Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04985305
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2021-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The GPs are blinded to their allocation prior to recruiting patients. Due to the nature of the intervention, it will not be possible to blind the participants, providers of care or other members of the research team after the allocation. The primary outcome is blinded to the research team when analyzed.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This trial is designed as a cluster randomized, non-blinded parallel group superiority trial with 1:1 allocation ratio. Enhanced care-as-usual will be used as a comparator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-19', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-30', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of antidepressant', 'timeFrame': 'Intervention period of three months for each patient.', 'description': 'The primary outcome is any reduction of any antidepressant from pre- to post intervention during the intervention period, in the intervention group compared to the control group, measured as a dichotomized response (reduction; yes/no). In case of reduction of an antidepressant and an addition of another antidepressant this will not be considered a reduction'}], 'secondaryOutcomes': [{'measure': 'Change in percentage of all antidepressants', 'timeFrame': 'Intervention period of three months for each patient.', 'description': 'A change in percentage of total amount of antidepressants per patient prescribed from pre- to post intervention'}, {'measure': 'Change in percentage of each class of antidepressants', 'timeFrame': 'Intervention period of three months for each patient.', 'description': 'A change in percentage of each class of antidepressants per patient prescribed from pre- to post intervention'}, {'measure': 'Change in percentage of other psychotropic drugs', 'timeFrame': 'Intervention period of three months for each patient.', 'description': 'A change in percentage of number of antipsychotics, anxiolytics, hypnotics, anticonvulsants, analgesics and anti-dementia drugs prescribed per patient from pre- to post intervention'}, {'measure': 'Change in BPSD symptoms', 'timeFrame': '4 weeks', 'description': 'Change in outcome severity of behavioural and psychological symptoms as assessed by the symptom scale 4 weeks after the home visit'}, {'measure': 'Hospital admission', 'timeFrame': 'Intervention period of three months for each patient.', 'description': 'Number of hospital admissions during the intervention period'}, {'measure': 'Falls', 'timeFrame': 'Intervention period of three months for each patient.', 'description': 'Number of falls requiring hospital admission or emergency department visit during the intervention period'}, {'measure': 'Mortality', 'timeFrame': 'Intervention period of three months for each patient.', 'description': 'Mortality at the end of intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Deprescriptions', 'Antidepressive Agents', 'BPSD']}, 'referencesModule': {'references': [{'pmid': '40462023', 'type': 'DERIVED', 'citation': 'Holmkjaer P, Rozing MP, Overbeck G, Siersma V, Holm A. Effects of deprescribing antidepressants in nursing home residents with dementia-a cluster randomized controlled trial. BMC Prim Care. 2025 Jun 3;26(1):190. doi: 10.1186/s12875-025-02894-y.'}, {'pmid': '38679697', 'type': 'DERIVED', 'citation': 'Shahrzad S, Overbeck G, Holm A, Hoj K, Holmkjaer P. Factors promoting and impeding efforts to deprescribe antidepressants among nursing home residents with dementia- a process evaluation guided by normalization process theory. BMC Nurs. 2024 Apr 28;23(1):287. doi: 10.1186/s12912-024-01932-x.'}, {'pmid': '35578351', 'type': 'DERIVED', 'citation': 'Holmkjaer P, Holm A, Overbeck G, Rozing MP. A cluster-randomized trial of a complex intervention to encourage deprescribing antidepressants in nursing home residents with dementia: a study protocol. Trials. 2022 May 16;23(1):410. doi: 10.1186/s13063-022-06368-9.'