Multidisciplinary Team-based approach to guide secondary risk prevention for cardiovascular and limb outcomes in patients with Peripheral Artery Disease (TEAM-PAD): A Randomised Controlled Trial

Participants assigned to the Multidisciplinary Team (MDT) care group will receive supported outpatient care by their treating vascular surgeon who will be provided management recommendations from the MDT. MDT would consist of Vascular Surgeon, Cardiologist, Endocrinologist, Nephrologist, Geriatrician and Clinical Pharmacist. The MDT will meet via the Microsoft Teams platform with both an MDT portal and a monthly online meeting. MDT members will be able to access the MDT portal using a secure, password protected account and review patient information and make recommendations for discussion at the monthly MDT meeting. A summary of the meeting will be forwarded to all members by the study coordinator. If any of the team members of the MDT are not available for the meeting, they can review the summary along with the information in the MDT teams portal and would be asked to provide their recommendations to study coordinators. MDT members will not be required to meet or treat individual patients. Patients will not attend the MDT meetings. MDT clinicians are not considered investigators in the study unless specified. MDT clinicians will not have access to the study data beyond what is available in the MDT Portal. During the monthly meetings, the MDT will discuss participants randomised to the MDT arm who are: • new participants • existing participants who have had a hospital admission for vascular or cardiac disease (subsequent to previous MDT review) • participants in whom the MDT recommended earlier review according to clinical need • participants who have reached the end of study visit. At each time a participant is discussed as the MDT, members will review baseline and updated clinical data or clinical events that may change recommendations (such as proceeding to vascular surgery) and make a recommendation on Best Medical Therapy to provide to the participant’s vascular surgeon. The MDT will develop a care plan by group consensus. The MDT team will review each patient’s SmartREACH score, and clinical parameters collected during baseline and follow up assessments, and develop personalised care recommendations for secondary prevention of cardiovascular and limb risk that align with the 2017 European Society of Cardiology (ESC) Guidelines on the Diagnosis and Treatment of Peripheral Arterial Disease in collaboration with the European Society for Vascular Surgery (ESVS) .The ESC/ESVS guidelines are the most commonly used guidelines in Australian practice. There are no Australian guidelines for secondary risk prevention in PAD. The American Society of Vascular Surgeons guidelines are less aligned to Australian models of care, investigations, and available medications. A series of consensus building, and educative meetings will be conducted prior to the first MDT to confirm all participating clinicians are familiar with the MDT processes and purpose, and that MDT members are familiar with the 2017 ESC guidelines. The MDT team will be blinded to the participant identity and only study identifiers (assigned by REDCAP) will be used for discussions in the MDT. Correspondence in the MDT MS teams portal, and between MDT members will use study numbers. Only the Study Coordinators will have access to the master record key and patient identities, to reduce the risk of bias during MDT discussions. Discussions and recommendations from the monthly meeting will be recorded by the Study Coordinators, and documented in the MDT portal against the participant’s record for members to review. In the week following the monthly meeting, MDT members will be emailed via their secure NSW Health email address to alert them that the care recommendation summary is complete. MDT members will log into the MS Teams account and approve the recommendations prior to distribution. The Study Coordinator will directly contact any clinicians who have not approved recommendations prior to distribution. The Study Coordinator will apply patient identifiers to any correspondence back to treating clinicians using the master record list. The recommendations from the MDT will be communicated in writing using a pro-forma to the participant’s treating vascular surgeon. The role of the MDT is not to prescribe medications, arrange additional investigations or initiate specialist referral, but rather to review current management and make recommendations to improve or optimise modifiable cardiovascular and limb risk factors. If further clinical information (beyond that which is shared with the MDT) is necessary to make a clinical recommendation, the MDT will recommend a specialist review to the vascular surgeon, where these additional parameters can be evaluated. Where possible, if patients have an existing care relationship with a specialist, these clinical arrangements can be retained. If the MDT’s recommendation to see a specialist for review, this will be communicated to the treating vascular surgeon, who will arrange this after discussion with the patient. Similarly, if the MDT recommends further investigations, or new medications be prescribed, the treating vascular surgeon will be advised via the care plan and will discuss these changes with the patient. The treating vascular surgeon is responsible for communicating changes in the patient’s management to their GP, and any other treating specialists, as part of standard clinical care. Patients will not have any engagement with clinicians in the MDT unless they have an existing clinical relationship with that clinician or are independently referred to an MDT clinician by the patient’s treating vascular surgeon or GP. The schedule for review of patients in the MDT is: • Patients with no recommended changes to their care will be reviewed by the MDT at 9 months. • Patients with recommended changes to their care will be reviewed by the MDT as determined by clinical need. • Once a month, hospital admission data for the vascular surgery team will be reviewed to see if study participants have had a hospital admission or vascular surgical procedure. Patients who have had an intervening hospital admission, or vascular surgical procedure will be flagged for earlier review, within 3 months. • Patients who are completing the 9-month study period will be reviewed by the MDT. • A final review of the medical records will take place 18 months after enrolment. The frequency and duration of the MDT meeting will be conducted will depend on the recruitment rate and the availability of clinicians. We anticipate that each MDT meeting will last 120 minutes. . During this time, we will discuss newly recruited patients and those scheduled for follow up review with the MDT (based on previous MDT recommendations, admission to hospital) and patients concluding the study intervention period. Using the virtual portal, MDT members will review patient variables prior to the meeting. The MDT Chair (Principle Investigator) will present the patient to the MDT using a standardised protocol. We anticipate the duration of discussion for most patients will be <10minutes, with more complex patients requiring 15-20minutes. A maximum of 12 patients will be included in each meeting. If more patients require discussion than can be accommodated, an adhoc MDT session will be scheduled.