Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-09 @ 9:05 PM
Study NCT ID:
NCT02647658
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2016-01-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cgp22@pitt.edu', 'phone': '412-383-4812', 'title': 'Dr. Charity Patterson', 'phoneExt': '4123834812', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were not collected.', 'description': 'The TARGET trial was a pragmatic trial in four health care systems. As such, we did not collect data on adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1207, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1093, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months from baseline', 'description': 'Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among participants with assessment data at 6 months'}, {'type': 'PRIMARY', 'title': 'Functional Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '25.4', 'upperLimit': '29.3'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '27.5', 'upperLimit': '31.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire.\n\nA measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with assessment data at 6 months.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Referred to Physical Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All screened excluding those not consented for EMR follow up at 12 months at 1 site.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Prescribed Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Medication prescription for opioids measured using electronic health records over 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All screened excluding patients that did not consent to EMR data at 12 months at 1 site.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Orders for Diagnostic Imaging Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Referred to Other Rehabilitation or Pain Management Specialist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Referred to Surgery Specialist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Undergoing Interventional Pain Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Had Back Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Documentation that patient underwent back surgery in electronic health records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Prescribed Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'OG000'}, {'value': '1093', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days after initial visit for acute low back pain', 'description': 'Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Referred to Physical Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'OG000'}, {'value': '1093', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'OG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'classes': [{'categories': [{'measurements': [{'value': '658', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days after initial visit for acute low back pain', 'description': 'Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records at the index baseline visit. This is a measure of intervention fidelity post-randomization of the clinics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'FG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '39', 'numSubjects': '1207'}, {'groupId': 'FG001', 'numUnits': '37', 'numSubjects': '1093'}]}, {'type': '6 Month Assessment', 'achievements': [{'groupId': 'FG000', 'numUnits': '38', 'numSubjects': '658'}, {'groupId': 'FG001', 'numUnits': '35', 'numSubjects': '635'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '39', 'numSubjects': '1192'}, {'groupId': 'FG001', 'numUnits': '37', 'numSubjects': '1069'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '15'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Consent refusal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'typeUnitsAnalyzed': 'Primary Care Clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1093', 'groupId': 'BG001'}, {'value': '2300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)\n\nGuideline Based Care plus Psychologically Informed Physical Therapy: PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement'}, {'id': 'BG001', 'title': 'Guideline Based Care', 'description': 'Guideline Based Care (GBC)\n\nGuideline Based Care (GBC): Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1093', 'groupId': 'BG001'}, {'value': '2300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.3', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '50.6', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '49.9', 'spread': '16.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1093', 'groupId': 'BG001'}, {'value': '2300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '721', 'groupId': 'BG000'}, {'value': '635', 'groupId': 'BG001'}, {'value': '1356', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '486', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '944', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1093', 'groupId': 'BG001'}, {'value': '2300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1087', 'groupId': 'BG000'}, {'value': '995', 'groupId': 'BG001'}, {'value': '2082', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1093', 'groupId': 'BG001'}, {'value': '2300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '949', 'groupId': 'BG000'}, {'value': '769', 'groupId': 'BG001'}, {'value': '1718', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Missing/Unknown', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race from electronic medical record', 'unitOfMeasure': 'Participants'}, {'title': 'Oswestry Disability Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1161', 'groupId': 'BG000'}, {'value': '1063', 'groupId': 'BG001'}, {'value': '2224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '17.4', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '17.5', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '17.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Oswestry Low Back Pain Disability Questionnaire. A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All of those patients who completed the survey.'}, {'title': 'STarT Back Total', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1093', 'groupId': 'BG001'}, {'value': '2300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'STarT Back Screening Tool for Risk Stratification, ranges from 0 to 9 with higher scores indicating higher risk for persistent disabling symptoms. It is designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'STarT Back Subscore', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1093', 'groupId': 'BG001'}, {'value': '2300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Questions 5 to 9 of the STarT Back Screening Tool for Risk Stratification. The distress subscale score is used to identify the high-risk subgroup. The items are fear, anxiety, catastrophising, depression and bothersomeness. Subscale scores range from 0 to 5 with patients scoring 4 or 5 being classified into the high-risk subgroup', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-01', 'size': 720826, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-04T12:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment of clusters (clinics). Cluster randomized trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2016-01-04', 'resultsFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-04', 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Patients Prescribed Opioids', 'timeFrame': 'Up to 21 days after initial visit for acute low back pain', 'description': 'Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.'}, {'measure': 'Number of Patients Referred to Physical Therapy', 'timeFrame': 'Up to 21 days after initial visit for acute low back pain', 'description': 'Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records at the index baseline visit. This is a measure of intervention fidelity post-randomization of the clinics.'