Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-27 @ 3:50 PM
Study NCT ID:
NCT02896257
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2016-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
De-implementing Inhaled Steroids to Improve Care and Safety in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'David.Au@va.gov', 'phone': '206-764-2504', 'title': 'Dr. David Au', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Adverse events were not collected from providers.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Standard practice (usual care). Primary care providers treat their patients as usual.', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 0, 'seriousNumAtRisk': 281, 'deathsNumAffected': 9, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.\n\nGuideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.', 'otherNumAtRisk': 269, 'deathsNumAtRisk': 269, 'otherNumAffected': 0, 'seriousNumAtRisk': 269, 'deathsNumAffected': 10, 'seriousNumAffected': 30}], 'seriousEvents': [{'term': 'Inpatient COPD Exacerbation', 'notes': 'Hospitalized for COPD exacerbation within the 180 days after the index date.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Outpatient COPD Exacerbation', 'notes': 'Experienced an outpatient COPD exacerbation within the 180 days after the index date.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Experienced either an inpatient or outpatient pneumonia event within 180 days after the index date.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 269, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Primary care providers treat their patients as usual.'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.66', 'ciLowerLimit': '2.50', 'ciUpperLimit': '5.38', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 6 months post primary care visit defined as (index date + 180 days)', 'description': 'Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient participants that are assigned to usual care or intervention primary care providers.'}, {'type': 'SECONDARY', 'title': 'Rate of COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Primary care providers treat their patients as usual.'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}, {'value': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.47', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 6 months defined as (index date +1 day) to (index date + 180 days)', 'description': 'Rate of COPD exacerbation within 6 months starting the day after index date.', 'unitOfMeasure': 'Events per 6 months of person-time', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Rate of Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Primary care providers treat their patients as usual.'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}, {'value': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.96', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 6 months defined as (index date +1 day) to (index date + 180 days)', 'description': 'Rate of pneumonia within 6 months starting the day after index date.', 'unitOfMeasure': 'Events per 6 months of person-time', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Primary care providers treat their patients as usual.'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)', 'description': 'Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Recommended to Stop Inhaled Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Collected at time of recommendation/order entry', 'description': 'Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient participants assigned to intervention PCPs.'}, {'type': 'SECONDARY', 'title': 'Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed during 6 months following index date', 'description': 'Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers', 'unitOfMeasure': 'Percentage of recommendations', 'reportingStatus': 'POSTED', 'populationDescription': 'Recommendations to discontinue inhaled corticosteroids. A recommendation to discontinue inhaled corticosteroids was made only once per patient.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 6 months post index date', 'description': 'Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients where ICS discontinuation recommendation was accepted.'}, {'type': 'SECONDARY', 'title': 'Number of Patients for Whom Recommendations Are Made', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Collected at time or recommendation order entry', 'description': 'Among patients assigned to intervention providers, number of patients for whom recommendations are made.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We identified 269 patients meeting entry and exclusion criteria cared for by a primary care provider assigned to the intervention group. Of these, 262 received an electronic consult with recommendations for guideline concordant COPD care.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Primary care providers treat their patients as usual.'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.'}], 'periods': [{'title': 'Providers', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '111', 'numSubjects': '88'}, {'groupId': 'FG001', 'numUnits': '109', 'numSubjects': '93'}]}, {'type': 'PCPs Assigned to 1 Primary Care Team', 'achievements': [{'groupId': 'FG000', 'numUnits': '68', 'numSubjects': '68'}, {'groupId': 'FG001', 'numUnits': '79', 'numSubjects': '79'}]}, {'type': 'PCPs Assigned to Two Primary Care Teams', 'achievements': [{'groupId': 'FG000', 'numUnits': '36', 'numSubjects': '18'}, {'groupId': 'FG001', 'numUnits': '24', 'numSubjects': '12'}]}, {'type': 'PCPs Assigned to 3 Primary Care Teams', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '2'}]}, {'type': 'PCPs Assigned to Four Primary Care Teams', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '76', 'numSubjects': '67'}, {'groupId': 'FG001', 'numUnits': '72', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '35', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '37', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Without eligible patients', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '28'}]}]}, {'title': 'Patients', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Eligible patient participants assigned to a usual care PCP=344', 'groupId': 'FG000', 'numUnits': '111', 'numSubjects': '344'}, {'comment': 'Eligible patient participants assigned to an intervention PCP=342', 'groupId': 'FG001', 'numUnits': '109', 'numSubjects': '342'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients with an eligible primary care appointment with a usual care PCP who were assigned an index date=281', 'groupId': 'FG000', 