Skip to main content
OpenTrials
Completed

NCT Number: NCT04142645

OptiMEDs Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WZC Sint-Jozef Deinze, Deinze, Oost-Vlaanderen, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OptiMEDs

Device

The OptiMEDs intervention is a multi-faceted intervention combining:

  • 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.
  • a multidisciplinary medication review with the input of GPs, trained community-pharmacists and nurses.

Primary outcomes

  1. Software/user problems

    Time frame: 6 months

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

  2. functionality problems

    Time frame: 6 months

    Number of functionality problems (n)

  3. workload

    Time frame: 6 months

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

  4. medication chart review

    Time frame: 6 months

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

  5. practical problems

    Time frame: 6 months

    listing of practical problems for organizing the medication chart review

  6. GPs that refuse

    Time frame: 6 months

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

  7. non-consenting eligible residents (n)

    Time frame: 6 months

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

  8. Non-consenting proxies for eligible residents (n)

    Time frame: 6 months

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

  9. Optimeds completion

    Time frame: 6 months

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

Secondary outcomes

  1. number of medications

    Time frame: 4 months

    number of medications (n)

  2. number of anticholinergics

    Time frame: 4 months

    number of anticholinergics (n)

  3. number of candidates for de-prescribing

    Time frame: 4 months

    number of candidates for de-prescribing (n)

  4. patient-related pain

    Time frame: 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)

  5. patient-related alertness

    Time frame: 4 months

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

  6. patient-related QOL

    Time frame: 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).

  7. patient-related falls

    Time frame: 4 months

    patient-related falls (n)

  8. Number of Consultations

    Time frame: 4 months

    Number of Consultations (n)

  9. Number of Hospitalization

    Time frame: 4 months

    Number of Hospitalization (n)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

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

Acronym: OptiMEDs

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.