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Improving Acute Hypertension Management Through Emergency Department Checklist

Primary Purpose

Hypertension, Hypertensive Crisis, Hypertensive Emergency

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
checklist
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring checklist, emergency department

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline

Intervention arm

Arm Description

Data on diagnosis and care of patients presenting with acute severe hypertension will be collected at baseline (prior to the implementation of a checklist)

The intervention arm will be enrolled after the checklist implementation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 11, 2020
Last Updated
August 12, 2021
Sponsor
Johns Hopkins University
Collaborators
Aga Khan University, Fogarty International Center of the National Institute of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04553653
Brief Title
Improving Acute Hypertension Management Through Emergency Department Checklist
Official Title
Improving Acute Hypertension Management Through Emergency Department Checklist
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Aga Khan University, Fogarty International Center of the National Institute of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypertensive Crisis, Hypertensive Emergency
Keywords
checklist, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This will be a before-after study. Baseline data capturing care and the outcomes of patients presenting with acute severe hypertension will be collected. A checklist will be developed and implemented and a post-implementation data collection will be conducted using the same tool as prior to the intervention.
Masking
Participant
Masking Description
Participants will be masked. Investigators and care providers are not masked due to the obvious design and logistics challenges.
Allocation
Non-Randomized
Enrollment
1161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Data on diagnosis and care of patients presenting with acute severe hypertension will be collected at baseline (prior to the implementation of a checklist)
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
The intervention arm will be enrolled after the checklist implementation.
Intervention Type
Other
Intervention Name(s)
checklist
Intervention Description
The checklist will be implemented and healthcare providers use the checklist to manage the patients.
Primary Outcome Measure Information:
Title
Change in frequency of diagnosis of hypertensive emergency
Description
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.
Time Frame
Baseline and 6 months after checklist implementation
Secondary Outcome Measure Information:
Title
Change in the use of appropriate medications for treatment of hypertensive emergency
Description
We will measure the compliance with the hypertensive emergency treatment protocol before and after implementation of the checklist.
Time Frame
Baseline and 6 months after checklist implementation
Other Pre-specified Outcome Measures:
Title
Compliance with chronic treatment of hypertension as assessed through a phone call
Description
We will follow up our patients on phone to assess their compliance with the use of antihypertensive medications.
Time Frame
Up to 6 months post discharge from the emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junaid A Razzak
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
ZIP/Postal Code
7440
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Acute Hypertension Management Through Emergency Department Checklist

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