Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia

NCT04985305 | Completed

• 1 other identifier: Velux00025829
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Deprescriptions; Antidepressive Agents; BPSD

Outcome Measures

Primary Outcomes (1)

• Reduction of antidepressant

  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

  Intervention period of three months for each patient.

Secondary Outcomes (7)

• Change in percentage of all antidepressants

  Intervention period of three months for each patient.

• Change in percentage of each class of antidepressants

  Intervention period of three months for each patient.

• Change in percentage of other psychotropic drugs

  Intervention period of three months for each patient.

• Change in BPSD symptoms

  4 weeks

• Hospital admission

  Intervention period of three months for each patient.

Study Arms (2)

Intervention Group

EXPERIMENTAL

* 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

Behavioral: Teaching material; Behavioral: Pre-visit reflection tool; Behavioral: Dialogue tool; Behavioral: Educational session for GPs; Behavioral: Symptom assessment scale

Control Group

ACTIVE COMPARATOR

* 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

Behavioral: Educational session for GPs; Behavioral: Symptom assessment scale

Interventions

Teaching material BEHAVIORAL

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.

Intervention Group

Pre-visit reflection tool BEHAVIORAL

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

Intervention Group

Dialogue tool BEHAVIORAL

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.

Intervention Group

Educational session for GPs BEHAVIORAL

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.

Control Group; Intervention Group

Symptom assessment scale BEHAVIORAL

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; Intervention Group

Eligibility Criteria

• Age: 72 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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);

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Velux Fonden: collaborator
• Danish College of General Practitioners: collaborator
• Region Capital Denmark: collaborator

Study Sites (1)

University of Copenhagen, department of Public Health, section of General Practice

Copenhagen, 1014, Denmark

Location

Related Publications (3)

• 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: 40462023 DERIVED

• 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: 38679697 DERIVED

• 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.

  PMID: 35578351 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maarten Pieter Rozing, MD, Ph.D.

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 2, 2021
• Study Start: October 15, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

DK (1)