Outcome monitoring after cardiac surgery
| ISRCTN | ISRCTN90204321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90204321 |
- Submission date
- 22/10/2014
- Registration date
- 21/01/2015
- Last edited
- 07/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Current plain English summary as of 06/02/2019:
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 March 2024
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Lucy Culliford
Previous 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
Contact information
Scientific
University of Bristol
Level 7 Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
| Phone | + 44 (0)117 342 4195 |
|---|---|
| lucy.culliford@bristol.ac.uk |
Study information
| Study design | Single centre prospective cohort study with a nested randomised controlled trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Outcome Monitoring After Cardiac Surgery: Cohort study with a nested randomised controlled trial |
| Study 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(s) | NRES Committee East Midlands - Nottingham 2, 04/12/2014, ref: 2 21/10/2014 |
| Condition | Cardiac surgery |
| Intervention | Current interventions as of 06/02/2019: 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. Blood samples will be collected from patients before, during and after surgery for use in other ethically approved studies. 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. Previous interventions: 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 |
| Primary outcome measure | 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 study start date | 03/12/2013 |
| Overall study end date | 26/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1590 for the nested study |
| Total final enrolment | 4069 |
| Participant inclusion criteria | Patients, aged 18 years or above, who have had cardiac surgery at the Bristol Heart Institute. |
| 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 | 03/06/2016 |
| Recruitment end date | 31/05/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Bristol
Level 7 Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
R&I Department
Level 3, UH Bristol Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
"ROR" |
https://ror.org/04nm1cv11 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| 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 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. Details of the repository yet to be confirmed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | Nested study results | 27/12/2019 | 31/12/2019 | Yes | No |
| Protocol article | 19/12/2022 | 20/12/2022 | Yes | No | |
| Other unpublished results | 11/07/2024 | No | No | ||
| Basic results | 15/07/2024 | No | No | ||
| Results article | Cohort profile | 05/02/2025 | 07/02/2025 | Yes | No |
Additional files
Editorial Notes
07/02/2025: Publication reference added.
15/07/2024: Basic results were uploaded.
11/07/2024: The following changes were made:
1. The overall study end date was changed from 31/12/2023 to 26/03/2024.
2. A summary of the results was uploaded.
07/12/2023: The following changes were made to the study record:
1. The overall study end date was changed from 30/11/2022 to 31/12/2023.
2. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
11/09/2023: The intention to publish date was changed from 31/03/2023 to 31/12/2023.
20/12/2022: Publication reference added.
08/11/2022: The intention to publish date was changed from 30/11/2022 to 31/03/2023.
04/08/2022: The recruitment start date was changed from 01/01/2015 to 03/06/2016.
19/05/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/05/2022 to 30/11/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 31/12/2022 to 30/11/2022.
3. The trial website has been added.
4. The individual participant data (IPD) sharing statement has been added and the IPD sharing summary has been changed from "Data sharing statement to be made available at a later date" to "Stored in publicly available repository".
09/07/2020: The trial contact details have been made publicly visible.
31/12/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
04/06/2019: The intention to publish date was changed from 31/12/2018 to 31/12/2022.
06/02/2019: The following changes were made:
1. The plain English summary was updated.
2. The interventions were updated.
11/07/2018: The intention to publish date was changed from 31/12/2017 to 31/12/2018.
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.
