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 |
| Protocol serial number | 7882 |
| Sponsor | University College London Hospitals NHS Foundation Trust (UK) |
| Funder | National Insititute for Health Research (NIHR) (UK) |
- 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
Scientific
Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom
| n.fitzpatrick@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment and screening study |
| Secondary study design | Randomised controlled trial |
| 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(s) |
General practice follow up for the recruited participants |
| Key secondary outcome measure(s) |
1. Further investigations and treatment procedures |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Epidemiology and Public Health
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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
