Drug Safety for Nursing-Home Residents-Findings of a Pragmatic, Cluster-Randomized, Controlled Intervention Trialin 44 Nursing Homes

Overview

Journal Dtsch Arztebl Int

Specialties General Medicine
Public Health

Date 2021 Aug 9

PMID 34366004

Citations 13

Authors

Ulrike Junius-Walker

Olaf Krause

Petra Thurmann

Simone Bernhard

Angela Fuchs

Lisa Sparenberg

Anja Wollny

Regina Stolz

Hannah Haumann

Antje Freytag

Claudia Kirsch

Svetlana Usacheva

Stefan Wilm

Birgitt Wiese

Affiliations

Soon will be listed here.

Abstract

Background: The safety of drug use by nursing-home residents can be impaired by polypharmacy, potentially inappropriate medications (PIM), and neuroleptics, as well as by a lack of adequate interprofessional coordination in the nursing home. The goal of the HIOPP-3-iTBX Trial was to improve drug safety in nursing-home residents, including a reduction of PIM and/or neu - roleptic use, by means of a complex interprofessional intervention.

Methods: This cluster-randomized, controlled trial was performed in nursing homes in Germany. Residents over age 65 were included in the trial. The intervention was carried out over six months and consisted of four elements: a drug review by trained pharmacists, educational sessions for general practitioners and nurses, a drug safety toolbox, and change management seminars for members of the three participating professions. The nursing homes in the control group continued to provide usual care. The primary endpoint was the prescription of at least one PIM and/or at least two neuroleptic drugs simultaneously. The secondary endpoints were the incidence of falls and hospitalizations, quality of life, and health-care costs. This trial is registered in the German Clinical Trials Registry (DRKS00013588).

Results: 44 nursing homes with 862 residents were randomized, 23 of them (with 452 residents) to the intervention group and 21 (with 410 residents) to the control group. 41% of all nursing-home residents initially took at least one PIM and/or at least two neuroleptic drugs simultaneously. Follow-up data (including, among other things, the current drug regimen) were obtained for 773 residents. The intention-to-treat analysis continued to show no difference between the intervention group and the control group with respect to the primary endpoint.

Conclusion: This trial of an intervention to improve drug safety in nursing homes led neither to reduced prescribing of PIM and/or neuroleptic drugs, nor to any improvement in the overall health status of the nursing-home residents.

Citing Articles

Individual Pharmacotherapy Management (IPM-II) for Patient and Drug Safety in Polypharmacy via Clinical Electronic Health Record Is Associated with Significant Fall Prevention.

Wolf U, Drewas L, Ghadir H, Bauer C, Becherer L, Delank K Pharmaceuticals (Basel). 2025; 17(12.

PMID: 39770429 PMC: 11676629. DOI: 10.3390/ph17121587.

Designing an Intervention to Improve Medication Safety for Nursing Home Residents Based on Experiential Knowledge Related to Patient Safety Culture at the Nursing Home Front Line: Cocreative Process Study.

Juhl M, Soerensen A, Vardinghus-Nielsen H, Mortensen L, Kristensen J, Olesen A JMIR Form Res. 2024; 8:e54977.

PMID: 39383532 PMC: 11499722. DOI: 10.2196/54977.

[Medication supply and polypharmacy in long-term care : An overview of possible interventions and the question of a functioning concept].

Graeb F, Berger B, Alf F, Reiber P, Essig G, Wolke R Z Gerontol Geriatr. 2024; .

PMID: 39136716 DOI: 10.1007/s00391-024-02340-1.

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.

Digital Medication Management in Polypharmacy—Findings of a Cluster-Randomized, Controlled Trial With a Stepped-Wedge Design in Primary Care Practices (AdAM).

Brunn R, Basten J, Lemke D, Piotrowski A, Soling S, Surmann B Dtsch Arztebl Int. 2024; 121(8):243-250.

PMID: 38377330 PMC: 11381212. DOI: 10.3238/arztebl.m2024.0007.

References

Mosshammer D, Haumann H, Morike K, Joos S . Polypharmacy-an Upward Trend with Unpredictable Effects. Dtsch Arztebl Int. 2016; 113(38):627-633. PMC: 5078862. DOI: 10.3238/arztebl.2016.0627. View

Koch K, Miksch A, Schurmann C, Joos S, Sawicki P . The German health care system in international comparison: the primary care physicians' perspective. Dtsch Arztebl Int. 2011; 108(15):255-61. PMC: 3088170. DOI: 10.3238/arztebl.2011.0255. View

Kirsch C, Doyle I, Krause O, Junius-Walker U, Wiese B, Thurmann P . [Lessons learned: Challenges faced in the recruitment process for the cluster-randomized nursing home study HIOPP-3 iTBX]. Z Evid Fortbild Qual Gesundhwes. 2020; 156-157:24-32. DOI: 10.1016/j.zefq.2020.07.002. View

