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DementiaNCT04985305

Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia

A study testing Teaching material, Pre-visit reflection tool and Dialogue tool in people with Dementia and Deprescriptions, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 72 years and older
Conditions the study is for
Dementia, Deprescriptions, Antidepressive Agents
What is being tested?
Teaching material, Pre-visit reflection tool and Dialogue tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteDenmark
Study dates
15 Oct 2021to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 72 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • ≥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);
Show all 12Show fewer
  • 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);

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

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

    Copenhagen, 1014

Other trials in Denmark

About this study

Official title: A Cluster Randomized Trial of a Complex Intervention to Encourage Deprescribing Antidepressants in Nursing Home Residents With Dementia

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.

Read the 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.

Being tested
Teaching material, Pre-visit reflection tool, Dialogue tool, Educational session for GPs, Symptom assessment scale
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teaching materialBehavioural

    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 toolBehavioural

    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 toolBehavioural

    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 GPsBehavioural

    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 scaleBehavioural

    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

Study groups in NCT04985305
Study groupRoleWhat they receive
Intervention GroupExperimental* 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
Receives: Behavioral: Teaching material; Behavioral: Pre-visit reflection tool; Behavioral: Dialogue tool; Behavioral: Educational session for GPs; Behavioral: Symptom assessment scale
Control GroupActive 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
Receives: Behavioral: Educational session for GPs; Behavioral: Symptom assessment scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Intervention period of three months for each patient.

Secondary outcomes (7)

  1. Change in percentage of all antidepressants

    A change in percentage of total amount of antidepressants per patient prescribed from pre- to post intervention

    Measured: Intervention period of three months for each patient.

  2. Change in percentage of each class of antidepressants

    A change in percentage of each class of antidepressants per patient prescribed from pre- to post intervention

    Measured: Intervention period of three months for each patient.

  3. Change in percentage of other psychotropic drugs

    A change in percentage of number of antipsychotics, anxiolytics, hypnotics, anticonvulsants, analgesics and anti-dementia drugs prescribed per patient from pre- to post intervention

    Measured: Intervention period of three months for each patient.

  4. Change in BPSD symptoms

    Change in outcome severity of behavioural and psychological symptoms as assessed by the symptom scale 4 weeks after the home visit

    Measured: 4 weeks

  5. Hospital admission

    Number of hospital admissions during the intervention period

    Measured: Intervention period of three months for each patient.

  6. Falls

    Number of falls requiring hospital admission or emergency department visit during the intervention period

    Measured: Intervention period of three months for each patient.

  7. Mortality

    Mortality at the end of intervention

    Measured: Intervention period of three months for each patient.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study start15 Oct 2021
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04985305
Sponsor's protocol ID
Velux00025829
Status last verified
Dec 2022
First submitted
21 Jul 2021
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40462023

  • 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.

    PubMed 38679697

  • 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.

    PubMed 35578351

Questions about this trial

What is this clinical trial studying?

A study testing Teaching material, Pre-visit reflection tool and Dialogue tool in people with Dementia and Deprescriptions, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of antidepressant (time frame: Intervention period of three months for each patient.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04985305, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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