Condition category
Surgery
Date applied
22/10/2014
Date assigned
21/01/2015
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lucy Culliford

ORCID ID

Contact details

University of Bristol
Level 7 Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Outcome Monitoring After Cardiac Surgery: Cohort study with a nested randomised controlled trial

Acronym

OMACS

Study hypothesis

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.

Ethics approval

NRES Committee East Midlands - Nottingham 2, 04/12/2014, ref: 2 21/10/2014

Study design

Single centre prospective cohort study with a nested randomised controlled trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Cardiac surgery

Intervention

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.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Primary outcome for the Outcome Monitoring
1. MACE
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

03/12/2013

Overall trial end date

31/05/2022

Reason abandoned

Eligibility

Participant inclusion criteria

Patients, aged 18 years or above, who have had cardiac surgery at the Bristol Heart Institute.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1590 for the nested study

Participant exclusion criteria

1. Prisoners
2. Patients unable to give consent through mental incapacity
3. Patients whose main residence is outside the UK

Recruitment start date

01/01/2015

Recruitment end date

31/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials and Evaluation Unit Bristol
School of Clinical Sciences University of Bristol Level 7 Queens Building Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

R&I Department
Level 3
UH Bristol Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) Cardiovascular BRU (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/10/2016: The overall trial end date has been updated from 01/01/2016 to 31/05/2022 and the recruitment end date has been updated from 01/01/2016 to 31/05/2021. 12/05/2016: The overall trial start date has been updated from 01/01/2015 to 03/12/2013. 09/05/2016: Ethics approval information added.