Evidence map›Paper›PMID 35578351›Full record

ArticleTrials2022

A cluster-randomized trial of a complex intervention to encourage deprescribing antidepressants in nursing home residents with dementia: a study protocol.

Pernille Hølmkjær, Anne Holm, Gritt Overbeck, Maarten Pieter Rozing

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04985305 (A Cluster Randomized Trial of a Complex Intervention to Encourage Deprescribing Antidepressants in Nursing Home Residents With Dementia), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04985305 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of CopenhagenRan2021 to 2022Enrolled180ConditionsDementia, Deprescriptions, Antidepressive Agents, BPSDArmsTeaching material, Pre-visit reflection tool, Dialogue tool, Educational session for GPs, Symptom assessment scale
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Selection and reporting of usual care comparators when designing primary care trials of complex health interventions: a systematic review.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
    Pooled it
  2. Pooled it
  3. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Pernille HølmkjærDepartment of Public Health, Section of General Practice and Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark. pernille.hoelmkjaer@sund.ku.dk.ORCID http://orcid.org/0000-0002-1191-1032
Anne HolmDepartment of Public Health, Section of General Practice and Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-3819-3429
Gritt OverbeckDepartment of Public Health, Section of General Practice and Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-1740-1148
Maarten Pieter RozingDepartment of Public Health, Section of General Practice and Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-0760-6251
University of Copenhagen · DK

Funding

Velux Fonden 00025829
6 · The paper itself

Abstract

backgroundThe effectiveness of psychotropic medication on behavioral and psychological symptoms of dementia (BPSD) is limited, while associated with a higher risk of adverse events. 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 medication in nursing home residents, they face many barriers. Therefore, we hypothesize that an intervention aimed at improving communication with and involvement of nursing home staff, relatives, and patients by GPs can optimize the pharmacological treatment of BPSD. The aim is to reduce the use of antidepressants in nursing home residents with dementia without increasing morbidity or mortality.

objectiveThe primary outcome is reduction of antidepressant. Secondary outcomes include difference in use of other psychotropic medication, mortality, morbidity, and severity of BPSD.

methodThe study is a cluster-randomized controlled trial based in general practices in Denmark. We aim to include 22 practices, each of which will recruit up to 15 patients with dementia living in nursing homes. The intervention period is 3 months, and the total study period is 1 year. Randomization is 1:1 to intervention and control group by computer algorithm. Both groups receive education on BPSD and its evidence-based treatment. The intervention includes three tailored components; (1) teaching material and training to be used by the GP to educate nursing home staff on BPSD, (2) a pre-visit reflection tool to encourage nursing home staff to evaluate symptoms and reflect on relatives involvement in the discontinuation process; and (3) a dialog tool to facilitate shared decision making on optimization of BPSD treatment during the visits at the nursing home. The control group includes enhanced care as usual. The primary and secondary outcomes will be assessed at the end of the study period. A process evaluation will be conducted to assess the implementability. DISCUSSION: We anticipate that the intervention will optimize the treatment of BPSD with antidepressants for nursing homes residents and enhance compliance with reduction of medication. The process evaluation should provide insights into the barriers and facilitators to changing the current practice of deprescribing.

trial registrationClinicaltrials.gov NCT04985305 . Registered on 30 July 2021.

Indexed as

DementiaDeprescriptionsAntidepressive AgentsHumansNursing HomesPsychotropic DrugsQuality of LifeRandomized Controlled Trials as TopicAntidepressive AgentsPsychotropic DrugsAntidepressantsBPSDDementiaDeprescribing

Identifiers

PMID35578351
PMCPMC9109433
OpenAlexW4280503274

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.