NCT02069015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

February 19, 2014

Results QC Date

December 28, 2019

Last Update Submit

December 21, 2020

Conditions

Keywords

Patient educationHypertensionPatient activation

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure (Systolic) at 180 Days

    Systolic Blood Pressure (SDB) at 180 days post-discharge

    180 days

Secondary Outcomes (1)

  • Patient Activation Measure (PAM)

    Baseline

Other Outcomes (2)

  • Emergency Department Visitation Rate

    Baseline to 180 days

  • Cost Effectiveness

    180 days

Study Arms (2)

Enhanced discharge

EXPERIMENTAL

Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge.

Behavioral: Patient education

Standard discharge

NO INTERVENTION

Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription

Interventions

Patient education on hypertension delivered through a touchscreen kiosk.

Enhanced discharge

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Receiving Hospital Emergency Department

Detroit, Michigan, 48201, United States

Location

Related Publications (6)

  • 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.

    PMID: 23948646BACKGROUND
  • 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.

    PMID: 19845553BACKGROUND
  • 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.

    PMID: 22658278BACKGROUND
  • 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.

    PMID: 26691646BACKGROUND
  • 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.

    PMID: 28784120BACKGROUND
  • 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.

MeSH Terms

Conditions

HypertensionPatient Participation

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Julie Gleason-Comstock
Organization
Wayne State University

Study Officials

  • Julie A Gleason-Comstock, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR
  • Phillip D Levy, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

December 22, 2020

Results First Posted

December 22, 2020

Record last verified: 2020-12

Locations