Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-26 @ 9:09 PM
Study NCT ID:
NCT04796961
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2021-03-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gdaumit@jhmi.edu', 'phone': '410-614-6460', 'title': 'Gail Daumit MD, MHS', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse Events Not Collected', 'eventGroups': [{'id': 'EG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.8', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '14.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.7', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months', 'description': 'Knowledge of evidence-based smoking cessation treatment: 16-item scale developed by our team. Items are true/false and score reflects number answered correctly. Average score range 0-16 with a higher score signifies an increased knowledge of smoking cessation treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected analyzed under modeling approach.'}, {'type': 'PRIMARY', 'title': 'Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Counseling Providers', 'description': 'Consented and enrolled staff participants at mental health organizations delivered smoking cessation counseling.'}, {'id': 'OG001', 'title': 'Prescribers', 'description': 'Consented and enrolled staff participants at mental health organizations who prescribe medications'}], 'classes': [{'title': 'Smoking Screening - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Screening - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Readiness to Quit Assessment - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Readiness to Quit Assessment - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Cessation Counseling - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Smoking Cessation Counseling - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Smoking Cessation Pharmacotherapy - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Cessation Pharmacotherapy - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.1', 'groupDescription': 'smoking screening', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.2', 'groupDescription': 'readiness to quit assessments', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.8', 'ciUpperLimit': '2.0', 'groupDescription': 'smoking cessation counseling', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.7', 'groupDescription': 'smoking cessation pharmacotherapy', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months', 'description': "Self-efficacy for a four components of the smoking cessation intervention were evaluated using an instrument adapted from Compeau and Higgins' task-focused self-efficacy scale. Responses for items are on a Likert scale of 1-10. Average score range 1-10 and higher scores signify greater self-efficacy for the smoking cessation task.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected analyzed under modeling approach.'}, {'type': 'SECONDARY', 'title': 'Number of Clients Recieved Smoking Status Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6011', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'categories': [{'measurements': [{'value': '3406', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 12 months', 'description': 'Assessment of smoking status measured by clinic documentation during client visits with the number below indicating the number of clients who had a smoking status assessment during the 12 month study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Mental health clinic clients'}, {'type': 'SECONDARY', 'title': 'Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1469', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'categories': [{'measurements': [{'value': '1192', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 12 months', 'description': 'Assessment of willingness to quit measured by clinic documentation during client visits, with the number below indicating the number of clients who reported smoking during a smoking status assessment who had a willingness to quit assessment during the 12 month study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1469', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Client Smokers Reported Interest in Quitting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '529', 'groupId': 'OG000'}]}]}, {'title': 'Clients Not Reported Interest In Quitting Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1085', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '759', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 12 months', 'description': 'Receipt of behavioral counseling measured by clinic documentation during client visits, with the number below indicating the number of clients interested in quitting smoking that reported smoking during a smoking status assessment who staff reported as receiving behavioral counseling during the 12 months study period.\n\nData is reported in two groups based upon whether the client had a recorded interest in quitting smoking or not, and only includes clients who reported smoking at some point during the study period. Clients can be reported in both groups if they responded differently to this question at two points over the course of the 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1469', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Client Smokers Reported Interest in Quitting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}]}]}, {'title': 'Client Smokers Not Reported Interest in Quitting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1085', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 12 months', 'description': 'Measured by clinic documentation during client visits with the number below indicating the number of clients interested in quitting smoking, that reported smoking during a smoking status assessment who staff reported as receiving smoking cessation pharmacotherapy during the 12 months study period.\n\nClients can be reported in both groups (Interested in quitting, not interested in quitting) if they responded differently to this question at two points over the course of the 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clients who had a smoking status assessment collected where they reported smoking during the study period were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Post Training', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Training (up to 2 weeks), 12 months', 'description': 'An adaptation of the Acceptability of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected, analyzed under modeling approach.'}, {'type': 'SECONDARY', 'title': 'Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Post Training', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Intervention Appropriateness Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected, analyzed under modeling approach.'}, {'type': 'SECONDARY', 'title': 'Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Post Training', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Feasibility of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected, analyzed under modeling approach.'}, {'type': 'SECONDARY', 'title': 'Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Post Training', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Acceptability of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected, analyzed under modeling approach.'}, {'type': 'SECONDARY', 'title': 'Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Post Training', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Intervention Appropriateness Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected, analyzed under modeling approach.'}, {'type': 'SECONDARY', 'title': 'Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'classes': [{'title': 'Post Training', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Feasibility of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Staff with data collected, analyzed under modeling approach.