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OptiMEDs Pilot Study

Sponsor
University Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT04142645
Collaborator
Universiteit Antwerpen (Other)
148
Enrollment
3
Locations
2
Arms
5.4
Actual Duration (Months)
49.3
Patients Per Site
9.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: OptiMEDs
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Oct 9, 2019
Actual Primary Completion Date :
Mar 20, 2020
Actual Study Completion Date :
Mar 20, 2020

Arms and Interventions

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: 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.
No Intervention: Control

The control group (i.e. all eligible and consented residents of one control NH) will receive usual care .

Outcome Measures

Primary Outcome Measures

  1. Software/user problems [6 months]

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

  2. functionality problems [6 months]

    Number of functionality problems (n)

  3. workload [6 months]

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

  4. medication chart review [6 months]

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

  5. practical problems [6 months]

    listing of practical problems for organizing the medication chart review

  6. GPs that refuse [6 months]

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

  7. non-consenting eligible residents (n) [6 months]

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

  8. Non-consenting proxies for eligible residents (n) [6 months]

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

  9. Optimeds completion [6 months]

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

Secondary Outcome Measures

  1. number of medications [4 months]

    number of medications (n)

  2. number of anticholinergics [4 months]

    number of anticholinergics (n)

  3. number of candidates for de-prescribing [4 months]

    number of candidates for de-prescribing (n)

  4. 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)

  5. patient-related alertness [4 months]

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

  6. 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).

  7. patient-related falls [4 months]

    patient-related falls (n)

  8. Number of Consultations [4 months]

    Number of Consultations (n)

  9. Number of Hospitalization [4 months]

    Number of Hospitalization (n)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 WZC Sint-Jozef Deinze Deinze Oost-Vlaanderen Belgium 9800
2 WZC Sint-Jozef Gent Gent Oost-Vlaanderen Belgium 9000
3 WZC Liberteyt Gent Belgium 9000

Sponsors and Collaborators

  • University Ghent
  • Universiteit Antwerpen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT04142645
Other Study ID Numbers:
  • B670201940251
First Posted:
Oct 29, 2019
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Ghent
Medication Reconciliation
Aged

Study Results

No Results Posted as of Nov 29, 2021