Trial Outcomes & Findings for Trial of Community Health Worker-led Decision Coaching (NCT NCT03726320)
NCT ID: NCT03726320
Last Updated: 2024-05-23
Results Overview
Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.
COMPLETED
NA
162 participants
Up to Month 3
2024-05-23
Participant Flow
Participants in the Patient Providers arm were not assigned to an intervention/control condition. Rather, these providers treated patient participants assigned to both the intervention group and the control group. As such, Participant Flow data on the Patient Provider participants is presented in 1 arm.
Participant milestones
| Measure |
Intervention Group: Patients
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group: Patients
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
Patient Providers
Patient provider participants included patients' physicians/nurse practitioners. Patient provider participants had appointments with both control and intervention patients.
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
12
|
|
Overall Study
COMPLETED
|
54
|
60
|
11
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
1
|
Reasons for withdrawal
| Measure |
Intervention Group: Patients
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group: Patients
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
Patient Providers
Patient provider participants included patients' physicians/nurse practitioners. Patient provider participants had appointments with both control and intervention patients.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
0
|
|
Overall Study
Time Constraints
|
4
|
1
|
0
|
|
Overall Study
Ineligible after enrollment
|
3
|
3
|
0
|
|
Overall Study
Clinic / insurance issue
|
2
|
0
|
0
|
|
Overall Study
Language barrier
|
1
|
0
|
0
|
|
Overall Study
Provider left the clinic
|
0
|
0
|
1
|
Baseline Characteristics
Sex information is missing from 1 participant in the patient provider arm.
Baseline characteristics by cohort
| Measure |
Intervention Group: Patients
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group: Patients
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
Patient Providers
n=12 Participants
Patient provider participants included patients' physicians/nurse practitioners.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 8.72 • n=54 Participants
|
54.7 years
STANDARD_DEVIATION 7.63 • n=60 Participants
|
41.7 years
STANDARD_DEVIATION 10.1 • n=12 Participants
|
49.87 years
STANDARD_DEVIATION 8.82 • n=126 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
0 Participants
n=60 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
8 Participants
n=11 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
8 Participants
n=125 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
|
Sex: Female, Male
Male
|
54 Participants
n=54 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
60 Participants
n=60 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
3 Participants
n=11 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
117 Participants
n=125 Participants • Sex information is missing from 1 participant in the patient provider arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=126 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
10 Participants
n=12 Participants
|
10 Participants
n=126 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
54 Participants
n=54 Participants
|
59 Participants
n=60 Participants
|
0 Participants
n=12 Participants
|
113 Participants
n=126 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=54 Participants
|
60 Participants
n=60 Participants
|
4 Participants
n=12 Participants
|
118 Participants
n=126 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=126 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=126 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=54 Participants
|
60 participants
n=60 Participants
|
12 participants
n=12 Participants
|
126 participants
n=126 Participants
|
PRIMARY outcome
Timeframe: Up to Month 3Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Screening Rates
|
77.8 Percentage of participants
|
76.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 1The 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.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Patient Knowledge Survey Score
|
8.13 score on a scale
Standard Deviation 1.33
|
5.23 score on a scale
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: Day 1Scale 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.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Decision Quality Score
|
11.2 score on a scale
Standard Deviation 5.42
|
10.8 score on a scale
Standard Deviation 3.99
|
PRIMARY outcome
Timeframe: Day 1Percentage 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 decision is recorded during post-appointment.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Percentage of Participants Who Make Informed Choice
|
64.8 Percentage of participants
|
43.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1The 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."
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Decision Self-Efficacy Scale Score
|
96 score on a scale
Standard Deviation 8.41
|
94.7 score on a scale
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Day 1The 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.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Doctor-Patient Communication Survey Score
|
4.28 score on a scale
Standard Deviation 0.395
|
4.31 score on a scale
Standard Deviation 0.412
|
SECONDARY outcome
Timeframe: Day 1PEPPI 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.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score
|
47.5 score on a scale
Standard Deviation 4.86
|
47.3 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Day 1The 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.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Change in Decisional Conflict Scale Score
|
17 score on a scale
Standard Deviation 11
|
21.9 score on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Day 16-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.
Outcome measures
| Measure |
Intervention Group
n=54 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=60 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Satisfaction With Decision Scale Score
|
4.48 score on a scale
Standard Deviation 0.48
|
4.31 score on a scale
Standard Deviation 0.539
|
SECONDARY outcome
Timeframe: Month 65-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.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
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.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW
|
Control Group
n=49 Participants
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.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification
|
|---|---|---|
|
Decisional Regret Scale Survey
|
21.2 score on a scale
Standard Deviation 15.3
|
27 score on a scale
Standard Deviation 18.2
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place