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Medication ReviewOptiMEDsNCT04142645

OptiMEDs Pilot Study

A study testing OptiMEDs in people with Medication Review and Nursing Home Resident, run by University Ghent at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
OptiMEDs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
3 sitesBelgium
Study dates
9 Oct 2019to 20 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
  • 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).

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • WZC Sint-Jozef Deinze

    Deinze, Oost-Vlaanderen, 9800

  • WZC Sint-Jozef Gent

    Ghent, Oost-Vlaanderen, 9000

  • WZC Liberteyt

    Ghent, 9000

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
OptiMEDs
Keywords
Medication Reconciliation, Aged

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.
    1. a multidisciplinary medication review with the input of GPs, trained community-pharmacists and nurses.
Study groups in NCT04142645
Study groupRoleWhat they receive
InterventionExperimentalThe 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.
Receives: Device: OptiMEDs
ControlNo interventionThe control group (i.e. all eligible and consented residents of one control NH) will receive usual care .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Software/user problems

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

    Measured: 6 months

  2. functionality problems

    Number of functionality problems (n)

    Measured: 6 months

  3. workload

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

    Measured: 6 months

  4. medication chart review

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

    Measured: 6 months

  5. practical problems

    listing of practical problems for organizing the medication chart review

    Measured: 6 months

  6. GPs that refuse

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

    Measured: 6 months

  7. non-consenting eligible residents (n)

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

    Measured: 6 months

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

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

    Measured: 6 months

  9. Optimeds completion

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

    Measured: 6 months

Secondary outcomes (9)

  1. number of medications

    number of medications (n)

    Measured: 4 months

  2. number of anticholinergics

    number of anticholinergics (n)

    Measured: 4 months

  3. number of candidates for de-prescribing

    number of candidates for de-prescribing (n)

    Measured: 4 months

  4. 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)

    Measured: 4 months

  5. patient-related alertness

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

    Measured: 4 months

  6. 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).

    Measured: 4 months

  7. patient-related falls

    patient-related falls (n)

    Measured: 4 months

  8. Number of Consultations

    Number of Consultations (n)

    Measured: 4 months

  9. Number of Hospitalization

    Number of Hospitalization (n)

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start9 Oct 2019
  3. Primary completion20 Mar 2020
  4. Study completion20 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142645
Sponsor's protocol ID
B670201940251
Acronym
OptiMEDs
Status last verified
Nov 2021
First submitted
30 Sep 2019
Last updated
29 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Almeida Mello J, Van Durme T, Macq J, Declercq A. Interventions to delay institutionalization of frail older persons: design of a longitudinal study in the home care setting. BMC Public Health. 2012 Aug 6;12:615. doi: 10.1186/1471-2458-12-615.

    PubMed 22867442

  • Azermai M, Elseviers M, Petrovic M, Van Bortel L, Vander Stichele R. Geriatric drug utilisation of psychotropics in Belgian nursing homes. Hum Psychopharmacol. 2011 Jan;26(1):12-20. doi: 10.1002/hup.1160.

    PubMed 21394786

  • Mann E, Kopke S, Haastert B, Pitkala K, Meyer G. Psychotropic medication use among nursing home residents in Austria: a cross-sectional study. BMC Geriatr. 2009 May 21;9:18. doi: 10.1186/1471-2318-9-18.

    PubMed 19460135

  • Turnheim K. When drug therapy gets old: pharmacokinetics and pharmacodynamics in the elderly. Exp Gerontol. 2003 Aug;38(8):843-53. doi: 10.1016/s0531-5565(03)00133-5.

    PubMed 12915206

  • Klotz U. Pharmacokinetics and drug metabolism in the elderly. Drug Metab Rev. 2009;41(2):67-76. doi: 10.1080/03602530902722679.

    PubMed 19514965

  • Basger BJ, Moles RJ, Chen TF. Application of drug-related problem (DRP) classification systems: a review of the literature. Eur J Clin Pharmacol. 2014 Jul;70(7):799-815. doi: 10.1007/s00228-014-1686-x. Epub 2014 May 2.

    PubMed 24789053

  • Shenoy P, Harugeri A. Elderly patients' participation in clinical trials. Perspect Clin Res. 2015 Oct-Dec;6(4):184-9. doi: 10.4103/2229-3485.167099.

    PubMed 26623388

  • Anrys P, Strauven G, Boland B, Dalleur O, Declercq A, Degryse JM, De Lepeleire J, Henrard S, Lacour V, Simoens S, Speybroeck N, Vanhaecht K, Spinewine A, Foulon V. Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON): study protocol of a cluster controlled trial. Implement Sci. 2016 Mar 11;11:35. doi: 10.1186/s13012-016-0394-6.

    PubMed 26968520

  • Azermai M, Wauters M, De Meester D, Renson L, Pauwels D, Peeters L, Warie H, Petrovic M. A quality improvement initiative on the use of psychotropic drugs in nursing homes in Flanders. Acta Clin Belg. 2017 Jun;72(3):163-171. doi: 10.1080/17843286.2017.1287230. Epub 2017 Feb 16.

    PubMed 28206874

  • Ivanova I, Elseviers M, Wauters M, Christiaens T, Vander Stichele R. European repository of explicit criteria of potentially inappropriate medications in old age. Geriatr Gerontol Int. 2018 Aug;18(8):1293-1297. doi: 10.1111/ggi.13331. Epub 2018 Apr 17.

    PubMed 29665270

  • Robertson J, Walkom E, Pearson SA, Hains I, Williamsone M, Newby D. The impact of pharmacy computerised clinical decision support on prescribing, clinical and patient outcomes: a systematic review of the literature. Int J Pharm Pract. 2010 Apr;18(2):69-87.

    PubMed 20441116

  • Lavan AH, Gallagher PF, O'Mahony D. Methods to reduce prescribing errors in elderly patients with multimorbidity. Clin Interv Aging. 2016 Jun 23;11:857-66. doi: 10.2147/CIA.S80280. eCollection 2016.

    PubMed 27382268

  • Forsetlund L, Eike MC, Gjerberg E, Vist GE. Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr. 2011 Apr 17;11:16. doi: 10.1186/1471-2318-11-16.

    PubMed 21496345

  • Alldred DP, Raynor DK, Hughes C, Barber N, Chen TF, Spoor P. Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD009095. doi: 10.1002/14651858.CD009095.pub2.

    PubMed 23450597

  • Majumdar SR, Soumerai SB. Why most interventions to improve physician prescribing do not seem to work. CMAJ. 2003 Jul 8;169(1):30-1. No abstract available.

    PubMed 12847036

Questions about this trial

What is this clinical trial studying?

A study testing OptiMEDs in people with Medication Review and Nursing Home Resident, run by University Ghent at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Software/user problems (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04142645, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.

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