Clinical trial NCT04142645: OptiMEDs Pilot 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Review
Nursing Home Resident
Nursing Home
Keywords: Medication Reconciliation
Aged
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2019-10-29
Enrollment: 148
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Software/user problems
timeFrame: 6 months
measure: functionality problems
timeFrame: 6 months
measure: workload
timeFrame: 6 months
measure: medication chart review
timeFrame: 6 months
measure: practical problems
timeFrame: 6 months
measure: GPs that refuse
timeFrame: 6 months
measure: non-consenting eligible residents (n)
timeFrame: 6 months
measure: Non-consenting proxies for eligible residents (n)
timeFrame: 6 months
measure: Optimeds completion
timeFrame: 6 months
Secondary outcomes:
measure: number of medications
timeFrame: 4 months
measure: number of anticholinergics
timeFrame: 4 months
measure: number of candidates for de-prescribing
timeFrame: 4 months
measure: patient-related pain
timeFrame: 4 months
measure: patient-related alertness
timeFrame: 4 months
measure: patient-related QOL
timeFrame: 4 months
measure: patient-related falls
timeFrame: 4 months
measure: Number of Consultations
timeFrame: 4 months
measure: Number of Hospitalization
timeFrame: 4 months
Other outcomes:
Locations:
city: Deinze
country: Belgium
facility: WZC Sint-Jozef Deinze
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: WZC Sint-Jozef Gent
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: WZC Liberteyt
Study officials:
affiliation: Faculty of Medicine and Health Sciences
name: Thierry Christiaens, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Klotz U. Pharmacokinetics and drug metabolism in the elderly. Drug Metab Rev. 2009;41(2):67-76. doi: 10.1080/03602530902722679.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Grimshaw JM, Shirran L, Thomas R, Mowatt G, Fraser C, Bero L, Grilli R, Harvey E, Oxman A, O'Brien MA. Changing provider behavior: an overview of systematic reviews of interventions. Med Care. 2001 Aug;39(8 Suppl 2):II2-45.
citation: Patterson SM, Hughes C, Kerse N, Cardwell CR, Bradley MC. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2012 May 16;(5):CD008165. doi: 10.1002/14651858.CD008165.pub2.
citation: Huiskes VJ, Burger DM, van den Ende CH, van den Bemt BJ. Effectiveness of medication review: a systematic review and meta-analysis of randomized controlled trials. BMC Fam Pract. 2017 Jan 17;18(1):5. doi: 10.1186/s12875-016-0577-x.
citation: Dilles T, Vander Stichele RH, Van Bortel LM, Elseviers MM. The development and test of an intervention to improve ADR screening in nursing homes. J Am Med Dir Assoc. 2013 May;14(5):379.e1-6. doi: 10.1016/j.jamda.2013.02.011. Epub 2013 Apr 2.
citation: Wouters H, Scheper J, Koning H, Brouwer C, Twisk JW, van der Meer H, Boersma F, Zuidema SU, Taxis K. Discontinuing Inappropriate Medication Use in Nursing Home Residents: A Cluster Randomized Controlled Trial. Ann Intern Med. 2017 Nov 7;167(9):609-617. doi: 10.7326/M16-2729. Epub 2017 Oct 10.
citation: Wauters M, Elseviers M, Vaes B, Degryse J, Dalleur O, Vander Stichele R, Christiaens T, Azermai M. Too many, too few, or too unsafe? Impact of inappropriate prescribing on mortality, and hospitalization in a cohort of community-dwelling oldest old. Br J Clin Pharmacol. 2016 Nov;82(5):1382-1392. doi: 10.1111/bcp.13055. Epub 2016 Aug 3.
citation: Wauters M, Elseviers M, Azermai M, Vander Stichele R. Availability and actual use in the Belgian market of potentially inappropriate medications (PIMs) from the EU(7)-PIM list. Eur J Clin Pharmacol. 2016 Feb;72(2):243-5. doi: 10.1007/s00228-015-1947-3. Epub 2015 Sep 26. No abstract available.
citation: Duran CE, Azermai M, Vander Stichele RH. Systematic review of anticholinergic risk scales in older adults. Eur J Clin Pharmacol. 2013 Jul;69(7):1485-96. doi: 10.1007/s00228-013-1499-3. Epub 2013 Mar 26.
citation: Klamer TT, Wauters M, Azermai M, Duran C, Christiaens T, Elseviers M, Vander Stichele R. A Novel Scale Linking Potency and Dosage to Estimate Anticholinergic Exposure in Older Adults: the Muscarinic Acetylcholinergic Receptor ANTagonist Exposure Scale. Basic Clin Pharmacol Toxicol. 2017 Jun;120(6):582-590. doi: 10.1111/bcpt.12699. Epub 2017 Jan 16.
citation: Wauters M, Klamer T, Elseviers M, Vaes B, Dalleur O, Degryse J, Duran C, Christiaens T, Azermai M, Vander Stichele R. Anticholinergic Exposure in a Cohort of Adults Aged 80 years and Over: Associations of the MARANTE Scale with Mortality and Hospitalization. Basic Clin Pharmacol Toxicol. 2017 Jun;120(6):591-600. doi: 10.1111/bcpt.12744. Epub 2017 Apr 6.
citation: Morin L, Laroche ML, Vetrano DL, Fastbom J, Johnell K. Adequate, questionable, and inadequate drug prescribing for older adults at the end of life: a European expert consensus. Eur J Clin Pharmacol. 2018 Oct;74(10):1333-1342. doi: 10.1007/s00228-018-2507-4. Epub 2018 Jun 23.
citation: Poudel A, Yates P, Rowett D, Nissen LM. Use of Preventive Medication in Patients With Limited Life Expectancy: A Systematic Review. J Pain Symptom Manage. 2017 Jun;53(6):1097-1110.e1. doi: 10.1016/j.jpainsymman.2016.12.350. Epub 2017 Feb 9.
citation: Todd A, Husband A, Andrew I, Pearson SA, Lindsey L, Holmes H. Inappropriate prescribing of preventative medication in patients with life-limiting illness: a systematic review. BMJ Support Palliat Care. 2017 Jun;7(2):113-121. doi: 10.1136/bmjspcare-2015-000941. Epub 2016 Jan 5.
citation: Warden V, Hurley AC, Volicer L. Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. J Am Med Dir Assoc. 2003 Jan-Feb;4(1):9-15. doi: 10.1097/01.JAM.0000043422.31640.F7.
citation: Ivanova I, Wauters M, Stichele RV, Christiaens T, De Wolf J, Dilles T, Elseviers M. Medication use in a cohort of newly admitted nursing home residents (Ageing@NH) in relation to evolving physical and mental health. Arch Gerontol Geriatr. 2018 Mar-Apr;75:202-208. doi: 10.1016/j.archger.2018.01.005. Epub 2018 Jan 17.
citation: Wauters M, Elseviers M, Vander Stichele R, Dilles T, Thienpont G, Christiaens T. Efficacy, feasibility and acceptability of the OptiMEDs tool for multidisciplinary medication review in nursing homes. Arch Gerontol Geriatr. 2021 Jul-Aug;95:104391. doi: 10.1016/j.archger.2021.104391. Epub 2021 Mar 17.