- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02398812
The Interprofessional Medication Assessment for Older Patients
The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Forssa, Finland, FI 30100
- Welfare district of Forssa
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Haapajärvi, Finland, FI 85800
- Selänne Basic Health Care District
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Juva, Finland, FI-51900
- Juva Health Care
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Lahti, Finland, FI-15100
- City of Lahti, home care
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Savonlinna, Finland, FI-57100
- Eastern Savo Hospital District
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Home dwelling ≥65 years-old persons registered to public home care services and who
- have had dizziness, orthostatic hypotension or have fallen or
- 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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
|
Ingen inngripen: Usual care
Usual care (reference group).
|
Hva måler studien?
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Pekka Mäntyselkä, MD, Professor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ILMA
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