- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Huddinge, Svezia, 14183
- Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Composite outcome: Unplanned hospitalisation or emergency department visit
Lasso di tempo: 9 months
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9 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Tutti causano mortalità
Lasso di tempo: 9 mesi
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9 mesi
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Unplanned hospitalisation
Lasso di tempo: 9 months
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9 months
|
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Emergency department visit
Lasso di tempo: 9 months
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9 months
|
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Length of hospital stay
Lasso di tempo: 9 months
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9 months
|
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Number of drug utilization reviews
Lasso di tempo: 9 months
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9 months
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Number of patients with polypharmacy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 9 months
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9 months
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Number of drugs with inappropriate drug dose regarding renal function
Lasso di tempo: 9 months
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9 months
|
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Number of drug interactions
Lasso di tempo: 9 months
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9 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jan Hasselström, MD, PhD, Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2012 1266-31
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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