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Trial of Community Health Worker-led Decision Coaching

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education Counseling Session for PSA Screening
General Health Counseling Coaching
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 7, 2018
Last Updated
October 20, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03726320
Brief Title
Trial of Community Health Worker-led Decision Coaching
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
September 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Counseling Session for PSA Screening
Intervention Description
counseling from extensively trained CHW
Intervention Type
Behavioral
Intervention Name(s)
General Health Counseling Coaching
Intervention Description
coaching using an educational tool focused on dietary and lifestyle modification
Primary Outcome Measure Information:
Title
Prostate Specific Antigen (PSA) Screening Rates
Description
Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.
Time Frame
Up to Month 3
Title
Change in Patient Knowledge Survey Score from Post-Coaching Session to Post-Appointments
Description
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.
Time Frame
Post-Coaching Session/Pre-Appointment, Post-Appointment (Day 1)
Title
Change in Measure of Informed Choice Attitudes Score
Description
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.
Time Frame
Post-Coaching Session/Pre-Appointment, Post-Appointment (Day 1)
Title
Change in Decision Quality Score
Description
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.
Time Frame
Post-Coaching Session/Pre-Appointment, Post-Appointment (Day 1)
Secondary Outcome Measure Information:
Title
Change in Decision Self-Efficacy Scale Score
Description
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.
Time Frame
Pre-Coaching Session/Pre-Appointment, Post-Appointment (Day 1)
Title
Doctor-Patient Communication Survey Score
Description
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.
Time Frame
Post-Appointment (Day 1)
Title
Change in Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score
Description
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.
Time Frame
Pre-Coaching Session/Pre-Appointment, Post-Appointment (Day 1)
Title
Change in Decisional Conflict Scale Score
Description
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.
Time Frame
Post-Coaching Session/Pre-Appointment (Day 1), Month 3
Title
Change in Satisfaction with Decision Scale Score
Description
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.
Time Frame
Post-Appointment (Day 1), Month 3
Title
Decisional Regret Scale Survey
Description
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.
Time Frame
Month 3

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gender Identity
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danil Makarov, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33568208
Citation
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.
Results Reference
derived

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Trial of Community Health Worker-led Decision Coaching

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