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The Interprofessional Medication Assessment for Older Patients

10. juni 2016 opdateret af: East Savo Hospital District

The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting

The objective of this pragmatic multi-center randomized controlled trial is to test the effectiveness of interprofessional medication assessment in older patients needing home care due to their diseases or decreased functional capacity in primary care. The main hypothesis is that intervention has a positive impact on functional capacity and for rational and safe use of medicines.

Studieoversigt

Detaljeret beskrivelse

Aging increases the risk of adverse effects and interactions caused by medication. Medication reconciliation and medication review are well-known practices to optimize medicines use. Both interventions usually require a team-based approach to be effective. Medication reconciliation is the process of obtaining and documenting a complete and accurate list of current patient medications and comparing this list with medication orders at each point of care transition to identify and rectify any discrepancies before patient harm occurs. Medication review is the process of evaluating current medication treatment to manage the risk and optimize the outcomes of medication treatment by detecting, solving, and preventing medication-related problems. The present study focuses on medication assessment including both medication reconciliation and review combined to clinical assessment of an individual patient.

According to a systematic review there is a need for research focusing on medication management in community settings and especially to assess the impact of medication assessment on clinical outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

514

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Forssa, Finland, FI 30100
        • Welfare district of Forssa
      • Haapajärvi, Finland, FI 85800
        • Selänne Basic Health Care District
      • Juva, Finland, FI-51900
        • Juva Health Care
      • Lahti, Finland, FI-15100
        • City of Lahti, home care
      • Savonlinna, Finland, FI-57100
        • Eastern Savo Hospital District

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Home dwelling ≥65 years-old persons registered to public home care services and who

  1. have had dizziness, orthostatic hypotension or have fallen or
  2. use at least six medicines

Exclusion Criteria:

Home care is not responsible for patient's medication, for example due to severe chronic illness (for example severe renal insufficiency or cancer with active treatment in secondary or tertiary care).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active comparator
In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it

Intervention

  • Phase I: A medication assessment conducted by an interprofessional team including nurse, pharmacist and physician. The assessment is based on current medication list and basic information cathered by nurse.
  • Phase II: This phase is needed if the assessment cannot be conducted safely without physical examination conducted by physician. The comprehensive interprofessional assessment takes place after the clinical examination conducted by home care physician.
Ingen indgriben: Usual care
Usual care (reference group).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Functional capacity IADL (Instrumental Activities of Daily Living)
Tidsramme: at 6 months from baseline
at 6 months from baseline
Functional capacity ADL (Activities of daily living;KATZ)
Tidsramme: at 6 months from baseline
at 6 months from baseline
Functional capacity TUG (Timed up and go)
Tidsramme: at 6 months from baseline
at 6 months from baseline
Functional capacity MMSE ( Mini-mental state examination)
Tidsramme: at 6 months from baseline
at 6 months from baseline
Functional capacity GDS (Geriatric Depression Scale)-15
Tidsramme: at 6 months from baseline
at 6 months from baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Use of health care services
Tidsramme: at 6 and 12 months from baseline
visits to physician, hospital days and nursing care at home
at 6 and 12 months from baseline
Need of services delivered to home
Tidsramme: at 6 and 12 months from baseline
at 6 and 12 months from baseline
Number of medicines
Tidsramme: at 6 and 12 months from baseline
at 6 and 12 months from baseline
Quality of medicines
Tidsramme: at 6 and 12 months from baseline
at 6 and 12 months from baseline
Cost of medicines
Tidsramme: at 6 and 12 months from baseline
at 6 and 12 months from baseline
Health related quality of life assessed with EQ-5D
Tidsramme: at 6 and 12 months from baseline
at 6 and 12 months from baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Pekka Mäntyselkä, MD, professor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2015

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Forventet)

1. december 2018

Datoer for studieregistrering

Først indsendt

13. marts 2015

Først indsendt, der opfyldte QC-kriterier

20. marts 2015

Først opslået (Skøn)

26. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ILMA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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