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Drug Therapy, CombinationNCT02545257

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

A study testing Coordinated medication management model in people with Drug Therapy, Combination and Inappropriate Prescribing, run by University of Helsinki at 2 sites in Finland.

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

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Coordinated medication management model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
2 sitesFinland
Study dates
Sep 2015to Dec 2018
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
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • Home care is not given regularly

Trial locations and contacts

2 sites in 1 country.

Finland2 sites
  • 1st Pharmacy of Lohja

    Lohja, 08100

  • Services for aged people

    Lohja, 08100

Other trials in Finland

About this study

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.

Read the detailed 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.

Being tested
Coordinated medication management model
Keywords
Aged people, Home care, Drug related problems, DRPs, Coordinated medication management model

What participants receive

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

  • 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

Study groups in NCT02545257
Study groupRoleWhat they receive
Active comparatorActive comparatorIn 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.
Receives: Other: Coordinated medication management model
Control group (standard care)No interventionNormal, standard care (control group)

What is being measured

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

  1. GDS-15 (Geriatric Depression Scale)

    Measured: Change from baseline at 12 and 24 months

  2. MMSE (Mini-Mental State Examination)

    Cognitive ability

    Measured: Change from baseline at 12 and 24 months

  3. MNA (Malnutrition Assessment)

    Measured: Change from baseline at 12 and 24 months

  4. Time to rise from a chair and return to the seated position 5 times (Lower extremity function).

    Measured: Change from baseline at 12 and 24 months

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

    Measured: Change from baseline at 12 and 24 months

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

    Measured: Change from baseline at 12 and 24 months

  7. UDI-6 (Urinary Distress Inventory)

    Measured: Change from baseline at 12 and 24 months

  8. Rava (Functioning and disability, Finnish Consulting Group)

    Measured: Change from baseline at 12 and 24 months

  9. 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).

    Measured: Change from baseline at 12 and 24 months

Secondary outcomes (3)
  1. Use of health care services: visits to physician

    Number of visits (previous 3 months)

    Measured: at 12 and 24 months from baseline

  2. Use of health care services: hospital days

    Number of hospital days (previous 3 months)

    Measured: at 12 and 24 months from baseline

  3. Use of health care services: home care services

    Services delivered to home (previous 3 months)

    Measured: at 12 and 24 months from baseline

Timeline

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

  1. First posted9 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2017
  4. Study completionDec 2018

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545257
Sponsor's protocol ID
153/13/03/00/2015
Status last verified
Mar 2019
First submitted
4 Sep 2015
Last updated
12 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26152737
  • 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.

    PubMed 24879605
  • 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.

    PubMed 21797829
  • 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.

    PubMed 24661800
  • 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.

    PubMed 22711383
  • 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.

    PubMed 21329402
  • 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.

    PubMed 19885077
  • 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.

    PubMed 23023843
  • 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.

    PubMed 23819202
  • 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.

    PubMed 24337417
  • 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.

    PubMed 22619661
  • 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.

    PubMed 22044595
  • 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.

    PubMed 23204431
  • 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.

    PubMed 18020536
  • 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.

    PubMed 29548304

Questions about this trial

What is this clinical trial studying?

A study testing Coordinated medication management model in people with Drug Therapy, Combination and Inappropriate Prescribing, run by University of Helsinki at 2 sites in Finland.

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 1 inclusion and 1 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. 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?

GDS-15 (Geriatric Depression Scale) (time frame: Change from baseline at 12 and 24 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 NCT02545257, which also lists 16 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 12 Mar 2019.

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