'numUnits': '76', 'numSubjects': '281'}, {'comment': 'Patients with an eligible primary care appointment with an intervention PCP who were assigned an index date=269', 'groupId': 'FG001', 'numUnits': '72', 'numSubjects': '269'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '35', 'numSubjects': '63'}, {'groupId': 'FG001', 'numUnits': '37', 'numSubjects': '73'}]}], 'dropWithdraws': [{'type': 'PFT entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'No capacity to review', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Appointment rescheduled/cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'PCP not assigned a clinic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No history of COPD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Deceased between review and index date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No ICS Rx upon review', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Hospice care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'PCP-Primary Care Teams', 'recruitmentDetails': 'Prior to study start, we stratified all primary care teams based on site, provider type, and median number of eligible patients. Primary care teams were the unit of randomization, and providers were randomized along with their primary care team in a 1:1 ratio. For new providers, the unit of randomization was at the level of the PCP (stratified by site, provider type and median number of eligible patients).Only PCPs were considered enrolled. Patients were not considered enrolled in this study.', 'preAssignmentDetails': 'Prior to study start, we identified 139 primary care teams eligible for randomization; 2 primary care teams lost their associated provider prior to study start, leaving 137 primary care teams for initial randomization. Periodically, the Corporate Data Warehouse was queried to determine active primary care providers(PCPs) and their care teams. New PCPs and new care teams were added, resulting in a total of 220 distinct PCP-primary care team combinations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '731', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care Patients', 'description': 'Standard practice (usual care). Primary care providers treat their patients as usual.'}, {'id': 'BG001', 'title': 'Intervention Patients', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.\n\nGuideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.'}, {'id': 'BG002', 'title': 'Usual Care Providers', 'description': 'Standard practice (usual care). Primary care providers treat their patients as usual.'}, {'id': 'BG003', 'title': 'Intervention Providers', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.\n\nGuideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '550', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected from providers.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '550', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '69.1', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '8.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not collected from providers.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '550', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '264', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected from providers.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '550', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected from providers.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '550', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '471', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected from providers.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '550', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected from providers.'}, {'title': 'Smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '550', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Former or Never Smoker', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG004'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected from providers.'}, {'title': 'Provider type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Physicians', 'measurements': [{'value': '57', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}, {'title': 'Advanced Practice Providers', 'measurements': [{'value': '31', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not applicable to patient participants.'}, {'title': 'Site', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '731', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Site 1', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}, {'title': 'Site 2', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '583', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean number of eligible patients', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '3.5', 'groupId': 'BG002'}, {'value': '4.1', 'spread': '3.6', 'groupId': 'BG003'}, {'value': '4.1', 'spread': '3.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Mean number of potentially eligible patients assigned to the PCP at time of randomization.', 'unitOfMeasure': 'number of patients', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not applicable to patient participants.'}], 'populationDescription': 'Baseline characteristics for age, sex, ethnicity, race not collected from primary care providers.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 1118355, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-13T20:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2016-08-12', 'resultsFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-16', 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months.', 'timeFrame': 'Assessed at 6 months post primary care visit defined as (index date + 180 days)', 'description': 'Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.'}], 'secondaryOutcomes': [{'measure': 'Rate of COPD Exacerbation', 'timeFrame': 'Within 6 months defined as (index date +1 day) to (index date + 180 days)', 'description': 'Rate of COPD exacerbation within 6 months starting the day after index date.'}, {'measure': 'Rate of Pneumonia', 'timeFrame': 'Within 6 months defined as (index date +1 day) to (index date + 180 days)', 'description': 'Rate of pneumonia within 6 months starting the day after index date.'