Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 11:56 AM
Study NCT ID:
NCT04275258
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-07', 'releaseDate': '2023-01-18'}, {'resetDate': '2024-05-01', 'releaseDate': '2023-11-08'}], 'estimatedResultsFirstSubmitDate': '2023-01-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "The team member that coordinates subject's follow-up survey completion after hospital discharge will be masked.\n\nTeam members involved with outcome analysis will be masked.\n\n."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will use a randomized controlled trial design. Patients taking opioids prior to trauma are at an increased risk for adverse opioid outcomes, therefore we will stratify randomization so that the intervention and control groups are half opioid exposed and half opioid naïve at the time of trauma, Patients with any prescription opioid use in the 30 days prior to trauma will be considered opioid-exposed, while those with no prescription opioid use in the prior 30 days will be considered opioid naïve.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility', 'timeFrame': '24 weeks', 'description': 'Percent of eligible patients approached, consented, assessed and contacted after discharge. Percent of primary care providers reached for at least one contact'}, {'measure': 'Sustainability', 'timeFrame': '24 weeks', 'description': 'Cost comparison of implementing collaborative opioid taper support vs. control'}, {'measure': 'Fidelity', 'timeFrame': '24 weeks', 'description': 'Degree to which the interventionist PA delivered the program as intended'}, {'measure': 'Adoption', 'timeFrame': '24 weeks', 'description': 'Uptake of the collaborative care intervention by PCPS (% of PCPs making contact)'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': '24 weeks', 'description': 'Level of satisfaction with the collaborative opioid taper program- 4 item measure range 4-20'}, {'measure': 'Intervention Appropriateness Measure (IAM)', 'timeFrame': '24 weeks', 'description': 'Perceived fit of the collaborative taper program with primary care practice4 item measure range 4-20'}, {'measure': 'PCP Feasibility of Intervention Measure (FIM) 4 item measure range 4-20', 'timeFrame': '24 weeks', 'description': 'PCP ease of engagement during collaborative care contacts'}], 'primaryOutcomes': [{'measure': 'Primary pain outcome: Pain, Enjoyment, General Activity (PEG)', 'timeFrame': '24 weeks', 'description': 'Patient reported 0-10 pain severity, enjoyment of life interference, general activity interference total score'}, {'measure': 'Primary opioid outcome: percent of patients at or below their pre-trauma opioid daily dose', 'timeFrame': '24 weeks', 'description': 'Percent of patients at or below pre-trauma opioid dose'}], 'secondaryOutcomes': [{'measure': 'PROMIS-29 health status', 'timeFrame': '24 weeks', 'description': 'Self-reported health status: physical function, anxiety, depression, fatigue, sleep, social. role satisfaction, pain interference, pain intensity Score range 29-150. HIgher scores better on positively worded items: physical function, social role satisfaction. Higher scores worse on negatively worded items: anxiety, depression, fatigue, sleep, pain interference, pain intensity'}, {'measure': 'Illicit drug use', 'timeFrame': '24 weeks', 'description': 'DAST-10 Drug screening questionnaire. Ten yes/no items scored 0 or 1. Score range 0-10'}, {'measure': 'Problem alcohol use', 'timeFrame': '24 weeks', 'description': 'AUDIT-C Alcohol Use Disorders Indentification Test'}, {'measure': 'Past-month cannabis use', 'timeFrame': '24 weeks', 'description': 'Monitoring the Future cannabis frequency questions'}, {'measure': 'satisfaction with pain care', 'timeFrame': '24 weeks', 'description': 'HUNT3 study- patient experience with PCP. 3 items scored 0-10. Range 0-30'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Pain, Postoperative', 'Opioid Use, Unspecified', 'Trauma', 'Opioid-use Disorder']}, 'referencesModule': {'references': [{'pmid': '38915106', 'type': 'DERIVED', 'citation': 'Sullivan MD, Katers L, Wang J, Arbabi S, Tauben D, Baldwin LM. A randomized trial of collaborative support for opioid taper after trauma hospitalization. Subst Abuse Treat Prev Policy. 2024 Jun 24;19(1):33. doi: 10.1186/s13011-024-00613-x.'}]}, 'descriptionModule': {'briefSummary': "The investigators will enroll 100 participants using a randomized control trial design to implement and evaluate an individualized opioid taper program supporting rural Primary Care Physicians (PCPs) caring for patients with moderate to severe trauma discharged on opioids. This study will link a trauma center Physician Assistant (PA) with rural PCPs to facilitate pain care and the individualized opioid taper. The investigators seek to improve patient's pain and opioid outcomes and support the PCPs who assume care for these complex patients after hospital discharge.\n\nOur long term goal is to provide a service that will help trauma patients as they go back into primary care and into pain- and opioid-free living.", 'detailedDescription': 'This study explores the feasibility, efficacy, and potential sustainability of a collaborative pain care/opioid taper strategy for patients discharged to a rural PCP practice on opioids after hospitalization for moderate to severe traumatic injury.\n\nThe randomized control study design will provide important pilot data on the efficacy of opioid taper in the context of engaged pain management care at the PCP level when the PCP is supported by expert consultation and has broad implications for patient and clinician education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be at least 18 years old\n2. Injury Severity Score of 9 or greater\n3. Resident of Washington state\n4. Will be discharged to a rural zip code outside of king county.\n5. Glasgow Coma Score of 15\n6. Able to read, speak, and write English or Spanish.\n7. Has an identifiable PCP or willing to accept referral to a local Federally Qualified Health Center (FQHC)\n8. Has an insurer included in the All Payer Claims Database\n9. Planned to be discharged on opioid medication\n10. Planned to be discharged back to the community\n\nExclusion Criteria:\n\n1. Less than 18 years old\n2. Injury Severity Score less than 9\n3. Patient is in judicial custody\n4. Resident of a state other than Washington\n5. Will not be discharged to a rural zip code outside of king county.\n6. Evidence of OUD diagnosis (including using heroin or other illicit opioids in the past month, a DSM-5 OUD diagnosis, or evidence of taking methadone, buprenorphine, or naltrexone).\n7. Currently in cancer treatment or enrolled in palliative or hospice care\n8. Residing in a nursing home or assisted living facility\n9. Using any implanted device for pain control\n10. Self-report of heroin or other illicit opioid use in the past month\n11. Psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).'}, 'identificationModule': {'nctId': 'NCT04275258', 'briefTitle': 'Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Collaborative Opioid Taper After Trauma: Preventing Opioid Misuse and Opioid Use Disorder', 'orgStudyIdInfo': {'id': 'STUDY00008440'}, 'secondaryIdInfos': [{'id': '1 R49CE003087-01-00', 'type': 'OTHER_GRANT', 'domain': 'CDC'}, {'id': '1R49CE003087-01', 'link': 'https://reporter.nih.gov/quickSearch/1R49CE003087-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Subjects will receive standard trauma discharge plan and no more than a 2-week supply of opioids. Subjects will complete surveys at baseline, 12-week, and 24-week post hospital discharge. In addition, subjects will receive:\n\n* A face-to-face meeting prior to discharge where the PA will discuss with the subject their individualized pain management plan and individualized opioid taper plan.\n* PA will contact subject on the phone within the first week after hospital discharge to ensure subject plans to follow up with PCP and to troubleshoot any subject concerns related to pain management.', 'interventionNames': ["Other: Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan"]}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Subjects will receive standard trauma discharge plan and no more than a 2-week supply of opioids. Subjects will complete surveys at baseline, 12-week, and 24-week post hospital discharge.'}], 'interventions': [{'name': "Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan", 'type': 'OTHER', 'description': 'PA checks in with PCP at 1,2,4,8, 12, 16, and 20 weeks post hospital discharge by secure e-mail, fax or phone to provide opioid taper and pain management guidance until patient has tapered off opioids or returned to pre-trauma doses. PCP may contact PA whenever needed.\n\nIf PCP requests assistance or reports deviation from the planned opioid taper, PA will provide individualized consultations, which may include a revised taper plan and/or adjunctive therapy recommendations.\n\nIf there is continued deviation from the planned taper, the PA will facilitate a UW TelePain multidisciplinary telemedicine consultation.\n\nThe collaborative pain care and opioid taper intervention ends at 20 weeks.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Sullivan, MD', 'role': 'CONTACT', 'email': 'sullimar@uw.edu', 'phone': '206-949-2744'}], 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Adrienne James', 'role': 'CONTACT', 'email': 'ajames1@uw.edu', 'phone': '206-744-4634'}], 'overallOfficials': [{'name': 'Mark Sullivan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'Harborview Injury Prevention and Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, School of Medicine', 'investigatorFullName': 'Mark Sullivan', 'investigatorAffiliation': 'University of Washington'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-18', 'type': 'RELEASE'}, {'date': '2023-11-07', 'type': 'RESET'}, {'date': '2023-11-08', 'type': 'RELEASE'}, {'date': '2024-05-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mark Sullivan, Professor, School of Medicine, University of Washington'}}}}