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Trial of Community Health Worker-led Decision Coaching

Sponsor
NYU Langone Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03726320
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
140
Enrollment
1
Location
2
Arms
40.5
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education Counseling Session for PSA Screening
  • Behavioral: General Health Counseling Coaching
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Screening
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
Actual Study Start Date :
Oct 15, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

a decision aid along with decision coaching on PSA screening from a Community Health Worker (CHW)

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.

Behavioral: General Health Counseling Coaching
coaching using an educational tool focused on dietary and lifestyle modification

Outcome Measures

Primary Outcome Measures

  1. Decision Self-Efficacy Scale [9 Months]

    11 item scale measuring self-efficacy to perform informed decision making (e.g. getting needed information, asking questions, expressing opinions, and asking for advice)

  2. Prostate Specific Antigen (PSA) screening Rates [5 Years]

    PSA rates collected through patient self-reported PSA testing and EHR data on PSA test utilization

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 69 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Danil Makarov, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03726320
Other Study ID Numbers:
  • 18-00514
  • 1R01MD012243-01A1
First Posted:
Oct 31, 2018
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 8, 2022