- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04601922
Qualitative Study of Long Term Cardiovascular Risk Prediction in the Emergency Department
Qualitative Study of Potential Barriers and Solutions to Long Term Cardiovascular Risk Prediction in the Emergency Department
One of the most common presentations to ED is chest pain, with the rapid rule out of heart attacks in the emergency department being common place. This moves a new onus of responsibility to the ED; the care of long term heart disease. A study conducted locally demonstrated that patient's with a heart attack ruled out felt the 'what next' question is not answered sufficiently at present. The strength of this opportunity is re-enforced by studies suggesting that chest pain presents a teachable moment where patients are more accepting of advice.
The study's overarching goal is to improve heart disease care (cardiovascular disease).The early warning signs for heart disease can be detected and treated enabling patients to live longer and healthier lives.
This is where it is believed that the Emergency Department (ED) can improve, EDs already collect the vast majority of data required to detect these early warning signs. In the United Kingdom more than 23.8 million attendances were registered last year, and ED is currently underusing a large amount of patient data of potentially great value to the population.
The study aims to explore the best way to use this long term heart disease prediction; how to communicate it to patients, who prescribes the necessary medication, who issues lifestyle advice, and who follows it up.
The investigators intend to answer these questions with a series of semi-structured interviews. The study will comprise of initial semistructured interviews made up of emergency medicine consultants, general practitioners, nurses, and patients. Then building on the knowledge gained from the initial interviews it is planned to build a prototype care pathway that will be explored in the second set of interviews.
Funded by The Royal College of Emergency Medicine
Ethical approval by the UK's HRA REC - 19/WA/0312
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Manchester, United Kingdom
- Manchester Royal Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Genaral Practitioner
- Emergency medicine consultant consultant
- acute care nurse
- emergency department patients with low risk chest pain.
Description
Inclusion Criteria:
- Genaral Practitioner / Emergency medicine consultant consultant /acute care nurse OR
- emergency department patients with low risk chest pain.
These patients are deemed low risk by a predictive algorithm that was validated in more than 10,000 and has subsequently been used in clinical practice safely in over 7,000 patients. Once deemed low risk they are then transferred to an ambulatory care unit where they receive further assessment.
Exclusion Criteria:
- The participants can not attend at least one of the semi-structured interviews
- Not fluent in English language
- The ambulatory ward patient's clinical condition has deteriorated or is severe to the extent that participating in the research would (a) interfere in their clinical care, or (b) that participating would be too strenuous. This will be judged by the nursing staff on the ambulatory care unit, and the clinical academics interviewing the patients.
- Unwilling to take part
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Emergency Medicine Consultants
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The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
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General Practitioners
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The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
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Acute care nursing staff
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The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
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Patients presenting with suspected cardiac chest pain
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The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Experience and views of barriers and solutions to the provision of preventative medicine in the emergency department.
Time Frame: 30-45 minutes
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Through semi-structured interviews the study will focus specifically on the prevention of cardiovascular disease in those patients presenting with chest pain.
Qualitative software will be used to thematically analyse the interviews.
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30-45 minutes
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Prototype care pathways for prevention of long term cardiovascular disease
Time Frame: through study completion, an average of 1 year
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The study is seeking through co-design to develop prototype care pathways for the prevention of cardiovascular disease.
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Richard Body, MbChB, PhD, FRCEM, University of Manchester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHS 001549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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