OptiMEDs Pilot Study (OptiMEDs)

November 25, 2021 updated by: University Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • WZC Liberteyt
    • Oost-Vlaanderen
      • Deinze, Oost-Vlaanderen, Belgium, 9800
        • WZC Sint-Jozef Deinze
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • WZC Sint-Jozef Gent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Device: OptiMEDs

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.
No Intervention: Control
The control group (i.e. all eligible and consented residents of one control NH) will receive usual care .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Software/user problems
Time Frame: 6 months
monthly number of interventions for software/user problems (n)
6 months
functionality problems
Time Frame: 6 months
Number of functionality problems (n)
6 months
workload
Time Frame: 6 months
Timing of workload for nurses & pharmacists regarding the use of OptiMEDs (time)
6 months
medication chart review
Time Frame: 6 months
duration of a medication chart review by GP and nurse (time)
6 months
practical problems
Time Frame: 6 months
listing of practical problems for organizing the medication chart review
6 months
GPs that refuse
Time Frame: 6 months
number of GPs that refuse to participate / accept to participate (n)
6 months
non-consenting eligible residents (n)
Time Frame: 6 months
Number of non-consenting eligible residents legally capable to give consent (n)
6 months
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
6 months
Optimeds completion
Time Frame: 6 months
Number of symptom observations and medication reviews completed (on time) (n)
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

Universiteit Antwerpen

Investigators

  • Principal Investigator: Thierry Christiaens, PhD, MD, Faculty of Medicine and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2019

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

March 20, 2020

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B670201940251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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