Clinical trial NCT04985305: Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia
Official title: A Cluster Randomized Trial of a Complex Intervention to Encourage Deprescribing Antidepressants in Nursing Home Residents With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Deprescriptions
Antidepressive Agents
BPSD
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Danish College of General Practitioners
name: Region Capital Denmark
First posted: 2021-08-02
Enrollment: 180
Sex: ALL
Minimum age (years): 72
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* ≥72 years old
* 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 under treatment of a psychiatrist.
* 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

Primary outcomes:
measure: Reduction of antidepressant
timeFrame: Intervention period of three months for each patient.
Secondary outcomes:
measure: Change in percentage of all antidepressants
timeFrame: Intervention period of three months for each patient.
measure: Change in percentage of each class of antidepressants
timeFrame: Intervention period of three months for each patient.
measure: Change in percentage of other psychotropic drugs
timeFrame: Intervention period of three months for each patient.
measure: Change in BPSD symptoms
timeFrame: 4 weeks
measure: Hospital admission
timeFrame: Intervention period of three months for each patient.
measure: Falls
timeFrame: Intervention period of three months for each patient.
measure: Mortality
timeFrame: Intervention period of three months for each patient.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, department of Public Health, section of General Practice
Study officials:
affiliation: University of Copenhagen
name: Maarten Pieter Rozing, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.