Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-28 @ 12:20 PM
Study NCT ID:
NCT06731361
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Prescribing for Older Nursing Home Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not possible due to the type of intervention'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomised controlled trial with 2 arms: intervention and control. Ratio 1:1. 2 clusters start in september, 2 clusters start in october and 2 clusters start in november.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'QOL (Quality of life)', 'timeFrame': 'at baseline - 6 months - 12 months', 'description': 'Quality of life measured with the EuroQol questionnaire (EQ-5D)'}, {'measure': 'Social wellbeing', 'timeFrame': 'at baseline - 6 months - 12 months', 'description': 'Measured with Revised index for social engagement (RISE) questionnaire'}, {'measure': 'Adverse outcomes', 'timeFrame': 'at baseline - 6 months - 12 months', 'description': "Adverse outcomes, such as: deaths, falls, hospital admissions/acute referrals, measured over the previous 6 months. (Only for ' deaths' not possible at baseline.)"}, {'measure': 'Pain assessment', 'timeFrame': 'at baseline - 6 months - 12 months', 'description': 'measured with the pain items of the Resident Assessment Instrument for Long-term Care Facilities (RAI-LTCF) questionnaire'}, {'measure': 'Process evaluation', 'timeFrame': 'Through 1 year and 3 months', 'description': 'Qualitative and quantitative data'}], 'primaryOutcomes': [{'measure': 'Potential under- and overprescribing', 'timeFrame': 'at baseline - 6 months - 12 months', 'description': 'Potential under- and overprescribing'}], 'secondaryOutcomes': [{'measure': 'Experienced involvement in decision-making', 'timeFrame': 'At baseline and 2-4 weeks after the medication review', 'description': 'Experienced involvement in decision-making measured with a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['limited life expectancy', 'ReNeWAL criteria (adjusted STOPP/START criteria)', 'decision making involvement', 'appropriate prescribing', 'Cluster randomised trial', 'Educational intervention', 'Prescribing practices'], 'conditions': ['Nursing Home Residents', 'Older People', 'Prescribing', 'Advance Care Planning', 'Medication Reviews', 'Decision Making', 'Prescribing Practices']}, 'descriptionModule': {'briefSummary': "Research aim:\n\nTo investigate the effect of training health care professionals in medication assessments on the medication use of nursing home residents with a limited life expectancy (\\< 1.5-2 years).\n\nThe core of the training is to tailor medication use to (palliative) treatment goals of nursing home residents.\n\nDesign:\n\nA cluster randomized controlled trial on long term care wards in nursing homes, with the nursing home care organisations as unit of randomisation. The investigators intent to include 6 organisations and 450 nursing home patients. The research starts in september and lasts 1 year and 3 months. Eligible patients are nursing home patients of 65 years and older with a limited life expectancy (\\< 1.5-2 year) of long term care wards.\n\nIntervention:\n\nThe intervention includes a method in which healthcare professionals (medical practitioner, pharmacist and care worker) are trained to tailor medication to the (palliative) treatment goals of nursing home patients with a limited life expectancy. The training consists of 2 components: 1) medication assessment, and 2) advance care planning (ACP). In the intervention group, healthcare professionals receive the training in combination with supporting tools and educational materials, in the control group care continues as normal. The allocation ratio for control and intervention groups is 1:1. A process evaluation will take place simultaneously with the intervention study. Data collection takes place before the start of the intervention (T0), after 6 months (T1) and after 12 months (T2).\n\nOutcome measures:\n\nThe primary outcome measure is potential under- and over-treatment with medication. The secondary outcome measure is experienced involvement in decision-making (measured with a short questionnaire based on the revised PATD (patients' attitude towards deprescribing)). Tertiary outcome measures are: quality of life, deaths, falls, hospital admissions/acute first aid referrals and pain.