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: May 2024
• 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	Patient Knowledge Survey Score	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.	Day 1
Primary	Decision Quality Score	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.	Day 1
Primary	Percentage of Participants Who Make Informed Choice	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.	Day 1
Secondary	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 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."	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 average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication.	Day 1
Secondary	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.	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. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation.	Day 1
Secondary	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. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision.	Day 1
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. 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.	Month 6