Trial of Community Health Worker-led Decision Coaching

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Education Counseling Session for PSA Screening; Behavioral: General Health Counseling Coaching

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Danil Makarov, MD, NYU Langone Health

Publications and helpful links

General Publications

• Makarov DV, Feuer Z, Ciprut S, Lopez NM, Fagerlin A, Shedlin M, Gold HT, Li H, Lynch G, Warren R, Ubel P, Ravenell JE. 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. Trials. 2021 Feb 10;22(1):128. doi: 10.1186/s13063-021-05064-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 18-00514; 1R01MD012243-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Aggregate participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).Researchers who provide a methodologically sound proposal will have access to the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No