Plain English Summary
Background and study aims
After cardiac (heart) surgery, patients routinely have a follow-up appointment six weeks after discharge. After this appointment the patient is usually referred back to the care of their general practitioner (GP) and no longer receives care from, nor is followed up by, the cardiac surgery team. This study will involve patients being monitored in the long-term after cardiac surgery (for example, to find out how many patients experience major adverse cardiac events). These data will allow audit of cardiac surgery services and provide data to investigate risk factors for poor outcomes.
Who can participate?
Patients aged 18 or over who have had cardiac surgery at the Bristol Heart Institute.
What does the study involve?
We propose to collect consent from potential participants to access their data collected in NHS databases (used for clinical care) and from Hospital Episode Statistics (HES). We are particularly interested in outcomes such as stroke or heart attack that occur after surgery. Participants will be given a choice of participating electronically or via post. If participants choose to receive postal newsletters, it will be made clear that they are providing their consent to outsource sending an annual newsletter to a mailing company. We will also ask participants to complete a questionnaire relevant to the surgery they have received and/or a quality of life questionnaire at 3 months and 12 months after the surgery. There will also be a nested study to investigate whether the presentation style and format of the paper information leaflets provided to potential participants has an effect on the consent rates to the study. Participants will be randomly allocated to receive the information in three different formats, one of which is used routinely, the other two representing new styles. The content of each format will be the same. Participants will not be informed about this nested study.
What are the possible benefits and risks of participating?
The main benefit to society is the provision of high quality evidence to identify areas where research may benefit patient care and inform the design of such studies. Future patients and the NHS may benefit from such research. Participants may perceive a benefit from continued contact from the centre where they had their heart surgery. This is an observational study that will not change the participants’ standard care. There are therefore no risks resulting from the study to participant safety. The main risk is reminding participants of a time that was stressful and perhaps difficult for them; however, in our experience the majority of participants do appreciate the additional follow-up. There are no risks or anticipated benefits to participants as a result of the nested study.
Where is the study run from?
The study is run from the Clinical Trials and Evaluation Unit Bristol, University of Bristol, and based in the Bristol Heart Institute, University Hospitals Bristol NHS Trust (UK)
When is the study starting and how long is it expected to run for?
January 2015 to January 2016.
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Lucy Culliford
Outcome Monitoring After Cardiac Surgery: Cohort study with a nested randomised controlled trial
The aim of this study is to collect information about the medium- and long-term health status of patients who have had cardiac surgery. This will be used to inform the design of future studies, and to provide data for observational studies.
We are also preforming a nested RCT where we hypothesise that the format of information given to patients will affect participation rates.
NRES Committee East Midlands - Nottingham 2, 04/12/2014, ref: 2 21/10/2014
Single centre prospective cohort study with a nested randomised controlled trial
Primary study design
Secondary study design
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
The patient information leaflets (PILs) have the same text, and the text varies from 2 formats used as standard in our institution: A4 sheet with no colour and A5 booklet with no colour, the 'intervention' which is a colour printed tri-fold leaflet. The randomisation sequence will be generated by our statistical team, and the study database will randomised participants in a 1:1:1 ratio to each of the PIL formats. The study will then compare uptake rates for the study in each of the groups.
Follow-up: patients will receive a QoL questionnaire at 3 months after their operation (with the PIL and consent form) and at 12 months, at which point active participation will cease and event data will be collected using Hospital Episode Statistics for 5 years.
Primary outcome measures
Primary outcome for the Outcome Monitoring
2. Mortality data from the Personal Demographics Service.
Primary outcomes for the nested RCT: Participant uptake in the study for each format of the information leaflet
Secondary outcome measures
1. NHS resource use
2. Quality of life instruments - Coronary Revascularisation Outcome Questionnaire (CROQ) and/or short-form-12 (SF12) questionnaire
3. International normalised ratio (INR) values e.g. in participants having valve surgery or with persistent post-operative atrial fibrillation.
Overall trial start date
Overall trial end date
Participant inclusion criteria
Patients, aged 18 years or above, who have had cardiac surgery at the Bristol Heart Institute.
Target number of participants
1590 for the nested study
Participant exclusion criteria
2. Patients unable to give consent through mental incapacity
3. Patients whose main residence is outside the UK
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Clinical Trials and Evaluation Unit Bristol
School of Clinical Sciences University of Bristol Level 7 Queens Building Bristol Royal Infirmary
National Institute for Health Research (NIHR) Cardiovascular BRU (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. Planned publication of the results of the nested study in peer reviewed journals
2. Production of an annual newsletter to disseminate information to participants
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting