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Completed

NCT Number: NCT03726320

Trial of Community Health Worker-led Decision Coaching

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.

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Key information

Age range

40 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education Counseling Session for PSA Screening

Behavioral

counseling from extensively trained CHW

General Health Counseling Coaching

Behavioral

coaching using an educational tool focused on dietary and lifestyle modification

Primary outcomes

  1. Prostate Specific Antigen (PSA) Screening Rates

    Time frame: Up to Month 3

    Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.

  2. Patient Knowledge Survey Score

    Time frame: Day 1

    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.

  3. Decision Quality Score

    Time frame: Day 1

    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.

  4. Percentage of Participants Who Make Informed Choice

    Time frame: Day 1

    Percentage of participants who made an Informed Choice to either undergo or decline PSA testing. Informed choices are those in which:

    • 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.

Secondary outcomes

  1. Decision Self-Efficacy Scale Score

    Time frame: Day 1

    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."

  2. Doctor-Patient Communication Survey Score

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

  4. Change in Decisional Conflict Scale Score

    Time frame: Day 1

    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.

  5. Satisfaction With Decision Scale Score

    Time frame: Day 1

    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.

  6. Decisional Regret Scale Survey

    Time frame: Month 6

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2018
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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