Drug Safety for Nursing-Home Residents-Findings of a Pragmatic, Cluster-Randomized, Controlled Intervention Trialin 44 Nursing Homes.
Journal
Deutsches Arzteblatt international
ISSN: 1866-0452
Titre abrégé: Dtsch Arztebl Int
Pays: Germany
ID NLM: 101475967
Informations de publication
Date de publication:
22 10 2021
22 10 2021
Historique:
received:
24
02
2021
revised:
24
02
2021
accepted:
14
07
2021
pubmed:
10
8
2021
medline:
27
1
2022
entrez:
9
8
2021
Statut:
ppublish
Résumé
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. 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). 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 34366004
pii: arztebl.m2021.0297
doi: 10.3238/arztebl.m2021.0297
pmc: PMC8767148
doi:
pii:
Substances chimiques
Pharmaceutical Preparations
0
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
705-712Références
Dtsch Arztebl Int. 2016 Sep 23;113(38):627-633
pubmed: 27743469
Dtsch Arztebl Int. 2011 Apr;108(15):255-61
pubmed: 21556263
Z Evid Fortbild Qual Gesundhwes. 2020 Nov;156-157:24-32
pubmed: 32861614
J Am Med Dir Assoc. 2019 Mar;20(3):330-339
pubmed: 30630722
BMC Geriatr. 2011 Apr 17;11:16
pubmed: 21496345
Age Ageing. 2011 Mar;40(2):150-62
pubmed: 21262782
Eur J Clin Pharmacol. 2015 Dec;71(12):1525-33
pubmed: 26407684
Cochrane Database Syst Rev. 2016 Feb 12;2:CD009095
pubmed: 26866421
J Am Med Dir Assoc. 2019 Nov;20(11):1404-1411
pubmed: 31402136
J Am Med Dir Assoc. 2012 Feb;13(2):187.e7-187.e13
pubmed: 21549645
J Clin Psychiatry. 2017 Jan;78(1):e76-e82
pubmed: 28129493
Int Psychogeriatr. 2021 Jun;33(6):577-586
pubmed: 32431251
J Am Geriatr Soc. 2016 Jun;64(6):1203-9
pubmed: 27321599
Prim Health Care Res Dev. 2017 Nov;18(6):591-602
pubmed: 28625197
Res Social Adm Pharm. 2017 Nov;13(6):1127-1134
pubmed: 27816566
PLoS One. 2016 Feb 03;11(2):e0146811
pubmed: 26840396
BMC Med. 2018 Feb 13;16(1):21
pubmed: 29433501
Ann Intern Med. 2017 Nov 7;167(9):609-617
pubmed: 29052691
Dtsch Arztebl Int. 2016 Nov 4;113(43):739-740
pubmed: 27890049
Z Evid Fortbild Qual Gesundhwes. 2012;106(10):712-6
pubmed: 23217723
Dtsch Arztebl Int. 2016 Feb 12;113(6):92-8
pubmed: 26931625
Age Ageing. 2016 Jan;45(1):115-20
pubmed: 26683048
BMC Geriatr. 2019 Jan 25;19(1):24
pubmed: 30683060
Z Evid Fortbild Qual Gesundhwes. 2009;103(6):404-9
pubmed: 19839218
Gesundheitswesen. 2019 Dec;81(12):1057-1068
pubmed: 29929202
Appl Nurs Res. 2017 Jun;35:118-125
pubmed: 28532718