Trial of Community Health Worker-led Decision Coaching

NCT ID: NCT03726320

Last Updated: 2024-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2023-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Education Counseling Session for PSA Screening

Intervention Type BEHAVIORAL

counseling from extensively trained CHW

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.

Group Type ACTIVE_COMPARATOR

General Health Counseling Coaching

Intervention Type BEHAVIORAL

coaching using an educational tool focused on dietary and lifestyle modification

Interventions

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Education Counseling Session for PSA Screening

counseling from extensively trained CHW

Intervention Type BEHAVIORAL

General Health Counseling Coaching

coaching using an educational tool focused on dietary and lifestyle modification

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Patients:

* Black
* Male
* Attending FQHC for routine primary care appointment

Providers:

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

Exclusion Criteria

* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danil Makarov, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33568208 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01MD012243-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-00514

Identifier Type: -

Identifier Source: org_study_id

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