Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 10:23 PM
Study NCT ID:
NCT02712268
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention to Improve Prescribing in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057189', 'term': 'Checklist'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-02', 'studyFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the proportion of patients prescribed potentially inappropriate medications (PIM) at discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': "The proportion of patients prescribed PIMs at discharge, according to STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) criteria, before and after the introduction of the checklist."}, {'measure': 'Change in the number of prescribed medications at discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'Number of prescribed medications at discharge, before and after the introduction of the checklist.'}], 'secondaryOutcomes': [{'measure': 'Number of prescribed drugs at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)'}, {'measure': 'Prevalence of polypharmacy at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'concomitant use of more than 5 drugs'}, {'measure': 'Prevalence of hyperpolypharmacy at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'concomitant use of more than 10 drugs'}, {'measure': 'Prevalence of potentially inappropriate prescribing omissions (PPO) at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'according to START (Screening Tool of Alert doctors to the Right Treatment) criteria'}, {'measure': 'Number of patients prescribed NSAID at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'Non-steroidal anti-inflammatory drugs (NSAID)'}, {'measure': 'Rate (%) of inappropriate prescriptions of NSAID at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'Non-steroidal anti-inflammatory drugs (NSAID)'}, {'measure': 'Number of patients prescribed proton pump inhibitors at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'proton pump inhibitor (PPI)'}, {'measure': 'Rate (%) of inappropriate prescriptions of proton pump inhibitors at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 'proton pump inhibitor (PPI)'}, {'measure': 'Number of patients prescribed systemic corticosteroids at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)'}, {'measure': 'Rate (%) of inappropriate prescriptions of systemic corticosteroids at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)'}, {'measure': 'Number of patients prescribed metamizole at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)'}, {'measure': 'Rate (%) of inappropriate prescriptions of metamizole at admission and discharge', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)'}, {'measure': 'In-Hospital mortality rate', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)'}, {'measure': 'All-cause re-hospitalization rate', 'timeFrame': 'In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)', 'description': 're-hospitalization rate 30 days after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polypharmacy', 'Clinical decision-making'], 'conditions': ['Elderly Internal Medicine Patients']}, 'descriptionModule': {'briefSummary': 'This study tested the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy in elderly adults admitted to an internal medicine unit.', 'detailedDescription': "Background: Polypharmacy and inappropriate medication prescriptions are associated with increased morbidity and mortality. Most interventions proposed to improve appropriate prescribing are time and resource intensive and therefore hardly applicable in daily clinical practice.\n\nObjective: To test the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy.\n\nDesign: single-center, interventional, quasi-experimental before-after study. Patients: Consecutive patients aged ≥65 years, hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).\n\nIntervention: Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards.\n\nMain Measures: The proportion of patients with prescription of potentially inappropriate medications (PIMs) at discharge, according to Screening tool of older people's prescriptions (STOPP) criteria, and the number of prescribed medications at discharge, before and after the introduction of the checklist. Secondary outcomes were the prevalence of polypharmacy (≥ 5 drugs) and hyperpolypharmacy (≥ 10 drugs), and the prevalence of potentially inappropriate prescribing omissions (PPOs) according to START criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients aged ≥65 years,\n* patients hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02712268', 'briefTitle': 'Intervention to Improve Prescribing in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Intervention to Improve Appropriate Prescribing and Reduce Polypharmacy in Elderly Patients Admitted to an Internal Medicine Unit', 'orgStudyIdInfo': {'id': '2013/039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'After introduction of the checklist', 'description': 'Review of medications of all consecutive admitted patients during the study period using a checklist', 'interventionNames': ['Other: Checklist']}], 'interventions': [{'name': 'Checklist', 'type': 'OTHER', 'description': 'Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards to review and adapt the medications of the patient.', 'armGroupLabels': ['After introduction of the checklist']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stefano Bassetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified individual participant data are available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}