Trial of Community Health Worker-led Decision Coaching

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726320
• Other study ID #: 18-00514
• Secondary ID: 1R01MD012243-01A
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: September 20, 2023

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 20, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Education Counseling Session for PSA Screening
counseling from extensively trained CHW
• General Health Counseling Coaching
coaching using an educational tool focused on dietary and lifestyle modification

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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