Optimising the Management of Angina (OMA): a pilot study for a cluster randomised controlled trial of a training and development quality programme and a cohort study in rapid access chest pain clinics

ISRCTN	ISRCTN54381840
DOI	https://doi.org/10.1186/ISRCTN54381840
Secondary identifying numbers	7882

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 09/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Natalie Fitzpatrick
Scientific

Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom

Email	n.fitzpatrick@ucl.ac.uk

Study information

Study design	Multicentre randomised interventional treatment and screening study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Optimising the Management of Angina (OMA): a pilot study for a cluster randomised controlled trial of a training and development quality programme and a cohort study in rapid access chest pain clinics
Study acronym	Optimising the Management of Angina (OMA)
Study objectives	The Optimising Management of Angina (OMA) pilot study is a pilot for a cluster randomised controlled trial of an intervention consisting of an educational and individual patient based decision support tool ("ask OMA") in rapid access chest pain clinics. In the absence of any previous outcome powered trials of any intervention targeting patients whose initial presentation is suspected angina at the time of first specialist referral, we will develop a multi-faceted intervention within chest pain clinics including an individual patient based decision support tool and clinician training to guide appropriate investigation and initial treatment decisions, pilot the intervention, analyse its potential effectiveness and cost-effectiveness and determine the need for a main trial. The pilot will test the feasibility and acceptability of the intervention, which aims to optimise the management of angina by implementing an educational programme for clinic staff consisting of further training in diagnosis (focused on a computerised decision support tool for appropriate investigation) and the prescribing of secondary prevention medication and behavioral modification. The need for better decisions with patients presenting with new onset stable chest pain has been highlighted by the 2010 NICE chest pain guidelines. Our intervention implements the patient tailored, risk based decisions recommended by that guideline.
Ethics approval(s)	MREC approved (ref: 08/H0709/85)
Health condition(s) or problem(s) studied	Topic: Primary Care Research Network for England, Cardiovascular; Subtopic: Not Assigned, Cardiovascular (all Subtopics); Disease: Cardiovascular, All Diseases
Intervention	An educational and patient specific decision support tool (askOMA) targeted at doctors and specialist nurses.
Intervention type	Other
Primary outcome measure	General practice follow up for the recruited participants
Secondary outcome measures	1. Further investigations and treatment procedures 2. Developing methods for pseudo-anonymising data in practices
Overall study start date	05/01/2009
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 200
Total final enrolment	294
Key inclusion criteria	1. All patients attending the rapid access chest pain clinic after referral by their GP 2. Male and female, above the age of 40 years
Key exclusion criteria	There are no clinical exclusion criteria however patients unable to read English when there is no interpreter or family member present who can translate will be excluded. Patients who are accompanied by a family member acting as an interpreter will be able to participate without being asked sensitive questions from the questionnaire.
Date of first enrolment	05/01/2009
Date of final enrolment	01/06/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Epidemiology and Public Health

London
WC1E 6BT
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

250 Euston Road
London
NW1 2PG
England
United Kingdom

Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Government

National Insititute for Health Research (NIHR) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2015	09/08/2019	Yes	No

Editorial Notes

09/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
21/07/2016: No publications found, verifying study status with principal investigator