}], 'primaryOutcomes': [{'measure': 'Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)', 'timeFrame': '6 months from baseline', 'description': 'Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.'}, {'measure': 'Functional Disability', 'timeFrame': '6 months', 'description': "Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire.\n\nA measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability."}], 'secondaryOutcomes': [{'measure': 'Number of Patients Referred to Physical Therapy', 'timeFrame': '12 months', 'description': 'Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.'}, {'measure': 'Number of Patients Prescribed Opioids', 'timeFrame': '12 months', 'description': 'Medication prescription for opioids measured using electronic health records over 12 months.'}, {'measure': 'Number of Patients With Orders for Diagnostic Imaging Tests', 'timeFrame': '12 months', 'description': 'Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records'}, {'measure': 'Number of Patients Referred to Other Rehabilitation or Pain Management Specialist', 'timeFrame': '12 months', 'description': 'Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records'}, {'measure': 'Number of Patients Referred to Surgery Specialist', 'timeFrame': '12 months', 'description': 'Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records'}, {'measure': 'Number of Patients Undergoing Interventional Pain Procedures', 'timeFrame': '12 months', 'description': 'Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records'}, {'measure': 'Number of Patients Who Had Back Surgery', 'timeFrame': '12 months', 'description': 'Documentation that patient underwent back surgery in electronic health records'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute low back pain', 'primary care', 'psychologically informed physical therapy', 'cluster randomized pragmatic trial', 'comparative effectiveness', 'secondary prevention'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '36534910', 'type': 'DERIVED', 'citation': 'Roseen EJ, Smith CN, Essien UR, Cozier YC, Joyce C, Morone NE, Phillips RS, Gergen Barnett K, Patterson CG, Wegener ST, Brennan GP, Delitto A, Saper RB, Beneciuk JM, Stevans JM. Racial and Ethnic Disparities in the Incidence of High-Impact Chronic Pain Among Primary Care Patients with Acute Low Back Pain: A Cohort Study. Pain Med. 2023 Jun 1;24(6):633-643. doi: 10.1093/pm/pnac193.'}, {'pmid': '35543647', 'type': 'DERIVED', 'citation': 'Beneciuk JM, George SZ, Patterson CG, Smith CN, Brennan GP, Wegener ST, Roseen EJ, Saper RB, Delitto A. Treatment effect modifiers for individuals with acute low back pain: secondary analysis of the TARGET trial. Pain. 2023 Jan 1;164(1):171-179. doi: 10.1097/j.pain.0000000000002679. Epub 2022 May 9.'}, {'pmid': '33870150', 'type': 'DERIVED', 'citation': 'Delitto A, Patterson CG, Stevans JM, Freburger JK, Khoja SS, Schneider MJ, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Beneciuk JM, George SZ, Saper RB. Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial. EClinicalMedicine. 2021 Mar 30;34:100795. doi: 10.1016/j.eclinm.2021.100795. eCollection 2021 Apr.'}, {'pmid': '33238964', 'type': 'DERIVED', 'citation': 'Middleton A, Fitzgerald GK, Delitto A, Saper RB, Gergen Barnett K, Stevans J. Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial. BMC Musculoskelet Disord. 2020 Nov 25;21(1):776. doi: 10.1186/s12891-020-03800-6.'}, {'pmid': '31136834', 'type': 'DERIVED', 'citation': 'Delitto A, Patterson CG, Stevans JM, Brennan GP, Wegener ST, Morrisette DC, Beneciuk JM, Freel JA, Minick KI, Hunter SJ, Ephraim PL, Friedman M, Simpson KN, George SZ, Daley KN, Albert MC, Tamasy M, Cash J, Lake DS, Freburger JK, Greco CM, Hough LJ, Jeong JH, Khoja SS, Schneider MJ, Sowa GA, Spigle WA, Wasan AD, Adams WG, Lemaster CM, Mishuris RG, Plumb DL, Williams CT, Saper RB. Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial). Contemp Clin Trials. 2019 Jul;82:66-76. doi: 10.1016/j.cct.2019.05.010. Epub 2019 May 25.'}, {'pmid': '31060589', 'type': 'DERIVED', 'citation': 'Beneciuk JM, George SZ, Greco CM, Schneider MJ, Wegener ST, Saper RB, Delitto A. Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial. Trials. 2019 May 6;20(1):256. doi: 10.1186/s13063-019-3350-3.'}]}, 'descriptionModule': {'briefSummary': 'Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. The first approach is to provide PCPs with information regarding a patient\'s risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines. The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP. The 1,860 patients expected to be enrolled at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study\'s primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.', 'detailedDescription': 'Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. Most patients see chiropractors or primary care physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a cluster randomized trial. Both treatments can be delivered in an outpatient PCP setting. The first approach is to provide PCPs with information regarding a patient\'s risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines (Guideline Based Care, GBC). The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP (GBC+PIPT). PIPT is designed to help patients identify and overcome physical and psychological barriers to recovery. The 1,860 patients expected to be enrolled as part of quality improvement at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study\'s primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period. This study was designed with input from a variety of national and local stakeholders, including patients with LBP, providers, payers, professional organizations, purchasers, and policy representatives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Receiving care for acute low back pain during a primary care clinic visit\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Medical contraindications to physical therapy based on the judgment of the primary care provider as documented in the medical record (i.e., "red flag" signs and symptoms of a potentially serious condition such as cauda equina syndrome, major or rapidly progressing neurological deficit, cancer, spinal infection or fracture)'}, 'identificationModule': {'nctId': 'NCT02647658', 'acronym': 'TARGET', 'briefTitle': 'Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PCS-1402-10867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GBC+PIPT', 'description': 'Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)', 'interventionNames': ['Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GBC', 'description': 'Guideline Based Care (GBC)', 'interventionNames': ['Behavioral: Guideline Based Care (GBC)']}], 'interventions': [{'name': 'Guideline Based Care plus Psychologically Informed Physical Therapy', 'type': 'BEHAVIORAL', 'description': 'PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement', 'armGroupLabels': ['GBC+PIPT']}, {'name': 'Guideline Based Care (GBC)', 'type': 'BEHAVIORAL', 'description': 'Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives', 'armGroupLabels': ['GBC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '84111', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Healthcare', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Anthony Delitto, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Robert Saper, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Medical Center', 'class': 'OTHER'}, {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Dean, SHRS', 'investigatorFullName': 'Anthony Delitto', 'investigatorAffiliation': 'University of Pittsburgh'}}}}