Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-26 @ 2:40 AM
Study NCT ID:
NCT03372967
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2017-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019859', 'term': 'Proto-Oncogene Proteins c-met'}, {'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D020794', 'term': 'Receptor Protein-Tyrosine Kinases'}, {'id': 'D011505', 'term': 'Protein-Tyrosine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D017978', 'term': 'Receptors, Growth Factor'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}, {'id': 'D011518', 'term': 'Proto-Oncogene Proteins'}, {'id': 'D015513', 'term': 'Oncogene Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6234}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vaccination rates for routinely recommended adult vaccinations', 'timeFrame': '6 months', 'description': 'Change from baseline rates'}], 'secondaryOutcomes': [{'measure': 'Number of vaccines administered', 'timeFrame': '6 months', 'description': 'Change from baseline rates'}, {'measure': 'Types of vaccines administered', 'timeFrame': '6 months', 'description': 'Change from baseline rates'}, {'measure': 'Number of unmet vaccination needs that were identified and met', 'timeFrame': '6 months', 'description': 'Measured through study completion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preventable disease', 'vaccine', 'public health', 'vaccine history', 'point-of-care'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to evaluate how implementing an innovative care model that provides the pharmacist access to a patient's vaccine history at the point-of-care impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations.", 'detailedDescription': "This multi-site study will use a pre-post design with a population-based comparison group to investigate the impact of implementing an innovative care model on the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations. The innovative care model enables the pharmacist to utilize a bi-directional IIS to assess patients' vaccination histories, identify unmet vaccination needs, and document the care provided. The project duration has been established to allow sufficient time for each pharmacy to implement the innovative care model and monitor each pharmacy for a 6-month study period. The American Pharmacists Association (APhA) Foundation has an a priori intent to publish the project results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults eligible to receive vaccinations for preventable diseases', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals eligible to be enrolled in the study include any person at least 18 years of age who is eligible for a comprehensive vaccination history review as determined by the pharmacist.\n\nExclusion Criteria:\n\n* n/a'}, 'identificationModule': {'nctId': 'NCT03372967', 'briefTitle': "Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration", 'organization': {'class': 'OTHER', 'fullName': 'American Pharmacists Association Foundation'}, 'officialTitle': "Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration", 'orgStudyIdInfo': {'id': '018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Comprehensive Vaccination History Review', 'description': 'Patients who receive a comprehensive vaccination history review at a participating pharmacy site will be eligible to: a) receive a vaccination forecast review, b) be evaluated for unmet vaccination needs, c) receive patient education, and d) have vaccination needs met.', 'interventionNames': ['Biological: Vaccine administration by a pharmacist', 'Behavioral: Unmet vaccination needs identified and met', 'Behavioral: Vaccination forecast review and patient education']}], 'interventions': [{'name': 'Vaccine administration by a pharmacist', 'type': 'BIOLOGICAL', 'description': 'Administration, number and types, of vaccines by a pharmacist', 'armGroupLabels': ['Comprehensive Vaccination History Review']}, {'name': 'Unmet vaccination needs identified and met', 'type': 'BEHAVIORAL', 'description': 'Identification of unmet vaccination needs and having those needs met', 'armGroupLabels': ['Comprehensive Vaccination History Review']}, {'name': 'Vaccination forecast review and patient education', 'type': 'BEHAVIORAL', 'description': 'Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs', 'armGroupLabels': ['Comprehensive Vaccination History Review']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50022', 'city': 'Atlantic', 'state': 'Iowa', 'country': 'United States', 'facility': 'Walmart Pharmacy', 'geoPoint': {'lat': 41.4036, 'lon': -95.01388}}, {'zip': '50047', 'city': 'Carlisle', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medicap Pharmacy', 'geoPoint': {'lat': 41.50082, 'lon': -93.49105}}, {'zip': '52241', 'city': 'Coralville', 'state': 'Iowa', 'country': 'United States', 'facility': 'NuCara Pharmacy', 'geoPoint': {'lat': 41.6764, 'lon': -91.58045}}, {'zip': '50533', 'city': 'Eagle Grove', 'state': 'Iowa', 'country': 'United States', 'facility': 'Eagle Pharmacy', 'geoPoint': {'lat': 42.66414, 'lon': -93.90439}}, {'zip': '50627', 'city': 'Eldora', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medicap Pharmacy', 'geoPoint': {'lat': 42.36082, 'lon': -93.09965}}, {'zip': '50125', 'city': 'Indianola', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medicap Pharmacy', 'geoPoint': {'lat': 41.35805, 'lon': -93.55744}}, {'zip': '52240', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Towncrest Pharmacy', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '52245', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Hy-Vee Pharmacy', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '50138', 'city': 'Knoxville', 'state': 'Iowa', 'country': 'United States', 'facility': 'Walmart Pharmacy', 'geoPoint': {'lat': 41.32083, 'lon': -93.10937}}, {'zip': '52060', 'city': 'Maquoketa', 'state': 'Iowa', 'country': 'United States', 'facility': 'Osterhaus Pharmacy', 'geoPoint': {'lat': 42.06891, 'lon': -90.66569}}, {'zip': '52302', 'city': 'Marion', 'state': 'Iowa', 'country': 'United States', 'facility': 'Hy-Vee Pharmacy', 'geoPoint': {'lat': 42.03417, 'lon': -91.59768}}, {'zip': '50219', 'city': 'Pella', 'state': 'Iowa', 'country': 'United States', 'facility': 'Walmart Pharmacy', 'geoPoint': {'lat': 41.40805, 'lon': -92.91631}}, {'zip': '50327', 'city': 'Pleasant Hill', 'state': 'Iowa', 'country': 'United States', 'facility': 'NuCara Pharmacy', 'geoPoint': {'lat': 41.58388, 'lon': -93.51994}}, {'zip': '50675', 'city': 'Traer', 'state': 'Iowa', 'country': 'United States', 'facility': 'NuCara Pharmacy', 'geoPoint': {'lat': 42.1936, 'lon': -92.46547}}, {'zip': '50702', 'city': 'Waterloo', 'state': 'Iowa', 'country': 'United States', 'facility': 'Greenwood Pharmacy', 'geoPoint': {'lat': 42.49276, 'lon': -92.34296}}, {'zip': '50677', 'city': 'Waverly', 'state': 'Iowa', 'country': 'United States', 'facility': 'Meyer Pharmacy', 'geoPoint': {'lat': 42.72581, 'lon': -92.47546}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Hy-Vee Pharmacy', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '52175', 'city': 'West Union', 'state': 'Iowa', 'country': 'United States', 'facility': 'NuCara Pharmacy', 'geoPoint': {'lat': 42.96276, 'lon': -91.80822}}, {'zip': '50273', 'city': 'Winterset', 'state': 'Iowa', 'country': 'United States', 'facility': 'Montross Pharmacy', 'geoPoint': {'lat': 41.33082, 'lon': -94.01384}}, {'zip': '98005', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Safeway Pharmacy', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98029', 'city': 'Issaquah', 'state': 'Washington', 'country': 'United States', 'facility': 'Safeway Pharmacy', 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}, {'zip': '98053', 'city': 'Redmond', 'state': 'Washington', 'country': 'United States', 'facility': 'Albertsons Sav-On Pharmacy', 'geoPoint': {'lat': 47.67399, 'lon': -122.12151}}], 'overallOfficials': [{'name': 'Benjamin M Bluml, BPharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Pharmacists Association Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Pharmacists Association Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}