Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/05/2018
Date assigned
07/06/2018
Last edited
07/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Diabetes is particularly common in people having heart surgery. People with diabetes whose blood sugar levels are too high tend to have a slower recovery after surgery. They are more likely to get infections (both chest infections and in their surgical wounds). They cannot go home as quickly after surgery as those with well controlled diabetes. Their risk of death is higher. A team at Bournemouth hospital has developed an outpatient based approach to improve blood sugar levels in the weeks before surgery. They have shown that in patients receiving joint replacements, this approach can reduce the time they have to stay in hospital. This study will adapt the Bournemouth approach so that it can be used for people undergoing heart surgery. It will first be tested in Southampton to assess whether people undergoing cardiac surgery and their healthcare team find the approach acceptable and easy to follow. The approach will be changed according to their feedback and will then be tested in up to 15 UK NHS hospitals.

Who can participate?
Patients aged over 18 with poorly controlled type 1 or type 2 diabetes who are awaiting elective cardiac surgery

What does the study involve?
Participants are randomly allocated to the intervention group or the usual care group. Participants in the intervention group are seen by the OCTOPuS practitioner immediately following the outpatient clinic appointment at which the decision to proceed to cardiac surgery is made. The OCTOPuS practitioner is a clinically qualified health care worker with expertise in diabetes. They are most likely to be a diabetes nurse specialist, but might, for example, be a pharmacist, dietitian or physician. During this session, the OCTOPuS practitioner assesses a number of factors known to be associated with poor surgical outcomes in people with diabetes. Although the focus of the intervention is to improve glucose control, the intervention also includes the management of other aspects of diabetes, such as weight, smoking, blood pressure and lipid profile, which are known to affect surgical outcomes. Based on this assessment, the OCTOPuS practitioner and participant agree a tailored plan of actions to improve their diabetes control over the 3 months before surgery. Treatment options are likely to include a graded exercise regimen, dietary advice, smoking cessation advice, medication review and specific advice about managing expectations. After the initial consultation, the OCTOPuS practitioner contacts the patient every 2 weeks, either face-to-face or by telephone to oversee medication regimens, signpost patients to local services, and to advocate on the patient’s behalf. Participants in the usual care group receive treatment as usual as per local practice in the cardiothoracic centre attended by the patient. This is likely to include brief advice from the patient’s surgeon to pay attention to their diabetes in the run up to surgery. Some patients may act on this advice, either on their own or in conjunction with their GP. ‘Usual care’ at all recruiting centres is documented. All patients then receive their cardiac surgery. Time in hospital varies for each patient. Patients are followed up at the time when the surgeon determines they are fit for discharge, and 7 days and 30 days after surgery. Patients do not need to attend for a trial visit after 30 days after surgery. After the first 100 patients in the study have had their surgery it is tested to see if the intervention has an effect on their diabetes control by seeing if their HbA1c, which is a measure of average blood sugar levels, has improved. If it has not changed, the trial is stopped, as it will be unlikely that the intervention works as hoped. If the blood sugar levels have improved, a further 326 people with diabetes are invited to take part. The trialists look to see if patients are ready to leave hospital earlier, and also what is the effect on infections and deaths. They also discuss with patients their experience of the intervention, to make sure that if patients do recover more quickly they think the effort involved in the intervention is worth it. They also assess the cost of introducing the intervention into NHS care.

What are the possible benefits and risks of participating?
It is expected that patients in the intervention group will benefit from the diabetes management review resulting in a better surgical experience. There is the potential to increase the risk of low sugar levels, although the intervention will largely advocate the use of drugs that are not associated with this side effect. Participants will be warned of this risk and advised how to recognise and treat low glucose values. It is possible that encouraging exercise in people with heart problems may worsen angina. Cardiac patients awaiting surgery may exacerbate ischaemic events. All OCTOPuS practitioners are health professionals and are fully trained in delivering the intervention and will be advised to only recommend gentle exercise that does not lead to symptoms.

