An interventional study of Clinical decision support tool recommended outcome in Prostate Cancer, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown at 2 sites in United Kingdom. Open to male participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Other
Around 375,000 cancers are diagnosed in the UK annually, with this figure expected to reach 500,000 by 2035. As the number of different cancer treatment options and our scientific understanding continue to grow rapidly, it can be difficult for clinicians to keep up-to-date with best practice, causing unjustified variations in the quality of care and clinical outcomes for patients.
Currently, when a patient has been referred to and seen by a clinician, their treatment is then discussed in a Multi-Disciplinary Team Meeting (MDTM). MDTM is a meeting of medical experts, including Surgeons, Oncologists, Nurses, and specialists in cancer, imaging and diagnosis. This is the case even if a treatment decision is straightforward.
A nationwide review published by CRUK in 2017 highlighted the demands on cancer teams and the MDTM process:
Deontics has a CE marked AI-based CDSS that integrates individual patient data and preferences with evidence-based clinical guidelines. This dynamically and transparently generates best-practice, individualised treatment recommendations which can help determine treatment. Deontics' AI tool has already been shown to provide personalised recommendations concordant with UK best practice while incorporating patient values, and can be used to safely triage less complex patients straight to treatment with minimal clinical oversight. Our project partners with Deontics to develop PROSAIC-DS - A CDSS for prostate cancer.
I
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 1,040 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients going through this arm have the decision support tool outcome visible to the MDTM
Other: Clinical decision support tool recommended outcome
Patients going through this arm will not have the decision support tool outcome visible to the MDTM
Other: Clinical decision support tool recommended outcome
The PROSAIC-DS tool will take the variables and produce a suggested outcome. It will supply supporting evidence and best practice for its recommendations
PROSAIC-DS as a triage tool
The % of patients the PROSAIC-DS tool can appropriately triage away non-complex Prostate Cancer cases from the MDTM with appropriate treatment plans as directed by approved guidelines (EAU, BAUS, NICE, AUA).
Time frame: 6-9 months
PROSAIC-DS influence on MDTM concordance with approved guidelines
Evaluation of PROSAIC-DS as a member of the MDTM via the impact of live PROSAIC-DS recommendations on MDTM decision concordance with approved guidelines (EAU, BAUS, NICE, AUA) on randomised patients discussed in the MDTM. This is measured through the difference in level of concordance between the MDTM with PROSAIC-DS switched off and the MDTM with PROSAIC-DS on when less complex cases (ones triaged away) are excluded.
Time frame: 6-9 months
Cost effectiveness of PROSAIC-DS
Estimate the financial savings that PROSAIC-DS brings by triaging non-complex cases away from the MDTM.
Time frame: 6-9 months - duration of data collection
Qualitative Analysis: Patient acceptability
We will use qualitative methods, and data capture methods including self-administered questionnaires, focus groups, semi-structured interviews and video analysis, to explore patient and staff views about, including concerns and satisfaction with, the use of AI technology to support clinical decisions in prostate cancer, both prior to their engagement with PROSAIC-DS, during and after deployment of the tool of the technology to patients.
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust