Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-16 @ 8:20 AM
Study NCT ID:
NCT03856593
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2019-02-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Encouraging Judicious Prescribing of Opioids in Los Angeles County
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdoctor@usc.edu', 'phone': '213.821.8142', 'title': 'Jason Doctor', 'organization': 'University of Southern California'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months following letter notification', 'description': 'We hypothesize that there will be no difference in the proportion of prescribers in the intervention versus control group who make substantial (\\>20%) reductions in opioid prescribing in the post-intervention period.', 'eventGroups': [{'id': 'EG000', 'title': 'Letter A Intervention', 'description': "The intervention arm will involve letter A sent to prescribers in Los Angeles County.\n\nLetter A: The letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 MME per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \\> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018.", 'otherNumAtRisk': 269, 'deathsNumAtRisk': 269, 'otherNumAffected': 0, 'seriousNumAtRisk': 269, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Letter B Intervention', 'description': 'The intervention arm will involve letter B sent to prescribers in Los Angeles County.\n\nLetter B: This letter includes all the details in Letter A plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 0, 'seriousNumAtRisk': 241, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Letter', 'description': "This arm will involve the Standard Letter sent to prescribers in Los Angeles County.\n\nStandard Letter: The letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 MME per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \\> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018."}, {'id': 'OG001', 'title': 'Comparator Letter', 'description': 'This intervention arm will involve Comparator Letter sent to prescribers in Los Angeles County.\n\nComparator Letter: This letter includes all the details in the Standard Letter plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.'}], 'classes': [{'title': '52 weeks pre-letter', 'categories': [{'measurements': [{'value': '157.70', 'groupId': 'OG000', 'lowerLimit': '153.45', 'upperLimit': '161.96'}, {'value': '157.81', 'groupId': 'OG001', 'lowerLimit': '153.85', 'upperLimit': '161.76'}]}]}, {'title': '4-52 weeks post-letter', 'categories': [{'measurements': [{'value': '103.16', 'groupId': 'OG000', 'lowerLimit': '100.34', 'upperLimit': '105.98'}, {'value': '89.96', 'groupId': 'OG001', 'lowerLimit': '87.70', 'upperLimit': '92.21'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly MME post-letter in the Outcome Measure Data table.', 'groupDescription': 'Please note that 10% of means in the pre-intervention period were trimmed to remove outliers.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)', 'description': 'Difference in average weekly MME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient).', 'unitOfMeasure': 'Estimated average weekly MME dispensed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Prescribers practicing in Los Angeles County with scheduled drug prescribing privileges who prescribed an opioid 52 weeks (1 year) prior to a patient death from a schedule II-IV overdose.'}, {'type': 'SECONDARY', 'title': 'Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Letter', 'description': "Prescribers randomized to this arm will be sent the standard letter.\n\nStandard letter: The standard letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 morphine milligram equivalents (MME) per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \\> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018."}, {'id': 'OG001', 'title': 'Comparator Letter', 'description': 'Prescribers randomized to this arm will be sent the comparator letter.\n\nComparator letter: The comparator letter includes all the details in the standard letter plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.'}], 'classes': [{'title': '52 weeks pre-intervention', 'categories': [{'measurements': [{'value': '47.18', 'groupId': 'OG000', 'lowerLimit': '45.90', 'upperLimit': '48.46'}, {'value': '43.09', 'groupId': 'OG001', 'lowerLimit': '41.82', 'upperLimit': '44.36'}]}]}, {'title': '4-52 weeks post-intervention', 'categories': [{'measurements': [{'value': '37.93', 'groupId': 'OG000', 'lowerLimit': '36.93', 'upperLimit': '38.94'}, {'value': '31.77', 'groupId': 'OG001', 'lowerLimit': '30.79', 'upperLimit': '32.75'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly VME post-letter in the Outcome Measure Data table.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout)', 'description': 'Difference in average weekly VME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient).', 'unitOfMeasure': 'Estimated average weekly VME dispensed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Prescribers practicing in Los Angeles County with scheduled drug prescribing privileges who prescribed a benzodiazepine 52 weeks (1 year) prior to a patient death from a schedule II-IV overdose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Letter', 'description': "The intervention arm will involve letter A sent to prescribers in Los Angeles County.\n\nStandard Letter: The letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 MME per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \\> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018."}, {'id': 'FG001', 'title': 'Comparator Letter', 'description': 'The intervention arm will involve the comparator letter B to prescribers in Los Angeles County.\n\nComparator Letter: This letter includes all the details in Standard Letter plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '257'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '241'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Prescriber had no opioid prescriptions or was missing prescription information during study period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'preAssignmentDetails': 'The Los Angeles Medical Examiner identified 316 decedents from a schedule II-IV Rx overdose from October 2018 to May 2020. 