NCT04601922

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

October 9, 2020

Last Update Submit

June 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    through study completion, an average of 1 year

Study Arms (4)

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

Interventions

The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways

Acute care nursing staffEmergency Medicine ConsultantsGeneral PractitionersPatients presenting with suspected cardiac chest pain

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Genaral Practitioner * Emergency medicine consultant consultant * acute care nurse * emergency department patients with low risk chest pain.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesEmergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Body, MbChB, PhD, FRCEM

    University of Manchester

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 26, 2020

Study Start

September 15, 2020

Primary Completion

January 18, 2022

Study Completion

January 18, 2022

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations