The development and feasibility of an intervention to reassure patients about test results in rapid access chest pain clinic
| ISRCTN | ISRCTN60618114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60618114 |
| Secondary identifying numbers | 9810 |
- Submission date
- 27/05/2011
- Registration date
- 27/05/2011
- Last edited
- 06/10/2014
- 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
Not provided at time of registration
Contact information
Prof Gill Furze
Scientific
Scientific
Coventry University
Room 309, Richard Crossman Building
Priory Street
Coventry
CV1 5FB
United Kingdom
Study information
| Study design | Randomised, interventional, observational qualitative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The development and feasibility of an intervention to reassure patients about test results in a rapid access chest pain clinic |
| Study hypothesis | The study has two parts: 1. In the first part (the development phase), an intervention will be developed with input from experts, patients and clinic staff. The intervention will be a brief (10 - 15 mins) face-to-face discussion delivered by a nurse to patients attending rapid access chest pain clinic (RACPC) that will explain to the patients the tests they are going to undergo in RACPC, the possible test results they may get, and what the possible treatments may be for the different test results. This discussion will take place before the patients undergo their test in RACPC and the aim of the intervention is to increase patientsÂ’ reassurance with their test results and ensuing treatment. A focus group of ten previous RACPC patients will be setup to gain their views on the draft intervention. The final draft intervention will be tested in ten patients in RACPC before being finalised. 2. (The pilot trial phase) we will undertake a pilot randomised controlled trial (RCT) with 120 patients in RACPC. The two-arm study will compare the intervention (face-to-face discussion developed in the first part of the study) PLUS usual care (a written leaflet giving the same information - tests that may be undertaken in RACPC, results and potential ensuing treatments) VERSUS usual care alone. The pilot RCT will inform the design of a future multicentre trial. |
| Ethics approval(s) | First MREC approval date 15/12/2010, ref: 10/H1014/82 |
| Condition | Cardiovascular disease |
| Intervention | 1. Nurse-facilitated intervention: a brief (10 - 15 mins) face-to-face discussion delivered by a nurse to patients attending rapid access chest pain clinic (RACPC) that will explain to the patients the tests they are going to undergo in RACPC, the possible test results they may get, and what the possible treatments may be. 2. Follow up length: 6 month(s) 3. Study entry: single randomisation only In the first stage of the study, ten participants will be recruited for the focus group and ten participants will be recruited for testing each draft of the intervention. For the pilot RCT, we propose to recruit 120 participants (60 per group). |
| Intervention type | Other |
| Primary outcome measure | 1. Patient reported reassurance 2. Timepoint(s): 1 month and six months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 30/03/2011 |
| Overall study end date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 140; UK Sample Size: 140; |
| Participant inclusion criteria | Applies to the developmental phase and the pilot study: 1. All patients attending RACPC for assessment of new-onset, non-urgent chest pain 2. Able to read written English 3. Able to comprehend spoken English 4. Aged 18 years and over 5. Able and willing to give informed consent 6. Target gender: male & female 7. Lower age limit 18 years |
| Participant exclusion criteria | Pilot study only: 1. Previously diagnosed cardiac pathology 2. No symptoms of chest pain 3. Undertaking the stress test as part of a pre-surgical medical examination 4. Pregnant 5. Currently involved in a research study 6. Severe documented psychiatric disorder (psychosis/bipolar disorder) 7. Life threatening co-morbidities |
| Recruitment start date | 30/03/2011 |
| Recruitment end date | 30/06/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Coventry University
Coventry
CV1 5FB
United Kingdom
CV1 5FB
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
Department of Health Sciences
York Trials Unit
Area 4
Sebohm Rowntree Building
Heslington
York
YO10 5DD
England
United Kingdom
| Website | http://www.york.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
NIHR Research for Patient Benefit Programme (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 | 04/10/2014 | Yes | No |
