Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-01 @ 4:55 PM
Study NCT ID:
NCT05113667
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2021-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appropriateness of Proton Pump Inhibitors Usage', 'timeFrame': 'during hospital stay, an average of 14 days', 'description': 'The rate of appropriateness use of proton pump inhibitors based on the guidelines at hospital stay'}, {'measure': 'Potentially Inappropriate Proton Pump Inhibitors Usage', 'timeFrame': 'at discharge, an average of 14 days after admission to hospital', 'description': 'The rate of potentially inappropriate use of proton pump inhibitors based on American Geriatric Society Beers Criteria© 2019'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome', 'timeFrame': '1 year', 'description': 'The number of patients who hospitalized for bleeding within 1 year after discharge'}, {'measure': 'Cost saving during hospital stay', 'timeFrame': 'during hospital stay, an average of 14 days', 'description': 'Medication cost for inappropriate PPI during hospital study'}, {'measure': 'Medication Appropriateness Index for Proton Pump Inhibitors at hospital stay', 'timeFrame': 'during hospital stay, an average of 14 days', 'description': 'Medication Appropriateness Index (MAI); included 10 items. Each item was weighted from 1-3. The highest score per medication was 18.\n\nHigher scores of this index represent more inappropriateness of each medication.'}, {'measure': 'Cost saving after discharge', 'timeFrame': 'a month', 'description': 'Medication cost for potentially inappropriate PPI after discharge'}, {'measure': 'Medication Appropriateness Index for Proton Pump Inhibitors at discharge', 'timeFrame': 'at discharge, an average of 14 days after admission to hospital', 'description': 'Medication Appropriateness Index (MAI); included 10 items. Each item was weighted from 1-3. The highest score per medication was 18.\n\nHigher scores of this index represent more inappropriateness of each medication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geriatric']}, 'referencesModule': {'references': [{'pmid': '35449351', 'type': 'DERIVED', 'citation': 'Dumlu HI, Sancar M, Ozdemir A, Okuyan B. Impact of a clinical pharmacist-led stewardship program for the appropriate use of acid suppression therapy in older hospitalized patients: a non-randomized controlled study. Int J Clin Pharm. 2022 Aug;44(4):914-921. doi: 10.1007/s11096-022-01394-8. Epub 2022 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of clinical pharmacist-led appropriate acid suppression therapy stewardship program in hospitalized older patients.', 'detailedDescription': 'This prospective, nonrandomized controlled study was conducted in older patients who ordered proton pump inhibitor (PPI) at admission in an internal medicine service of tertiary training and research hospital. In the intervention group, clinical pharmacist-led services (including medication reconciliation and medication review) were conducted during hospitalization and at discharge by using the guidelines and potentially inappropriate medications (PIM) criteria \\[American Geriatric Society-AGS Beers Criteria©, 2019\\]. Medication Appropriateness Index (MAI), inappropriate PPI cost, and hospitalization for gastrointestinal bleeding within 1 year after discharge were calculated in both groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years old or greater\n* Admitted to the hospital with any reason\n* Ordered at least one PPI dose within 48 hours of admission\n\nExclusion Criteria:\n\n* Transferred to another ward (including an intensive care unit)\n* Having active gastrointestinal bleeding\n* Having active malignity'}, 'identificationModule': {'nctId': 'NCT05113667', 'briefTitle': 'Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Impact of Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program on Hospitalized Older Patients: A Non-Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MUHSI-2019/29-78'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical pharmacist-led services', 'description': 'Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program', 'interventionNames': ['Other: Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care'}], 'interventions': [{'name': 'Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program', 'type': 'OTHER', 'description': 'Clinical pharmacist provided medication reconciliation and medication review during the hospital stay.', 'armGroupLabels': ['Clinical pharmacist-led services']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Betul Okuyan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.', 'investigatorFullName': 'Betul Okuyan', 'investigatorAffiliation': 'Marmara University'}}}}