Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care

Polypharmacy Clinical Trial

Official title:

Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545257
• Other study ID #: 153/13/03/00/2015
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this randomized controlled trial is to develop a coordinated, multiprofessional medication management model for home-dwelling aged in primary care and to study the effectiveness of this model. The main hypothesis is that the new model helps to identify aged people having potential risks with their medications and thus allows solving these risks.

Description:

The demand for long-term home health care services is increasing due the demographic and societal developments. Aged people needing home care are increasingly older, have many chronic diseases and use multiple medicines and thus, are at high risk for drug-related problems (DRPs). In Finland, national and local healthcare and aged care strategies target to allowing aged people (over 65 years) living in their own homes as long as possible. This minimizes the costs of institutionalized care and also targets to add the quality of life of aged people. New approaches and service models are needed to meet these challenges.

The present study focuses on the development of a coordinated medication management model which aims to ensure the safe medication practises for home-dwelling aged in primary care. In the previous parts of this study project were developed a model for comprehensive medication review process (CMR) and a Drug-Related Problem Risk Assessment Tool. The present study uses a multistage intervention in which medications are reviewed (prescription review) in a community pharmacy using the SFINX-database to identify clinically significant drug-drug interactions and the Salko-database which identifies potentially inappropriate medications for aged people. In the next stage practical nurses use the Drug-Related Problem Risk Assessment Tool to identify potential risks. The following stages are based on the results from the risk assessment tool. Potential options are, e.g.,physician consultation, more frequent home care visits, counselling given by the community pharmacy or comprehensive medication review (CMR). The CMR process is only targeted to a limited group of study participants with clinically significant DRP who probably will benefit from more comprehensive CMR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Home-dwelling over 65 year-old persons receiving regular home care from the City of Lohja

Exclusion Criteria:

• Home care is not given regularly

Related Conditions & MeSH terms

• Drug Therapy, Combination
• Inappropriate Prescribing
• Polypharmacy

Intervention

Other:
• Coordinated medication management model
Stage I: a prescription review conducted by community pharmacists Stage II: practical nurse-administered Drug-related Problem Risk Assessment Tool Stage III: Required health care action based on the result of the DRP -Risk Assessment Tool

Locations

Country	Name	City	State
Finland	1st Pharmacy of Lohja	Lohja
Finland	Services for aged people	Lohja

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University	City of Lohja, Services for Aged People, Lohjan 1. Apteekki, Social Insurance Institution, Finland

Country where clinical trial is conducted

Finland, 

References & Publications (15)

Bulajeva A, Labberton L, Leikola S, Pohjanoksa-Mäntylä M, Geurts MM, de Gier JJ, Airaksinen M. Medication review practices in European countries. Res Social Adm Pharm. 2014 Sep-Oct;10(5):731-40. doi: 10.1016/j.sapharm.2014.02.005. Epub 2014 Feb 24. — View Citation

Dimitrow M, Leikola S, Kivelä SL, Airaksinen M, Mykkänen S, Puustinen J. [Inappropriate medication use among the aged. Review of the criteria]. Duodecim. 2013;129(11):1159-66. Review. Finnish. — View Citation

Dimitrow MS, Airaksinen MS, Kivelä SL, Lyles A, Leikola SN. Comparison of prescribing criteria to evaluate the appropriateness of drug treatment in individuals aged 65 and older: a systematic review. J Am Geriatr Soc. 2011 Aug;59(8):1521-30. doi: 10.1111/ — View Citation

Dimitrow MS, Leikola SN, Kivelä SL, Passi S, Lukkari P, Airaksinen MS. Feasibility of a practical nurse administered risk assessment tool for drug-related problems in home care. Scand J Public Health. 2015 Nov;43(7):761-9. doi: 10.1177/1403494815591719. E — View Citation

Dimitrow MS, Mykkänen SI, Leikola SN, Kivelä SL, Lyles A, Airaksinen MS. Content validation of a tool for assessing risks for drug-related problems to be used by practical nurses caring for home-dwelling clients aged =65 years: a Delphi survey. Eur J Clin — View Citation

Leikola S, Dimitrow M, Lyles A, Pitkälä K, Airaksinen M. Potentially inappropriate medication use among Finnish non-institutionalized people aged =65 years: a register-based, cross-sectional, national study. Drugs Aging. 2011 Mar 1;28(3):227-36. doi: 10.2 — View Citation

