Clinical trial NCT02069015: Achieving Blood Pressure Control Through Enhanced Discharge
Official title: Achieving Blood Pressure Control Through Enhanced Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Patient education
Hypertension
Patient activation
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2014-02-21
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. Enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period.

Detailed description: A targeted sample of patients with uncontrolled blood pressure at the time of their emergency department visit discharge will be randomized into either standard or enhanced discharge. To control for medication effects in achieving blood pressure control, both groups will receive similar blood pressure medication while actively participating in the study.

Eligibility criteria: Inclusion Criteria:

* Present with uncontrolled blood pressure to the emergency department (\>140/90 for non-diabetics and \>130/80 for diabetics)
* Self-reported history of hypertension

Exclusion Criteria:

* End-stage renal disease
* No history of hypertension
* Do not present with uncontrolled blood pressure

Primary outcomes:
measure: Blood Pressure (Systolic) at 180 Days
timeFrame: 180 days
Secondary outcomes:
measure: Patient Activation Measure (PAM)
timeFrame: Baseline
Other outcomes:
measure: Emergency Department Visitation Rate
timeFrame: Baseline to 180 days
measure: Cost Effectiveness
timeFrame: 180 days
Locations:
city: Detroit
country: United States
facility: Detroit Receiving Hospital Emergency Department
state: Michigan
Study officials:
affiliation: Wayne State University
name: Julie A Gleason-Comstock, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Phillip D Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gleason-Comstock JA, Streater A, Jen KL, Artinian NT, Timmins J, Baker S, Joshua B, Paranjpe A. Consumer health information technology in an adult public health primary care clinic: a heart health education feasibility study. Patient Educ Couns. 2013 Dec;93(3):464-71. doi: 10.1016/j.pec.2013.07.010. Epub 2013 Aug 12.
citation: Levy PD, Cline D. Asymptomatic hypertension in the emergency department: a matter of critical public health importance. Acad Emerg Med. 2009 Nov;16(11):1251-7. doi: 10.1111/j.1553-2712.2009.00512.x. Epub 2009 Oct 20.
citation: Levy P, Ye H, Compton S, Zalenski R, Byrnes T, Flack JM, Welch R. Subclinical hypertensive heart disease in black patients with elevated blood pressure in an inner-city emergency department. Ann Emerg Med. 2012 Oct;60(4):467-74.e1. doi: 10.1016/j.annemergmed.2012.03.030. Epub 2012 May 31.
citation: Gleason-Comstock J, Streater A, Ager J, Goodman A, Brody A, Kivell L, Paranjpe A, Vickers J, Mango L, Dawood R, Levy P. Patient education and follow-up as an intervention for hypertensive patients discharged from an emergency department: a randomized control trial study protocol. BMC Emerg Med. 2015 Dec 21;15:38. doi: 10.1186/s12873-015-0052-3.
citation: Gleason-Comstock J, Streater A, Goodman A, Janisse J, Brody A, Mango L, Dawood R, Levy P. Willingness to pay and willingness to accept in a patient-centered blood pressure control study. BMC Health Serv Res. 2017 Aug 7;17(1):538. doi: 10.1186/s12913-017-2451-5.
citation: Gleason Comstock J, Janisse J, Streater A, Brody A, Goodman A, Zhang L, Mango L, Dawood R, Costello W, Patton S, Paranjpe A, Welsh C, Welch R, Levy P. Efficacy of enhanced emergency department discharge for chronic hypertension management - Results of a randomized controlled trial. Contemp Clin Trials Commun. 2020 Jul 18;19:100613. doi: 10.1016/j.conctc.2020.100613. eCollection 2020 Sep.