Condition category
Circulatory System
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Natalie Fitzpatrick

ORCID ID

Contact details

Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom
-
n.fitzpatrick@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7882

Study information

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

Acronym

Optimising the Management of Angina (OMA)

Study hypothesis

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

MREC approved (ref: 08/H0709/85)

Study design

Multicentre randomised interventional treatment and screening study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

05/01/2009

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 200

Participant 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.

Recruitment start date

05/01/2009

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor type

Government

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Government

Funder name

National Insititute for Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/07/2016: No publications found, verifying study status with principal investigator