Leikola S, Tuomainen L, Peura S, Laurikainen A, Lyles A, Savela E, Airaksinen M. Comprehensive medication review: development of a collaborative procedure. Int J Clin Pharm. 2012 Aug;34(4):510-4. doi: 10.1007/s11096-012-9662-y. Epub 2012 Jun 19. — View Citation

Leikola SN, Tuomainen L, Ovaskainen H, Peura S, Sevón-Vilkman N, Tanskanen P, Airaksinen MS. Continuing education course to attain collaborative comprehensive medication review competencies. Am J Pharm Educ. 2009 Oct 1;73(6):108. — View Citation

Leikola SN, Virolainen J, Tuomainen L, Tuominen RK, Airaksinen MS. Comprehensive medication reviews for elderly patients: findings and recommendations to physicians. J Am Pharm Assoc (2003). 2012 Sep-Oct;52(5):630-3. — View Citation

Nurminen J, Puustinen J, Piirtola M, Vahlberg T, Lyles A, Kivelä SL. Opioids, antiepileptic and anticholinergic drugs and the risk of fractures in patients 65 years of age and older: a prospective population-based study. Age Ageing. 2013 May;42(3):318-24. — View Citation

Puustinen J, Lähteenmäki R, Polo-Kantola P, Salo P, Vahlberg T, Lyles A, Neuvonen PJ, Partinen M, Räihä I, Kivelä SL. Effect of withdrawal from long-term use of temazepam, zopiclone or zolpidem as hypnotic agents on cognition in older adults. Eur J Clin P — View Citation

Puustinen J, Nurminen J, Kukola M, Vahlberg T, Laine K, Kivelä SL. Associations between use of benzodiazepines or related drugs and health, physical abilities and cognitive function: a non-randomised clinical study in the elderly. Drugs Aging. 2007;24(12) — View Citation

Puustinen J, Nurminen J, Löppönen M, Vahlberg T, Isoaho R, Räihä I, Kivelä SL. Use of CNS medications and cognitive decline in the aged: a longitudinal population-based study. BMC Geriatr. 2011 Nov 1;11:70. doi: 10.1186/1471-2318-11-70. — View Citation

Puustinen J, Nurminen J, Vahlberg T, Lyles A, Isoaho R, Räihä I, Kivelä SL. CNS medications as predictors of precipitous cognitive decline in the cognitively disabled aged: a longitudinal population-based study. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1 — View Citation

Toivo T, Dimitrow M, Puustinen J, Savela E, Pelkonen K, Kiuru V, Suominen T, Kinnunen S, Uunimäki M, Kivelä SL, Leikola S, Airaksinen M. Coordinating resources for prospective medication risk management of older home care clients in primary care: procedur — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GDS-15 (Geriatric Depression Scale)		Change from baseline at 12 and 24 months
Primary	MMSE (Mini-Mental State Examination)	Cognitive ability	Change from baseline at 12 and 24 months
Primary	MNA (Malnutrition Assessment)		Change from baseline at 12 and 24 months
Primary	Time to rise from a chair and return to the seated position 5 times (Lower extremity function).		Change from baseline at 12 and 24 months
Primary	Orthostatic hypotension (Short test, Freeman et al. 2011)		Change from baseline at 12 and 24 months
Primary	AUDIT-C (Alcohol Use Disorder Identification Test, version C)		Change from baseline at 12 and 24 months
Primary	UDI-6 (Urinary Distress Inventory)		Change from baseline at 12 and 24 months
Primary	Rava (Functioning and disability, Finnish Consulting Group)		Change from baseline at 12 and 24 months
Primary	Potentially inappropriate medicines (PIM) (Clinically significant drug-drug interactions, potentially inappropriate medicines for aged), identified from medication list review chart	PIMs are identified with prescription review using SFINX database (clinically significant drug-drug interactions) and Salko database (e.g., for identifying potentially inappropriate medicines for the aged, anticholinergic and serotonergic load).	Change from baseline at 12 and 24 months
Secondary	Use of health care services: visits to physician	Number of visits (previous 3 months)	at 12 and 24 months from baseline
Secondary	Use of health care services: hospital days	Number of hospital days (previous 3 months)	at 12 and 24 months from baseline
Secondary	Use of health care services: home care services	Services delivered to home (previous 3 months)	at 12 and 24 months from baseline

External Links

•   Leikola S. Development and Application of Comprehensive Medication Review Procedure to Community-Dwelling Elderly. Doctoral Thesis, University of Helsinki, 2012
•   Puustinen J. Benzodiazepines and Cognitive Functioning in Older Adults. With Emphasis on Long-Term Use and Withdrawal. Doctoral Thesis, University of Turku, 2014