Smart PSA Screening Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- PSA
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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:
- What age to start?
- How often to repeat screening?
- What age to stop?
- 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
Investigators
Peter Gann
Principal Investigator
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •PCP employed by MSHC who provides care for male adult patients
Exclusion Criteria
- •Not a PCP employed by MSHC who provides care for male adult patients
- •Inclusion Criteria for Patient navigator/care coordinator:
- •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:
- •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)
Outcomes
Primary Outcomes
PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention
Time Frame: Monthly for 12 months during intervention
Review Pathology Laboratory Services, UI Health PSA results
Number of prostate biopsy complications 12 months prior to the intervention
Time Frame: 12 months prior to intervention
Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening
Number of PCPs that have confidence in discussing prostate issues during the the intervention
Time Frame: 12 months after 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
Number of PSA tests ordered per number of clinical encounters 12 months prior to the intervention
Time Frame: Monthly for 12 months prior to intervention
Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders
Number of PSA tests ordered per number of clinical encounters during the intervention
Time Frame: Monthly for 12 months during intervention
Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders
Number of Urology referrals during the intervention
Time Frame: 12 months after intervention
Review electronic medical records for urology referrals
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
Time Frame: 12 months prior to the intervention
Review electronic medical records for biopsies performed
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
Time Frame: 12 months after the intervention
Review electronic medical records for biopsies performed
Benefit and harm analysis during the intervention
Time Frame: 12 months after 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
Number of PSA levels categorized as <4.0, 4.0-10.0 and >10.0 12 month prior to the intervention
Time Frame: Monthly for 12 months prior to intervention
Review Pathology Laboratory Services, UI Health PSA results
Number of Urology referrals 12 months prior to the intervention
Time Frame: 12 months prior to intervention
Review electronic medical records for urology referrals
Number of prostate biopsy complications during the intervention
Time Frame: 12 months after intervention
Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening
Benefit and harm analysis 12 months prior to the intervention
Time Frame: 12 months prior to 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
Number of patients referred to specialty care 12 months prior to patient navigation/ care coordination
Time Frame: 12 months prior to intervention
Review electronic medical records for referral to specialty care
Number of patients referred to specialty care through patient navigation/ care coordination during the intervention
Time Frame: 12 months after intervention
Review electronic medical records for referral to specialty care
Number of PCPs that have confidence in discussing prostate issues 12 months prior to the intervention
Time Frame: 12 months prior to 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