Optimization of Deprescribing Antidepressants in Nursing Home Residents With Dementia

NCT04985305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-12-20

No results posted yet for this study

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

Interventions

BEHAVIORAL

Teaching material

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.

BEHAVIORAL

Pre-visit reflection tool

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

BEHAVIORAL

Dialogue tool

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.

BEHAVIORAL

Educational session for GPs

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.

BEHAVIORAL

Symptom assessment scale

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

Sponsors & Collaborators

  • Velux Fonden

    collaborator OTHER
  • Danish College of General Practitioners

    collaborator OTHER
  • Region Capital Denmark

    collaborator OTHER
  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Maarten Pieter Rozing, MD, Ph.D. · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-11-01
Completion
2022-11-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985305 on ClinicalTrials.gov