NCT02545257

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

September 4, 2015

Last Update Submit

March 8, 2019

Conditions

Drug Therapy, CombinationInappropriate PrescribingPolypharmacy

Keywords

Aged peopleHome careDrug related problems, DRPsCoordinated medication management model

Outcome Measures

Primary Outcomes (9)

  • GDS-15 (Geriatric Depression Scale)

    Change from baseline at 12 and 24 months

  • MMSE (Mini-Mental State Examination)

    Cognitive ability

    Change from baseline at 12 and 24 months

  • MNA (Malnutrition Assessment)

    Change from baseline at 12 and 24 months

  • 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

  • Orthostatic hypotension (Short test, Freeman et al. 2011)

    Change from baseline at 12 and 24 months

  • AUDIT-C (Alcohol Use Disorder Identification Test, version C)

    Change from baseline at 12 and 24 months

  • UDI-6 (Urinary Distress Inventory)

    Change from baseline at 12 and 24 months

  • Rava (Functioning and disability, Finnish Consulting Group)

    Change from baseline at 12 and 24 months

  • 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 Outcomes (3)

  • Use of health care services: visits to physician

    at 12 and 24 months from baseline

  • Use of health care services: hospital days

    at 12 and 24 months from baseline

  • Use of health care services: home care services

    at 12 and 24 months from baseline

Study Arms (2)

Active comparator

ACTIVE COMPARATOR

In addition to normal, standard care, participants allocated to intervention group will receive a coordinated medication management model containing prescription review, drug-related problems (DRP) risk assessment and required action based on the DRP risk assessment.

Other: Coordinated medication management model

Control group (standard care)

NO INTERVENTION

Normal, standard care (control group)

Interventions

Coordinated medication management modelOTHER

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

Active comparator

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Home care is not given regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1st Pharmacy of Lohja

Lohja, 08100, Finland

Location

Services for aged people

Lohja, 08100, Finland

Location

Related Publications (16)

  • Dimitrow MS, Leikola SN, Kivela 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. Epub 2015 Jul 7.

    PMID: 26152737RESULT

  • Dimitrow MS, Mykkanen SI, Leikola SN, Kivela 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 Pharmacol. 2014 Aug;70(8):991-1002. doi: 10.1007/s00228-014-1699-5. Epub 2014 Jun 1.

    PMID: 24879605RESULT

  • Dimitrow MS, Airaksinen MS, Kivela 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/j.1532-5415.2011.03497.x. Epub 2011 Jul 28.

    PMID: 21797829RESULT

  • Bulajeva A, Labberton L, Leikola S, Pohjanoksa-Mantyla 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.

    PMID: 24661800RESULT

  • 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.

    PMID: 22711383RESULT

  • Leikola S, Dimitrow M, Lyles A, Pitkala 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: 10.2165/11586890-000000000-00000.

    PMID: 21329402RESULT

  • Leikola SN, Tuomainen L, Ovaskainen H, Peura S, Sevon-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. doi: 10.5688/aj7306108.

    PMID: 19885077RESULT

  • 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. doi: 10.1331/JAPhA.2012.10163.

    PMID: 23023843RESULT

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

    PMID: 23819202RESULT

  • Puustinen J, Lahteenmaki R, Polo-Kantola P, Salo P, Vahlberg T, Lyles A, Neuvonen PJ, Partinen M, Raiha I, Kivela SL. Effect of withdrawal from long-term use of temazepam, zopiclone or zolpidem as hypnotic agents on cognition in older adults. Eur J Clin Pharmacol. 2014 Mar;70(3):319-29. doi: 10.1007/s00228-013-1613-6. Epub 2013 Dec 12.

    PMID: 24337417RESULT

  • Puustinen J, Nurminen J, Vahlberg T, Lyles A, Isoaho R, Raiha I, Kivela 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):57-68. doi: 10.1159/000336710. Epub 2012 Mar 16.

    PMID: 22619661RESULT

  • Puustinen J, Nurminen J, Lopponen M, Vahlberg T, Isoaho R, Raiha I, Kivela 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.

    PMID: 22044595RESULT

  • Nurminen J, Puustinen J, Piirtola M, Vahlberg T, Lyles A, Kivela 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. doi: 10.1093/ageing/afs178. Epub 2012 Nov 29.

    PMID: 23204431RESULT

  • Puustinen J, Nurminen J, Kukola M, Vahlberg T, Laine K, Kivela 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):1045-59. doi: 10.2165/00002512-200724120-00007.

    PMID: 18020536RESULT

  • Toivo T, Dimitrow M, Puustinen J, Savela E, Pelkonen K, Kiuru V, Suominen T, Kinnunen S, Uunimaki M, Kivela SL, Leikola S, Airaksinen M. Coordinating resources for prospective medication risk management of older home care clients in primary care: procedure development and RCT study design for demonstrating its effectiveness. BMC Geriatr. 2018 Mar 16;18(1):74. doi: 10.1186/s12877-018-0737-z.

    PMID: 29548304RESULT

  • Toivo T, Airaksinen M, Dimitrow M, Savela E, Pelkonen K, Kiuru V, Suominen T, Uunimaki M, Kivela SL, Leikola S, Puustinen J. Enhanced coordination of care to reduce medication risks in older home care clients in primary care: a randomized controlled trial. BMC Geriatr. 2019 Nov 27;19(1):332. doi: 10.1186/s12877-019-1353-2.

    PMID: 31775650DERIVED

Related Links

Study Officials

  • Marja SA Airaksinen, Professor

    University of Helsinki

    STUDY CHAIR

  • Juha T Puustinen, Docent

    University of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project coordinator, MSc (Pharm), PhD student

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

FI(2)