PROSAIC-DS Study (PROState AI in Cancer - Decision Support)
NCT ID: NCT05355727
Last Updated: 2022-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1040 participants
INTERVENTIONAL
2022-06-30
2022-12-31
Brief Summary
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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:
* Increased caseloads are causing dramatic increases in the time spent by clinicians in MDTMs, leading to an unsustainable rise in costs: the cost in England has increased from £88m to £159m in 4 years;
* There is not enough time in the MDTM to discuss complex cases;
* There is a failure to involve patients in the decision-making process: around 75% of patients feel their views are unrepresented in MDTMs; In our study we are looking at the potential of technology - particularly Clinical Decision Support Systems (CDSS) - to improve MDTM decision making.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Arm A: Visible to MDTM
Patients going through this arm have the decision support tool outcome visible to the MDTM
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
Arm B: Not-visible to MDTM
Patients going through this arm will not have the decision support tool outcome visible to the MDTM
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
35 Years
MALE
Yes
Sponsors
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King's College Hospital NHS Trust
OTHER
King's College London
OTHER
Deontics Limited
UNKNOWN
Somerset NHS Foundation Trust
OTHER
Prostate Cancer UK
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Danny Ruta, MBBS MSc
Role: PRINCIPAL_INVESTIGATOR
Guys and St Thomas NHS Foundation Trust
Locations
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Guys and St Thomas Hospitals
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Knight SR, Cao KN, South M, Hayward N, Hunter JP, Fox J. Development of a Clinical Decision Support System for Living Kidney Donor Assessment Based on National Guidelines. Transplantation. 2018 Oct;102(10):e447-e453. doi: 10.1097/TP.0000000000002374.
Taylor C, Atkins L, Richardson A, Tarrant R, Ramirez AJ. Measuring the quality of MDT working: an observational approach. BMC Cancer. 2012 May 29;12:202. doi: 10.1186/1471-2407-12-202.
Munro AJ. Multidisciplinary Team Meetings in Cancer Care: An Idea Whose Time has Gone? Clin Oncol (R Coll Radiol). 2015 Dec;27(12):728-31. doi: 10.1016/j.clon.2015.08.008. Epub 2015 Sep 11. No abstract available.
Patkar V, Acosta D, Davidson T, Jones A, Fox J, Keshtgar M. Cancer multidisciplinary team meetings: evidence, challenges, and the role of clinical decision support technology. Int J Breast Cancer. 2011;2011:831605. doi: 10.4061/2011/831605. Epub 2011 Jul 17.
Miles A, Chronakis I, Fox J, Mayer A. Use of a computerised decision aid (DA) to inform the decision process on adjuvant chemotherapy in patients with stage II colorectal cancer: development and preliminary evaluation. BMJ Open. 2017 Mar 24;7(3):e012935. doi: 10.1136/bmjopen-2016-012935.
Patkar V, Acosta D, Davidson T, Jones A, Fox J, Keshtgar M. Using computerised decision support to improve compliance of cancer multidisciplinary meetings with evidence-based guidance. BMJ Open. 2012 Jun 25;2(3):e000439. doi: 10.1136/bmjopen-2011-000439. Print 2012.
Patkar V, Hurt C, Steele R, Love S, Purushotham A, Williams M, Thomson R, Fox J. Evidence-based guidelines and decision support services: A discussion and evaluation in triple assessment of suspected breast cancer. Br J Cancer. 2006 Dec 4;95(11):1490-6. doi: 10.1038/sj.bjc.6603470. Epub 2006 Nov 21.
Peleg M, Fox J, Patkar V, Glasspool D, Chronakis I, South M, Nassar S, Gaglia JL, Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Garber JR. A Computer-Interpretable Version of the AACE, AME, ETA Medical Guidelines for Clinical Practice for the Diagnosis and Management of Thyroid Nodules. Endocr Pract. 2014 Apr;20(4):352-9. doi: 10.4158/EP13271.OR.
Bury J, Hurt C, Roy A, Cheesman L, Bradburn M, Cross S, Fox J, Saha V. LISA: a web-based decision-support system for trial management of childhood acute lymphoblastic leukaemia. Br J Haematol. 2005 Jun;129(6):746-54. doi: 10.1111/j.1365-2141.2005.05541.x.
Tural C, Ruiz L, Holtzer C, Schapiro J, Viciana P, Gonzalez J, Domingo P, Boucher C, Rey-Joly C, Clotet B; Havana Study Group. Clinical utility of HIV-1 genotyping and expert advice: the Havana trial. AIDS. 2002 Jan 25;16(2):209-18. doi: 10.1097/00002030-200201250-00010.
Walton RT, Gierl C, Yudkin P, Mistry H, Vessey MP, Fox J. Evaluation of computer support for prescribing (CAPSULE) using simulated cases. BMJ. 1997 Sep 27;315(7111):791-5. doi: 10.1136/bmj.315.7111.791.
Patkar V, Fox J. Clinical guidelines and care pathways: a case study applying PROforma decision support technology to the breast cancer care pathway. Stud Health Technol Inform. 2008;139:233-42.
Related Links
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Meeting Patients Needs: Improving the effectiveness of Multidisciplinary Team Meetings in Cancer Services. 2018
Transforming Multidisciplinary Team Meetings (MDTMs): Report by Prof Martin Gore (2017) for NHS England
NHS England : Streamlining Multi-Disciplinary Team Meetings
Other Identifiers
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304825
Identifier Type: -
Identifier Source: org_study_id
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