OptiMEDs Pilot Study

University Ghent148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

148

Conditions

Medication Review Nursing Home Resident Nursing Home

Interventions

OptiMEDsDEVICE

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

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

WZC Sint-Jozef Deinze

Deinze, Oost-Vlaanderen, Belgium

WZC Sint-Jozef Gent

Ghent, Oost-Vlaanderen, Belgium

WZC Liberteyt

Ghent, Belgium

Outcomes

Primary Outcomes

Software/user problems

monthly number of interventions for software/user problems (n)

Time frame: 6 months

functionality problems

Number of functionality problems (n)

Time frame: 6 months

workload

Timing of workload for nurses \& pharmacists regarding the use of OptiMEDs (time)

Time frame: 6 months

medication chart review

duration of a medication chart review by GP and nurse (time)

Time frame: 6 months

practical problems

listing of practical problems for organizing the medication chart review

Time frame: 6 months

GPs that refuse

number of GPs that refuse to participate / accept to participate (n)

Time frame: 6 months

non-consenting eligible residents (n)

Number of non-consenting eligible residents legally capable to give consent (n)

Time frame: 6 months

Non-consenting proxies for eligible residents (n)

Number of non-consenting proxies for eligible residents legally not capable to give consent

Time frame: 6 months

Optimeds completion

Number of symptom observations and medication reviews completed (on time) (n)

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

number of medications

number of medications (n)

Time frame: 4 months

number of anticholinergics

number of anticholinergics (n)

Time frame: 4 months

number of candidates for de-prescribing

number of candidates for de-prescribing (n)

Time frame: 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)

Time frame: 4 months

patient-related alertness

patient-related alertness (score); nurse-observation using VAS scale (1 - 6, 1 = being alert)

Time frame: 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).

Time frame: 4 months

patient-related falls

patient-related falls (n)

Time frame: 4 months

Number of Consultations

Number of Consultations (n)

Time frame: 4 months

Number of Hospitalization

Number of Hospitalization (n)

Time frame: 4 months