Where is the study run from?
University Southampton Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2018 to October 2022

Who is funding the study?
NIHR Health Technology Assessment Programme (HTA) (UK)

Who is the main contact?
Mrs Liz Dixon

Trial website

https://www.journalslibrary.nihr.ac.uk/programmes/hta/162512/#/

Contact information

Type

Public

Primary contact

Mrs Liz Dixon

ORCID ID

http://orcid.org/0000-0002-9876-9533

Contact details

Southampton Clinical Trials Unit
MP131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 16/25/12

Study information

Scientific title

A multicentre, parallel group, single-masked, individually randomised trial incorporating a pre-planned futility analysis comparing time from surgery until clinically fit for discharge in adults with poorly controlled type 1 or 2 diabetes undergoing elective cardiothoracic surgery between the OCTOPuS intervention and usual care

Acronym

OCTOPuS

Study hypothesis

To develop an outpatient intervention to be delivered to adults with poorly controlled diabetes in need of elective cardiac surgery to assess whether the intervention can improve glycaemic control and reduce the length of stay of the surgical admission.

Ethics approval

South Central - Hampshire A or B - approval pending

Study design

A multicentre, parallel group, single-masked, individually randomised trial incorporating a pre-planned futility analysis comparing time from surgery until clinically fit for discharge in adults with poorly controlled type 1 or 2 diabetes undergoing elective cardiothoracic surgery between the OCTOPuS intervention and usual care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

People who require elective major cardiac surgery and who have poorly controlled diabetes

Intervention

A manualised out-patient intervention to be delivered by a trained health professional to people with poorly controlled diabetes to improve cardiac surgical outcomes compared to treatment as usual.

Patients will be randomised using an online randomisation system in a 1:1 ratio between arms and stratified by centre, using pre-generated permuted blocks to prevent clinicians anticipating the allocation.

The trialists will develop a manualised outpatient intervention to be delivered to adults with poorly controlled diabetes in need of elective cardiac surgery to assess whether the intervention can improve glycaemic control in the pre-operative period and reduce the length of stay of the surgical admission compared to treatment as usual.

Arm A: OCTOPuS Intervention
The OCTOPuS intervention comprises several elements, which are brought together in a systematic way. Participants who receive the intervention arm will be seen by the OCTOPuS practitioner immediately following the outpatient clinic appointment at which the decision to proceed to cardiac surgery is made. The OCTOPuS practitioner is a clinically qualified health care worker with expertise in diabetes. They are most likely to be a diabetes nurse specialist, but might, for example, be a pharmacist, dietitian or physician.
During this session, the OCTOPuS practitioner will assess a number of factors known to be associated with poor surgical outcomes in people with diabetes. Although the focus of the intervention is to improve glucose control, the intervention also includes the management of other aspects of diabetes, such as weight, smoking, blood pressure and lipid profile, which are known to affect surgical outcomes. Based on this assessment, the OCTOPuS practitioner and participant will agree a tailored plan of actions to improve their diabetes control over the approx. 3 months prior to surgery.
Treatment options are likely to include a graded exercise regimen, dietary advice, smoking cessation advice, medication review and specific advice about managing expectations.
After the initial consultation, The OCTOPuS practitioner will contact the patient every 2 weeks, either face-to-face or by telephone. They need to oversee medication regimens, signpost patients to local services, and to advocate on patient’s behalf.

Arm B: Usual care
Patients will receive treatment as usual as per local practice in the cardiothoracic centre attended by the patient. This is likely to contain brief advice from the patient’s surgeon to pay attention to their diabetes in the run up to surgery. Some patients may act on this advice, either on their own or in conjunction with their GP. ‘Usual care’ at all recruiting centres will be documented.

All patients will then receive their cardiac surgery. Time in hospital will vary for each patient. The total duration of intervention will be from the point of listing for surgery until surgery. For most participants this will be approximately 3-4 months based on current waiting list times for elective cardiac surgery. Participants will be followed up at the time when the surgeon determines they are fit for discharge, 7 days and 30 days post-surgery. The trialists will also collect HbA1c at 90-180 days post-surgery from standard care tests during this period. Patients will not need to attend for a trial visit after 30 days post-surgery.