}]}, 'descriptionModule': {'briefSummary': 'The effectiveness of psychotropic medication on behavioral and psychological symptoms in dementia (BPDS) is limited, while they are associated with a higher risk of morbidity and mortality. Non-pharmacological treatment of BPSD is advocated as treatment of first choice. However, many general practitioners (GPs) find it difficult to initiate deprescribing and when attempting to discontinue psychotropic drugs in nursing home residents, they can face substantial barriers both among nursing home staff and relatives. Therefore, the investigators have developed an intervention specifically aimed at increasing knowledge on deprescribing and improving communication and collaboration between GPs, nursing home staff, relatives and patients to optimize the pharmacological treatment of BPSD.', 'detailedDescription': 'It is estimated that more than 87.000 in Denmark are living with dementia, with more than 8000 new cases each year. The majority of older persons with dementia are living at home but in a minority problems with daily activities necessitates relocation to a nursing home. Besides cognitive impairment, up to 90 % of the institutionalized older people with dementia may experience behavioral and psychological symptoms of dementia (BPSD) such as anxiety, agitation, hallucinations, depression, and apathy. An overuse of antidepressants is reported and in Denmark, about half of all nursing home residents receive at least one antidepressant and many receive other psychotropic drugs such as antipsychotics, anxiolytics and hypnotics in addition to the antidepressants. However, recent research has shown that the benefits of treatment with antidepressants in patients suffering from dementia are limited while increasing the risk of falls and cardiovascular adverse events in institutionalized older persons. Given the limited effectiveness of psychotropic medication and its high risk of side-effects such as dizziness and falls, the use of antipsychotics and anxiolytics have been recommended against for a long period, while recommendations considering antidepressants have been more mixed. Danish national guidelines recommend against the use of antidepressants in older people suffering from dementia and advocate non-pharmacological treatment of BPSD as treatment of first choice.\n\nHowever in contradiction with the guidelines, a recent study showed that moving into a nursing homes, was accompanied with an increase in the number of new drug treatments including antidepressants and that this number remained unchanged for at least two years. Studies on the implementation and retention of strategies to discontinuation of psychotropic medication have shown varying effects. A recent qualitative systematic review has shown that discontinuation is often hindered by 1) the GP not getting the necessary information from the staff, 2) both relatives and staff can have concerns about the reduction or discontinuation of psychotropic medication or 3) the GP does not feel sufficiently competent/confident on their knowledge of the medication to make adjustments. These factors complicate the evaluation and adjustment of pharmacological treatment of neuropsychiatric symptoms. A Danish national strategy to try to reduce antipsychotics have been initialized in 2020, but to our knowledge there is no focused initiative to reduce antidepressants.\n\nIn Denmark each patient has a General Practitioner (GP), and the majority of nursing homes in the Capital Region has a GP who is affiliated with the nursing home. The patients may choose to accept this GP as their nursing home physician when moving to the nursing home. A nursing home physician helps improve continuity and reduces the risk of hospitalization for the patients when compared to patients without a nursing home physician.\n\nThe investigators therefore chose to apply the intervention to the nursing home physicians and their patients since more and more patients are having a nursing home physician and research has shown that is reduces amongst other things, hospitalization. Since the study is a cluster randomized controlled study set place in the Capital Region of Denmark, the investigators first invited nursing home physicians to participate. In order to be included, they had to have at least 10 patients at a nursing home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '72 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥72 years old\n* Either have a diagnosis of dementia or have a severe cognitive impairment as judged by the GP\n* Are permanently living at the nursing home\n* Are prescribed at least one antidepressant with the following ATC-codes\n\n * Selective serotonin reuptake inhibitors (SSRIs): N06AB10 (Escitalopram); N06AB04 (Citalopram); N06AB08 (Fluvoxamin); N06AB03 (Fluoxetin); N06AB05 (Paroxetin); N06AB06 (Sertralin);\n * Serotonin-Norepinephrine Reuptake inhibitors (SNRIs): N06AX21 (Duloxetin); N06AX16 (Venlafaxin);\n * Tricyclic antidepressants (TCAs): N06AA09 (Amitriptylin); N06AA04 (Clomipramin); N06AA02 (Imipramin); N06AA10 (Nortriptylin); (Dosulepin); N06AA17\n * Noradrenergic and specific serotonergic antidepressants (NaSSAs) / Atypical antidepressants N06AX03 (Mianserin); N06AX11 (Mirtazapin);\n * Monoamine oxidase inhibitors (MAOIs):N06AF01 (Isocarboxazid);\n * Noradrenaline reuptake inhibitor (NARI): N06AX18 (Reboxetin);\n * Other antidepressant with effect on the serotonin-system: N06AX26 (Vortioxetin);\n * Melatonin agonists: N06AX22 (Agomelatin);\n\nExclusion Criteria:\n\n* They are under treatment of a psychiatrist.