Cardiovascular DiseasesNCT04601922
Qualitative Study of Long Term Cardiovascular Risk Prediction in the Emergency Department
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by University of Manchester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, Emergencies
- What is being tested?
- Semi-structured interview
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2020to 18 Jan 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: * Genaral Practitioner * Emergency medicine consultant consultant * acute care nurse * emergency department patients with low risk chest pain.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Semi-structured interview
- Medical subject headings
- Cardiovascular Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
| Study group | Role | What they receive |
|---|---|---|
| Emergency Medicine Consultants | Not described Receives: Other: Semi-structured interview | |
| General Practitioners | Not described Receives: Other: Semi-structured interview | |
| Acute care nursing staff | Not described Receives: Other: Semi-structured interview | |
| Patients presenting with suspected cardiac chest pain | Not described Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience and views of barriers and solutions to the provision of preventative medicine in the emergency department.
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.
Measured: 30-45 minutes
Prototype care pathways for prevention of long term cardiovascular disease
The study is seeking through co-design to develop prototype care pathways for the prevention of cardiovascular disease.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start15 Sep 2020
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Emergency Medicine
- Responsible party
- Principal investigator, Richard Body, University of Manchester
- Investigators
- Richard Body, MbChB, PhD, FRCEM, Study director, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601922
- Sponsor's protocol ID
- NHS 001549
- Status last verified
- Jun 2022
- First submitted
- 9 Oct 2020
- Last updated
- 5 Jul 2022
- 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 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study of Potential Barriers and Solutions to Long Term Cardiovascular Risk Prediction in the Emergency Department
- ClinicalTrials.gov ID
- NCT04601922
- Acronym / sponsor ID
- NHS 001549
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Royal College of Emergency Medicine
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 26 Oct 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Emergency Medicine Consultants | – | Other: Semi-structured interview |
| General Practitioners | – | Other: Semi-structured interview |
| Acute care nursing staff | – | Other: Semi-structured interview |
| Patients presenting with suspected cardiac chest pain | – | Other: Semi-structured interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Genaral Practitioner * Emergency medicine consultant consultant * acute care nurse * emergency department patients with low risk chest pain.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Semi-structured interviewThe interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways | Other | Acute care nursing staff, Emergency Medicine Consultants, General Practitioners, Patients presenting with suspected cardiac chest pain |
Primary outcome
Experience and views of barriers and solutions to the provision of preventative medicine in the emergency department.
Time frame: 30-45 minutes
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.
Prototype care pathways for prevention of long term cardiovascular disease
Time frame: through study completion, an average of 1 year
The study is seeking through co-design to develop prototype care pathways for the prevention of cardiovascular disease.
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 5 Jul 2022.
- Ethical approval registerLink provided by the sponsor.
- 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.
Richard Body, MbChB, PhD, FRCEM study director
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by University of Manchester at 1 site in United Kingdom.
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 3 inclusion and 4 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 5 Jul 2022. 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 United Kingdom. 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?
Experience and views of barriers and solutions to the provision of preventative medicine in the emergency department. (time frame: 30-45 minutes). The study lists 2 primary outcomes in all. 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 5 Jul 2022.