Smart PSA Screening Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention
研究概览
简要总结
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?
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PCP employed by MSHC who provides care for male adult patients
排除标准
- •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)
- •Exclusion Criteria for chart and database review:
- •Not meeting the inclusion criteria
结局指标
主要结局
PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 12 months after the intervention
Review electronic medical records for biopsies performed
Number of PSA levels categorized as <4.0, 4.0-10.0 and >10.0 12 month prior to the intervention
时间窗: 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
时间窗: 12 months prior to intervention
Review electronic medical records for urology referrals
Number of prostate biopsy complications during the intervention
时间窗: 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
Number of patients referred to specialty care 12 months prior to patient navigation/ care coordination
时间窗: 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
时间窗: 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
时间窗: 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
Benefit and harm analysis 12 months prior to the intervention
时间窗: 12 months prior to 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
Benefit and harm analysis during the intervention
时间窗: 12 months after 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.
次要结局
未报告次要终点
研究者
Peter Gann
Principal Investigator
University of Illinois at Chicago