Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-02 @ 7:14 AM
Study NCT ID:
NCT02113592
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2014-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pain Program for Active Coping & Training
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lynn.debar@kp.org', 'phone': '206-287-2900', 'title': 'Lynn DeBar, PhD, MPH, Principal Investigator', 'organization': 'Kaiser Permanente Washington Health Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were monitored for serious adverse events during the one-year period of study participation.', 'description': 'The only adverse events monitored were serious adverse events, defined as hospitalizations and deaths, assessed systematically from electronic health record data. Assessments were conducted every 6 months throughout the study and reviewed by an independent monitor. For deaths, chart abstraction determined relatedness.', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 433, 'otherNumAffected': 0, 'seriousNumAtRisk': 433, 'deathsNumAffected': 4, 'seriousNumAffected': 94}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 417, 'otherNumAffected': 0, 'seriousNumAtRisk': 417, 'deathsNumAffected': 8, 'seriousNumAffected': 112}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'All hospitalizations were unrelated to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 433, 'numEvents': 116, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 171, 'numAffected': 112}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.485', 'groupId': 'OG000', 'lowerLimit': '6.290', 'upperLimit': '6.681'}, {'value': '6.645', 'groupId': 'OG001', 'lowerLimit': '6.447', 'upperLimit': '6.843'}]}]}, {'title': '3-Month Follow-Up', 'categories': [{'measurements': [{'value': '5.486', 'groupId': 'OG000', 'lowerLimit': '5.272', 'upperLimit': '5.699'}, {'value': '6.210', 'groupId': 'OG001', 'lowerLimit': '5.994', 'upperLimit': '6.426'}]}]}, {'title': '6-Month Follow-Up', 'categories': [{'measurements': [{'value': '5.516', 'groupId': 'OG000', 'lowerLimit': '5.316', 'upperLimit': '5.715'}, {'value': '6.197', 'groupId': 'OG001', 'lowerLimit': '5.994', 'upperLimit': '6.399'}]}]}, {'title': '9-Month Follow-up', 'categories': [{'measurements': [{'value': '5.546', 'groupId': 'OG000', 'lowerLimit': '5.342', 'upperLimit': '5.750'}, {'value': '6.183', 'groupId': 'OG001', 'lowerLimit': '5.976', 'upperLimit': '6.390'}]}]}, {'title': '12-Month Follow-Up', 'categories': [{'measurements': [{'value': '5.576', 'groupId': 'OG000', 'lowerLimit': '5.349', 'upperLimit': '5.803'}, {'value': '6.170', 'groupId': 'OG001', 'lowerLimit': '5.940', 'upperLimit': '6.400'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected every 3 months for 1 year', 'description': "Reliable and valid tool that measures patients' pain intensity and functional interference. The primary outcome of pain impact is assessed with the 4-item PEGS scale, a composite of pain intensity, and interference with enjoyment of life, general activity, and sleep (range, 0-10, higher score = worse pain impact).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain-related Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.672', 'groupId': 'OG000', 'lowerLimit': '0.652', 'upperLimit': '0.691'}, {'value': '0.692', 'groupId': 'OG001', 'lowerLimit': '0.672', 'upperLimit': '0.711'}]}]}, {'title': '3-Month Follow-Up', 'categories': [{'measurements': [{'value': '0.612', 'groupId': 'OG000', 'lowerLimit': '0.591', 'upperLimit': '0.633'}, {'value': '0.675', 'groupId': 'OG001', 'lowerLimit': '0.654', 'upperLimit': '0.696'}]}]}, {'title': '6-Month Follow-Up', 'categories': [{'measurements': [{'value': '0.609', 'groupId': 'OG000', 'lowerLimit': '0.590', 'upperLimit': '0.629'}, {'value': '0.678', 'groupId': 'OG001', 'lowerLimit': '0.658', 'upperLimit': '0.698'}]}]}, {'title': '9-Month Follow-Up', 'categories': [{'measurements': [{'value': '0.607', 'groupId': 'OG000', 'lowerLimit': '0.586', 'upperLimit': '0.627'}, {'value': '0.681', 'groupId': 'OG001', 'lowerLimit': '0.660', 'upperLimit': '0.701'}]}]}, {'title': '12-Month Follow-Up', 'categories': [{'measurements': [{'value': '0.604', 'groupId': 'OG000', 'lowerLimit': '0.581', 'upperLimit': '0.626'}, {'value': '0.683', 'groupId': 'OG001', 'lowerLimit': '0.661', 'upperLimit': '0.706'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected every 3 months for 1 year', 'description': 'Pain-related disability will be assessed using the 24-item Roland Morris Disability Questionnaire (range, 0-1, higher score = worse function)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Dose of Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47.458', 'groupId': 'OG000', 'lowerLimit': '40.647', 'upperLimit': '54.269'}, {'value': '55.252', 'groupId': 'OG001', 'lowerLimit': '48.333', 'upperLimit': '62.171'}]}]}, {'title': '3-Month Follow-Up', 'categories': [{'measurements': [{'value': '46.641', 