baseline ]
    Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.

  3. Change in cardiovascular risk score/profile. [ Time Frame: Baseline, 3 months and 6 months after baseline ]

    As measured by the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Estimator Plus at baseline, 3 months, and then at 6 months.

    Atherosclerotic Cardiovascular Disease Risk Estimator Plus provides a patient's 10-year risk and a lifetime of developing atherosclerotic cardiovascular disease. The 10-year calculated ASCVD risk a quantitative estimation of absolute risk based upon data from representative population samples. The lifetime calculated ASCVD risk represents a quantitative estimation of absolute risk for a 50 year old man or woman with the same risk profile.

    The estimator provides risk as a percentage, ranging from 0-100%. A higher percentage is considered a worse outcome.


  4. Change in medication adherence. [ Time Frame: Baseline, 3 months and 6 months after baseline ]

    As measured by the Morisky Medication Adherence Scale at baseline, 3 months, and then at 6 months.

    The 4-item Morisky Medication Adherence Scale (MMAS-4) is a validated instrument to assess self-reported patient adherence related to antihypertensive medication. The modified Morisky scale provides a total score with a range of 0 to 4, with higher scores indicating lower adherence to medication. The scores of the modified Morisky scale can be classified as low compliers (3-4), medium compliers (1-2) and high compliers (0) based on its criterion validity with BP control. A higher score on the scale is a worse outcome.


  5. Primary care engagement. [ Time Frame: 1 month after baseline ]
    Measured by compliance with outpatient follow-up appointment at 1 month after baseline.

  6. Change in hypertension knowledge. [ Time Frame: Baseline and 6 months after baseline ]

    As measured by a validated HTN knowledge survey at baseline and then at 6 months.

    The hypertension knowledge survey is a 10-item, validated tool developed to assess hypertension knowledge in low literacy patient populations. The scale assesses respondents' knowledge in defining hypertension, lifestyle, and behaviors that may affect BP levels, and the long-term consequences of HTN. The survey has been validated in an urban population that included a high proportion of black and Latino patients. Scores are categorized into tertiles that indicate low (≤7), medium (8), or high (9-10) levels of HTN knowledge. The tool comes from: Shane S, Muntner P, Kawasaki L, Hyre A, DeSalvo K. Hypertension Knowledge Among Patients from an Urban Clinic. Ethnicity & Disease. 2008; 18: 42-47.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BP>=140/90 and <=180/110 mm Hg at time of discharge from ED
  • Verbal fluency in English or Spanish
  • Age 18-75 years

Exclusion Criteria:

  • Unable to verbalize comprehension of study, impaired decision-making or documented dementia
  • Plans to move from Chicago area within the next year
  • Pregnant or trying to get pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749499


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Heather Prendergast, MD, MPH, MS University of Illinois at Chicago
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Responsible Party: Heather Prendergast, Professor (CT), Associate Head for Academic Affairs, Resident Research Director, Emergency Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03749499    
Other Study ID Numbers: 2017-0118
1R61HL139454-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The TOUCHED data sets will be submitted to the NHLBI Data repository, and will include the following:

  • Data Information collected and recorded from study participants, including baseline, interim visit, ancillary data, outcome data, laboratory measurements not otherwise summarized, blood pressure measurements; quantitative results from survey assessments; clinical event surveillance and follow-up contacts.
  • Study documentation: Descriptive information regarding the conduct of the study and collection of Data, including study protocol, manual of operations/procedures, annotated data collection forms, codebooks /data dictionary, and descriptions of data derived from procedures.

In the preparation and delivery of the Data to the NHLBI Data Repository, all personal identifiers will be eliminated. A summary of all proposed modifications and deletions to be made to a data set will be submitted to and approved by the NHLBI Data Repository representative prior to their implementation.

Supporting Materials: Study Protocol
Analytic Code
Time Frame: The TOUCHED data set will be submitted to the NHLBI Program Officer, no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heather Prendergast, University of Illinois at Chicago:
Emergency Department
Minorities
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Emergencies
Cardiovascular Diseases
Disease Attributes
Pathologic Processes