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Trial record 1 of 1 for:    b670201940251
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OptiMEDs Pilot Study (OptiMEDs)

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ClinicalTrials.gov Identifier: NCT04142645
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
University Ghent

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
Medication Review Nursing Home Resident Nursing Home Device: OptiMEDs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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.
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 : October 9, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

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 .



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142645


Contacts
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Contact: Maarten Wauters, PhD +3293320040 maarten.wauters@ugent.be
Contact: Thierry Christiaens, PhD, MD +3293325800 thierry.christiaens@ugent.be

Locations
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Belgium
WZC Sint-Jozef Deinze Recruiting
Deinze, Oost-Vlaanderen, Belgium, 9800
Contact: Valerie Opbrouck, RN         
Principal Investigator: Kris Van Caenegem, MD         
WZC Sint-Jozef Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Johan Banneel, RN         
Principal Investigator: Erik Kegels, MD         
WZC Liberteyt Recruiting
Gent, Belgium, 9000
Contact: Liesbeth De Vogelaere, RN         
Principal Investigator: Vera De Vleesschauwer, MD         
Sponsors and Collaborators
University Ghent
Universiteit Antwerpen
Investigators
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Principal Investigator: Thierry Christiaens, PhD, MD Faculty of Medicine and Health Sciences
Publications:

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT04142645    
Other Study ID Numbers: B670201940251
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
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