TY - JOUR

T1 - A cluster-randomized trial of a complex intervention to encourage deprescribing antidepressants in nursing home residents with dementia

T2 - a study protocol

AU - Hølmkjær, Pernille

AU - Holm, Anne

AU - Overbeck, Gritt

AU - Rozing, Maarten Pieter

N1 - © 2022. The Author(s).

PY - 2022

Y1 - 2022

N2 - BACKGROUND: The 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.OBJECTIVE: The primary outcome is reduction of antidepressant. Secondary outcomes include difference in use of other psychotropic medication, mortality, morbidity, and severity of BPSD.METHOD: The 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 REGISTRATION: Clinicaltrials.gov NCT04985305 . Registered on 30 July 2021.

AB - BACKGROUND: The 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.OBJECTIVE: The primary outcome is reduction of antidepressant. Secondary outcomes include difference in use of other psychotropic medication, mortality, morbidity, and severity of BPSD.METHOD: The 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 REGISTRATION: Clinicaltrials.gov NCT04985305 . Registered on 30 July 2021.

KW - Antidepressive Agents/adverse effects

KW - Dementia/diagnosis

KW - Deprescriptions

KW - Humans

KW - Nursing Homes

KW - Psychotropic Drugs/therapeutic use

KW - Quality of Life/psychology

KW - Randomized Controlled Trials as Topic

KW - Complex Intervention

U2 - 10.1186/s13063-022-06368-9

DO - 10.1186/s13063-022-06368-9

M3 - Journal article

C2 - 35578351

VL - 23

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 410

ER -