Lesley Wilson Senior Vascular Research Nurse Newcastle upon Tyne

1. ACST 2 Lesley Wilson Senior Vascular Research Nurse Newcastle upon Tyne

2. The key importance of research staff to ensure successful recruitment in to ACST-2

3. Aims • Background to Newcastle upon Tyne. • Recruitment problems with ACST2. • Study set up to optimise recruitment. • Barriers • Solutions • Conclusion

4. Newcastle upon Tyne • Large teaching hospital-2 sites • Population- 900,000 80-100 CEA per year 25-40 CAS per year • 6 vascular surgeons • 2 interventional radiologist • 3 research nurses

5. Asymptomatic carotid disease • From 2008 to end 2012 • CEA 425 – 64 asymptomatic (15%) • CAS 163 – 67 asymptomatic (41%) • More than one treatment option available • Decisions regarding management opinions often vary • Many referral pathways

6. Referrals

7. Barriers for ACST - 2 • Small numbers - (1st year(2008) 22pts • Lack of awareness of ACST2 • Randomisation options not available in many centers- recruitment restricted • Logistics initially seemed problematic!

8. Study set up • Establish links with regional hospitals • Set up meeting to discuss ACST-2 • Each site had different requirement. • Involve research staff wherever possible • Seek NHS approvals • Agree referral mechanism • Clear patient pathway

9. Freeman & RVI Sunderland Durham Bishop Auckland Middlesbrough

10. “ Hub & Spoke ”: Catchment Area 3 Million Recruitment from 6 centres n=114 : Sunderland Royal Hospital James Cook University Hospital, Middlesbrough CAS AT THE FREEMAN HOSPITAL Royal Victoria Infirmary, Newcastle North Durham University Hospital Bishop Auckland Hospital, Cumberland Infirmary, Carlisle

11. ACST 2 Hub and Spoke • Referring centre: Potential eligible patient Imaging ( duplex) Patient interested in treatment/trial Confirmatory imaging ( MRA/CTA) • Phone – interventional radiology Imaging sent via PAC system + clinical history • MDT • Plan for treatment

12. Weekly -Multi-disciplinary team meeting (MDT) • Consultant Vascular Surgeons • Stroke physicians • Interventional Radiologists • Medical Physics Laboratory • Research Nurses

13. Hub and Spoke recruitment by year *Only 17 asymptomatic cases performed out of the trial

14. Barriers !

15. Time ! • Out patient clinics : • Inadequate referral information. • Imaging not available • Referral template currently being devised

16. Patient unclear of reason for referral • Early mention of ACST-2 + information sheet • Clear explanation- reduce risk of bias. • Time to answer questions

17. Patients perspective. • Expectation • New treatment better • Patient choice • Procedural differences • Dr should know best! • Trial – delays? • Randomisation • Follow up

18. Attribution of research activity • ACST-2 was adopted by the stroke research network (SRN) of the UK (HTA sponsored trial) • Funding for this studies follows recruitment • Important to agree how this will be calculated amongst centers as this funds research staff

19. Conclusion What has been key to success? • Commitment to research • Communication • Team work • Research Nurses working within the department • Hub and Spoke • Increase recruitment by 100% • Regular number of referrals