Smart Prostate Specific Antigen (PSA) Screening Study

Study Overview
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Brief Summary
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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: What age to start? How often to repeat screening? What age to stop? What PSA threshold should trigger a biopsy referral?

Detailed Description
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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

Official Title
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Smart PSA Screening Study

Conditions
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PSA, Prostate Cancer

Intervention / Treatment
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* Other: Completing surveys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PCP Evaluation of Smart PSA Screening Guidelines<br>Completing surveys at baseline, 3, 6, 9 and 12 months | Other: Completing surveys<br>* Completing surveys at baseline, 3, 6, 9, and 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of PSA tests ordered per number of clinical encounters 12 months prior to the intervention | Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders | Monthly for 12 months prior to intervention | 
| Number of PSA tests ordered per number of clinical encounters during the intervention | Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders | Monthly for 12 months during intervention | 
| Number of PSA levels categorized as <4.0, 4.0-10.0 and >10.0 12 month prior to the intervention | Review Pathology Laboratory Services, UI Health PSA results | Monthly for 12 months prior to intervention | 
| PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention | Review Pathology Laboratory Services, UI Health PSA results | Monthly for 12 months during intervention | 
| Number of Urology referrals 12 months prior to the intervention | Review electronic medical records for urology referrals | 12 months prior to intervention | 
| Number of Urology referrals during the intervention | Review electronic medical records for urology referrals | 12 months after intervention | 
| 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 | Review electronic medical records for biopsies performed | 12 months prior to the intervention | 
| 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 | Review electronic medical records for biopsies performed | 12 months after the intervention | 
| Number of prostate biopsy complications 12 months prior to the intervention | Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening | 12 months prior to intervention | 
| Number of prostate biopsy complications during the intervention | Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening | 12 months after intervention | 
| Benefit and harm analysis 12 months prior to the intervention | Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient diagnosed per NCCN: Very Low, Low, Favorable intermediate, Unfavorable Intermediate, High, Very High. Subgroup analyses by age, race and previous screening history will be performed. Attention will be focused on relative changes in the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate (thus all localized Gleason 7); clinically insignificant cases will be defined as NCCN Very Low (PSA<10, Gleason grade ≤ 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15 | 12 months prior to intervention | 
| Benefit and harm analysis 12 months prior to the intervention | Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on age and race | 12 months prior to intervention | 
| Benefit and harm analysis 12 months prior to the intervention | Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on previous screening history | 12 months prior to intervention | 
| Benefit and harm analysis 12 months prior to the intervention | Compare the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate with localized Gleason grade 7, clinically insignificant cases will be defined as NCCN Very Low PSA<10, Gleason grade ≤ 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15 | 12 months prior to intervention | 
| Benefit and harm analysis during the intervention | Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient diagnosed per NCCN: Very Low, Low, Favorable intermediate, Unfavorable Intermediate, High, Very High. | 12 months after intervention | 
| Benefit and harm analysis during the intervention | Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on age and race | 12 months after intervention | 
| Benefit and harm analysis during the intervention | Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on previous screening history | 12 months after intervention | 
| Benefit and harm analysis during the intervention | Compare the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate with localized Gleason grade 7, clinically insignificant cases will be defined as NCCN Very Low PSA<10, Gleason grade ≤ 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15 | 12 months after intervention | 
| Number of PCPs that have confidence in discussing prostate issues 12 months prior to the intervention | Analyses of graphing mean trajectories in response to repeat surveys among PCPs at baseline, 3, 6, 9 and 12 months. Subgroup analyses will compare responses stratified by gender, years in practice, race and site | 12 months prior to intervention | 
| Number of PCPs that have confidence in discussing prostate issues during the the intervention | Analyses of graphing mean trajectories in response to repeat surveys among PCPs at baseline, 3, 6, 9 and 12 months. Subgroup analyses will compare responses stratified by gender, years in practice, race and site | 12 months after intervention | 
| Number of patients referred to specialty care 12 months prior to patient navigation/ care coordination | Review electronic medical records for referral to specialty care | 12 months prior to intervention | 
| Number of patients referred to specialty care through patient navigation/ care coordination during the intervention | Review electronic medical records for referral to specialty care | 12 months after intervention |