A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities

NCT03093532 | Completed DMC

• 2 other identifiers: 2015-0323R56HL126657
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effective interventions that can address uncontrolled hypertension, particularly in underrepresented populations that use the emergency department (ED) for primary care, are critically needed. Uncontrolled hypertension (HTN) contributes significantly to cardiovascular morbidity and mortality and is more frequently encountered among patients presenting to the ED as compared to the primary care setting. EDs serve as the point of entry into the health care system for many high-risk patient populations, including minority and low-income patients. Based upon recent studies, the prevalence of uncontrolled/undiagnosed HTN in patients presenting to the ED is alarmingly high. Thus emergency department engagement and early risk assessment/stratification is a feasible innovation to help close health disparity gaps in HTN. This proposal involves a three-arm randomized controlled trial of 120 patients from the Emergency Department at University of Illinois Hospital with elevated blood pressure (BP) and no established primary care provider (PCP). The overarching goal is to improve follow-up rates and transition to PCP care at a federally qualified community health center (FQHC). The primary outcome will be blood pressure control. Secondary outcomes will be blood pressure improvement, treatment adherence, and hypertension knowledge. The central hypothesis of the proposal is that an ED-based screening, brief intervention, and referral for treatment program for HTN (SBIRT-HTN) using existing ED resources, coupled with a follow-up visit to an ED pharmacist-initiated Post-Acute Care Hypertension Transition Clinic (PACHT-c), can be impactful in a predominately underrepresented hypertensive population.

Conditions

Hypertension

Keywords

emergency department; stage 2 hypertension; minorities

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Control (BP < 140/90 mmHg) at 6 Months

  In order to be eligible for the study, patients must have uncontrolled BP. At 6 months, we will determine if patients have controlled their BP, as evidenced by BP \< 140/90 mmHg. BP measurements will be recorded on seated participants after at least five minutes in a quiet room. ED-pharmacists and trained research assistants will perform BP, measurements using digital BP meters using standardized procedures.

  6 months

Secondary Outcomes (3)

• Change from Baseline Blood Pressure (Systolic/Diastolic mm Hg) at 6 Months

  0, 6 months

• Change in Hypertension Knowledge at 6 Months (Hypertension Knowledge Survey)

  0, 6 months

• Change in Treatment Adherence at 6 Months (Modified Morisky Scale)

  0, 6 months

Study Arms (3)

Usual Care

NO INTERVENTION

The Usual Care group arm will received pre-printed discharge instructions and an outpatient referral. (This group represents standard of care.)

ED SBIRT-HTN

ACTIVE COMPARATOR

The ED SBIRT-HTN (The Emergency Department Screening Brief Intervention and Referral for Treatment) arm consists of a series of risk assessment tools (surveys, video, and noninvasive bedside assessments) designed to be efficient, patient-centered and educational for participants in an emergency department setting. Through the intervention, participants will learn more about hypertension management and complications associated with uncontrolled BP. Participants in the ED-SBIRT-HTN group will receive the following interventions: 1\) screening (risk assessment/stratification), 2) a limited bedside echocardiogram (looking for evidence of subclinical cardiac disease), and 3) a urine microalbumin test (marker of early cardiovascular disease).

Other: ED SBIRT-HTN

E SBIRT-HTN + PACTH-c

ACTIVE COMPARATOR

Participants randomized to the SBIRT-HTN +PACHT-c (Post-Acute Care Hypertension Transition Clinic) arm will receive all interventions of the ED SBIRT-HTN arm plus a 48-72 hour follow-up in the Post-Acute Care Hypertension Transition Clinic for repeat blood pressure assessment, review of screening assessments, and secured PCP appointment with a federally qualified health center within the study site's health system.

Other: ED SBIRT-HTN; Other: PACHT-c

Interventions

ED SBIRT-HTN OTHER

Participants in the ED-SBIRT-HTN group will receive the following interventions: 1\) screening (risk assessment/stratification), 2) a limited bedside echocardiogram (looking for evidence of subclinical cardiac disease), and 3) a urine microalbumin test (marker of early cardiovascular disease).

Also known as: Screening,Brief Intervention,Referral for Treatment HTN

E SBIRT-HTN + PACTH-c; ED SBIRT-HTN

PACHT-c OTHER

Participants randomized to the SBIRT-HTN +PACHT-c (Post-Acute Care Hypertension Transition Clinic) arm will receive all interventions of the ED SBIRT-HTN arm plus a 48-72 hour follow-up in the Post-Acute Care Hypertension Transition Clinic for repeat blood pressure assessment, review of screening assessments, and secured PCP appointment with a federally qualified health center within the study site's health system.

Also known as: Post Acute Care Hypertension Transition Clinic

E SBIRT-HTN + PACTH-c

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Stage 2 Hypertension- Elevated BP of ≥160/100 at time of discharge from ED
• Verbal fluency in English or Spanish
• Age 30 to 64 years

You may not qualify if:

• Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
• History of heart failure, myocardial infarction, or stroke
• Lives outside Chicago communities
• Plans to move from Chicago area within the next year
• Pregnant or trying to get pregnant

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Hypertension; Emergencies

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair Clinical Affairs, Emergency Medicine

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 28, 2017
• Study Start: September 8, 2015
• Primary Completion: July 30, 2017
• Study Completion: September 8, 2017
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share