- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01732302
Educational Intervention to Reduce Drug-related Hospitalizations in Elderly Primary Health Care Patients
Educational Intervention to Reduce Drug-related Hospitalizations and Visits in Emergency Departments in Elderly Primary Health Care Patients - a Cluster-randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Inappropriate medication in the elderly patient leads to substantial morbidity, possibly causing up to 20% of hospitalizations in this patient group (1). To improve prescribing and thus reduce undesired drug effects is a great challenge for doctors and nurses in primary health care.
Performance of drug utilization reviews is recommended in order to reduce the negative impact of inappropriate prescribing in the elderly. However, scientific evidence on their efficacy is lacking, especially regarding patient-related health outcomes (2,3). Most studies are carried out in inpatient care, making it difficult to draw conclusions regarding primary health care (2). Moreover, studies in this scientific field diverge regarding the content and structure of drug utilization reviews, which implies that comparison between studies becomes challenging, if not impossible.
This trial aims at educating health care providers in how to perform drug utilization reviews, and to help them implement theory into practice.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Huddinge, Sverige, 14183
- Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- primary health care center in Stockholm County
- authorized by Stockholm County Council since at least 3 years
- at least 5% of patients attributed to primary health care center are 65 years and older
- primary health care center takes care of at least 10 home care patients
Exclusion Criteria:
- less than 3000 patients listed in primary health care center
- primary health care centers where researchers carrying out the present study work
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Educational intervention
Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months.
At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given.
Education of relevant subjects will be given in relation to detected problems.
On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers.
At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.
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Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months.
At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given.
Education of relevant subjects will be given in relation to detected problems.
On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers.
At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.
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Ingen indgriben: Delayed educational intervention
Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Composite outcome: Unplanned hospitalisation or emergency department visit
Tidsramme: 9 months
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9 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Alle forårsager dødelighed
Tidsramme: 9 måneder
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9 måneder
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Unplanned hospitalisation
Tidsramme: 9 months
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9 months
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Emergency department visit
Tidsramme: 9 months
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9 months
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Length of hospital stay
Tidsramme: 9 months
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9 months
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Number of drug utilization reviews
Tidsramme: 9 months
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9 months
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Number of patients with polypharmacy
Tidsramme: 9 months
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polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient
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9 months
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Inappropriate drug use according to national guidelines
Tidsramme: 9 months
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see link
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9 months
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Number of patients with contraindicated drugs regarding renal function
Tidsramme: 9 months
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9 months
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Number of drugs with inappropriate drug dose regarding renal function
Tidsramme: 9 months
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9 months
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Number of drug interactions
Tidsramme: 9 months
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9 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jan Hasselström, MD, PhD, Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
Publikationer og nyttige links
Generelle publikationer
- Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.
- Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54. doi: 10.1023/a:1015570104121.
- Stewart S, Pearson S, Luke CG, Horowitz JD. Effects of home-based intervention on unplanned readmissions and out-of-hospital deaths. J Am Geriatr Soc. 1998 Feb;46(2):174-80. doi: 10.1111/j.1532-5415.1998.tb02535.x.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012 1266-31
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