Qualitative Study of Long Term Cardiovascular Risk Prediction in the Emergency Department

June 29, 2022 updated by: Richard Body, University of Manchester

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

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Manchester, United Kingdom
        • Manchester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency Medicine Consultants
The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
General Practitioners
The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
Acute care nursing staff
The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
Patients presenting with suspected cardiac chest pain
The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30-45 minutes
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Richard Body, MbChB, PhD, FRCEM, University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2020

Primary Completion (ACTUAL)

January 18, 2022

Study Completion (ACTUAL)

January 18, 2022

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (ACTUAL)

October 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NHS 001549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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