'groupId': 'OG000', 'lowerLimit': '39.610', 'upperLimit': '53.627'}, {'value': '56.695', 'groupId': 'OG001', 'lowerLimit': '49.556', 'upperLimit': '63.834'}]}]}, {'title': '6-Month Follow-Up', 'categories': [{'measurements': [{'value': '45.606', 'groupId': 'OG000', 'lowerLimit': '38.574', 'upperLimit': '52.638'}, {'value': '55.563', 'groupId': 'OG001', 'lowerLimit': '48.421', 'upperLimit': '62.704'}]}]}, {'title': '9-Month Follow-Up', 'categories': [{'measurements': [{'value': '44.571', 'groupId': 'OG000', 'lowerLimit': '37.396', 'upperLimit': '51.745'}, {'value': '54.430', 'groupId': 'OG001', 'lowerLimit': '47.142', 'upperLimit': '61.719'}]}]}, {'title': '12-Month Follow-Up', 'categories': [{'measurements': [{'value': '43.536', 'groupId': 'OG000', 'lowerLimit': '36.085', 'upperLimit': '50.986'}, {'value': '53.298', 'groupId': 'OG001', 'lowerLimit': '45.725', 'upperLimit': '60.871'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected every 3 months for 1 year', 'description': 'Average daily dose of opioids per 3-month quarter measured in morphine milligram equivalents (MME)', 'unitOfMeasure': 'MME/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'title': 'Satisfaction with primary care services (Baseline)', 'categories': [{'measurements': [{'value': '4.263', 'groupId': 'OG000', 'lowerLimit': '4.162', 'upperLimit': '4.365'}, {'value': '4.237', 'groupId': 'OG001', 'lowerLimit': '4.134', 'upperLimit': '4.339'}]}]}, {'title': 'Satisfaction with primary care services (Post-Treatment)', 'categories': [{'measurements': [{'value': '4.240', 'groupId': 'OG000', 'lowerLimit': '4.115', 'upperLimit': '4.365'}, {'value': '3.984', 'groupId': 'OG001', 'lowerLimit': '3.856', 'upperLimit': '4.112'}]}]}, {'title': 'Satisfaction with pain services (Baseline)', 'categories': [{'measurements': [{'value': '3.658', 'groupId': 'OG000', 'lowerLimit': '3.540', 'upperLimit': '3.776'}, {'value': '3.581', 'groupId': 'OG001', 'lowerLimit': '3.461', 'upperLimit': '3.700'}]}]}, {'title': 'Satisfaction with pain services (Post-Treatment)', 'categories': [{'measurements': [{'value': '4.080', 'groupId': 'OG000', 'lowerLimit': '3.954', 'upperLimit': '4.205'}, {'value': '3.667', 'groupId': 'OG001', 'lowerLimit': '3.538', 'upperLimit': '3.796'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected at baseline and 6 months (post-treatment)', 'description': 'Patient satisfaction with health care services will be assessed using two distinct items:\n\n* \\[Satisfaction with primary care services\\]: In the past 3 months, how satisfied have you been with your primary care services? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied)\n* \\[Satisfaction with pain services\\]: In the past 3 months, how satisfied have you been with the pain services you have received? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied)\n\nEach item is scored individually; (range=1-5, higher score = greater satisfaction)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Care Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'title': 'Total Health Care Costs', 'categories': [{'measurements': [{'value': '21,372', 'groupId': 'OG000', 'lowerLimit': '18,114', 'upperLimit': '24,630'}, {'value': '25,648', 'groupId': 'OG001', 'lowerLimit': '22,350', 'upperLimit': '28,946'}]}]}, {'title': 'Total Pain-Related Health Care Costs', 'categories': [{'measurements': [{'value': '9,395', 'groupId': 'OG000', 'lowerLimit': '7,216', 'upperLimit': '11,574'}, {'value': '11,343', 'groupId': 'OG001', 'lowerLimit': '9,137', 'upperLimit': '13,549'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Costs were measured based on patient utilization of health care services and all prescription/medication costs. The costs of health care encounters during the 1-year follow-up were estimated using the standardized relative resource cost algorithm (SRRCA).\n\nPain-related health care costs were based on the pain-related health care encounters identified using diagnostic and procedure coding.', 'unitOfMeasure': 'Dollars', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Health Care Encounters by Type (Health Care Utilization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'title': 'Total Ambulatory Encounters', 'categories': [{'measurements': [{'value': '20.85', 'groupId': 'OG000', 'lowerLimit': '19.40', 'upperLimit': '22.41'}, {'value': '21.59', 'groupId': 'OG001', 'lowerLimit': '20.07', 'upperLimit': '23.22'}]}]}, {'title': 'Total Pain-Related Ambulatory Encounters', 'categories': [{'measurements': [{'value': '10.42', 'groupId': 'OG000', 'lowerLimit': '9.62', 'upperLimit': '11.28'}, {'value': '10.11', 'groupId': 'OG001', 'lowerLimit': '9.33', 'upperLimit': '10.96'}]}]}, {'title': 'Telephone or Email Encounters', 'categories': [{'measurements': [{'value': '24.04', 'groupId': 'OG000', 'lowerLimit': '22.57', 'upperLimit': '25.60'}, {'value': '23.18', 'groupId': 'OG001', 'lowerLimit': '21.75', 'upperLimit': '24.71'}]}]}, {'title': 'Inpatient Hospital Encounters', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.28'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.36'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Total Ambulatory Encounters includes encounters in the following health care service categories: Primary care; Physical therapy; Pain clinic; Other specialty medical care; Mental health; Complementary and alternative medicine; ED, urgent care, and observation beds; Hospital ambulatory visits; Same day surgeries; and Home health.