}, {'measure': 'Mortality', 'timeFrame': 'Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)', 'description': 'Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)'}, {'measure': 'Number of Patients Recommended to Stop Inhaled Corticosteroids', 'timeFrame': 'Collected at time of recommendation/order entry', 'description': 'Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids'}, {'measure': 'Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers', 'timeFrame': 'Assessed during 6 months following index date', 'description': 'Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers'}, {'measure': 'Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date', 'timeFrame': 'Assessed at 6 months post index date', 'description': 'Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date'}, {'measure': 'Number of Patients for Whom Recommendations Are Made', 'timeFrame': 'Collected at time or recommendation order entry', 'description': 'Among patients assigned to intervention providers, number of patients for whom recommendations are made.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality Improvement', 'Quality Enhancement Research Initiatives', 'QuERI', 'Interventional', 'Multicenter', 'Inhaled corticosteroids', 'Pneumonia', 'Safety', 'De-implementation', 'Respiratory Tract Diseases', 'Lung Diseases', 'Lung Diseases, Obstructive', 'Pulmonary Diseases, Chronic Obstructive COPD'], 'conditions': ['Treatment of Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This Quality Enhancement Research Initiative (QuERI) project is designed to determine efficacy and acceptance of an intervention method to provide primary care providers with patient-tailored electronic consults and corresponding unsigned orders for de-implementation of inhaled corticosteroids (ICS) for patients with COPD when ICS are not indicated by guidelines.', 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) is among the most common medical diagnoses among Veterans. Approximately half of those who carry a diagnosis of COPD are prescribed inhaled corticosteroids (ICS), despite ICS having no role among those patients without fixed airflow obstruction (AFO) and a limited role among those who do. Guidelines explicitly state that ICS for COPD patients should be limited to those with severe AFO and those with frequent exacerbations. Even this benefit comes at a cost, as ICS use has been shown in multiple randomized controlled trials to increase rates of pneumonia. After prolonged exposure, ICS is also associated with higher bone fracture risk, incidence of cataracts and poor diabetes control. Among patients without disease or with mild-moderate AFO and low risk of exacerbation, ICS have no demonstrated efficacy, but retain the risk of harm. For this reason, evidence-based guidelines specifically recommend against their use in mild-moderate AFO.\n\nThe goal of this project is to improve the delivery and safety of care by de-implementing the ineffective use of ICS among Veterans with a diagnosis of COPD who otherwise lack a clinical indication for the medication. The primary aim is to reduce ICS use among Veterans with limited clinical indication for the medication. Investigators will test an intervention to de-implement unnecessary use of inhaled corticosteroids in Veterans with chronic obstructive pulmonary disease (COPD) by having pulmonologists assume more responsibility for supporting COPD patients. The investigators will compare a substitution approach using proactive patient-tailored electronic consult (E-consult) compared to usual care with a single-session education outreach, which represents a non-intensive unlearning approach. The investigators are targeting the intervention to Patient Aligned Care Team (PACT) providers who are randomized to either receive the intervention or not receive the intervention. For patients within intervention PACTs, the project clinicians will leverage the VA's integrated healthcare informatics system using specialist support through proactive patient-tailored electronic consults (E-consult) and inputting unsigned orders on behalf of Primary Care Providers (PCPs) to recommend and facilitate de-implementation of ICS. Primary care providers will have final say in accepting (signing), modifying, or declining the recommendations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProvider:\n\nPrimary care provider (medical doctor/osteopathic physician, nurse practitioner, physician assistant \\[MD/DO, NP, PA\\]) assigned to a PACT from VA Puget Sound Health Care System or Edith Nourse Rogers Memorial Veterans Hospital (Bedford VA).\n\nPatient:\n\n* Patient is a Veteran who is assigned a VA PCP and has received Rx for an inhaled corticosteroid within the past 180 days.\n* Patient has an inpatient or outpatient diagnosis of COPD in the prior two years.\n* Patient has undergone spirometry in the past 5 years that indicates either no airflow obstruction or mild to moderate airflow obstruction indicated by a forced expiratory volume 1 (FEV1)/\\[greater of forced vital capacity (FVC) or vital capacity (VC)\\] =\\< 0.7 \\& FEV1% predicted \\>= 30%.\n\nExclusion Criteria:\n\nPatients:\n\n* Very severe airflow obstruction (\\<30% FEV1 % predicted)\n* Severe disease as indicated by 1 inpatient COPD exacerbation in the year prior\n* Severe disease as indicated by 2 outpatient COPD exacerbations in the year prior\n* International Classification of Diseases (ICD) 9 and/or 10 diagnosed or clinically indicated asthmatics\n* Significant bronchodilator response on spirometry (\\>12% increase in FEV1 post bronchodilator; \\>375 mL post-bronchodilator improvement)'}, 'identificationModule': {'nctId': 'NCT02896257', 'acronym': 'DISCUSS COPD', 'briefTitle': 'De-implementing Inhaled Steroids to Improve Care and Safety in COPD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-471)', 'orgStudyIdInfo': {'id': 'QUX 16-009'}, 'secondaryIdInfos': [{'id': 'QUE 15-271', 'type': 'OTHER_GRANT', 'domain': 'Department of Veterans Affairs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Proactive patient-tailored electronic consult (E-consult)', 'description': 'Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.', 'interventionNames': ['Other: Guideline treatment recommendations']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Standard practice (usual care). Primary care providers treat their patients as usual.'}], 'interventions': [{'name': 'Guideline treatment recommendations', 'type': 'OTHER', 'description': 'Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.', 'armGroupLabels': ['Proactive patient-tailored electronic consult (E-consult)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01730-1114', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Bedford HealthCare System, Bedford, MA', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}, {'zip': '98108-1532', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David H. Au, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}, {'name': 'Christian D. Helfrich, PhD MPH BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}