Improving Acute Hypertension Management Through Emergency Department Checklist

NCT ID: NCT04553653

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2021-04-30

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.

Conditions

Hypertension; Hypertensive Crisis; Hypertensive Emergency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention arm

The intervention arm will be enrolled after the checklist implementation.

Group Type: EXPERIMENTAL

checklist

Intervention Type: OTHER

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

Interventions

checklist

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junaid A Razzak

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Aga Khan University

Karachi, , Pakistan

Countries

Pakistan

Other Identifiers

5R21TW011175-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00195002

Identifier Type: -

Identifier Source: org_study_id