\n\nTotal Pain-Related Ambulatory Encounters are a subset of Total Ambulatory Encounters and were identified using CPT, HCPCS, and ICD-9-PCS or ICD-10-PCS codes', 'unitOfMeasure': 'Health care encounters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inpatient Hospital Days (Health Care Utilization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.26'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Inpatient hospital days is the average number of days that patients stayed in hospital (total number of days spent by inpatients during the 1 year post-randomization divided by the total number of inpatient admissions)', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Pharmacy Dispenses (Health Care Utilization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.45', 'groupId': 'OG000', 'lowerLimit': '48.53', 'upperLimit': '52.44'}, {'value': '52.22', 'groupId': 'OG001', 'lowerLimit': '50.21', 'upperLimit': '54.30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Total Pharmacy Dispenses is a count of the unique medication prescriptions dispensed.', 'unitOfMeasure': 'Prescriptions dispensed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '53', 'numSubjects': '433'}, {'groupId': 'FG001', 'numUnits': '53', 'numSubjects': '417'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '53', 'numSubjects': '414'}, {'groupId': 'FG001', 'numUnits': '53', 'numSubjects': '402'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '19'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '15'}]}]}], 'typeUnitsAnalyzed': 'Primary care provider cluster'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '850', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Behavioral Therapy (CBT) Intervention', 'description': 'Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '60.3', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '573', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic ethnicity', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'White (race)', 'categories': [{'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '651', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American (race)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Other (race)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '433', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '850', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average daily dose of opioids', 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'groupId': 'BG000', 'lowerLimit': '16.0', 'upperLimit': '53.2'}, {'value': '30.8', 'groupId': 'BG001', 'lowerLimit': '16.0', 'upperLimit': '75.1'}, {'value': '29.6', 'groupId': 'BG002', 'lowerLimit': '16.0', 'upperLimit': '62.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-07', 'size': 2810684, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-26T18:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 850}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2014-04-07', 'resultsFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2014-04-10', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-27', 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")', 'timeFrame': 'Collected every 3 months for 1 year', 'description': "Reliable and valid tool that measures patients' pain intensity and functional interference. The primary outcome of pain impact is assessed with the 4-item PEGS scale, a composite of pain intensity, and interference with enjoyment of life, general activity, and sleep (range, 0-10, higher score = worse pain impact)."}], 'secondaryOutcomes': [{'measure': 'Pain-related Disability', 'timeFrame': 'Collected every 3 months for 1 year', 'description': 'Pain-related disability will be assessed using the 24-item Roland Morris Disability Questionnaire (range, 0-1, higher score = worse function)'}, {'measure': 'Average Daily Dose of Opioids', 'timeFrame': 'Collected every 3 months for 1 year', 'description': 'Average daily dose of opioids per 3-month quarter measured in morphine milligram equivalents (MME)'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Collected at baseline and 6 months (post-treatment)', 'description': 'Patient satisfaction with health care services will be assessed using two distinct items:\n\n* \\[Satisfaction with primary care services\\]: In the past 3 months, how satisfied have you been with your primary care services? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied)\n* \\[Satisfaction with pain services\\]: In the past 3 months, how satisfied have you been with the pain services you have received? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied)\n\nEach item is scored individually; (range=1-5, higher score = greater satisfaction)'}, {'measure': 'Health Care Costs', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Costs were measured based on patient utilization of health care services and all prescription/medication costs. The costs of health care encounters during the 1-year follow-up were estimated using the standardized relative resource cost algorithm (SRRCA).\n\nPain-related health care costs were based on the pain-related health care encounters identified using diagnostic and procedure coding.'}, {'measure': 'Count of Health Care Encounters by Type (Health Care Utilization)', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Total Ambulatory Encounters includes encounters in the following health care service categories: Primary care; Physical therapy; Pain clinic; Other specialty medical care; Mental health; Complementary and alternative medicine; ED, urgent care, and observation beds; Hospital ambulatory visits; Same day surgeries; and Home health.\n\nTotal Pain-Related Ambulatory Encounters are a subset of Total Ambulatory Encounters and were identified using CPT, HCPCS, and ICD-9-PCS or ICD-10-PCS codes'}, {'measure': 'Inpatient Hospital Days (Health Care Utilization)', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Inpatient hospital days is the average number of days that patients stayed in hospital (total number of days spent by inpatients during the 1 year post-randomization divided by the total number of inpatient admissions)'}, {'measure': 'Total Pharmacy Dispenses (Health Care Utilization)', 'timeFrame': 'Collected for 1 year post-randomization', 'description': 'Total Pharmacy Dispenses is a count of the unique medication prescriptions dispensed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain management', 'Opioid use', 'Pragmatic', 'Collaborative care', 'Primary care'], 'conditions': ['Chronic Non-malignant Pain']}, 'referencesModule': {'references': [{'pmid': '35352703', 'type': 'RESULT', 'citation': "Smith DH, O'Keeffe-Rosetti M, Leo MC, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, McMullen C, Owen-Smith A, Trinacty CM, Vollmer WM, DeBar L. Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain. Med Care. 2022 Jun 1;60(6):423-431. doi: 10.1097/MLR.0000000000001713. Epub 2022 Mar 30."}, {'pmid': '34724405', 'type': 'RESULT', 'citation': 'DeBar L, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial. Ann Intern Med. 2022 Jan;175(1):46-55. doi: 10.7326/M21-1436. Epub 2021 Nov 2.'}, {'pmid': '32083219', 'type': 'DERIVED', 'citation': 'Mayhew M, Leo MC, Vollmer WM, DeBar LL, Kiernan M. Interactive group-based orientation sessions: A method to improve adherence and retention in pragmatic clinical trials. Contemp Clin Trials Commun. 2020 Jan 21;17:100527. doi: 10.1016/j.conctc.2020.100527. eCollection 2020 Mar.'}, {'pmid': '29633139', 'type': 'DERIVED', 'citation': 'Owen-Smith A, Mayhew M, Leo MC, Varga A, Benes L, Bonifay A, DeBar L. Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research. J Gen Intern Med. 2018 May;33(Suppl 1):31-37. doi: 10.1007/s11606-018-4326-9.'}, {'pmid': '29522897', 'type': 'DERIVED', 'citation': 'DeBar L, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Mayhew M, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2018 Apr;67:91-99. doi: 10.1016/j.cct.2018.02.015. Epub 2018 Mar 6.'}, {'pmid': '26772801', 'type': 'DERIVED', 'citation': 'Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and sustainable within the primary care setting.', 'detailedDescription': "Pain is a common and very costly public health problem. Common chronic pain conditions are expensive and pervasive, affecting at least 116 million American adults at an annual cost of $560 billion in direct medical treatment costs and lost productivity, and disproportionally affect vulnerable populations. Pain is the primary reason patients seek medical care and, as the first point of contact, primary care providers (PCPs) deliver the majority of that care. Unfortunately, PCPs face many challenges in managing these patients' care and often have little specific training in pain medicine. Yet with proper system support, PCPs are in the best position to coordinate pain management longitudinally. While pharmacotherapy is the predominant treatment approach for many PCPs, this limits the patient's role to taking medication, and he or she can become a passive recipient of care-leading to poor outcomes, potential overmedication, and possible disillusionment with the medical system. Further, increases in opiate prescribing for pain treatment-amidst increasing awareness of adverse