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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04553653
Other study ID # IRB00195002
Secondary ID 5R21TW011175-02
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2019
Est. completion date April 30, 2021

Study information

Verified date August 2021
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1161
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility 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 Design


Intervention

Other:
checklist
The checklist will be implemented and healthcare providers use the checklist to manage the patients.

Locations

Country Name City State
Pakistan Aga Khan University Karachi

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University Aga Khan University, Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
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