OptiMEDs Pilot Study

Not Applicable

Completed

• Conditions: Medication Review; Nursing Home Resident; Nursing Home
• Interventions: Device: OptiMEDs

• Registration Number: NCT04142645
• Lead Sponsor: University Ghent

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-09-30
• Study Start: 2019-10-09
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	OptiMEDs	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.

Primary Outcome Measures

Name	Time	Method
functionality problems	6 months	Number of functionality problems (n)
practical problems	6 months	listing of practical problems for organizing the medication chart review
workload	6 months	Timing of workload for nurses \& pharmacists regarding the use of OptiMEDs (time)
medication chart review	6 months	duration of a medication chart review by GP and nurse (time)
GPs that refuse	6 months	number of GPs that refuse to participate / accept to participate (n)
Optimeds completion	6 months	Number of symptom observations and medication reviews completed (on time) (n)
Software/user problems	6 months	monthly number of interventions for software/user problems (n)
non-consenting eligible residents (n)	6 months	Number of non-consenting eligible residents legally capable to give consent (n)
Non-consenting proxies for eligible residents (n)	6 months	Number of non-consenting proxies for eligible residents legally not capable to give consent

Secondary Outcome Measures

Name	Time	Method
number of anticholinergics	4 months	number of anticholinergics (n)
patient-related alertness	4 months	patient-related alertness (score); nurse-observation using VAS scale (1 - 6, 1 = being alert)
patient-related falls	4 months	patient-related falls (n)
number of medications	4 months	number of medications (n)
patient-related QOL	4 months	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).
Number of Hospitalization	4 months	Number of Hospitalization (n)
Number of Consultations	4 months	Number of Consultations (n)
number of candidates for de-prescribing	4 months	number of candidates for de-prescribing (n)
patient-related pain	4 months	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)

Trial Locations

Locations (3)

WZC Sint-Jozef Gent; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

WZC Sint-Jozef Deinze; 🇧🇪 Deinze, Oost-Vlaanderen, Belgium

WZC Liberteyt; 🇧🇪 Gent, Belgium