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Trial of Community Health Worker-led Decision Coaching
NA trial testing Education Counseling Session for PSA Screening in Prostate Cancer in 162 participants. Completed in 20 September 2023.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | screening |
| Enrollment | 162 |
| Start date | 15 October 2019 |
| Primary completion | 21 April 2023 |
| Estimated completion | 20 September 2023 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
Adults 40 to 69, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 77.8 | |
| Control Group | 76.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 8.13 | ± 1.33 |
| Control Group | 5.23 | ± 2.24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 11.2 | ± 5.42 |
| Control Group | 10.8 | ± 3.99 |
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 de
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 64.8 | |
| Control Group | 43.3 |
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."
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 96 | ± 8.41 |
| Control Group | 94.7 | ± 9.15 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 4.28 | ± 0.395 |
| Control Group | 4.31 | ± 0.412 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 47.5 | ± 4.86 |
| Control Group | 47.3 | ± 4.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 17 | ± 11 |
| Control Group | 21.9 | ± 13.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 4.48 | ± 0.48 |
| Control Group | 4.31 | ± 0.539 |
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
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 21.2 | ± 15.3 |
| Control Group | 27 | ± 18.2 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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