Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-09 @ 4:29 PM
Study NCT ID:
NCT05880368
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2023-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partnership in Resilience for Medication Safety (PROMIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-10', 'size': 98416, 'label': 'Informed Consent Form: Patient engagement survey consent form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-09T14:04', 'hasProtocol': False}, {'date': '2023-05-10', 'size': 98672, 'label': 'Informed Consent Form: Provider consent form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-09T14:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stepped wedge with a parallel control arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication use and self-efficacy', 'timeFrame': 'Within 4 hours after primary care visit (one time assessment)', 'description': "Medication use and self-efficacy, which is a validated 8-item, 4-point Likert scale survey with a score range of 8-32 and higher indicating higher self-efficacy. The items are: (1) It is easy for me to take my medicine on time, (2) It is easy to remember to take all my medicines, (3) It is easy for me to set a schedule to take my medicines each day, (4) It is easy for me to take my medicines each day, (5) It is easy for me to ask my pharmacist questions about my medicine, (6) It is easy for me to understand my pharmacist's instructions for my medicine, (7) It is easy for me to understand instructions on medicine bottles, (8) It is easy for me to get all the information I need about my medicine."}], 'secondaryOutcomes': [{'measure': 'Medication regimen problems', 'timeFrame': 'Within 4 hours after primary care visit (one time assessment)', 'description': 'The number of medication regimen problems identified by the provider during the visit, using a medication review form, with higher number of problems indicating higher risks for medication regimen problems. Different types of regimen problems, such as unintentional duplication, will be countered and added.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication safety', 'Primary care'], 'conditions': ['Patient Engagement', 'Patient Empowerment', 'Patient Activation']}, 'referencesModule': {'references': [{'pmid': '20650594', 'type': 'BACKGROUND', 'citation': "Cameron KA, Ross EL, Clayman ML, Bergeron AR, Federman AD, Bailey SC, Davis TC, Wolf MS. Measuring patients' self-efficacy in understanding and using prescription medication. Patient Educ Couns. 2010 Sep;80(3):372-6. doi: 10.1016/j.pec.2010.06.029. Epub 2010 Jul 21."}, {'type': 'BACKGROUND', 'citation': 'Brega AG, Barnard J, Mabachi NM, et al. AHRQ Health Literacy Universal Precautions Toolkit, Second Edition. Rockville, MD: AHRQ Publication No. 15-0023-EF;2015'}, {'pmid': '38684080', 'type': 'DERIVED', 'citation': 'Xiao Y, Fulda KG, Young RA, Hendrix ZN, Daniel KM, Chen KY, Zhou Y, Roye JL, Kosmari L, Wilson J, Espinoza AM, Sutcliffe KM, Pitts SI, Arbaje AI, Chui MA, Blair S, Sloan D, Jackson M, Gurses AP. Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial. JMIR Res Protoc. 2024 Apr 29;13:e57878. doi: 10.2196/57878.'}]}, 'descriptionModule': {'briefSummary': "The trial is to assess the impact of two patient partnership tools: (1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making; and (2) a series of short educational videos that clinic staff can encourage patients to watch.", 'detailedDescription': "Preventable patient harms from medications are significant threats to patient safety in ambulatory and community settings and contributed 700,000 emergency department visits each year. More than a third of community-dwelling 65 years or older adults take 5 or more prescription medications. In ambulatory and community settings, more so than in inpatient settings, medication safety is shaped by interactions among patient/caregivers and different professionals across locations. We developed a set of patient partnership tools to encourage and empower patients to make use of their office visits through setting expectations of information sharing, learning basics of medication self-management, and working with community pharmacy resources. The trial will be conducted at private and safety-net primary care clinics to assess the impact of the partnership tools: 1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making; and (2) a series of short educational videos that clinic staff can encourage patients to watch. A step-wedge design will be used, with medication use self-efficacy as the primary outcome, as measured by a validated tool. Secondary outcomes are issues identified by medication review."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community dwelling (e.g., not in skilled nursing facilities)\n* Age 50 years or older\n* Taking 5 or more medications\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Non-English and non-Spanish speaking\n* Impaired decision making capacity\n* Non-consenting'}, 'identificationModule': {'nctId': 'NCT05880368', 'acronym': 'PROMIS', 'briefTitle': 'Partnership in Resilience for Medication Safety (PROMIS)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas at Arlington'}, 'officialTitle': 'Partnership in Resilience for Medication Safety', 'orgStudyIdInfo': {'id': '2019-0439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient partnership tool', 'description': 'Study participants as patients visiting primary care providers in the clinics using the study patient engagement tools aimed to reduce preventable adverse drug events.', 'interventionNames': ['Other: Patient partnership tools']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Study participants as patients visiting primary care providers in the clinics without the study patient engagement tools.'}], 'interventions': [{'name': 'Patient partnership tools', 'type': 'OTHER', 'description': "The intervention consists of two patient partnership tools: (1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the primary care provider, with the intention to improve communication and shared decision-making; and (2) a series of short educational videos that clinic staff can encourage patients to watch. The interventions will be included in the workflow of the clinics during the intervention periods (i.e., clinics either do not use the intervention or use them for all relevant patients depending on study period).", 'armGroupLabels': ['Patient partnership tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Care', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '96104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'John Peter Smith Health', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Yan Xiao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Arlington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared to protect patient privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas at Arlington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}