OptiMEDs Pilot Study

Nursing Home Clinical Trial

— OptiMEDs  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142645
• Other study ID #: B670201940251
• Status: Completed
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Review
• Nursing Home
• Nursing Home Resident

Intervention

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.

Locations

Country	Name	City	State
Belgium	WZC Sint-Jozef Deinze	Deinze	Oost-Vlaanderen
Belgium	WZC Liberteyt	Gent
Belgium	WZC Sint-Jozef Gent	Gent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

References & Publications (30)

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. Review. Update in: Cochrane Database Syst Rev. 2016;2:CD009095. — View Citation

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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. — View 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. — View 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. Review. — View Citation

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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. — View Citation

Durán 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. — View 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. Review. — View Citation

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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. Review. — View 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. — View 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. — View Citation

Klamer TT, Wauters M, Azermai M, Durán 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. — View Citation

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

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Majumdar SR, Soumerai SB. Why most interventions to improve physician prescribing do not seem to work. CMAJ. 2003 Jul 8;169(1):30-1. Review. — View Citation

Mann E, Köpke S, Haastert B, Pitkälä 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;(10):CD008165. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Turnheim K. When drug therapy gets old: pharmacokinetics and pharmacodynamics in the elderly. Exp Gerontol. 2003 Aug;38(8):843-53. Review. — View 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. — View 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. — View 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. — View Citation

Wauters M, Klamer T, Elseviers M, Vaes B, Dalleur O, Degryse J, Durán 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. — View 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. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Software/user problems	monthly number of interventions for software/user problems (n)	6 months
Primary	functionality problems	Number of functionality problems (n)	6 months
Primary	workload	Timing of workload for nurses & pharmacists regarding the use of OptiMEDs (time)	6 months
Primary	medication chart review	duration of a medication chart review by GP and nurse (time)	6 months
Primary	practical problems	listing of practical problems for organizing the medication chart review	6 months
Primary	GPs that refuse	number of GPs that refuse to participate / accept to participate (n)	6 months
Primary	non-consenting eligible residents (n)	Number of non-consenting eligible residents legally capable to give consent (n)	6 months
Primary	Non-consenting proxies for eligible residents (n)	Number of non-consenting proxies for eligible residents legally not capable to give consent	6 months
Primary	Optimeds completion	Number of symptom observations and medication reviews completed (on time) (n)	6 months
Secondary	number of medications	number of medications (n)	4 months
Secondary	number of anticholinergics	number of anticholinergics (n)	4 months
Secondary	number of candidates for de-prescribing	number of candidates for de-prescribing (n)	4 months
Secondary	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)	4 months
Secondary	patient-related alertness	patient-related alertness (score); nurse-observation using VAS scale (1 - 6, 1 = being alert)	4 months
Secondary	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).	4 months
Secondary	patient-related falls	patient-related falls (n)	4 months
Secondary	Number of Consultations	Number of Consultations (n)	4 months
Secondary	Number of Hospitalization	Number of Hospitalization (n)	4 months