Trial of Community Health Worker-led Decision Coaching

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Education Counseling Session for PSA Screening; Behavioral: General Health Counseling Coaching

• Registration Number: NCT03726320
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2019-10-15
• Primary Completion: 2023-04-21
• Study Completion: 2023-09-20
• Results First Submitted: 2024-03-29
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Results First Posted: 2024-05-23
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 162

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

Read More

Exclusion Criteria

• Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
• Caring for patients that fit inclusion criteria

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Education Counseling Session for PSA Screening	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.
Control Group	General Health Counseling Coaching	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.

Primary Outcome Measures

Name	Time	Method
Patient Knowledge Survey Score	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	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.
Percentage of Participants Who Make Informed Choice	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.
Prostate Specific Antigen (PSA) Screening Rates	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.

Secondary Outcome Measures

Name	Time	Method
Change in Decisional Conflict Scale Score	Day 1	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. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation.
Decisional Regret Scale Survey	Month 6	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. Higher scores indicate greater regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. The final score presented ranges from 0 to 100, higher scores indicate greater regret.
Doctor-Patient Communication Survey Score	Day 1	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 average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication.
Decision Self-Efficacy Scale Score	Day 1	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 raw score is the sum of responses and is transformed to a standard total score ranging from 0 to 100; higher scores indicate "extremely high self-efficacy."
Satisfaction With Decision Scale Score	Day 1	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. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision.
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score	Day 1	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States