Smart Prostate Specific Antigen (PSA) Screening Study

Prostate Cancer Clinical Trial

Official title: Smart PSA Screening Study

Status Active, not recruiting

Clinical Trial Summary

This intervention includes the introduction of the Prostate Cancer Working Group (PCWG )Smart PSA Screening Guidelines and implementation of patient navigation/ care coordination for men with elevated PSA (>4.0 ng/mL).

The guidelines include:

1. What age to start?

2. How often to repeat screening?

3. What age to stop?

4. What PSA threshold should trigger a biopsy referral?

Clinical Trial Description

Primary care providers (PCP) hold the key to implementing effective early detection of Prostate Cancer (PCa), but uncertainty about how to use PSA for screening without causing undue overtreatment of indolent cancer, has greatly inhibited implementation, even in high-risk communities. This is a single-arm intervention study to test implementation of the Smart PSA strategy plus system-level patient navigation/ care coordination in the Mile Square Health Center(MSHC), in order to: a) identify barriers and facilitators to inform implementation of care, b) evaluate the impact on provider confidence regarding prostate cancer screening, and, c) measure its effect on observed PSA levels, biopsy referral rates, and biopsy outcomes.

100 PCPs employed by MSHC who provide care for male adults will be asked to participate in surveys at baseline, (prior to an in-service training) and at 3,6, 9 and 12 months. The surveys will use 5-point Likert scales to assess the respondent's self-report of their knowledge regarding PSA screening, attitudes, behavior; and confidence in presenting the issue, discussing it with patients, interpreting results and making recommendations based on them; and to elicit comments on how to improve implementation.

Historical data of 4500 patients covering a one year period prior to the intervention will be used to measure the impact of the intervention on measurable outcomes ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• PSA

• NCT number: NCT04782713
• Study type: Interventional
• Source: University of Illinois at Chicago
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2021
• Completion date: November 2024