Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-25 @ 6:42 AM
Study NCT ID:
NCT03726320
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Community Health Worker-led Decision Coaching
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Danil.Makarov@nyulangone.org', 'phone': '212-263-4961', 'title': 'Danil Makarov', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'The occurrence of an AE or SAE may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor. Note that participants in the patient provider arm were not assessed for deaths or adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW", 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification", 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prostate Specific Antigen (PSA) Screening Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 3', 'description': 'Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Knowledge Survey Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '8.13', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '5.23', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Decision Quality Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '3.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Make Informed Choice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000'}, {'value': '43.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "Percentage of participants who made an Informed Choice to either undergo or decline PSA testing. Informed choices are those in which:\n\n1\\. 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.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decision Self-Efficacy Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'spread': '8.41', 'groupId': 'OG000'}, {'value': '94.7', 'spread': '9.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', '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 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."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Doctor-Patient Communication Survey Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '4.28', 'spread': '0.395', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '0.412', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', '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 average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'spread': '4.86', 'groupId': 'OG000'}, {'value': '47.3', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', '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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Decisional Conflict Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '11', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', '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. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Decision Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '4.48', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '0.539', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', '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. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decisional Regret Scale Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'OG001', 'title': 'Control Group', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '27', 'spread': '18.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', '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. 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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group: Patients', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'FG001', 'title': 'Control Group: Patients', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}, {'id': 'FG002', 'title': 'Patient Providers', 'description': "Patient provider participants included patients' physicians/nurse practitioners. Patient provider participants had appointments with both control and intervention patients."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Time Constraints', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ineligible after enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Clinic / insurance issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Language barrier', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Provider left the clinic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group: Patients', '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.\n\nEducation Counseling Session for PSA Screening: counseling from extensively trained CHW"}, {'id': 'BG001', 'title': 'Control Group: Patients', '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.\n\nGeneral Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification"}, {'id': 'BG002', 'title': 'Patient Providers', 'description': "Patient provider participants included patients' physicians/nurse practitioners."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53.2', 'spread': '8.72', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '7.63', 'groupId': 'BG001'}, {'value': '41.7', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '49.87', 'spread': '8.82', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex information is missing from 1 participant in the patient provider arm.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-16', 'size': 815306, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-29T16:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2018-09-07', 'resultsFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-22', 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate Specific Antigen (PSA) Screening Rates', 'timeFrame': 'Up to Month 3', 'description': 'Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.'}, {'measure': 'Patient Knowledge Survey Score', 'timeFrame': 'Day 1', '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.'}, {'measure': 'Decision Quality Score', 'timeFrame': 'Day 1', 'description': "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."}, {'measure': 'Percentage of Participants Who Make Informed Choice', 'timeFrame': 'Day 1', 'description': "Percentage of participants who made an Informed Choice to either undergo or decline PSA testing. Informed choices are those in which:\n\n1\\. 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."}], 'secondaryOutcomes': [{'measure': 'Decision Self-Efficacy Scale Score', 'timeFrame': 'Day 1', '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 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."'}, {'measure': 'Doctor-Patient Communication Survey Score', 'timeFrame': 'Day 1', '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 average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication.'}, {'measure': 'Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score', 'timeFrame': 'Day 1', '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."}, {'measure': 'Change in Decisional Conflict Scale Score', 'timeFrame': 'Day 1', '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. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation.'}, {'measure': 'Satisfaction With Decision Scale Score', 'timeFrame': 'Day 1', '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. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision."}, {'measure': 'Decisional Regret Scale Survey', 'timeFrame': 'Month 6', '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. 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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '33568208', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Gender Identity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Black\n* Male\n* Attending FQHC for routine primary care appointment\n\nProviders:\n\n* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)\n* Caring for patients that fit inclusion criteria\n\nExclusion Criteria:\n\n* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)\n* Caring for patients that fit inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03726320', 'briefTitle': 'Trial of Community Health Worker-led Decision Coaching', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '18-00514'}, 'secondaryIdInfos': [{'id': '1R01MD012243-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MD012243-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', '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.", 'interventionNames': ['Behavioral: Education Counseling Session for PSA Screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', '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.", 'interventionNames': ['Behavioral: General Health Counseling Coaching']}], 'interventions': [{'name': 'Education Counseling Session for PSA Screening', 'type': 'BEHAVIORAL', 'description': 'counseling from extensively trained CHW', 'armGroupLabels': ['Intervention Group']}, {'name': 'General Health Counseling Coaching', 'type': 'BEHAVIORAL', 'description': 'coaching using an educational tool focused on dietary and lifestyle modification', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Danil Makarov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Aggregate participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).', 'accessCriteria': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}