Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-04-17 @ 5:27 PM
Study NCT ID:
NCT02070003
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2014-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized', 'timeFrame': 'Duration of the study - up to 2 years per participant', 'description': 'Factors that contribute to non-completion of the study, measured at baseline for each patient, will be analyzed.'}], 'secondaryOutcomes': [{'measure': 'Efficacy - time to opioid cessation', 'timeFrame': 'Duration of the trial - Up to 2 years per participant', 'description': 'Time to opioid cessation between the two groups will be analyzed using survival analysis'}]}, 'conditionsModule': {'conditions': ['Opioid Cessation']}, 'referencesModule': {'references': [{'pmid': '33294812', 'type': 'DERIVED', 'citation': 'Hah JM, Trafton JA, Narasimhan B, Krishnamurthy P, Hilmoe H, Sharifzadeh Y, Huddleston JI, Amanatullah D, Maloney WJ, Goodman S, Carroll I, Mackey SC. Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial. EClinicalMedicine. 2020 Oct 16;28:100596. doi: 10.1016/j.eclinm.2020.100596. eCollection 2020 Nov.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+\n* Undergoing a scheduled surgery\n* English speaking\n* Ability and willingness to complete questionnaires and assessments.\n\nExclusion Criteria:\n\n* Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator.\n* Known Pregnancy\n* Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts.\n* Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target'}, 'identificationModule': {'nctId': 'NCT02070003', 'acronym': 'PROMPT', 'briefTitle': 'Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'orgStudyIdInfo': {'id': '26234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing and Physician Guided Opioid Weaning', 'description': 'Patients will go through motivational interviewing with the study physician via phone once a week for 7 weeks, and once a month up to a year as applicable, until patient completes the protocol.', 'interventionNames': ['Behavioral: Motivational Interviewing and Physician Guided Opioid Weaning']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Motivational Interviewing and Physician Guided Opioid Weaning', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Motivational Interviewing and Physician Guided Opioid Weaning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Jennifer Hah, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Hah', 'investigatorAffiliation': 'Stanford University'}}}}