A Cluster-randomized Trial of a Complex Intervention to Encourage Deprescribing Antidepressants in Nursing Home Residents with Dementia: a Study Protocol

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2022 May 16

PMID 35578351

Authors

Pernille Holmkjaer

Anne Holm

Gritt Overbeck

Maarten Pieter Rozing

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Factors promoting and impeding efforts to deprescribe antidepressants among nursing home residents with dementia- a process evaluation guided by normalization process theory.

Shahrzad S, Overbeck G, Holm A, Hoj K, Holmkjaer P BMC Nurs. 2024; 23(1):287.

PMID: 38679697 PMC: 11057106. DOI: 10.1186/s12912-024-01932-x.

Models for delivery and co-ordination of primary or secondary health care (or both) to older adults living in aged care facilities.

Putrik P, Grobler L, Lalor A, Ramsay H, Gorelik A, Karnon J Cochrane Database Syst Rev. 2024; 3:CD013880.

PMID: 38426600 PMC: 10905654. DOI: 10.1002/14651858.CD013880.pub2.

Using Shared Decision-Making Resources in Long-Term Care: a Qualitative Study.

Thompson W, McCarthy L, Galley E, Homan L, Farrell B Can Geriatr J. 2023; 26(2):253-258.

PMID: 37265981 PMC: 10198683. DOI: 10.5770/cgj.26.657.

Tailoring a complex intervention to reduce antidepressants in institutionalized older persons with dementia.

Holmkjaer P, Vermehren C, Holm A, Rozing M, Hoj K, Overbeck G BMC Health Serv Res. 2022; 22(1):1582.

PMID: 36572903 PMC: 9791154. DOI: 10.1186/s12913-022-08961-9.

References

Zakarias J, Norgaard A, Jensen-Dahm C, Gasse C, Laursen T, Palm H . Risk of hospitalization and hip fracture associated with psychotropic polypharmacy in patients with dementia: A nationwide register-based study. Int J Geriatr Psychiatry. 2021; 36(11):1691-1698. DOI: 10.1002/gps.5587. View

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M . Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008; 337:a1655. PMC: 2769032. DOI: 10.1136/bmj.a1655. View

Kessing L, Harhoff M, Andersen P . Treatment with antidepressants in patients with dementia--a nationwide register-based study. Int Psychogeriatr. 2006; 19(5):902-13. DOI: 10.1017/S1041610206004376. View

Huybrechts K, Rothman K, Silliman R, Brookhart M, Schneeweiss S . Risk of death and hospital admission for major medical events after initiation of psychotropic medications in older adults admitted to nursing homes. CMAJ. 2011; 183(7):E411-9. PMC: 3080558. DOI: 10.1503/cmaj.101406. View

Borda M, Jaramillo-Jimenez A, Oesterhus R, Santacruz J, Tovar-Rios D, Soennesyn H . Benzodiazepines and antidepressants: Effects on cognitive and functional decline in Alzheimer's disease and Lewy body dementia. Int J Geriatr Psychiatry. 2020; 36(6):917-925. DOI: 10.1002/gps.5494. View

Cummings J, Mega M, Gray K, Carusi D, Gornbein J . The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994; 44(12):2308-14. DOI: 10.1212/wnl.44.12.2308. View

May C, Cummings A, Girling M, Bracher M, Mair F, May C . Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. Implement Sci. 2018; 13(1):80. PMC: 5992634. DOI: 10.1186/s13012-018-0758-1. View

Lundby C, Jensen J, Larsen S, Hoffmann H, Pottegard A, Reilev M . Use of medication among nursing home residents: a Danish drug utilisation study. Age Ageing. 2020; 49(5):814-820. DOI: 10.1093/ageing/afaa029. View

Grill P, Marwick C, De Souza N, Burton J, Hughes C, Guthrie B . The burden of psychotropic and anticholinergic medicines use in care homes: population-based analysis in 147 care homes. Age Ageing. 2020; 50(1):183-189. DOI: 10.1093/ageing/afaa122. View

10.

Moth A, Holmkjaer P, Holm A, Rozing M, Overbeck G . What Makes Deprescription of Psychotropic Drugs in Nursing Home Residents with Dementia so Challenging? A Qualitative Systematic Review of Barriers and Facilitators. Drugs Aging. 2021; 38(8):671-685. PMC: 8342345. DOI: 10.1007/s40266-021-00875-1. View

11.

Hsu T, Stubbs B, Liang C, Chen T, Yeh T, Pan C . Efficacy of serotonergic antidepressant treatment for the neuropsychiatric symptoms and agitation in dementia: A systematic review and meta-analysis. Ageing Res Rev. 2021; 69:101362. DOI: 10.1016/j.arr.2021.101362. View

12.

Wood S, Cummings J, Hsu M, Barclay T, Wheatley M, Yarema K . The use of the neuropsychiatric inventory in nursing home residents. Characterization and measurement. Am J Geriatr Psychiatry. 2000; 8(1):75-83. DOI: 10.1097/00019442-200002000-00010. View

13.

Xu S, Jin X, Liu C, Jin Y, Xu Y, Chen L . Investigating the Prevalence of Dementia and Its Associated Risk Factors in a Chinese Nursing Home. J Clin Neurol. 2016; 13(1):10-14. PMC: 5242154. DOI: 10.3988/jcn.2017.13.1.10. View

14.

Selbaek G, Engedal K, Saltyte Benth J, Bergh S . The course of neuropsychiatric symptoms in nursing-home patients with dementia over a 53-month follow-up period. Int Psychogeriatr. 2013; 26(1):81-91. DOI: 10.1017/S1041610213001609. View

15.

Lapeyre-Mestre M . A Review of Adverse Outcomes Associated with Psychoactive Drug Use in Nursing Home Residents with Dementia. Drugs Aging. 2016; 33(12):865-888. DOI: 10.1007/s40266-016-0414-x. View

16.

Smeets C, Smalbrugge M, Koopmans R, Nelissen-Vrancken M, van der Spek K, Teerenstra S . Can the PROPER intervention reduce psychotropic drug prescription in nursing home residents with dementia? Results of a cluster-randomized controlled trial. Int Psychogeriatr. 2020; 33(6):577-586. DOI: 10.1017/S1041610220000629. View

17.

Maust D, Kim H, Seyfried L, Chiang C, Kavanagh J, Schneider L . Antipsychotics, other psychotropics, and the risk of death in patients with dementia: number needed to harm. JAMA Psychiatry. 2015; 72(5):438-45. PMC: 4439579. DOI: 10.1001/jamapsychiatry.2014.3018. View

18.

Izza M, Lunt E, Gordon A, Gladman J, Armstrong S, Logan P . Polypharmacy, benzodiazepines, and antidepressants, but not antipsychotics, are associated with increased falls risk in UK care home residents: a prospective multi-centre study. Eur Geriatr Med. 2020; 11(6):1043-1050. PMC: 7716922. DOI: 10.1007/s41999-020-00376-1. View

19.

Gaugler J, Yu F, Davila H, Shippee T . Alzheimer's disease and nursing homes. Health Aff (Millwood). 2014; 33(4):650-7. PMC: 5767317. DOI: 10.1377/hlthaff.2013.1268. View

20.

Gourdon M, Petit L, Delpierre S, Sebbagh-Eczet M, Estrada J, Marquis C . Overuse of antidepressants in older outpatients with Alzheimer's disease and associated disorders: an observational study. Geriatr Psychol Neuropsychiatr Vieil. 2021; . DOI: 10.1684/pnv.2021.0934. View