Trial of Community Health Worker-led Decision Coaching

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Education Counseling Session for PSA Screening
* Behavioral: General Health Counseling Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients: Black Male Attending FQHC for routine primary care appointment Providers: Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC) Caring for patients that fit inclusion criteria Exclusion Criteria: Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC) Caring for patients that fit inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Behavioral: Education Counseling Session for PSA Screening<br>* counseling from extensively trained CHW<br>|
| Active Comparator: Control Group<br>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. | Behavioral: General Health Counseling Coaching<br>* coaching using an educational tool focused on dietary and lifestyle modification<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Specific Antigen (PSA) Screening Rates | Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data. | Up to Month 3 | 
| Change in Patient Knowledge Survey Score from Post-Coaching Session to Post-Appointments | 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. This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment. | Post-Coaching Session/Pre-Appointment, Post-Appointment (Day 1) | 
| Change in Measure of Informed Choice Attitudes Score | The Measure of Informed Choice Attitudes Survey comprises 4 questions assessing participants' attitudes toward PSA testing. Each item is rated on a scale from 1-7. The total score is the sum of responses (the third item is reverse-scored) and ranges from 4 to 28; lower scores indicate more positive attitudes toward PSA screening. This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment. | Post-Coaching Session/Pre-Appointment, Post-Appointment (Day 1) | 
| Change in Decision Quality Score | The Decision Quality survey includes 12 items assessing participants' attitudes toward prostate cancer treatment and screening. Each item is rated on a scale from 1-5, where 1 = strongly disagree and 5 = strongly agree. The total score is the sum of responses and ranges from 12 to 60; higher scores indicate more positive attitudes toward treatment and screening. This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment. | Post-Coaching Session/Pre-Appointment, Post-Appointment (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Decision Self-Efficacy Scale Score | The Decision Self-Efficacy Scale is an 11-item survey measuring confidence in making an informed choice. Each item is rated on a scale from 0-4, where 0 = not at all confident and 4 = very confident. The total score ranges from 0 to 44; higher scores indicate greater confidence in making an informed choice. | Pre-Coaching Session/Pre-Appointment, Post-Appointment (Day 1) | 
| Doctor-Patient Communication Survey Score | The Doctor-Patient Communication Survey includes 19 items assessing how participants felt they were able to communicate with their provider. Each item is rated on a scale from 1-5, where 1 = strongly disagree and 5 = strongly agree. The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater doctor-patient communication. This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment. | Post-Appointment (Day 1) | 
| Change in Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score | PEPPI is a 10-item assessment of participant's perceived self-efficacy for communicating with their provider. Each item is rated on a scale from 1-5, where 1 = not at all confident and 5 = very confident. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater self-efficacy in communicating with providers. | Pre-Coaching Session/Pre-Appointment, Post-Appointment (Day 1) | 
| Change in Decisional Conflict Scale Score | The Decisional Conflict Scale is a 16-item survey assessing the level of decisional conflict for participants when deciding whether to have prostate cancer screening. Each item is rated on a 0-4 scale, where 0 = strongly agree and 4 = strongly disagree. The total score is the sum of responses and ranges from 0 to 64; lower scores indicate lower levels of decisional conflict. | Post-Coaching Session/Pre-Appointment (Day 1), Month 3 | 
| Change in Satisfaction with Decision Scale Score | 6-item assessment of participants' satisfaction with their prostate cancer screening decisions. Each item is rated on a 1-5 scale, where 1 = strongly disagree and 5 = strongly agree. Higher scores indicate greater satisfaction. | Post-Appointment (Day 1), Month 3 | 
| Decisional Regret Scale Survey | 5-item assessment of participants' regret toward the first decision they made about prostate cancer screening after speaking with their provider. Each item is rated on a scale from 1-5, where 1 = strongly agree and 5 = strongly disagree. The total score is the sum of responses and ranges from 5 to 25; lower scores indicate lower levels of regret/greater satisfaction. | Month 3 |