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OptiMEDs Pilot Study

Pilot Study of the OptiMEDs Intervention: a Complex Intervention for Multidisciplinary Medication Review (Including Nurses, Pharmacists, and Physicians) in Nursing Homes, With ICT-support for the Evaluation of the Appropriateness of Prescribing and for Side-effect Monitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04142645
Acronym
OptiMEDs
Enrollment
148
Registered
2019-10-29
Start date
2019-10-09
Completion date
2020-03-20
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Review, Nursing Home, Nursing Home Resident

Keywords

Medication Reconciliation, Aged

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.

Interventions

DEVICEOptiMEDs

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.

Sponsors

Universiteit Antwerpen
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for nursing homes: * located in East Flanders * 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 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: * 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

for residents Residents will not be considered for inclusion if: * 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

Design outcomes

Primary

MeasureTime frameDescription
GPs that refuse6 monthsnumber of GPs that refuse to participate / accept to participate (n)
non-consenting eligible residents (n)6 monthsNumber of non-consenting eligible residents legally capable to give consent (n)
Non-consenting proxies for eligible residents (n)6 monthsNumber of non-consenting proxies for eligible residents legally not capable to give consent
Optimeds completion6 monthsNumber of symptom observations and medication reviews completed (on time) (n)
Software/user problems6 monthsmonthly number of interventions for software/user problems (n)
functionality problems6 monthsNumber of functionality problems (n)
workload6 monthsTiming of workload for nurses & pharmacists regarding the use of OptiMEDs (time)
medication chart review6 monthsduration of a medication chart review by GP and nurse (time)
practical problems6 monthslisting of practical problems for organizing the medication chart review

Secondary

MeasureTime frameDescription
number of medications4 monthsnumber of medications (n)
number of anticholinergics4 monthsnumber of anticholinergics (n)
number of candidates for de-prescribing4 monthsnumber of candidates for de-prescribing (n)
patient-related pain4 monthsScore; 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)
patient-related alertness4 monthspatient-related alertness (score); nurse-observation using VAS scale (1 - 6, 1 = being alert)
patient-related QOL4 monthspatient-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).
patient-related falls4 monthspatient-related falls (n)
Number of Consultations4 monthsNumber of Consultations (n)
Number of Hospitalization4 monthsNumber of Hospitalization (n)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026