Improving Acute Hypertension Management Through Emergency Department Checklist

The investigators hypothesize that the implementation of a checklist in acute severe hypertension would result in improving short and long-term outcomes of patients with acute severe hypertension treated in the emergency department (ED). The investigators hypothesize that in the short-term, a checklist would improve the diagnosis and management of end-organ damage as well as reduce the length of stay of acute severe hypertensive patients in the ED. The investigators hypothesize that the checklist will result in better compliance with anti-hypertensive medications than without the checklist at six-month post-discharge.

Study Overview

• Status: Completed
• Conditions: Hypertension; Hypertensive Emergency; Hypertensive Crisis
• Intervention / Treatment: Other: checklist

Detailed Description

Hypertension is a global public health issue and results in over 10 million deaths every year. The disease affects one-third of people living in low- and middle-income countries (LMICs) and contributes to half of all productivity losses in LMICs due to non-communicable diseases. Though hypertension often presents as a chronic asymptomatic illness, hypertension-related emergencies represent a significant burden to the health care system. Acute severe hypertension [i.e., systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg] make up to 5% of all emergency admission. One-third of these patients present with end-organ damage; a condition called a hypertensive crisis. More worrisome is the fact that a number of ED visits, as a result, severe acute hypertension and hypertensive crises have almost tripled between 2006 and 2013 in the US. Treatment approaches to managing acute severe hypertension (~5% of ED patients) are largely unclear and only 6% of ED patients with acute severe hypertension receive appropriate work-up for the end-organ damage, indicating a huge care gap. One approach, which has been used successfully in managing other complex and critical conditions, is the use of checklists. Checklists are a listing of actions to be performed in a given clinical setting with the aim of improving adherence to standards, reducing errors and thus improving patient outcomes. The investigators hypothesize that the use of a Checklist, if appropriately implemented, can lead to an improvement in the care of patients presenting with hypertensive crisis. During this study, the investigators will measure the prevalence of acute severe hypertension and assess the current quality of care for these patients. This will be followed by the development of a checklist for the management of the hypertensive crises in the ED. The investigators will follow these patients to see the impact of the checklist on the quality of care and long-term outcomes.

• Study Type: Interventional
• Enrollment (Actual): 1161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan, 7440
    • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults who visit the Aga Khan University Hospital Emergency Department with acute severe hypertension
• able to provide consent to participate
• Age >25 years of age
• Meeting the criteria of acute severe hypertension (SBP>180 and DBP>110).

Exclusion Criteria:

• Patients not providing consent or are unconscious are excluded from participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline; Data on diagnosis and care of patients presenting with acute severe hypertension will be collected at baseline (prior to the implementation of a checklist)
Experimental: Intervention arm; The intervention arm will be enrolled after the checklist implementation.	Other: checklist; The checklist will be implemented and healthcare providers use the checklist to manage the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of diagnosis of hypertensive emergency	The frequency of correct diagnosis of hypertensive emergency in patients with severe hypertension with evidence of end-organ damage in the ED before and after the implementation of the checklist.	Baseline and 6 months after checklist implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the use of appropriate medications for treatment of hypertensive emergency	We will measure the compliance with the hypertensive emergency treatment protocol before and after implementation of the checklist.	Baseline and 6 months after checklist implementation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with chronic treatment of hypertension as assessed through a phone call	We will follow up our patients on phone to assess their compliance with the use of antihypertensive medications.	Up to 6 months post discharge from the emergency department

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Aga Khan University; Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Junaid A Razzak, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2019
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: emergency department; checklist
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Hypertension; Emergencies
• Other Study ID Numbers: IRB00195002; 5R21TW011175-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No