Trial of Community Health Worker-led Decision Coaching

NCT03726320 | Completed Results DMC

• 2 other identifiers: 18-005141R01MD012243-01A1
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Decision Self-Efficacy Scale Score

  Day 1

• Doctor-Patient Communication Survey Score

  Day 1

• Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score

  Day 1

• Change in Decisional Conflict Scale Score

  Day 1

• Satisfaction With Decision Scale Score

  Day 1

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Education Counseling Session for PSA Screening BEHAVIORAL

counseling from extensively trained CHW

Intervention Group

General Health Counseling Coaching BEHAVIORAL

coaching using an educational tool focused on dietary and lifestyle modification

Control Group

Eligibility Criteria

• Age: 40 Years - 69 Years
• Gender Eligibility Details: Gender Identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• Black
• Male
• Attending FQHC for routine primary care appointment
• Providers:
• Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)

You may not qualify if:

• Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 33568208 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Danil Makarov
• Organization: NYU Langone Health

Danil.Makarov@nyulangone.org

212-263-4961

Study Officials

• Danil Makarov, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: October 31, 2018
• Study Start: October 15, 2019
• Primary Completion: April 21, 2023
• Study Completion: September 20, 2023
• Last Updated: May 23, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)