\n\nDiscussion:\n\nThe intervention is expected to result in a decrease in chronic and preventive medication prescriptions, an increase in medication for symptom treatment and more involvement (and satisfaction) of the nursing home resident in decision-making, without adverse effects.", 'detailedDescription': 'Additional information on the method:\n\nWe included 2 nursinghome organizations in september, 2 in october, and 3 in november.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNursing home patients:\n\n* Age 65years and above\n* Living at long term care wards in nursing homes\n* Living at a long term care ward for at least 4 weeks before start of the study\n\nExclusion Criteria:\n\n* Temporary nursing home patients (i.e. geriatric rehabilitation or end-of-life/hospice care)\n* Life expectancy \\< 4 weeks\n* Life expectancy clearly \\> 1.5 - 2 years (i.e. patients with Huntingtons disease)'}, 'identificationModule': {'nctId': 'NCT06731361', 'acronym': 'IMPETUS', 'briefTitle': 'Improved Prescribing for Older Nursing Home Patients', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Improving Medication Prescription in the contExt of Advance Care Planning for paTients Receiving Long Term nUrSing Home Care', 'orgStudyIdInfo': {'id': '839160003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group, care as usual'}, {'type': 'EXPERIMENTAL', 'label': 'Educational intervention', 'description': 'The clusters that fall into the experimental arm receive the educational intervention: they receive an in-house training in combination with supporting tools, educational materials and intervision moments.', 'interventionNames': ['Combination Product: Systematic multidisciplinary medication review + ACP (SMMR+)']}], 'interventions': [{'name': 'Systematic multidisciplinary medication review + ACP (SMMR+)', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['ReNeWAL criteria', 'Pocket card'], 'description': 'The intervention is a training in medication assessment. The goal is to align prescription with the treatment goals of nursing home patients which are set in advance care planning conversations. The training consists of 2 components:\n\n1. Medication assessment with the use of the ReNeWAL criteria (adjusted STOPP/START criteria, tailored to nursing home patients with a limited life expectancy)\n2. Advance care planning component. Discussing medication in line with the treatment goals set in advance care planning conversations.\n\nHealthcare professionals receive the training in combination with supporting tools (pocket card) and educational material (the ReNeWAL criteria and PowerPoint slides of the training if requested). Also, intervision moments are planned.', 'armGroupLabels': ['Educational intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7334DV', 'city': 'Apeldoorn', 'state': 'Gelderland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '3844 JW', 'city': 'Harderwijk', 'state': 'Gelderland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'zip': '1057 DZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'role': 'CONTACT', 'phone': '(0031) 020-5898650'}], 'facility': 'Cordaan, location Nieuw Vredenburgh', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1215 SE', 'city': 'Hilversum', 'state': 'North Holland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Amaris, Location Alporti and Rubina', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'zip': '3401 BN', 'city': 'IJsselstein', 'state': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'role': 'CONTACT', 'phone': '(0031) 030-6881914'}], 'facility': 'AxionContinu, location Isselwaerde and de Schutse', 'geoPoint': {'lat': 52.02, 'lon': 5.04306}}, {'zip': '4133 GX', 'city': 'Vianen', 'state': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'role': 'CONTACT', 'phone': '(0031) 030-6007140'}], 'facility': 'Zorgspectrum, location de Plataan', 'geoPoint': {'lat': 51.9925, 'lon': 5.09167}}, {'zip': '9743XV', 'city': 'Groningen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Dignis, location de Veldspaat', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Marlies Dijk, MD', 'role': 'CONTACT', 'email': 'm.dijk5@amsterdamumc.nl', 'phone': '020-4445785', 'phoneExt': '0031'}, {'name': 'Eefje Sizoo, MD, PhD', 'role': 'CONTACT', 'email': 'e.sizoo@amsterdamumc.nl', 'phone': '020-4445785', 'phoneExt': '0031'}], 'overallOfficials': [{'name': 'Martin Smalbrugge, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amsterdam UMC, location VUmc, departement Medicine for Older People'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, professor of Medicine for Older People and chair of the Department of Medicine for Older People', 'investigatorFullName': 'Martin Smalbrugge', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}