Skip to content

Trial of Community Health Worker-led Decision Coaching

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03726320
Enrollment
162
Registered
2018-10-31
Start date
2019-10-15
Completion date
2023-09-20
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

BEHAVIORALEducation Counseling Session for PSA Screening

counseling from extensively trained CHW

BEHAVIORALGeneral Health Counseling Coaching

coaching using an educational tool focused on dietary and lifestyle modification

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
40 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prostate Specific Antigen (PSA) Screening RatesUp 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.
Patient Knowledge Survey ScoreDay 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.
Decision Quality ScoreDay 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.
Percentage of Participants Who Make Informed ChoiceDay 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.

Secondary

MeasureTime frameDescription
Satisfaction With Decision Scale ScoreDay 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.
Change in Decisional Conflict Scale ScoreDay 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.
Decisional Regret Scale SurveyMonth 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.
Decision Self-Efficacy Scale ScoreDay 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.
Doctor-Patient Communication Survey ScoreDay 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.
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) ScoreDay 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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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
54
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
60
Patient Providers
Patient provider participants included patients' physicians/nurse practitioners.
12
Total126

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyClinic / insurance issue200
Overall StudyIneligible after enrollment330
Overall StudyLanguage barrier100
Overall StudyLost to Follow-up240
Overall StudyProvider left the clinic001
Overall StudyTime Constraints410

Baseline characteristics

CharacteristicIntervention Group: PatientsTotalPatient ProvidersControl Group: Patients
Age, Continuous53.2 years
STANDARD_DEVIATION 8.72
49.87 years
STANDARD_DEVIATION 8.82
41.7 years
STANDARD_DEVIATION 10.1
54.7 years
STANDARD_DEVIATION 7.63
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants3 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants10 Participants10 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
54 Participants113 Participants0 Participants59 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants3 Participants3 Participants0 Participants
Race (NIH/OMB)
Black or African American
54 Participants118 Participants4 Participants60 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants0 Participants
Race (NIH/OMB)
White
0 Participants3 Participants3 Participants0 Participants
Region of Enrollment
United States
54 participants126 participants12 participants60 participants
Sex: Female, Male
Female
0 Participants8 Participants8 Participants0 Participants
Sex: Female, Male
Male
54 Participants117 Participants3 Participants60 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 540 / 60
other
Total, other adverse events
0 / 540 / 60
serious
Total, serious adverse events
0 / 540 / 60

Outcome results

Primary

Decision Quality Score

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.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Intervention GroupDecision Quality Score11.2 score on a scaleStandard Deviation 5.42
Control GroupDecision Quality Score10.8 score on a scaleStandard Deviation 3.99
Primary

Patient Knowledge Survey Score

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.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Intervention GroupPatient Knowledge Survey Score8.13 score on a scaleStandard Deviation 1.33
Control GroupPatient Knowledge Survey Score5.23 score on a scaleStandard Deviation 2.24
Primary

Percentage of Participants Who Make Informed Choice

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 decision is recorded during post-appointment.

Time frame: Day 1

ArmMeasureValue (NUMBER)
Intervention GroupPercentage of Participants Who Make Informed Choice64.8 Percentage of participants
Control GroupPercentage of Participants Who Make Informed Choice43.3 Percentage of participants
Primary

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.

Time frame: Up to Month 3

ArmMeasureValue (NUMBER)
Intervention GroupProstate Specific Antigen (PSA) Screening Rates77.8 Percentage of participants
Control GroupProstate Specific Antigen (PSA) Screening Rates76.7 Percentage of participants
Secondary

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. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Intervention GroupChange in Decisional Conflict Scale Score17 score on a scaleStandard Deviation 11
Control GroupChange in Decisional Conflict Scale Score21.9 score on a scaleStandard Deviation 13.2
Secondary

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. 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.

Time frame: Month 6

ArmMeasureValue (MEAN)Dispersion
Intervention GroupDecisional Regret Scale Survey21.2 score on a scaleStandard Deviation 15.3
Control GroupDecisional Regret Scale Survey27 score on a scaleStandard Deviation 18.2
Secondary

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 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.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Intervention GroupDecision Self-Efficacy Scale Score96 score on a scaleStandard Deviation 8.41
Control GroupDecision Self-Efficacy Scale Score94.7 score on a scaleStandard Deviation 9.15
Secondary

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 average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Intervention GroupDoctor-Patient Communication Survey Score4.28 score on a scaleStandard Deviation 0.395
Control GroupDoctor-Patient Communication Survey Score4.31 score on a scaleStandard Deviation 0.412
Secondary

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.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Intervention GroupPerceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score47.5 score on a scaleStandard Deviation 4.86
Control GroupPerceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score47.3 score on a scaleStandard Deviation 4.4
Secondary

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. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Intervention GroupSatisfaction With Decision Scale Score4.48 score on a scaleStandard Deviation 0.48
Control GroupSatisfaction With Decision Scale Score4.31 score on a scaleStandard Deviation 0.539

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026