After the first 100 patients in the study have had their surgery the trialists will test to see if the intervention has an effect on their diabetes control, by seeing if their HbA1c, which is a measure of average blood sugar levels, has improved. If it has not changed, they will stop the trial, as it will be unlikely that the intervention works as hoped. If the blood sugar levels have improved, they will then invite a further 326 people with diabetes to take part.

The trialists will look to see if patients are ready to leave hospital earlier, and also what is the effect on infections and deaths. They will also discuss with patients their experience of the intervention, to make sure that if patients do recover more quickly they think the effort involved in the intervention is worth it. They will also assess the cost of implementing the intervention into NHS care.

Intervention type

Phase

Drug names

Primary outcome measure

Time from surgery until clinically fit for discharge, as judged by the surgical team, measured using medical notes at 7 and 30 days post-surgery

Secondary outcome measures

1. Time from surgery to actual discharge from hospital, measured using medical notes at 7, 30 and 90-180 days post-surgery
2. Mortality, measured using medical notes on admission for surgery and at 7, 30 and 90-180 days post-surgery
3. Sternal infections, measured using medical notes at 7, 30 and 90-180 days post-surgery
4. Leg wound infections in participants who provide donor vein, measured using medical notes at 7, 30 and 90-180 days post-surgery
5. Chest infections, measured using medical notes at 7, 30 and 90-180 days post-surgery
6. Weight, measured using scales at baseline, on admission for surgery and at 7, 30 and 90-180 days post-surgery
7. Renal function, measured using laboratory tests at baseline, on admission for surgery and at 7, 30 and 90-180 days post-surgery
8. HbA1c, measured using laboratory tests at baseline, on admission for surgery and at 90-180 days post-surgery
9. Number of operations cancelled because of poor glycaemic control, measured using medical notes on admission for surgery
10. Quality of life, measured using EQ-5D at baseline, on admission for surgery, and 90-180 days post-surgery (In the first phase the trialists will also explore the utility of collecting EQ-5D at 30 days post-surgery. This has the potential for providing an extra data point, but the increased participant burden may risk the loss of completeness of days at 90 days)
11. Patient experience, measured using qualitative interviews at baseline, on admission for surgery, and at 3, 6 and 12 months post-surgery

Overall trial start date

01/01/2018

Overall trial end date

31/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults (aged >18 years) with poorly controlled type 1 or type 2 diabetes. Poor control is defined as an HbA1c > 53 mmol/mol using a near patient test at the cardiothoracic outpatients appointment where the decision to proceed to surgery is made
2. Awaiting elective cardiac surgery, where it is anticipated the delay before surgery will be at least 3 months
3. Ability to give informed consent
4. Ability to interact with the study documentation and processes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Intervention Pilot: approx. 20; Main Trial: 426

Participant exclusion criteria

1. Malignancy
2. Pregnancy
3. Previous cardiac surgery
4. Other illnesses or conditions that would preclude engagement with the OCTOPuS intervention

Recruitment start date

01/08/2019

Recruitment end date

30/11/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Southampton Hospital NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospital Southampton NHS Foundation Trust

Sponsor details

R&D Department
University Hospital Southampton NHS Foundation Trust
SGH
Level E
Laboratory & Pathology Block
SCBR
MP 138
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trialists plan to publish the protocol once finalised and following ethics approval. This will include details of the statistical analysis. Prior to this, study protocol and statistical analysis plan will be made available to the trial steering committee and data monitoring and ethics committee. The manual and all patient facing information will be made available after the trial’s completion.

The trialists plan to publish the results in Health Technology Assessment and other high impact peer reviewed journals. If the intervention is shown to be superior to standard care, then they will undertake further action to disseminate the work. They will discuss their findings with organisations such as NICE, the Joint British Diabetes Societies, and the Society for Cardiothoracic Surgery in Great Britain and Ireland with a view to integrating the intervention into guidelines and professional practice.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Liz Dixon (octopus@soton.ac.uk). Further details on data will be added once the main trial is finalised.

Intention to publish date

31/10/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes