Clinical Evaluation of the Benefits of the MiProstate Platform: Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,329
- Locations
- 1
- Primary Endpoint
- Pre-operative conference quality
Study Overview
Brief Summary
This is an observational cohort study with a non-concurrent comparison group evaluating the use of a digital decision support tool (MiProstate/ISPM) at pre-prostatectomy, multidisciplinary conferences.
Detailed Description
In the study cohort, all clinically relevant data on patients undergoing radical prostatectomy at Karolinska University Hospital were registered on the platform and subsequently presented using the platform at the conferences in which a detailed treatment plan was devised for each patient.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pre-operative conference quality
Time Frame: Recorded at pre-operative conference held <30 days prior to surgery
Quality of pre-operative conference as measured by MDT-MODe (MultiDisciplinary Therapy conference - Metric Of Decision Making) score assigned by an external observer. After prostate cancer diagnosis, work-up, and the decision to offer the patient surgical treatment with curative intent, a conference is held in which surgical strategies are discussed.
Efficiency - time spent in pre-operative conference
Time Frame: Recorded at pre-operative conference held <30 days prior to surgery
Time spent per patient in pre-operative, multidisciplinary conference, measured by an external observer. After prostate cancer diagnosis, work-up, and the decision to offer the patient surgical treatment with curative intent, a conference is held in which surgical strategies are discussed.
Secondary Outcomes
- PROM1 - patient-reported outcome measure on urinary function(At 12 months post surgery (11-18 months is tolerated))
- PLND - pelvic lymph node dissection strategy(Recorded at pre-operative conference (<30 days prior to surgery))
- PSM - positive surgical margin(At surgery. Reported within 30 days after surgery)
- PROM2 -patient-reported outcome measure on erectile function(At 12 months post surgery (11-18 months is tolerated))
- Nerve-sparing strategy(Recorded at pre-operative conference (<30 days prior to surgery))
Investigators
Olof Akre
Professor
Karolinska University Hospital