Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-01-09 @ 7:52 PM
Study NCT ID:
NCT03798405
Status:
TERMINATED
Last Update Posted:
2022-07-22
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reactive vs. Proactive Pain Control in IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The primary investigators will be blinded, as will the computer programmers who collect the data.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score \\> 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline - all patients will receive a FitBit exercise tracker.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'COVID-19-related restrictions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-Reported Pain Scores', 'timeFrame': 'Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days.', 'description': 'Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain))'}], 'secondaryOutcomes': [{'measure': 'Healthcare Utilization', 'timeFrame': 'From hospital admission until hospital discharge, typically 7 days.', 'description': 'Hospital length of stay (in days)'}, {'measure': 'Functional Activity', 'timeFrame': 'From hospital admission until hospital discharge, typically 7 days.', 'description': 'FitBit activity (number of steps per day)'}, {'measure': 'Opioid-Consumption', 'timeFrame': 'From hospital admission until hospital discharge, typically 7 days.', 'description': 'Milligram morphine-equivalents consumed per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Inflammatory Bowel Disease', 'Opioids'], 'conditions': ['Inflammatory Bowel Diseases', 'Pain', 'Opioid Use', 'Crohn Disease', 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '38104145', 'type': 'DERIVED', 'citation': 'Berry SK, Takakura W, Patel D, Govalan R, Ghafari A, Kiefer E, Huang SC, Bresee C, Nuckols TK, Melmed GY. A randomized controlled trial of a proactive analgesic protocol demonstrates reduced opioid use among hospitalized adults with inflammatory bowel disease. Sci Rep. 2023 Dec 16;13(1):22396. doi: 10.1038/s41598-023-48126-0.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution\'s Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive" analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.\n\nAims:\n\nAim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.\n\nAim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.\n\nAim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.', 'detailedDescription': "Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with confirmed IBD diagnosis\n* Admitted for primary IBD-related sign or symptom\n\nExclusion Criteria:\n\n* Admitted for primary non-IBD complaint\n* Surgery in the last 30 days\n* Alternative (non-IBD) GI diagnosis determined\n* Age \\<18\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03798405', 'acronym': 'PAIN-Sparing', 'briefTitle': 'Reactive vs. Proactive Pain Control in IBD', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Reactive vs. Proactive Pain Control in Hospitalized Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'Pro00050742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proactive', 'description': 'Proactive Analgesic Inpatient Narcotic-Sparing:\n\nPain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol".', 'interventionNames': ['Behavioral: Proactive Analgesic Inpatient Narcotic-Sparing']}, {'type': 'NO_INTERVENTION', 'label': 'Reactive (Control Group)', 'description': 'Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group.'}], 'interventions': [{'name': 'Proactive Analgesic Inpatient Narcotic-Sparing', 'type': 'BEHAVIORAL', 'otherNames': ['P.A.I.N.-Sparing Bundle'], 'description': 'Medications suggested to the physician with enhanced ease of ordering.', 'armGroupLabels': ['Proactive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Gil Y Melmed, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}, {'name': 'Sameer K Berry, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'co-Director, Inflammatory Bowel Disease Center, Principal Investigator', 'investigatorFullName': 'Gil Melmed', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}