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Tobacco Smoking Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'timeFrame': 'Baseline, 12 Months', 'description': '7-day patient abstinence reported in medical record', 'reportingStatus': 'POSTED', 'populationDescription': 'Information data source was the health record and this data was not present routinely. When available the data appeared not to be valid.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '91'}]}, {'type': 'Mental Health Clinic Clients (Not Enrolled)', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '6011'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Left Organization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'typeUnitsAnalyzed': 'Clinics', 'recruitmentDetails': 'Mental health clinic staff (providers and prescribers) were recruited from 5 mental health clinics.', 'preAssignmentDetails': 'Ninety-one mental health clinic staff (providers and prescribers) were enrolled in the study. The mental health clinics had 6,011 clients with data that were included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.\n\nImplementation Intervention: The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Staff Role', 'classes': [{'categories': [{'title': 'Counseling Provider', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Prescriber', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Role of the staff member as it relates to delivery of the evidence-based practice intervention.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-17', 'size': 373981, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-01T13:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2021-03-10', 'resultsFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-06', 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Tobacco Smoking Abstinence', 'timeFrame': 'Baseline, 12 Months', 'description': '7-day patient abstinence reported in medical record'}], 'primaryOutcomes': [{'measure': 'Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale', 'timeFrame': 'Baseline, 12 months', 'description': 'Knowledge of evidence-based smoking cessation treatment: 16-item scale developed by our team. Items are true/false and score reflects number answered correctly. Average score range 0-16 with a higher score signifies an increased knowledge of smoking cessation treatment.'}, {'measure': 'Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment', 'timeFrame': 'Baseline, 12 months', 'description': "Self-efficacy for a four components of the smoking cessation intervention were evaluated using an instrument adapted from Compeau and Higgins' task-focused self-efficacy scale. Responses for items are on a Likert scale of 1-10. Average score range 1-10 and higher scores signify greater self-efficacy for the smoking cessation task."}], 'secondaryOutcomes': [{'measure': 'Number of Clients Recieved Smoking Status Assessment', 'timeFrame': 'Baseline through 12 months', 'description': 'Assessment of smoking status measured by clinic documentation during client visits with the number below indicating the number of clients who had a smoking status assessment during the 12 month study period.'}, {'measure': 'Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment', 'timeFrame': 'Baseline through 12 months', 'description': 'Assessment of willingness to quit measured by clinic documentation during client visits, with the number below indicating the number of clients who reported smoking during a smoking status assessment who had a willingness to quit assessment during the 12 month study period.'}, {'measure': 'Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling', 'timeFrame': 'Baseline through 12 months', 'description': 'Receipt of behavioral counseling measured by clinic documentation during client visits, with the number below indicating the number of clients interested in quitting smoking that reported smoking during a smoking status assessment who staff reported as receiving behavioral counseling during the 12 months study period.\n\nData is reported in two groups based upon whether the client had a recorded interest in quitting smoking or not, and only includes clients who reported smoking at some point during the study period. Clients can be reported in both groups if they responded differently to this question at two points over the course of the 12 months.'}, {'measure': 'Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy', 'timeFrame': 'Baseline through 12 months', 'description': 'Measured by clinic documentation during client visits with the number below indicating the number of clients interested in quitting smoking, that reported smoking during a smoking status assessment who staff reported as receiving smoking cessation pharmacotherapy during the 12 months study period.\n\nClients can be reported in both groups (Interested in quitting, not interested in quitting) if they responded differently to this question at two points over the course of the 12 months.'}, {'measure': 'Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure', 'timeFrame': 'Post Training (up to 2 weeks), 12 months', 'description': 'An adaptation of the Acceptability of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.'}, {'measure': 'Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Intervention Appropriateness Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.'}, {'measure': 'Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Feasibility of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility.'}, {'measure': 'Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Acceptability of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.'}, {'measure': 'Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Intervention Appropriateness Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.'}, {'measure': 'Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure', 'timeFrame': 'Post Training (up to 2 weeks), 12 Months', 'description': 'An adaptation of the Feasibility of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Smoking']}, 'referencesModule': {'references': [{'pmid': '37171851', 'type': 'DERIVED', 'citation': 'Dickerson F, Goldsholl S, Yuan CT, Dalcin A, Eidman B, Minahan E, Gennusa Rd JV, Mace E, Cullen B, Evins AE, Cather C, Wang NY, McGinty EM, Daumit GL. Promoting Evidence-Based Tobacco Cessation Treatment in Community Mental Health Clinics: Protocol for a Prepost Intervention Study. JMIR Res Protoc. 2023 May 12;12:e44787. doi: 10.2196/44787.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will examine whether an implementation intervention will improve delivery of evidence-based treatment for tobacco smoking cessation for patients in community mental health clinics.', 'detailedDescription': "In this pilot study, the investigators will work with community mental health clinical and pilot test an implementation intervention to improve mental health providers' delivery of evidence-based tobacco smoking cessation treatment in community mental health clinics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* study population: community mental health clinic staff and providers\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04796961', 'acronym': 'IMPACT', 'briefTitle': 'Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics', 'orgStudyIdInfo': {'id': 'IRB00231836'}, 'secondaryIdInfos': [{'id': '1P50MH115842-01', 'link': 'https://reporter.nih.gov/quickSearch/1P50MH115842-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Implementation Intervention', 'description': 'All participants will receive the implementation intervention.', 'interventionNames': ['Other: Implementation Intervention']}], 'interventions': [{'name': 'Implementation Intervention', 'type': 'OTHER', 'description': 'The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.', 'armGroupLabels': ['Implementation Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Gail Daumit, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}