outcomes, including addiction-and limited efficacy suggest the importance of broader treatment approaches that focus on patients' improvement of functioning. Although opiates may reduce pain symptoms while prescribed, patients are unlikely to experience significant and sustained improvements without the use of other nonpharmacologic pain management approaches. Medical management of patients with persistent pain and complex problems is often fragmented, which leads patients to seek a wide variety of primary and specialty care services in an effort to manage their pain and related conditions. Such fragmented care leads to poorer outcomes and significantly increases health care costs as patients often receive unneeded diagnostic and medical procedures. While research has identified evidence-based multidisciplinary behavioral treatment approaches that are effective for such patients and can even prevent the disability associated with persistent pain when offered earlier in the course of care, these interventions are rarely available in everyday practice settings and will require data from pragmatic clinical trials to change the care paradigm.\n\nTo address these issues, we are conducting a large-scale, mixed-methods, cluster-randomized pragmatic clinical trial throughout three regions of Kaiser Permanente - Northwest, Georgia, and Hawaii. This trial will evaluate the integration of multidisciplinary services within the primary care environment as compared to usual care in these settings. This project embeds an intervention into everyday clinical practice flow utilizing assessment measures and intervention staff directly from the clinical care system rather than utilizing a research-developed and administered structure. The intervention is an integrated, interdisciplinary program that guides all pain-related care for intervention patients. This study compares this primary care-based intervention to usual care using systematic, clinic-based assessments. The trial will include up to 1,000 patients and 500 primary care providers (half of each receiving active treatment) with intervention care being delivered by behavioral specialists, nurses, physical therapists, pharmacists, and other affiliated staff. Patients include those selected by their primary care providers who have non-malignant chronic pain (pain persisting for ≥ 3 months) and who are on long-term opiate therapy for the treatment of their condition. This intervention brings together elements often available in health plans but organized in a less integrated fashion, and it will ensure flexibility in implementation to best fit individual clinic environments and the needs of chronic pain patients on long-term opiate therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Patient inclusion criteria are:\n\n1. Adult (18 years of age or older) Kaiser Permanente (KP) health plan members from the KP Northwest, KP Georgia, and KP Hawaii regions who receive their primary care services from participating primary care providers\n2. Kaiser Permanente health plan membership of at least 180 days duration\n3. Long term opioid use defined by: 90+ day supply of short acting opioid spanning at least 120 days or 2 or more long acting opioid dispense in the past 180 days\n4. Pain diagnosis within the past year (based on ICD-9 or ICD-10 diagnostic codes)\n5. English speaking\n\nPatient exclusion criteria are:\n\n1. Currently enrolled in intensive addiction medicine services or evidence of active substance dependence\n2. Cognitive impairment severe enough to preclude patient's participation in a behavioral/lifestyle change program\n3. Current malignant cancer diagnosis\n4. Having received hospice or other end-of-life palliative care within past year"}, 'identificationModule': {'nctId': 'NCT02113592', 'acronym': 'PPACT', 'briefTitle': 'Pain Program for Active Coping & Training', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Collaborative Care for Chronic Pain in Primary Care', 'orgStudyIdInfo': {'id': 'Pro00004169'}, 'secondaryIdInfos': [{'id': 'UH3NS088731', 'link': 'https://reporter.nih.gov/quickSearch/UH3NS088731', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interdisciplinary pain program', 'description': 'Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.', 'interventionNames': ['Behavioral: Interdisciplinary pain program']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Patients in this arm will receive care as usual and utilize services as they currently exist in the health plan system.'}], 'interventions': [{'name': 'Interdisciplinary pain program', 'type': 'BEHAVIORAL', 'description': 'Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.', 'armGroupLabels': ['Interdisciplinary pain program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30305', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Lynn DeBar, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}