Smart Prostate Specific Antigen (PSA) Screening Study

University of Illinois

Status: Completed

Conditions: Prostate Cancer; PSA

Treatments: Other: Completing surveys

Study type: Interventional

Funder types: Other

Identifiers

NCT04782713

2020-1251

Details and patient eligibility

About

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?

Full 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

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for PCP:

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

Exclusion Criteria for PCP:

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

Inclusion Criteria for Patient navigator/care coordinator:

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

Exclusion Criteria for Patient navigator/care coordinator:

• Not meeting the inclusion criteria

Inclusion criteria for chart and database review:

• 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 for chart and database review:

• Not meeting the inclusion criteria

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

PCP Evaluation of Smart PSA Screening Guidelines

Other group

Description:

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

Treatment:

Other: Completing surveys