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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
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Pilot study of the OptiMEDs intervention: a complex intervention for multidisciplinary medication review (including nurses, pharmacists, and physicians) in nursing homes (NH), with ICT-support for the evaluation of the appropriateness of prescribing and for side-effect monitoring.
The interest in improving the pharmacotherapy of older adults in nursing homes is growing. The OptiMEDs interventions intends to support the decision of GPs regarding the pharmacotherapy of older adults through 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 focussed nurse observations (guided by a list of potential medication symptoms based on the individual medication chart of the resident), that will serve as the basis for a multidisciplinary medication review with the input of the GP, community pharmacist and nurse.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Control | No Intervention | The control group (i.e. all eligible and consented residents of one control NH) will receive usual care . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OptiMEDs | Device | The OptiMEDs intervention is a multi-faceted intervention combining:
|
| Measure | Description | Time Frame |
|---|---|---|
| Software/user problems | monthly number of interventions for software/user problems (n) | 6 months |
| functionality problems | Number of functionality problems (n) | 6 months |
| workload | Timing of workload for nurses & pharmacists regarding the use of OptiMEDs (time) | 6 months |
| medication chart review | duration of a medication chart review by GP and nurse (time) | 6 months |
| practical problems | listing of practical problems for organizing the medication chart review | 6 months |
| GPs that refuse | number of GPs that refuse to participate / accept to participate (n) | 6 months |
| non-consenting eligible residents (n) | Number of non-consenting eligible residents legally capable to give consent (n) | 6 months |
| Non-consenting proxies for eligible residents (n) | Number of non-consenting proxies for eligible residents legally not capable to give consent | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of medications | number of medications (n) | 4 months |
| number of anticholinergics | number of anticholinergics (n) | 4 months |
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Inclusion criteria for nursing homes:
Inclusion criteria for residents:
All residents of all wards of the participating nursing homes will be considered for inclusion if they meet the following inclusion criteria:
Exclusion criteria for residents
Residents will not be considered for inclusion if:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Christiaens, PhD, MD | Faculty of Medicine and Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WZC Sint-Jozef Deinze | Deinze | Oost-Vlaanderen | 9800 | Belgium | ||
| WZC Sint-Jozef Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22867442 | Background | De Almeida Mello J, Van Durme T, Macq J, Declercq A. Interventions to delay institutionalization of frail older persons: design of a longitudinal study in the home care setting. BMC Public Health. 2012 Aug 6;12:615. doi: 10.1186/1471-2458-12-615. | |
| 21394786 | Background | Azermai M, Elseviers M, Petrovic M, Van Bortel L, Vander Stichele R. Geriatric drug utilisation of psychotropics in Belgian nursing homes. Hum Psychopharmacol. 2011 Jan;26(1):12-20. doi: 10.1002/hup.1160. |
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A pragmatic cluster-randomized trial with the inclusion of two NHs where the feasibility and acceptability of the OptiMEDs intervention will be tested and one NH where the standard of care will be registered.
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|
| Optimeds completion | Number of symptom observations and medication reviews completed (on time) (n) | 6 months |
| number of candidates for de-prescribing | number of candidates for de-prescribing (n) | 4 months |
| patient-related pain | Score; In patients with dementia: nurse-observation using PAIN-AD scale (0 - 10, 10 = worst pain), patients without dementia: Pain VAS scale (0 - 10, 10 = worst pain) | 4 months |
| patient-related alertness | patient-related alertness (score); nurse-observation using VAS scale (1 - 6, 1 = being alert) | 4 months |
| patient-related QOL | patient-related QOL (score and/or profile); EQ-5D-5L; 5 dimensions (mobility / self-care / usual activities / pain or discomfort / anxiety or depression) and 5 levels (no / slight / moderate / severe / extreme problems). | 4 months |
| patient-related falls | patient-related falls (n) | 4 months |
| Number of Consultations | Number of Consultations (n) | 4 months |
| Number of Hospitalization | Number of Hospitalization (n) | 4 months |
| Ghent |
| Oost-Vlaanderen |
| 9000 |
| Belgium |
| WZC Liberteyt | Ghent | 9000 | Belgium |
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| 12915206 | Background | Turnheim K. When drug therapy gets old: pharmacokinetics and pharmacodynamics in the elderly. Exp Gerontol. 2003 Aug;38(8):843-53. doi: 10.1016/s0531-5565(03)00133-5. |
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| 33819776 | Derived | 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. |