Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision Making for Prostate Cancer Screening Among Black Male Patients and Their Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Make Informed Choice
研究概览
简要总结
Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a Community Health Worker-led decision coaching program to facilitate Shared Decision Making (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision quality, the decision making process, patient-provider communication and PSA utilization for Black men in the primary care setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Attending FQHC for routine primary care appointment
- •Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
- •Caring for patients that fit inclusion criteria
排除标准
- •Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
- •Caring for patients that fit inclusion criteria
研究组 & 干预措施
Intervention Group
A decision aid along with decision coaching on PSA screening from a Community Health Worker (CHW). The intervention will be administered directly prior to the participant's appointment with their provider.
干预措施: Education Counseling Session for PSA Screening (Behavioral)
Control Group
A decision aid along with CHW interaction on dietary and lifestyle modification to serve as an attention control. The intervention will be administered directly prior to the participant's appointment with their provider.
干预措施: General Health Counseling Coaching (Behavioral)
结局指标
主要结局
Percentage of Participants Who Make Informed Choice
时间窗: Day 1
Percentage of participants who made an Informed Choice to either undergo or decline PSA testing. Informed choices are those in which: 1\. Men with good knowledge and positive measure of informed choice attitudes (\> or = 22) choose to undergo the test OR 2) Men with good knowledge but negative measure of informed choice attitudes (\<22) towards the test, do not undergo the test The Measure of Informed Choice Attitudes survey is administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment and the patient's screening decision is recorded during post-appointment.
Patient Knowledge Survey Score
时间窗: Day 1
The Patient Knowledge Survey comprises 12 items assessing participants' understanding of PSA testing and prostate cancer. Respondents provide an answer of "True," "Unsure," or "False." The total score is the sum of correct responses and ranges from 0-12; higher scores indicate greater knowledge.
Decision Quality Score
时间窗: Day 1
Scale consists of 12 items assessing participants' attitudes toward prostate cancer treatment and screening (6 Pros and 6 Cons of testing) scored on a 5 point Likert scale (Strongly Disagree to Strongly Agree). The total score is the sum of responses and ranges from -24 to +24; Positive scores indicate a more favorable assessment of the pros versus the cons of the test.This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment.
Prostate Specific Antigen (PSA) Screening Rates
时间窗: Up to Month 3
Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.
次要结局
- Change in Decisional Conflict Scale Score(Day 1)
- Decisional Regret Scale Survey(Month 6)
- Doctor-Patient Communication Survey Score(Day 1)
- Decision Self-Efficacy Scale Score(Day 1)
- Satisfaction With Decision Scale Score(Day 1)
- Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score(Day 1)