Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000995673
Ethics application status
Approved
Date submitted
15/08/2023
Date registered
13/09/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
13/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 310358 0
None
Universal Trial Number (UTN)
U1111-1296-5098
Trial acronym
TEAM PAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 331092 0
Condition category
Condition code
Cardiovascular 327878 327878 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326778 0
Treatment: Other
Intervention code [2] 326779 0
Prevention
Comparator / control treatment
Participants assigned to the usual care group will receive their standard outpatient care from their treating vascular surgeon, as well as study assessment at study commencement and conclusion.

In the context of this study, "standard care" encompasses the established and commonly practiced medical procedures and protocols delivered by Vascular surgeons as part of patient treatment. This includes routine follow-up appointments, to assess patient progress and recovery status, based on individual surgeon preferences but generally aligning to evidence-based practices and guidelines for Peripheral Artery Disease. There is considerable variability in how frequently patients with PAD are reviewed based on symptom severity, surveillance intervals, and recency of surgical or endovascular procedures. In general, patients with asymptomatic or intermittent claudication are reviewed 6-12 monthly, and patients who have had revascularisation 3-6 monthly. Those with more severe disease or CLTI may be seen more frequently to manage symptoms and wounds.
Control group
Active

Outcomes
Primary outcome [1] 335752 0
Change in 10-year cardiovascular risk percentage from baseline to 9 months according to the SmartREACH model

The data used to calculate the risk percentage using the SmartREACH model will be sourced from patient questionnaires completed during face-to-face clinical assessments and review of the electronic medical record, at baseline and 9 months after randomisation follow-up appointments.
Timepoint [1] 335752 0
9 months post-randomisation
Secondary outcome [1] 425451 0
Change in Peripheral Artery Disease: Ankle Brachial Index

It is calculated by using the defined standardised protocol employed in the vascular ultrasound laboratory, using sphygmomanometer and doppler signals.

Timepoint [1] 425451 0
9 months post-randomisation
Secondary outcome [2] 425452 0
Unplanned admissions to hospital

This will be collected through review of the electronic medical record and hospital coded data, at baseline and 9 months after randomisation follow-up appointments.
Timepoint [2] 425452 0
9 months post-randomisation
Secondary outcome [3] 425453 0
Unplanned admissions to hospital

This will be collected through review of the electronic medical record and hospital coded data, at baseline and 9 months after randomisation follow-up appointments.
Timepoint [3] 425453 0
18 months post-randomisation
Secondary outcome [4] 425454 0
Incidence of vascular surgery interventions

This will be collected through review of the electronic medical record and hospital coded data, at baseline and 9 months after randomisation follow-up appointments.
Timepoint [4] 425454 0
9 months post-randomisation
Secondary outcome [5] 425455 0
Incidence of vascular surgery interventions

This will be collected through review of the electronic medical record and hospital coded data, at baseline and 9 months after randomisation follow-up appointments.
Timepoint [5] 425455 0
18 months post-randomisation
Secondary outcome [6] 425457 0
Incidence of major adverse cardiac events (examples: Acute myocardial infarction, Acute coronary syndrome, unplanned hospital admission for cardiac disease and unplanned cardiac intervention)

This will be collected through review of the electronic medical record and hospital coded data, at baseline and 9 months after randomisation follow-up appointments.
Timepoint [6] 425457 0
9 months post-randomisation
Secondary outcome [7] 425458 0
Incidence of major adverse cardiac events (examples: Acute myocardial infarction, Acute coronary syndrome, unplanned hospital admission for cardiac disease and unplanned cardiac intervention)

This will be collected through review of the electronic medical record and hospital coded data, at baseline and 18 months after randomisation follow-up appointments.
Timepoint [7] 425458 0
18 months post-randomisation
Secondary outcome [8] 425459 0
All cause mortality
Timepoint [8] 425459 0
18 months post-randomisation
Secondary outcome [9] 425460 0
Cardiovascular mortality
Timepoint [9] 425460 0
18 months post-randomisation
Secondary outcome [10] 425461 0
Quality of life: assessed by change in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) score
Timepoint [10] 425461 0
9 months post-randomisation
Secondary outcome [11] 425462 0
Health status: change in PAQ (Peripheral Artery Questionnaire) score
Timepoint [11] 425462 0
9 months post-randomisation
Secondary outcome [12] 425505 0
Quality of Life: status change in EQ-5D-5L
Timepoint [12] 425505 0
9 months post-randomisation
Secondary outcome [13] 426356 0
Patient and clinician perspectives and experience in the MDT

Assessed through qualitative semi-structured, one-on-one interviews with a member of the research team (virtual or face-to face dependent on participant preference), virtual semi-structured focus group interviews facilitated by a member of the research team. A survey employing 10-point Likert scales, developed for this project will also be used.
Timepoint [13] 426356 0
Within 18 months post-randomisation
Secondary outcome [14] 426357 0
Cost effectiveness

The data will be collected through data linkage with Hospital's Performance Monitoring data. The research team will also note the cost involved in the intervention.
Timepoint [14] 426357 0
18 months post-randomisation

