HypertensionNCT04553653
Improving Acute Hypertension Management Through Emergency Department Checklist
A study testing checklist in people with Hypertension and Hypertensive Crisis, run by Johns Hopkins University at 1 site in Pakistan.
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). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hypertension, Hypertensive Crisis, Hypertensive Emergency
- What is being tested?
- checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,161 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients not providing consent or are unconscious are excluded from participation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- checklist
- Keywords
- checklist, emergency department
- Medical subject headings
- Hypertension, Hypertensive Crisis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
checklistOther
The checklist will be implemented and healthcare providers use the checklist to manage the patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months after checklist implementation
Secondary outcomes (1)
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.
Measured: Baseline and 6 months after checklist implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start15 Jun 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Junaid A Razzak, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553653
- Sponsor's protocol ID
- IRB00195002
- Other IDs
- 5R21TW011175-02
- Status last verified
- Aug 2021
- First submitted
- 11 Sep 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Acute Hypertension Management Through Emergency Department Checklist
- ClinicalTrials.gov ID
- NCT04553653
- Acronym / sponsor ID
- IRB00195002
- Conditions
- Hypertension, Hypertensive Crisis, Hypertensive Emergency
- Keywords
- checklist, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,161 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Aga Khan University, Fogarty International Center of the National Institute of Health
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: checklistThe intervention arm will be enrolled after the checklist implementation. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients not providing consent or are unconscious are excluded from participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| checklistThe checklist will be implemented and healthcare providers use the checklist to manage the patients. | Other | Intervention arm |
Primary outcome
Change in frequency of diagnosis of hypertensive emergency
Time frame: Baseline and 6 months after checklist implementation
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.
1 secondary outcome
Change in the use of appropriate medications for treatment of hypertensive emergency
Time frame: Baseline and 6 months after checklist implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junaid A Razzak principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing checklist in people with Hypertension and Hypertensive Crisis, run by Johns Hopkins University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of diagnosis of hypertensive emergency (time frame: Baseline and 6 months after checklist implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.