Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT05252767
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Engagement in Perioperative Pain Management Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D010358', 'term': 'Patient Participation'}], '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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient engagement as assessed by a patient engagement survey', 'timeFrame': "Time of each participant's standard of care clinic visit, up to 1 year from enrollment", 'description': 'Patient engagement survey measures level of patient engagement on five-point Likert scale'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption as assessed by daily morphine milligram equivalents', 'timeFrame': "Time of each participant's standard of care clinic visit, up to 1 year from enrollment", 'description': 'Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine'}, {'measure': 'Pain level as assessed by the Brief Pain Inventory', 'timeFrame': "Time of each participant's standard of care clinic visit, up to 1 year from enrollment", 'description': 'Brief Pain Inventory assesses pain severity and impact of pain on functional status on 10-point scale (1=no pain, no interference and 10 = worst pain, complete interference)'}, {'measure': 'Pain level as assessed by the Present Pain Intensity scale of the McGill Pain Questionnaire', 'timeFrame': "Time of each participant's standard of care clinic visit, up to 1 year from enrollment", 'description': 'Present Pain Intensity scale of the McGill Pain Questionnaire measures pain intensity on 4-point scale (0 = none, 3 = severe)'}, {'measure': 'Pain level as assessed by the Pain Catastrophizing Scale', 'timeFrame': "Time of each participant's standard of care clinic visit, up to 1 year from enrollment", 'description': 'Pain Catastrophizing Scale measures level of pain catastrophizing (0 = not at all, 4 = all the time)'}, {'measure': 'Functional status as assessed by the Insomnia Severity Index', 'timeFrame': "Time of each participant's standard of care clinic visit, up to 1 year from enrollment", 'description': 'Insomnia Severity Index measures severity of insomnia on five-point scale (0=none, 4=severe, were score of 0-7 indicates no clinically significant insomnia and score of 22-28 indicates clinical or severe insomnia)'}, {'measure': 'Functional status as assessed by the 36-Item Short Form Health Survey', 'timeFrame': "Time of each participant's standard of care clinic visit, up to 1 year from enrollment", 'description': '36-Item Short Form Health Survey measures overall health status (converted into 0-100 scale, were lower score indicates more disability)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient engagement', 'Patient activation'], 'conditions': ['Pain, Postoperative', 'Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'Previously, the study team evaluated the implementation and effectiveness of the Johns Hopkins Perioperative Pain Program (PPP), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. Based on the findings of that project, the study team developed an educational intervention intended to improve patient engagement in perioperative pain management. In this project, the study team will formally implement a randomized controlled trial to evaluate the effectiveness of the intervention developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients in Johns Hopkins Personalized Pain Program Clinic\n\nExclusion Criteria:\n\n* Active suicidal ideation at study entry\n* Primary psychotic disorder\n* Non-English speaker'}, 'identificationModule': {'nctId': 'NCT05252767', 'briefTitle': 'Patient Engagement in Perioperative Pain Management Project', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Evaluation of an Intervention for Improving Patient Engagement in Perioperative Pain Management', 'orgStudyIdInfo': {'id': 'IRB00307176'}, 'secondaryIdInfos': [{'id': 'R01CE003150', 'link': 'https://reporter.nih.gov/quickSearch/R01CE003150', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A - Patient Engagement Tools', 'description': "Participants will be enrolled from the a pain management clinic. Participants randomized into the experimental cohort will receive access to a clinic brochure, clinic website, as well as 'My Pain Passport' and 'My Treatment Plan' tools.", 'interventionNames': ['Behavioral: Patient Engagement Tools']}, {'type': 'SHAM_COMPARATOR', 'label': 'Cohort B - Educational Guide', 'description': 'Participants randomized into the control cohort will receive a brief educational guide on general pain management.', 'interventionNames': ['Behavioral: Educational Guide']}], 'interventions': [{'name': 'Patient Engagement Tools', 'type': 'BEHAVIORAL', 'description': 'Experimental participants will receive the patient engagement tools or the educational guide after randomization. The participants in the experimental cohort will utilize the tools between visits with their clinic providers. During visits, clinic providers will review the completed tools with participants.', 'armGroupLabels': ['Cohort A - Patient Engagement Tools']}, {'name': 'Educational Guide', 'type': 'BEHAVIORAL', 'description': 'Control participants will receive a brief educational guide about pain management.', 'armGroupLabels': ['Cohort B - Educational Guide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Anping Xie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}