Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2019-10-09
2020-03-20
Brief Summary
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Detailed Description
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The aim of the OptiMEDs intervention is to obtain a more appropriate, safer, and more cost-effective pharmacotherapy in nursing home residents (e.g. less medication-related symptoms, less potentially inappropriate prescribing, a better quality of life, less hospitalisations, health care usage, or mortality)
Before investigating the effectiveness of the OptiMEDs intervention in a large pragmatic clinical trial comparing results of the intervention with standard of care, a pilot study will be undertaken. The aim of the pilot study is to test the feasibility and acceptability of all components of the OptiMEDs interventions in 3 nursing homes in Flanders, Belgium.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention
The intervention group (i.e. all eligible and consented residents of 2 NHs) will receive the OptiMEDs intervention: the combination of an electronic decision support tool (for the appraisal of potentially inappropriate medication use, anticholinergic use, or medications that can be de-prescribed in view of limited life expectancy) with focused nurse observations (using a list of potential medication-related symptoms based on the individual medication chart of the nursing home residents), that will serve as the basis during a multidisciplinary medication review with the input of GPs, trained community pharmacists and nurses.
OptiMEDs
The OptiMEDs intervention is a multi-faceted intervention combining:
1. an ICT platform:
* automatic and secure capture of individual prescribing information from the electronic medication administration records in the nursing home
* a tool for structured nurse observations of side effects, derived from the existing Pharmanurse application (20) (used to list potential medication side effects, based on the individual medication chart of the nursing home residents) to support monitoring of medication safety by nurses.
* an electronic decision support tool for the appraisal of potentially inappropriate medication (explicit criteria of misuse and underused of medication, based on existing lists of explicit criteria (PIMs)), use of medication with anticholinergic properties and medication inappropriate in view of the limited life expectancy.
2. a multidisciplinary medication review with the input of GPs, trained community-pharmacists and nurses.
Control
The control group (i.e. all eligible and consented residents of one control NH) will receive usual care .
No interventions assigned to this group
Interventions
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OptiMEDs
The OptiMEDs intervention is a multi-faceted intervention combining:
1. an ICT platform:
* automatic and secure capture of individual prescribing information from the electronic medication administration records in the nursing home
* a tool for structured nurse observations of side effects, derived from the existing Pharmanurse application (20) (used to list potential medication side effects, based on the individual medication chart of the nursing home residents) to support monitoring of medication safety by nurses.
* an electronic decision support tool for the appraisal of potentially inappropriate medication (explicit criteria of misuse and underused of medication, based on existing lists of explicit criteria (PIMs)), use of medication with anticholinergic properties and medication inappropriate in view of the limited life expectancy.
2. a multidisciplinary medication review with the input of GPs, trained community-pharmacists and nurses.
Eligibility Criteria
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Inclusion Criteria
* size: \> 100 beds
* mixed population of high care dependent and low care-dependent residents with and without dementia
* software of Care Solutions or Farmad is used for electronic handling of the medication chart
* the NH management as well as the responsible CRA and the community pharmacist who delivers the medication in the NH give their written agreement to participate
* aged 65 years or older
* mentally fit as well as cognitive impaired NH residents will be included after Informed Consent given by the resident (mentally capable residents) or his representative (cognitive impaired residents, defined as a sumscore of 6 or more on the KATZ items of disorientation in time and place).
Exclusion Criteria
* they have a limited life-expectancy (less than 3 months, as judged and documented by the treating GP)
* they are residing in a short-stay / revalidation bed
* GP refused to have his NH residents included in this pilot
65 Years
ALL
Yes
Sponsors
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Universiteit Antwerpen
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Thierry Christiaens, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine and Health Sciences
Locations
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WZC Sint-Jozef Deinze
Deinze, Oost-Vlaanderen, Belgium
WZC Sint-Jozef Gent
Ghent, Oost-Vlaanderen, Belgium
WZC Liberteyt
Ghent, , Belgium
Countries
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References
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Mann E, Kopke S, Haastert B, Pitkala K, Meyer G. Psychotropic medication use among nursing home residents in Austria: a cross-sectional study. BMC Geriatr. 2009 May 21;9:18. doi: 10.1186/1471-2318-9-18.
