Condition category
Circulatory System
Date applied
27/05/2011
Date assigned
27/05/2011
Last edited
06/10/2014
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

Prof Gill Furze

ORCID ID

Contact details

Coventry University
Room 309
Richard Crossman Building
Priory Street
Coventry
CV1 5FB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9810

Study information

Scientific title

The development and feasibility of an intervention to reassure patients about test results in a rapid access chest pain clinic

Acronym

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

First MREC approval date 15/12/2010, ref: 10/H1014/82

Study design

Randomised, interventional, observational qualitative trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient reported reassurance
2. Timepoint(s): 1 month and six months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

30/03/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 140; UK Sample Size: 140;

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

United Kingdom

Trial participating centre

Coventry University
Coventry
CV1 5FB
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Department of Health Sciences
York Trials Unit
Area 4
Sebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit Programme (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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25280578

Publication citations

  1. Results

    Hicks K, Cocks K, Corbacho Martin B, Elton P, MacNab A, Colecliffe W, Furze G, An intervention to reassure patients about test results in rapid access chest pain clinic: a pilot randomised controlled trial., BMC Cardiovasc Disord, 2014, 14, 138, doi: 10.1186/1471-2261-14-138.

Additional files

Editorial Notes