Improving Acute Hypertension Management Through Emergency Department Checklist

NCT04553653 | Completed

• 2 other identifiers: IRB001950025R21TW011175-02
• Study Type: interventional
• Target: 1,161
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hypertensive Crisis; Hypertensive Emergency

Keywords

checklist; emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in the use of appropriate medications for treatment of hypertensive emergency

  Baseline and 6 months after checklist implementation

Other Outcomes (1)

• Compliance with chronic treatment of hypertension as assessed through a phone call

  Up to 6 months post discharge from the emergency department

Study Arms (2)

Baseline

NO INTERVENTION

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

Intervention arm

EXPERIMENTAL

The intervention arm will be enrolled after the checklist implementation.

Other: checklist

Interventions

checklist OTHER

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

Intervention arm

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Aga Khan University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Aga Khan University

Karachi, 7440, Pakistan

Location

MeSH Terms

Conditions

Hypertension; Hypertensive Crisis; Emergencies

Interventions

Checklist

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Junaid A Razzak

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked. Investigators and care providers are not masked due to the obvious design and logistics challenges.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: June 15, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)