What is Randomized PCA

EvEnt-PCA

  • Nationwide evaluation study for patient education in non-metastatic prostate cancer.
  • The course of study fits easily into routine care.
  • Expense allowance per subject 120 euros (for study doctors).
  • End of patient recruitment: December 31, 2020.
  • EvEnt-PCA follow-up survey phase will run until August 31, 2021.

Information video: Background (7:11 min) and course schedule (8:40 min)

Video background

Video study schedule

background

On April 1, 2018, the project work on a large-scale randomized evaluation study of the prostate cancer decision-making aid began. The innovation fund of the Federal Joint Committee supports the project over four years with approx. 800,000 euros and thus enables a valid comparison with the previous standard. The aim is to demonstrate the possible benefits of multimedia patient information with level I evidence. A guideline recommendation could build on this and the additional remuneration for efforts to achieve shared decision-making could also be objectively justified.Further professional information for urologists can be found here

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In the randomized study on the “Evaluation of a patient-oriented online decision-making aid for non-metastatic prostate cancer” (EvEnt-PCA), the decision-making aid is to be compared with the “Patient Guideline Prostate Cancer” as the current standard. The course of the study fits into the routine care without any problems: After the initial diagnosis, the attending physician offers to participate in the study. 750 patients are randomly assigned to either use the prostate cancer decision-making aid or they receive the printed brochure. The primary endpoint is the guideline-compliant use of a wait-and-see approach. In addition, the intervention is also intended to improve other qualities of decision-making. In addition, the medical point of view is also recorded as part of the study.

procedure

A total of 1,500 patients are to be included in the two-arm randomized evaluation study (end of recruitment: December 31, 2020). On the patient side, three survey times are planned (intervention and follow-up after one and 14 months). For the study physicians, the scope of work includes two survey times (study inclusion and follow-up after 14 months). The aim is to demonstrate the possible benefits of multimedia patient information with level I evidence. A guideline recommendation could build on this and additional remuneration for efforts to achieve shared decision-making could be well justified.

fee

The expense allowance for study doctors is 120 euros per subject. Participating study doctors will receive a study folder in advance with all study documents for an initial ten patients.

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