Smart Prostate Specific Antigen (PSA) Screening Study

NCT ID: NCT04782713

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2024-11-15

Brief 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?

Detailed 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

Conditions

PSA; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

PCP Evaluation of Smart PSA Screening Guidelines

Completing surveys at baseline, 3, 6, 9 and 12 months

Group Type: OTHER

Completing surveys

Intervention Type: OTHER

Completing surveys at baseline, 3, 6, 9, and 12 months

Interventions

Completing surveys

Completing surveys at baseline, 3, 6, 9, and 12 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• PCP employed by MSHC who provides care for male adult patients

• Male
• Age 40-75
• Clinic visit at a MSHC site
• Elevated PSA (>4.0 ng/ml)

• Male
• Age 40-75
• Clinic visit at a MSHC site from date of study start through 12 months (comparison of 12-month intervention period to periods before and after intervention implementation)

Exclusion Criteria

• Not a PCP employed by MSHC who provides care for male adult patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Peter Gann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Gann, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Mile Square Health Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2020-1251

Identifier Type: -

Identifier Source: org_study_id