Clinical trial NCT04782713: Smart Prostate Specific Antigen (PSA) Screening Study
Official title: Smart PSA Screening Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PSA
Prostate Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm intervention with historical control trial where the direct recipients of the intervention are PCPs. There are three components to the project with corresponding data collection activities - I) PCP Evaluation of the Smart PSA Screening Guidelines
Primary purpose: SCREENING

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

Eligibility 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

Primary outcomes:
measure: Number of PSA tests ordered per number of clinical encounters 12 months prior to the intervention
timeFrame: Monthly for 12 months prior to intervention
measure: Number of PSA tests ordered per number of clinical encounters during the intervention
timeFrame: Monthly for 12 months during intervention
measure: Number of PSA levels categorized as <4.0, 4.0-10.0 and >10.0 12 month prior to the intervention
timeFrame: Monthly for 12 months prior to intervention
measure: PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention
timeFrame: Monthly for 12 months during intervention
measure: Number of Urology referrals 12 months prior to the intervention
timeFrame: 12 months prior to intervention
measure: Number of Urology referrals during the intervention
timeFrame: 12 months after intervention
measure: Number of prostate biopsies performed using the risk levels of the National Comprehensive Cancer Network (NCCN) of very low, Favorable intermittent, Unfavorable intermittent, High, very high 12 months prior to the intervention
timeFrame: 12 months prior to the intervention
measure: Number of prostate biopsies performed using the risk levels of the National Comprehensive Cancer Network (NCCN) of very low, Favorable intermittent, Unfavorable intermittent, High, very high during the intervention
timeFrame: 12 months after the intervention
measure: Number of prostate biopsy complications 12 months prior to the intervention
timeFrame: 12 months prior to intervention
measure: Number of prostate biopsy complications during the intervention
timeFrame: 12 months after intervention
measure: Benefit and harm analysis 12 months prior to the intervention
timeFrame: 12 months prior to intervention
measure: Benefit and harm analysis 12 months prior to the intervention
timeFrame: 12 months prior to intervention
measure: Benefit and harm analysis 12 months prior to the intervention
timeFrame: 12 months prior to intervention
measure: Benefit and harm analysis 12 months prior to the intervention
timeFrame: 12 months prior to intervention
measure: Benefit and harm analysis during the intervention
timeFrame: 12 months after intervention
measure: Benefit and harm analysis during the intervention
timeFrame: 12 months after intervention
measure: Benefit and harm analysis during the intervention
timeFrame: 12 months after intervention
measure: Benefit and harm analysis during the intervention
timeFrame: 12 months after intervention
measure: Number of PCPs that have confidence in discussing prostate issues 12 months prior to the intervention
timeFrame: 12 months prior to intervention
measure: Number of PCPs that have confidence in discussing prostate issues during the the intervention
timeFrame: 12 months after intervention
measure: Number of patients referred to specialty care 12 months prior to patient navigation/ care coordination
timeFrame: 12 months prior to intervention
measure: Number of patients referred to specialty care through patient navigation/ care coordination during the intervention
timeFrame: 12 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mile Square Health Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Peter Gann, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References: