Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
Study NCT ID:
NCT04336592
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2020-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Management Intervention Preparatory to a Future Pragmatic Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2020-04-03', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-Pharmacological options participation', 'timeFrame': '1 month post-operative', 'description': 'Number of participants to complete the non-pharmacological options in post-operative Hospital and Rehabilitative Management'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Pharmacological Pain Management']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure at Mayo Clinic.', 'detailedDescription': 'This is a pilot study to test promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure. This pilot study will confirm the feasibility of patient-facing as well as clinician-facing decision support components of an electronic health record (EHR) imbedded evidence-based bundle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to receive a surgical procedure at Mayo Clinic and their clinicians involved in the care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to receive a surgical spine procedure at Mayo Clinic\n* Surgeons, Physician pain specialists and allied health caring for patients meeting patient inclusion criteria\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04336592', 'briefTitle': 'Pain Management Intervention Preparatory to a Future Pragmatic Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Testing a Pain Management Intervention Preparatory to a Future Pragmatic Trial (NOHARM)', 'orgStudyIdInfo': {'id': '20-001864'}, 'secondaryIdInfos': [{'id': 'UG3AG067593', 'link': 'https://reporter.nih.gov/quickSearch/UG3AG067593', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients scheduled to receive a surgical spine procedure at Mayo Clinic', 'interventionNames': ['Behavioral: Non-pharmacological Options in post-operative Hospital and Rehabilitative Management (NOHARM)']}, {'label': 'Clinicians', 'description': 'Surgeons, Physician pain specialists and allied health caring for participating patients', 'interventionNames': ['Behavioral: Non-pharmacological Options in post-operative Hospital and Rehabilitative Management (NOHARM)']}], 'interventions': [{'name': 'Non-pharmacological Options in post-operative Hospital and Rehabilitative Management (NOHARM)', 'type': 'BEHAVIORAL', 'description': 'Gathers patient preferences for non-pharmacological pain management strategies through medical record and inform clinicians (via prompts, orders, etc.) of these preferences and encourages conversation about these preferences throughout their routine pre- and post-surgical interactions with patients. Resources will be provided to bedside clinicians as they assist patients in identifying a personalized post-discharge pain management strategy.', 'armGroupLabels': ['Clinicians', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health System in Mankato', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '54703', 'city': 'Eau Claire', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System - Eau Claire', 'geoPoint': {'lat': 44.81135, 'lon': -91.49849}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System - Franciscan Healthcare', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Jon Tilburt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jon C. Tilburt', 'investigatorAffiliation': 'Mayo Clinic'}}}}