Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 3:42 AM
Study NCT ID:
NCT05278650
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation
Sponsor:
Organization:
Raw JSON
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Medication Therapy Management (MTM);\n2. Medication co-payment assistance;\n3. Tailored community referrals; and\n4. Medicare insurance counseling', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Communities Adopting Senior PharmAssist Implementation Toolkit', 'description': 'Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit.\n\nThe toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place.\n\nSenior PharmAssist\\^TM Program Implementation: Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community.\n\nCommunity champions will be trained to deliver a community-based program to deliver the core components of SPA:\n\n1. 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Medicare insurance counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '42.86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '13 months post-completion of learning collaborative', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Older Adults Receiving Medicare Counseling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Communities Adopting Senior PharmAssist Implementation Toolkit', 'description': 'Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit.\n\nThe toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place.\n\nSenior PharmAssist\\^TM Program Implementation: Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community.\n\nCommunity champions will be trained to deliver a community-based program to deliver the core components of SPA:\n\n1. Medication Therapy Management (MTM);\n2. Medication co-payment assistance;\n3. Tailored community referrals; and\n4. 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Medication Therapy Management (MTM);\n2. Medication co-payment assistance;\n3. Tailored community referrals; and\n4. Medicare insurance counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Communities Adopting Senior PharmAssist Implementation Toolkit', 'description': 'Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit.\n\nThe toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place.\n\nSenior PharmAssist\\^TM Program Implementation: Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community.\n\nCommunity champions will be trained to deliver a community-based program to deliver the core components of SPA:\n\n1. Medication Therapy Management (MTM);\n2. Medication co-payment assistance;\n3. Tailored community referrals; and\n4. Medicare insurance counseling'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'spread': '10.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-11', 'size': 191984, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-05T10:11', 'hasProtocol': True}, {'date': '2022-10-25', 'size': 138314, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-22T09:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2022-03-04', 'resultsFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-05', 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Self-rated Health', 'timeFrame': 'Baseline, 13 months post-completion of learning collaborative', 'description': 'Change from baseline in proportion of participants who rate their health as good to excellent.\n\nScale of rating ranges from 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent.'}], 'primaryOutcomes': [{'measure': 'Number of Older Adults Seeking Service Who Received All 4 Components of Senior PharmAssist Intervention', 'timeFrame': '13 months post-completion of learning collaborative'}], 'secondaryOutcomes': [{'measure': 'Percentage of Older Adults Receiving Medication Therapy Management', 'timeFrame': '13 months post-completion of learning collaborative'}, {'measure': 'Percentage of Older Adults Receiving Medication Co-pay Assistance', 'timeFrame': '13 months post-completion of learning collaborative'}, {'measure': 'Percentage of Older Adults Receiving at Least One Tailored Community Referral', 'timeFrame': '13 months post-completion of learning collaborative'}, {'measure': 'Percentage of Older Adults Receiving Medicare Counseling', 'timeFrame': '13 months post-completion of learning collaborative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medication Therapy Management', 'Implementation Science']}, 'descriptionModule': {'briefSummary': 'This project aims to evaluate the scalability of an established, evidence-based, multi-component intervention, Senior PharmAssist\\^TM (SPA), designed to improve function and quality of life of older adults with limited incomes. The investigators propose to refine existing SPA replication materials such as community readiness assessments, educational tools to facilitate implementation of care processes, and data collection tools for quality improvement with input from community stakeholders interested in implementation of the SPA intervention. After gathering feedback from key stakeholders in 3 diverse communities in North Carolina, and refining tools accordingly, SPA staff will then provide technical assistance to support implementation in these communities, using the Institute for Healthcare Improvement learning collaborative approach, to facilitate community agency staff implementation of the SPA core components with racially diverse older adults with limited incomes using small scale tests of change with feedback.\n\nThe investigators will collect data from key stakeholders including older adults, community volunteers, and agency staff regarding facilitators and barriers to implementation of SPA, and obtain aggregate data regarding older adult participants served, including demographics, participant satisfaction, and self-rated health. Data will be analyzed using a multiple case study design that incorporates both qualitative data on barriers and facilitators, as well as aggregated data on older adults enrolled in community programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60 or older\n* Currently or soon to be enrolled in Medicare\n* Income is at or below 200% of Poverty Line\n* Lives in one of 3 targeted communities learning to implement the Senior PharmAssist\\^TM core services\n* Seeks assistance with medications, Medicare counseling, or tailored referrals from agencies participating in Senior PharmAssist\\^TM learning collaborative\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT05278650', 'briefTitle': 'Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation', 'orgStudyIdInfo': {'id': 'Pro00110307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Communities Adopting Senior PharmAssist Implementation Toolkit', 'description': 'Three communities will commit to learning how to implement the evidence-based, multi-component intervention, Senior PharmAssistTM (SPA), designed to improve function and quality of life of older adults with limited incomes using the SPA toolkit.\n\nThe toolkit, co-developed with community leaders, will help to create a community model for implementation that addresses equitable access to medications, medication management, and community supports that promote physical function and healthy aging in place.', 'interventionNames': ['Other: Senior PharmAssist^TM Program Implementation']}], 'interventions': [{'name': 'Senior PharmAssist^TM Program Implementation', 'type': 'OTHER', 'description': 'Representatives from three diverse communities will participate in co-design workshops to refine the Senior PharmAssistTM (SPA) implementation toolkit, which will then be delivered to agency staff from these partnering communities through a series of learning collaborative sessions to facilitate implementation of SPA core components in each community.\n\nCommunity champions will be trained to deliver a community-based program to deliver the core components of SPA:\n\n1. Medication Therapy Management (MTM);\n2. Medication co-payment assistance;\n3. Tailored community referrals; and\n4. Medicare insurance counseling', 'armGroupLabels': ['Communities Adopting Senior PharmAssist Implementation Toolkit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Eleanor McConnell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}