- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Huddinge, Schweden, 14183
- Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Composite outcome: Unplanned hospitalisation or emergency department visit
Zeitfenster: 9 months
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9 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Alle verursachen Sterblichkeit
Zeitfenster: 9 Monate
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9 Monate
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Unplanned hospitalisation
Zeitfenster: 9 months
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9 months
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Emergency department visit
Zeitfenster: 9 months
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9 months
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Length of hospital stay
Zeitfenster: 9 months
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9 months
|
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Number of drug utilization reviews
Zeitfenster: 9 months
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9 months
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Number of patients with polypharmacy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 9 months
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9 months
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Number of drugs with inappropriate drug dose regarding renal function
Zeitfenster: 9 months
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9 months
|
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Number of drug interactions
Zeitfenster: 9 months
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9 months
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Jan Hasselström, MD, PhD, Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2012 1266-31
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