Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT03927820
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 914}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to either hospital readmission or ER visit', 'timeFrame': '6 months', 'description': 'Combined time (days) to either hospital readmission or emergency department visit after hospitalization (all outcomes measured at 6 months post-discharge with a 3 month interim analysis)'}], 'secondaryOutcomes': [{'measure': 'Frequency of ED visit', 'timeFrame': '6 months', 'description': 'number of ED visits 6 months post-discharge'}, {'measure': 'frequency of hospital readmissions', 'timeFrame': '6 months', 'description': 'number of hospital readmission 6 months post-discharge'}, {'measure': 'time to 1st ED visit (days)', 'timeFrame': '6 months', 'description': 'time until the first ED visit post-discharge'}, {'measure': 'time to 1st readmission (days)', 'timeFrame': '6 months', 'description': 'time until the first readmission post-discharge'}, {'measure': 'frequency of prescribed inhaler at discharge', 'timeFrame': '6 months', 'description': 'number of times the recommended inhaler was prescribed at discharge'}, {'measure': 'frequency of short course prescription of oral steroid', 'timeFrame': '6 months', 'description': 'number of oral steroid prescriptions in the 6 months post-discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inhaler', 'pharmacy'], 'conditions': ['COPD', 'Asthma']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient admitted to Vanderbilt University Medical Center (VUMC) (excluding surgery services)\n* on a long acting inhaler or prescribed a long acting inhaler during admission.\n\nExclusion Criteria:\n\n* Diagnosis of cystic fibrosis\n* Diagnosis of graft versus host disease (GVHD)\n* no medication insurance\n* discharge to any post-acute care facility or inpatient hospice\n* death during hospitalization'}, 'identificationModule': {'nctId': 'NCT03927820', 'acronym': 'PILLAR', 'briefTitle': 'A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)', 'orgStudyIdInfo': {'id': 'PILLAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacist Intervention', 'description': "Patients randomized to the intervention arm received usual care plus inhaler review by study pharmacist who made recommendations for inhaler changes based on clinical guideline and insurance formulary compliance. Recommendations were sent to the patient's team for final approval prior to discharge.", 'interventionNames': ['Other: Benefits investigation']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients randomized to the usual care arm received care by the primary team which includes an inpatient pharmacist who does not have access to benefits investigation technology. The study pharmacist was not involved to review inhalers for optimization prior to discharge.'}], 'interventions': [{'name': 'Benefits investigation', 'type': 'OTHER', 'description': "The study pharmacist will review the prescribed inhaler for 1) insurance coverage and 2) clinical appropriateness. The pharmacist will conduct a benefits investigation at time of hospital admission. The benefits investigation involves running test claims for inhalers to determine the most cost-effective inhaler for the patient's insurance plan. The study pharmacist will utilize clinical practice guidelines to assess appropriateness of the prescribed inhaler. Based on this review, the study pharmacist will submit a pharmacy consult to the inpatient pharmacist on the patient's healthcare team who will pend the inhaler orders (changing the patient's prescribed inhaler, if necessary) for the prescriber to send to the Meds to Beds discharge pharmacy. The Meds to Beds pharmacist will counsel the patient on inhaler use techniques prior to discharge.", 'armGroupLabels': ['Pharmacist Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Univeristy Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Kristina Niehoff, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist', 'investigatorFullName': 'Tate Davis', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}