Eligibility
Key inclusion criteria
1. Aged 18 years and above
2. Receiving outpatient care for PAD in the Concord Repatriation General Hospital vascular surgery clinics (in 3 West or High Risk Foot Clinic), inpatient care under the vascular department at Concord Repatriation General Hospital, or directly referred to study investigators from private consulting rooms of Concord Repatriation General Hospital affiliated vascular surgeons.
OR Receiving outpatient care for PAD in the Royal Prince Alfred Hospital vascular surgery clinics (or High Risk Foot Clinic)
OR Receiving outpatient care for PAD in the Nepean Hospital vascular surgery clinics (or High Risk Foot Clinic)
3. Evidence of PAD defined by either Ankle Brachial Index (ABI) < 0.9 or Toe Brachial Index (TBI) < 0.6
OR Previous vascular surgical or endovascular intervention for PAD
OR Other means of diagnosing PAD (medical imaging, clinical grading)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who do not provide consent due to incapacity to consent or who decline to participate.
2. Patients who have a life limiting condition (terminal illness or estimated life expectancy less than one year) and would not benefit from being included in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study ensures allocation concealment since eligibility screening takes place before randomisation, and the study coordinators remain unaware of the randomisation during the eligibility screening stage. This process maintains the integrity of the study and serves as a measure to prevent any potential bias or manipulation in the assignment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will employ simple randomisation through a randomisation table created by computer software (i.e., the REDCap module). With this approach, the REDCap module generates a random allocation sequence to determine treatment assignments for participants. We have selected this method to ensure randomness and eliminate any potential bias in the allocation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary analyses will be unadjusted, following an intention-to-treat principle, and treatment allocations will be blinded. Characteristics between groups will be compared with independent t tests for continuous variables and chi square test for categorical variables. Kolmogorov–Smirnov test will be conducted to assess normal distribution of the data. Comparative statistics will be employed to compare group based mean risk score and would involve calculating odds ratios along with their corresponding 95% confidence intervals. If the data do not meet the assumption of normality, the non-parametric Mann-Whitney U tests will be utilized as an alternate measure for comparing the group. If significant difference in the study arms are identified, multivariate analyses will be conducted to control potential confounding factors and isolate the effect of the intervention. Depending upon the confounding variable, multiple regression analysis, analysis of covariance (ANCOVA) or logistic regression would be applied. Participants who are lost to follow-up, will be analysed as per intention to treat with missing data noted.

Prespecified subgroup analyses will be conducted for the following:
1. Participants with chronic limb threatening ischaemia (CLTI) vs. intermittent claudication (IC) and asymptomatic PAD
2. Gendered differences
3. Patients with diabetes vs no diabetes
4. Age > 75 years vs. age < 75 years
5. Proportion adherent / not adherent to guideline recommended medications at baseline / study conclusion

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/09/2023
Actual
27/10/2023
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
20/12/2025
Actual
Sample size
Target
150
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25377 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 26689 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 26690 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 41107 0
2139 - Concord
Recruitment postcode(s) [2] 42730 0
2050 - Camperdown
Recruitment postcode(s) [3] 42731 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 314560 0
Hospital
Name [1] 314560 0
Concord Institute of Academic Surgery
Country [1] 314560 0
Australia
Funding source category [2] 314741 0
Hospital
Name [2] 314741 0
Vascular Department, Concord Repatriation General Hospital
Country [2] 314741 0
Australia
Primary sponsor type
Hospital
Name
Investigator initiated study, sponsored by Vascular Department, Concord Repatriation General Hospital, SLHD
Address
Concord Repatriation General Hospital, Sydney Local Health DistrictHospital RoadConcord West NSW 2139
Country
Australia
Secondary sponsor category [1] 316543 0
University
Name [1] 316543 0
The University of Sydney
Address [1] 316543 0
Concord Clinical School, Faculty of Medicine and HealthThe University of SydneyConcord Medical Education Centre, B26, Hospital Rd, Concord West NSW 2139
Country [1] 316543 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313597 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 313597 0
Ethics committee country [1] 313597 0
Australia
Date submitted for ethics approval [1] 313597 0
10/05/2023
Approval date [1] 313597 0
28/07/2023
Ethics approval number [1] 313597 0
2023/ETH00929

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128694 0
A/Prof Sarah Aitken
Address 128694 0
Building 20 (Level 1) Clinical Sciences Building, Hospital Road, Concord Repatriation General Hospital Concord, NSW 2139
Country 128694 0
Australia
Phone 128694 0
+61 2 9767 9992
Fax 128694 0
Email 128694 0
[email protected]
Contact person for public queries
Name 128695 0
Sarah Aitken
Address 128695 0
Building 20 (Level 1) Clinical Sciences Building, Hospital Road, Concord Repatriation General Hospital Concord, NSW 2139
Country 128695 0
Australia
Phone 128695 0
+61 2 9767 9992
Fax 128695 0
Email 128695 0
[email protected]
Contact person for scientific queries
Name 128696 0
Sarah Aitken
Address 128696 0
Level 1, Building 20, Clinical Sciences Building, Hospital Rd, Concord Repatriation General Hospital, Concord, NSW 2139
Country 128696 0
Australia
Phone 128696 0
+61 2 9767 9992
Fax 128696 0
Email 128696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The decision not to share individual participant data from the clinical trial is based on concerns regarding participant confidentiality, ethical considerations, data sensitivity and data custodianship.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.