Husebo B, Ballard C, Aarsland D, Selbaek G, Slettebo D, Gulla C . The Effect of a Multicomponent Intervention on Quality of Life in Residents of Nursing Homes: A Randomized Controlled Trial (COSMOS). J Am Med Dir Assoc. 2019; 20(3):330-339. DOI: 10.1016/j.jamda.2018.11.006. View

Forsetlund L, Eike M, Gjerberg E, Vist G . Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr. 2011; 11:16. PMC: 3108292. DOI: 10.1186/1471-2318-11-16. View

Loganathan M, Singh S, Franklin B, Bottle A, Majeed A . Interventions to optimise prescribing in care homes: systematic review. Age Ageing. 2011; 40(2):150-62. DOI: 10.1093/ageing/afq161. View

Hedna K, Hakkarainen K, Gyllensten H, Jonsson A, Petzold M, Hagg S . Potentially inappropriate prescribing and adverse drug reactions in the elderly: a population-based study. Eur J Clin Pharmacol. 2015; 71(12):1525-33. PMC: 4643104. DOI: 10.1007/s00228-015-1950-8. View

Alldred D, Kennedy M, Hughes C, Chen T, Miller P . Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst Rev. 2016; 2:CD009095. PMC: 7111425. DOI: 10.1002/14651858.CD009095.pub3. View

Strauven G, Anrys P, Vandael E, Henrard S, De Lepeleire J, Spinewine A . Cluster-Controlled Trial of an Intervention to Improve Prescribing in Nursing Homes Study. J Am Med Dir Assoc. 2019; 20(11):1404-1411. DOI: 10.1016/j.jamda.2019.06.006. View

10.

Richter T, Mann E, Meyer G, Haastert B, Kopke S . Prevalence of psychotropic medication use among German and Austrian nursing home residents: a comparison of 3 cohorts. J Am Med Dir Assoc. 2011; 13(2):187.e7-187.e13. DOI: 10.1016/j.jamda.2011.03.007. View

11.

Liperoti R, Sganga F, Landi F, Topinkova E, Denkinger M, van der Roest H . Antipsychotic Drug Interactions and Mortality Among Nursing Home Residents With Cognitive Impairment. J Clin Psychiatry. 2017; 78(1):e76-e82. DOI: 10.4088/JCP.15m10303. View

12.

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

13.

Bakken M, Schjott J, Engeland A, Engesaeter L, Ruths S . Antipsychotic Drugs and Risk of Hip Fracture in People Aged 60 and Older in Norway. J Am Geriatr Soc. 2016; 64(6):1203-9. DOI: 10.1111/jgs.14162. View

14.

Tsakitzidis G, Anthierens S, Timmermans O, Truijen S, Meulemans H, Van Royen P . Do not confuse multidisciplinary task management in nursing homes with interprofessional care!. Prim Health Care Res Dev. 2017; 18(6):591-602. DOI: 10.1017/S146342361700024X. View

15.

Seidling H, Send A, Bittmann J, Renner K, Dewald B, Lange D . Medication review in German community pharmacies - Post-hoc analysis of documented drug-related problems and subsequent interventions in the ATHINA-project. Res Social Adm Pharm. 2016; 13(6):1127-1134. DOI: 10.1016/j.sapharm.2016.10.016. View

16.

Endres H, Kaufmann-Kolle P, Steeb V, Bauer E, Bottner C, Thurmann P . Association between Potentially Inappropriate Medication (PIM) Use and Risk of Hospitalization in Older Adults: An Observational Study Based on Routine Data Comparing PIM Use with Use of PIM Alternatives. PLoS One. 2016; 11(2):e0146811. PMC: 4740421. DOI: 10.1371/journal.pone.0146811. View

17.

Beuscart J, Knol W, Cullinan S, Schneider C, Dalleur O, Boland B . International core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy. BMC Med. 2018; 16(1):21. PMC: 5809844. DOI: 10.1186/s12916-018-1007-9. View

18.

Wouters H, Scheper J, Koning H, Brouwer C, Twisk J, van der Meer H . Discontinuing Inappropriate Medication Use in Nursing Home Residents: A Cluster Randomized Controlled Trial. Ann Intern Med. 2017; 167(9):609-617. DOI: 10.7326/M16-2729. View

19.

Th Rmann P . Medication Safety-Models of Interprofessional Collaboration. Dtsch Arztebl Int. 2016; 113(43):739-740. PMC: 5159680. DOI: 10.3238/arztebl.2016.0739. View

20.

Jaehde U, Thurmann P . [Medication safety in nursing homes]. Z Evid Fortbild Qual Gesundhwes. 2012; 106(10):712-6. DOI: 10.1016/j.zefq.2012.10.021. View