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Azermai M, Wauters M, De Meester D, Renson L, Pauwels D, Peeters L, Warie H, Petrovic M. A quality improvement initiative on the use of psychotropic drugs in nursing homes in Flanders. Acta Clin Belg. 2017 Jun;72(3):163-171. doi: 10.1080/17843286.2017.1287230. Epub 2017 Feb 16.
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Majumdar SR, Soumerai SB. Why most interventions to improve physician prescribing do not seem to work. CMAJ. 2003 Jul 8;169(1):30-1. No abstract available.
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Dilles T, Vander Stichele RH, Van Bortel LM, Elseviers MM. The development and test of an intervention to improve ADR screening in nursing homes. J Am Med Dir Assoc. 2013 May;14(5):379.e1-6. doi: 10.1016/j.jamda.2013.02.011. Epub 2013 Apr 2.
Wouters H, Scheper J, Koning H, Brouwer C, Twisk JW, van der Meer H, Boersma F, Zuidema SU, Taxis K. Discontinuing Inappropriate Medication Use in Nursing Home Residents: A Cluster Randomized Controlled Trial. Ann Intern Med. 2017 Nov 7;167(9):609-617. doi: 10.7326/M16-2729. Epub 2017 Oct 10.
Wauters M, Elseviers M, Vaes B, Degryse J, Dalleur O, Vander Stichele R, Christiaens T, Azermai M. Too many, too few, or too unsafe? Impact of inappropriate prescribing on mortality, and hospitalization in a cohort of community-dwelling oldest old. Br J Clin Pharmacol. 2016 Nov;82(5):1382-1392. doi: 10.1111/bcp.13055. Epub 2016 Aug 3.
Wauters M, Elseviers M, Azermai M, Vander Stichele R. Availability and actual use in the Belgian market of potentially inappropriate medications (PIMs) from the EU(7)-PIM list. Eur J Clin Pharmacol. 2016 Feb;72(2):243-5. doi: 10.1007/s00228-015-1947-3. Epub 2015 Sep 26. No abstract available.
Duran CE, Azermai M, Vander Stichele RH. Systematic review of anticholinergic risk scales in older adults. Eur J Clin Pharmacol. 2013 Jul;69(7):1485-96. doi: 10.1007/s00228-013-1499-3. Epub 2013 Mar 26.
Klamer TT, Wauters M, Azermai M, Duran C, Christiaens T, Elseviers M, Vander Stichele R. A Novel Scale Linking Potency and Dosage to Estimate Anticholinergic Exposure in Older Adults: the Muscarinic Acetylcholinergic Receptor ANTagonist Exposure Scale. Basic Clin Pharmacol Toxicol. 2017 Jun;120(6):582-590. doi: 10.1111/bcpt.12699. Epub 2017 Jan 16.
Wauters M, Klamer T, Elseviers M, Vaes B, Dalleur O, Degryse J, Duran C, Christiaens T, Azermai M, Vander Stichele R. Anticholinergic Exposure in a Cohort of Adults Aged 80 years and Over: Associations of the MARANTE Scale with Mortality and Hospitalization. Basic Clin Pharmacol Toxicol. 2017 Jun;120(6):591-600. doi: 10.1111/bcpt.12744. Epub 2017 Apr 6.
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Ivanova I, Wauters M, Stichele RV, Christiaens T, De Wolf J, Dilles T, Elseviers M. Medication use in a cohort of newly admitted nursing home residents (Ageing@NH) in relation to evolving physical and mental health. Arch Gerontol Geriatr. 2018 Mar-Apr;75:202-208. doi: 10.1016/j.archger.2018.01.005. Epub 2018 Jan 17.
Wauters M, Elseviers M, Vander Stichele R, Dilles T, Thienpont G, Christiaens T. Efficacy, feasibility and acceptability of the OptiMEDs tool for multidisciplinary medication review in nursing homes. Arch Gerontol Geriatr. 2021 Jul-Aug;95:104391. doi: 10.1016/j.archger.2021.104391. Epub 2021 Mar 17.
Other Identifiers
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B670201940251
Identifier Type: -
Identifier Source: org_study_id