CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Teaching material +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04985305
NCT04985305N/ACompleted

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

University of Copenhagen·interventional·Posted Aug 2, 2021·Updated Dec 20, 2022

In Brief

A clinical study evaluating Teaching material, Pre-visit reflection tool, and 3 other interventions for Dementia and 3 related conditions. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 2, 2021
Enrollment StartOct 15, 2021
Primary CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.9 years ago

Interventions

Teaching materialbehavioral

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 toolbehavioral

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 toolbehavioral

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 GPsbehavioral

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 scalebehavioral

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