Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia
NCT ID: NCT04985305
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2021-10-15
2022-11-01
Brief Summary
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Detailed Description
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However 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.
In 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.
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention Group
* Educational session for GPs
* Instructed to complete 10-15 home visits at the nursing home with the optimizing antidepressants and other psychotropic drugs
* Instructed to evaluate neuropsychiatric symptoms before and after the visit using a structured form
* Instructed to complete a teaching session at the nursing home with a pre-defined teaching material
* 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
* Dialogue tool
Teaching material
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.
Pre-visit reflection tool
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
Dialogue tool
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.
Educational session for GPs
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.
Symptom assessment scale
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
Control Group
* Educational session for GPs
* Instructed to complete 10-15 home visits at the nursing home with the optimizing antidepressants and other psychotropic drugs
* Instructed to evaluate neuropsychiatric symptoms before and after the visit using a structured form
Educational session for GPs
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.
Symptom assessment scale
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
Interventions
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Teaching material
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.
Pre-visit reflection tool
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
Dialogue tool
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.
Educational session for GPs
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.
Symptom assessment scale
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
Eligibility Criteria
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Inclusion Criteria
* Either have a diagnosis of dementia or have a severe cognitive impairment as judged by the GP
* Are permanently living at the nursing home
* Are prescribed at least one antidepressant with the following ATC-codes
* Selective serotonin reuptake inhibitors (SSRIs): N06AB10 (Escitalopram); N06AB04 (Citalopram); N06AB08 (Fluvoxamin); N06AB03 (Fluoxetin); N06AB05 (Paroxetin); N06AB06 (Sertralin);
* Serotonin-Norepinephrine Reuptake inhibitors (SNRIs): N06AX21 (Duloxetin); N06AX16 (Venlafaxin);
* Tricyclic antidepressants (TCAs): N06AA09 (Amitriptylin); N06AA04 (Clomipramin); N06AA02 (Imipramin); N06AA10 (Nortriptylin); (Dosulepin); N06AA17
* Noradrenergic and specific serotonergic antidepressants (NaSSAs) / Atypical antidepressants N06AX03 (Mianserin); N06AX11 (Mirtazapin);
* Monoamine oxidase inhibitors (MAOIs):N06AF01 (Isocarboxazid);
* Noradrenaline reuptake inhibitor (NARI): N06AX18 (Reboxetin);
* Other antidepressant with effect on the serotonin-system: N06AX26 (Vortioxetin);
* Melatonin agonists: N06AX22 (Agomelatin);
Exclusion Criteria
* They are enrolled in another psychopharmacological trial
* There is a suspicion of a current clinical, major depression or suicidal behavior and intentions.
* Receiving end-of-life care
72 Years
ALL
No
Sponsors
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Velux Fonden
OTHER
Danish College of General Practitioners
OTHER
Region Capital Denmark
OTHER
University of Copenhagen
OTHER
Responsible Party
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Pernille Hølmkjær
Principal Investigator
Principal Investigators
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Maarten Pieter Rozing, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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University of Copenhagen, department of Public Health, section of General Practice
Copenhagen, , Denmark
Countries
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References
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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.
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.
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.
Other Identifiers
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Velux00025829
Identifier Type: -
Identifier Source: org_study_id