\n* They are enrolled in another psychopharmacological trial\n* There is a suspicion of a current clinical, major depression or suicidal behavior and intentions.\n* Receiving end-of-life care'}, 'identificationModule': {'nctId': 'NCT04985305', 'briefTitle': 'Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'A Cluster Randomized Trial of a Complex Intervention to Encourage Deprescribing Antidepressants in Nursing Home Residents With Dementia', 'orgStudyIdInfo': {'id': 'Velux00025829'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '* Educational session for GPs\n* Instructed to complete 10-15 home visits at the nursing home with the optimizing antidepressants and other psychotropic drugs\n* Instructed to evaluate neuropsychiatric symptoms before and after the visit using a structured form\n* Instructed to complete a teaching session at the nursing home with a pre-defined teaching material\n* Instructed to contact the nursing home before the home visit to encourage participation of regular staff and relatives in the home visit or, alternatively, to obtain information from regular staff and relatives before the home visit\n* Dialogue tool', 'interventionNames': ['Behavioral: Teaching material', 'Behavioral: Pre-visit reflection tool', 'Behavioral: Dialogue tool', 'Behavioral: Educational session for GPs', 'Behavioral: Symptom assessment scale']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': '* Educational session for GPs\n* Instructed to complete 10-15 home visits at the nursing home with the optimizing antidepressants and other psychotropic drugs\n* Instructed to evaluate neuropsychiatric symptoms before and after the visit using a structured form', 'interventionNames': ['Behavioral: Educational session for GPs', 'Behavioral: Symptom assessment scale']}], 'interventions': [{'name': 'Teaching material', 'type': 'BEHAVIORAL', 'description': 'The GPs receive a power-point slide show to use at the nursing home. The slide show includes a description of BPSD symptoms, what the mechanism, effect and adverse events of antidepressants and a rationale for deprescribing.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Pre-visit reflection tool', 'type': 'BEHAVIORAL', 'description': 'The GPs receive a checklist and an email template to ensure; 1) The home visit is planned on a day where the staff at the nursing home that knows the patient best is at work. 2) The staff at the nursing home contacts the relevant relatives and informs about the home visit. 3) The symptom assessment scale is complete by the nursing home staff and returned to the GP prior to the home visit', 'armGroupLabels': ['Intervention Group']}, {'name': 'Dialogue tool', 'type': 'BEHAVIORAL', 'description': "The dialogue tool includes a list of questions to help the GP explore the nursing home staffs', patients' and relatives' concerns and views on deprescribing antidepressants, as well as information on when to contact the GP. The intervention has been developed during a tailoring process involving GPs, nursing home staff, interviews with patients and other experts in the field.", 'armGroupLabels': ['Intervention Group']}, {'name': 'Educational session for GPs', 'type': 'BEHAVIORAL', 'description': 'Before randomization all participating GPs receive a ½-day course on the evaluation and treatment of neuropsychiatric symptoms that occur in patients with dementia. Elaborate information about antidepressants to this population and reasons to discontinue use. A sSpecialists in general practice, pharmacology and geriatrics/gerontopsychiatrics teaches the course. The course is mandatory for the participating GPs, but voluntary for the staff at the GPs office. The course is preferably held with actual attendance, but may be converted to an online meeting due to the COVID-19 pandemic.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Symptom assessment scale', 'type': 'BEHAVIORAL', 'description': 'An email template containing 12 screening questions from the Neuropsychiatric Inventory Nursing Home Edition is given to the GPs to distribute to the nursing home prior to the home visit and 1 month after the home visit', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1014', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, department of Public Health, section of General Practice', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Maarten Pieter Rozing, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Velux Fonden', 'class': 'OTHER'}, {'name': 'Danish College of General Practitioners', 'class': 'OTHER'}, {'name': 'Region Capital Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pernille Hølmkjær', 'investigatorAffiliation': 'University of Copenhagen'}}}}