Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-04-16 @ 11:40 AM
Study NCT ID:
NCT01876095
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discontinuing Inappropriate Medication in Nursing Home Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-12-14', 'releaseDate': '2018-05-29'}], 'estimatedResultsFirstSubmitDate': '2018-05-29'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 992}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '4 months', 'description': 'Cognitive function as assessed with standardized cognitive tests called the Severe Impairment Battery and the Mini Mental Status Examination'}, {'measure': 'Neuropsychiatric Symptoms', 'timeFrame': '4 months', 'description': 'Assessment of change in neuropsychiatric symptoms (e.g. hallucinations \\& delusions) with the Neuropsychiatric Inventory (NPI) (nursing home version).'}], 'primaryOutcomes': [{'measure': 'Successful medication discontinuation', 'timeFrame': '4 months', 'description': 'The number of residents for whom ≥1 inappropriate medication(s) are succesfully discontinued i.e. without relapse or severe withdrawal effects'}], 'secondaryOutcomes': [{'measure': 'Medication initiation', 'timeFrame': '4 months', 'description': 'Number of residents for whom ≥1 medication(s) are initiated (s) that should be started on the basis of the Screening Tool to Alert doctors to Right Treatment (START) criteria'}, {'measure': 'Dose adjustment', 'timeFrame': '4 months', 'description': 'Number of residents for whom ≥1 dose(s) are lowered or increased'}, {'measure': 'Safer alternative medication', 'timeFrame': '4 months', 'description': 'The percentage of residents for whom ≥1 medication(s) is replaced by a safer alternative'}, {'measure': 'Drug burden index', 'timeFrame': '4 months', 'description': "A measure of a person's cumulative exposure to anticholinergic and sedative medications, which has been associated with falls in nursing home patients"}, {'measure': 'Quality of Life', 'timeFrame': '4 months', 'description': 'Quality of life will be measured using a disease specific instrument (DQI (Scholzel-Dorenbosch et al, in press) and a generic instrument EQ-5D-5L for all patients (Herdman et al, 2011).'}, {'measure': 'adverse drug withdrawal events', 'timeFrame': '4 months', 'description': 'The rate of adverse drug withdrawal events related to the discontinued medication'}, {'measure': 'Death', 'timeFrame': '4 months', 'description': 'Incidence of death'}, {'measure': 'Hospital admission', 'timeFrame': '4 months', 'description': 'Hospital admission'}, {'measure': 'Falling', 'timeFrame': '4 months', 'description': 'Defined as any event in which a nursing home resident touches the ground in an unintentional sudden manner without cues of emergency'}, {'measure': 'Bone fractures', 'timeFrame': '4 months', 'description': 'Bone fractures caused by falling'}, {'measure': 'number of visits to outpatient clinics / emergency rooms / by medical consultants', 'timeFrame': '4 months', 'description': 'number of visits to outpatient clinics, emergency rooms, number of visits by medical consultants i.e. physicians who visit the patients in the nursing homes,'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents']}, 'referencesModule': {'references': [{'pmid': '29052691', 'type': 'DERIVED', 'citation': 'Wouters H, Scheper J, Koning H, Brouwer C, Twisk JW, van der Meer H, Boersma F, Zuidema SU, Taxis K. Discontinuing Inappropriate Medication Use in Nursing Home Residents: A Cluster Randomized Controlled Trial. Ann Intern Med. 2017 Nov 7;167(9):609-617. doi: 10.7326/M16-2729. Epub 2017 Oct 10.'}, {'pmid': '25296655', 'type': 'DERIVED', 'citation': 'Wouters H, Quik EH, Boersma F, Nygard P, Bosman J, Bottger WM, Mulder H, Maring JG, Wijma-Vos L, Beerden T, van Doormaal J, Postma MJ, Zuidema SU, Taxis K. Discontinuing inappropriate medication in nursing home residents (DIM-NHR Study): protocol of a cluster randomised controlled trial. BMJ Open. 2014 Oct 8;4(10):e006082. doi: 10.1136/bmjopen-2014-006082.'