236 received a schedule II-IV Rx in the 12 months prior to their death from 541 prescribers who were randomized to either the standard letter or comparator. 510 of these clinicians prescribed at least one opioid to 219 decedents and were included in the primary analysis. The secondary analysis included 528 clinicians who prescribed a benzodiazepine to 220 decedents.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Letter', 'description': "The intervention arm will involve the Standard Letter sent to prescribers in Los Angeles County.\n\nStandard Letter: The letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 MME per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \\> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018."}, {'id': 'BG001', 'title': 'Comparator Letter', 'description': 'The intervention arm will involve the Comparator Letter sent to prescribers in Los Angeles County.\n\nComparator Letter: This letter includes all the details in the Standard Letter plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'No age data were collected'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Some participants are missing biological sex information or declined to disclose.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-01', 'size': 646063, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-29T13:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 541}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2019-02-25', 'resultsFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-27', 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed', 'timeFrame': '52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)', 'description': 'Difference in average weekly MME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient).'}], 'secondaryOutcomes': [{'measure': 'Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.', 'timeFrame': '52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout)', 'description': 'Difference in average weekly VME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioids', 'Safe prescribing'], 'conditions': ['Substance-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '38216566', 'type': 'DERIVED', 'citation': 'Doctor JN, Kelley MA, Goldstein NJ, Lucas J, Knight T, Stewart EP. A randomized trial looking at planning prompts to reduce opioid prescribing. Nat Commun. 2024 Jan 12;15(1):263. doi: 10.1038/s41467-023-44573-5.'}]}, 'descriptionModule': {'briefSummary': "In collaboration with the Los Angeles County Medical Examiner's Office and the State of California's controlled Substance Utilization Review and Evaluation System (CURES), the investigators propose to review opioid poisonings over 12 months and send letters to prescribers in California when at least one of the provider's prescription(s) was filled by a patient who died of an opioid poisoning in Los Angeles County. The letters will be non-judgmental and factual, explaining that a patient of the provider who was being treated with prescription narcotics died of an opioid poisoning. The letters will also encourage judicious prescribing including use of the CURES system before prescribing. The investigators will evaluate physician prescribing practices over 24 months (12 months pre- and 12 months post-letter) using data from the CURES database. The investigators' hypothesis is that letters will make the risk of opioids more cognitively available and that physicians will respond by prescribing opioids more carefully, resulting in fewer deaths due to misuse and more frequent use of the CURES system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "The investigators will not be enrolling subjects. This is an evaluation of a public health intervention involving sending prescriber's factual and nonjudgmental letters, signed by the County Medical Examiner, that would state that a patient the provider had treated with controlled substances died of an opioid poisoning.\n\nInclusion Criteria:\n\n* Prescribers in California for whom at least one of their prescription(s) was filled by a patient who died of an opioid poisoning in Los Angeles County\n\nExclusion Criteria:\n\n* Prescriber is licensed outside the State of California and does not hold a California license, but the prescription was filled in California\n* The prescriber does not have a CURES report on record\n* The prescriber has issued only one opioid prescription in the last 12 months since the time of the deceased death (and the prescription was to the deceased)\n* Prescriptions with unknown Drug Enforcement Agency (DEA) number"}, 'identificationModule': {'nctId': 'NCT03856593', 'briefTitle': 'Encouraging Judicious Prescribing of Opioids in Los Angeles County', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Comparative Effectiveness of Two Letters to Encourage Judicious Prescribing of Opioids: A County-wide Project in Los Angeles', 'orgStudyIdInfo': {'id': 'UP-19-00172'}, 'secondaryIdInfos': [{'id': 'P30AG024968', 'link': 'https://reporter.nih.gov/quickSearch/P30AG024968', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard letter', 'description': 'Prescribers randomized to this arm will be sent the standard letter.', 'interventionNames': ['Behavioral: Standard letter']}, {'type': 'EXPERIMENTAL', 'label': 'Comparator letter', 'description': 'Prescribers randomized to this arm will be sent the comparator letter.', 'interventionNames': ['Behavioral: Comparator letter']}], 'interventions': [{'name': 'Standard letter', 'type': 'BEHAVIORAL', 'description': "The standard letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 morphine milligram equivalents (MME) per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \\> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018.", 'armGroupLabels': ['Standard letter']}, {'name': 'Comparator letter', 'type': 'BEHAVIORAL', 'description': 'The comparator letter includes all the details in the standard letter plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.', 'armGroupLabels': ['Comparator letter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Los Angeles County Medical Examiner's Office", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jason Doctor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jason Doctor', 'investigatorAffiliation': 'University of Southern California'}}}}