The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol
Introduction Cardiothoracic surgical outcomes are poorer in people with diabetes compared with those without diabetes. There are two important uncertainties in the management of people with diabetes undergoing major surgery: (1) how to improve diabetes management in the weeks leading up to an electi...
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BMJ Publishing Group
2021-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/6/e050919.full |
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| author | Mark Green Mayank Patel Joanne Lord Kerensa Thorne Elizabeth Dixon Andrew Cook Giorgos Dritsakis Richard Ian Gregory Holt Helen Partridge Sunil Ohri Katharine Barnard-Kelly Amy Whitehead Lauren Cohen Philip Newland-Jones Suvitesh Luthra Kareem Salhiyyah John Niven |
| author_facet | Mark Green Mayank Patel Joanne Lord Kerensa Thorne Elizabeth Dixon Andrew Cook Giorgos Dritsakis Richard Ian Gregory Holt Helen Partridge Sunil Ohri Katharine Barnard-Kelly Amy Whitehead Lauren Cohen Philip Newland-Jones Suvitesh Luthra Kareem Salhiyyah John Niven |
| author_sort | Mark Green |
| collection | DOAJ |
| description | Introduction Cardiothoracic surgical outcomes are poorer in people with diabetes compared with those without diabetes. There are two important uncertainties in the management of people with diabetes undergoing major surgery: (1) how to improve diabetes management in the weeks leading up to an elective procedure and (2) whether that improved management leads to better postoperative outcomes. We previously demonstrated the feasibility of delivering the Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) intervention, an outpatient intervention delivered by diabetes healthcare professionals for people with suboptimally managed diabetes over 8–12 weeks before elective cardiac surgery. The present study will assess the clinical and cost-effectiveness of the intervention in cardiothoracic centres across the UK.Methods and analysis A multicentre, parallel group, single-blinded 1:1 individually randomised trial comparing time from surgery until clinically fit for discharge in adults with suboptimally managed type 1 diabetes or type 2 diabetes undergoing elective surgery between the OCTOPuS intervention and usual care (primary endpoint). Secondary endpoints will include actual time from surgery to discharge from hospital; days alive and either out of hospital or judged as clinically fit for discharge; mortality; time on intensive therapy unit (ITU)/ventilator; infections; acute myocardial infarction; change in weight; effect on postoperative renal function and incidence of acute kidney injury; change in HbA1c; frequency and severity of self-reported hypoglycaemia; operations permanently cancelled for suboptimal glycaemic levels; cost-effectiveness; psychosocial questionnaires. The target sample size will be 426 recruited across approximately 15 sites. The primary analysis will be conducted on an intention-to-treat population. A two-sided p value of 0.05 or less will be used to declare statistical significance for all analyses and results will be presented with 95% CIs.Ethics and dissemination The trial was approved by the South Central–Hampshire A Research Ethics Committee (20/SC/0271). Results will be disseminated through conferences, scientific journals, newsletters, magazines and social media.Trial registration number ISRCTN10170306. |
| format | Article |
| id | doaj-art-1dc14891fb834268b49c04bb2983bc27 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-06-01 |
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| spelling | doaj-art-1dc14891fb834268b49c04bb2983bc272024-11-19T13:40:09ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2021-050919The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocolMark Green0Mayank Patel1Joanne Lord2Kerensa Thorne3Elizabeth Dixon4Andrew Cook5Giorgos Dritsakis6Richard Ian Gregory Holt7Helen Partridge8Sunil Ohri9Katharine Barnard-Kelly10Amy Whitehead11Lauren Cohen12Philip Newland-Jones13Suvitesh Luthra14Kareem Salhiyyah15John Niven16Department of Diabetes and Endocrinology, University Hospital Southampton, Southampton, Hampshire, UKDepartment of Diabetes and Endocrinology, University Hospital Southampton, Southampton, Hampshire, UKSouthampton Health Technology Assessments Centre, University of Southampton, Southampton, Hampshire, UKClinical Trial Units, University of Southampton, Southampton, UKSouthampton Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UKWessex Institute, University of Southampton, Southampton, UKClinical Trial Units, University of Southampton, Southampton, UKHuman Development and Health, Faculty of Medicine, University of Southampton, Southampton, UKDiabetes and Endocrinology, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth, Bournemouth, UKDepartment of Cardiac Surgery, Southampton University Hospitals NHS Trust, Southampton, UKBarnard Health, BHR Limited, Hampshire, UKClinical Trial Units, University of Southampton, Southampton, UKBarnard Health – Health Psychology Research, Fareham, UKDepartment of Diabetes and Endocrinology, University Hospital Southampton, Southampton, Hampshire, UKDivision of Cardiac Surgery, Wessex Cardiothoracic Centre, University Hospital Southampton, Southampton, Hampshire, UKMiddle East University, Amman, JordanPatient Representative, Southampton, UKIntroduction Cardiothoracic surgical outcomes are poorer in people with diabetes compared with those without diabetes. There are two important uncertainties in the management of people with diabetes undergoing major surgery: (1) how to improve diabetes management in the weeks leading up to an elective procedure and (2) whether that improved management leads to better postoperative outcomes. We previously demonstrated the feasibility of delivering the Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) intervention, an outpatient intervention delivered by diabetes healthcare professionals for people with suboptimally managed diabetes over 8–12 weeks before elective cardiac surgery. The present study will assess the clinical and cost-effectiveness of the intervention in cardiothoracic centres across the UK.Methods and analysis A multicentre, parallel group, single-blinded 1:1 individually randomised trial comparing time from surgery until clinically fit for discharge in adults with suboptimally managed type 1 diabetes or type 2 diabetes undergoing elective surgery between the OCTOPuS intervention and usual care (primary endpoint). Secondary endpoints will include actual time from surgery to discharge from hospital; days alive and either out of hospital or judged as clinically fit for discharge; mortality; time on intensive therapy unit (ITU)/ventilator; infections; acute myocardial infarction; change in weight; effect on postoperative renal function and incidence of acute kidney injury; change in HbA1c; frequency and severity of self-reported hypoglycaemia; operations permanently cancelled for suboptimal glycaemic levels; cost-effectiveness; psychosocial questionnaires. The target sample size will be 426 recruited across approximately 15 sites. The primary analysis will be conducted on an intention-to-treat population. A two-sided p value of 0.05 or less will be used to declare statistical significance for all analyses and results will be presented with 95% CIs.Ethics and dissemination The trial was approved by the South Central–Hampshire A Research Ethics Committee (20/SC/0271). Results will be disseminated through conferences, scientific journals, newsletters, magazines and social media.Trial registration number ISRCTN10170306.https://bmjopen.bmj.com/content/11/6/e050919.full |
| spellingShingle | Mark Green Mayank Patel Joanne Lord Kerensa Thorne Elizabeth Dixon Andrew Cook Giorgos Dritsakis Richard Ian Gregory Holt Helen Partridge Sunil Ohri Katharine Barnard-Kelly Amy Whitehead Lauren Cohen Philip Newland-Jones Suvitesh Luthra Kareem Salhiyyah John Niven The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol BMJ Open |
| title | The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol |
| title_full | The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol |
| title_fullStr | The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol |
| title_full_unstemmed | The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol |
| title_short | The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol |
| title_sort | optimising cardiac surgery outcomes in people with diabetes octopus randomised controlled trial to evaluate an outpatient pre cardiac surgery diabetes management intervention a study protocol |
| url | https://bmjopen.bmj.com/content/11/6/e050919.full |
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