}]}, 'descriptionModule': {'briefSummary': 'Nursing home residents are among the frailest patient groups with a high number of co-morbidities and a high use of medicines. Inappropriate polypharmacy (i.e. often overprescribing) is one of the major problems in the nursing home population increasing the number of adverse drug reactions, falls, hospital admissions, mortality as well as having an impact on health care utilization. Multidisciplinary medication reviews have a great potential to reduce inappropriate medication use. The purpose of this study is to determine the efficacy of a multidisciplinary medication review model focussing on discontinuing inappropriate medication in a cluster randomized controlled trial in 600 nursing home residents. The primary outcome measure is the difference in proportion of residents who successfully discontinued medication between intervention and control group after four months. Secondary outcome measures will be the drug burden index, adverse drug withdrawal events related to the discontinued medication, death, referral to hospitals and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Nursing Home Wards:\n\nInclusion criteria:\n\n* Long stay ward\n* Capability and commitment to perform a multidisciplinary multistep medication review.\n\nExclusion criteria:\n\n* Short stay, revalidation or observation wards\n* Specialized ward where patients with an atypical etiology are cared for.\n* Elderly care physicians who have recently received or who are to receive recertification at short notice with regard to systematic medication review methodology.\n* Participation in other studies aimed at improving the quality of drug prescription (in the past 12 months).\n\nNursing Home Residents:\n\nInclusion criteria:\n\n* A life expectancy of \\>4 weeks as judged by the treating elderly care physician.\n* IC provided by patients themselves or provided by a legal representative for incapacitated patients.\n\nExclusion criteria:\n\n* Refusal of treatment with medicines.\n* Having received a multidisciplinary systematic medication review in the past 6 months.\n* Being terminally ill and having a life expectancy ≤ 4 weeks as judged by the treating elderly care physician.\n* Other reasons at the discretion of the elderly care physician / nursing staff'}, 'identificationModule': {'nctId': 'NCT01876095', 'briefTitle': 'Discontinuing Inappropriate Medication in Nursing Home Residents', 'organization': {'class': 'OTHER', 'fullName': 'University of Groningen'}, 'officialTitle': 'Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DIM-NHR study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multidisciplinary medication review', 'description': "The multidisciplinary medication review consists of 5 steps:\n\nStep #1: Assessing patients' experiences and preferences regarding medicine use en assessing their medical history, allergies and lab results Step #2: Drug reviewing to assess contra-indicated medication and duplicate medication using consensus criteria e.g. START STOPP Beers criteria Step #3: Reflecting on results of drug reviewing Step #4: Setting up a pharmacotherapeutical action plan Step #5: Execution of pharmacotherapeutical action plan", 'interventionNames': ['Procedure: Multidisciplinary medication review']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'Includes medication safety monitoring and ad hoc medication reviews on clinical indication that differ in quality and frequency, but no standardized multidisciplinary multistep medication reviews in the way as described for the intervention arm'}], 'interventions': [{'name': 'Multidisciplinary medication review', 'type': 'PROCEDURE', 'description': "Consists of the following steps:\n\n* 1\\. Elderly care physician and nursing staff evaluate with the patient the experience of taking medicines, adverse drug reactions and patient's preferences.\n* 2\\. Pharmacist reviews medication to identify drug related problems using START/STOPP en Beers criteria.\n* 3/4. Meeting of elderly care physician, pharmacist. Possibilities to discontinue prescribed medication will be examined resulting in pharmaceutical care plan that optimizes the patient's medication i.e. which inappropriate medication should be discontinued following a prioritization and time schedule.\n* 5\\. Execution of pharmaceutical care plan according to agreed schedule.", 'armGroupLabels': ['Multidisciplinary medication review']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO Box 72 9700 AB', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University of Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Katja Taxis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groningen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pharmacotherapy and Clinical Pharmacy', 'investigatorFullName': 'Katja Taxis', 'investigatorAffiliation': 'University of Groningen'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-05-29', 'type': 'RELEASE'}, {'date': '2018-12-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Katja Taxis, Professor of Pharmacotherapy and Clinical Pharmacy, University of Groningen'}}}}