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Effect of Pharmacist Provided Drug Information Services After Hospital Discharge

4. Juni 2019 aktualisiert von: Tim Emil Vejborg, Region Hovedstadens Apotek

Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.

Objective:

The aim of this study is to evaluate if offering drug counseling from a hospital pharmacy increases patient satisfaction and sense of security regarding drug treatment after hospital discharge.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Method and design:

This study was estimated to include 250 participants in a clinical randomized controlled trial. The participants were included from the Acute Medical Ward and the Department of Respiratory Medicine at Bispebjerg Hospital when discharged. The participants were randomized to one of two groups with unequal sizes: the control (50 participants) or intervention group (200 participants). This study used blocked randomization with block sizes of 5/10/15/20/25. The control group received the normal care following the Danish standard procedure. Participants in the intervention group also received the normal care but was also offered the possibility to contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Data for the primary outcome measures was collected 14 days after discharge through structured phone interviews. An interview guide with a semi-structured questionnaire and already validated questions were developed, pre-tested and optimized. The participants were asked to answer open-ended questions, closed-ended question and rate statements or questions on a five-point scale.

The participants in the control group were asked to answer 13 items (seven questions or statements on a five-point scale, four closed-ended questions and two open-ended questions).

The participants in the intervention group who did not make any queries were asked the same questions as the participants in the control group and additionally three closed-ended questions. A total of 16 items.

The participants in the intervention group who made queries were asked the same questions as the participants in the intervention group who did not make any queries and additionally five questions on a five-point scale, four closed-ended and one open-ended question. A total of 27 items.

The effect of the drug counseling regarding patient safety was evaluated by a pharmaceutical assessment in which it was assessed whether the drug counseling had potentially prevented a drug-related problem.

Quantitative data from the phone interviews will be analyzed in Microsoft excel with descriptive statistics and simple parametric statistics. An analysis will determine whether there is a difference in the primary outcome measures.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

250

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Dänemark
    • København NV
      • Copenhagen, København NV, Dänemark, 2400
        • Capital Regions Hospital Pharmacy

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Patients discharged from the acute medical ward and department of respiratory medicine at Bispebjerg Hospital.
  • Patients discharged to own home.
  • Can speak the danish language.
  • ≥18 years old.
  • Can be contacted by phone.

Exclusion Criteria:

  • Cognitive and communicative problems (e.g. dementia, aphasia, suicidal) or other barriers that unable the participant to use the intervention service.
  • Patient does not answer phone within five attempts on five different days, when trying to conduct patient interview.
  • Cognitive and communicative problems that unable the participant to answer questions in the patient interview.
  • Deceased or readmitted before patient interview.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control group
Participants in the control group received the normal care following the Danish standard procedure.
Aktiver Komparator: Intervention group
Participants in the intervention group received the normal care following the Danish stadard procedure. Additionally the participants was also offered the possibility to contact a hospital pharmacy department by phone or mail for drug counseling.
Sonstiges: Drug counseling
Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sense of security regarding drug treatment and satisfaction with drug counseling.
Zeitfenster: 2-4 weeks after discharge.
The questionnaire comprised closed-ended questions, open-ended questions and questions or statements where the respondents were asked to rate the questions or statements on a five-point scale. The scale used is a attitude measurement scale that assess attitudes by presenting respondents with sentences that state beliefs about the particular attitude being measured. The respondents then decide to what extent he or she agrees with the statement. The responses are divided numerically into a series of ordered responses. Ratings: 1 = not at all, 2 = to a small extent, 3 = to some extent, 4 = to a great extent, 5 = to a very great extent.
2-4 weeks after discharge.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of medications by admission.
Zeitfenster: Within one week after discharge.
Number of medications will be read in admission report.
Within one week after discharge.
Number of medications by discharge.
Zeitfenster: Within one week after discharge.
Number of medications will be read in discharge report..
Within one week after discharge.
Number of patients that received medication review by pharmacist during admission.
Zeitfenster: Within one week after discharge.
The patient's journal will be searched for a medication review.
Within one week after discharge.
Number of patients that received help with medication at home after discharge.
Zeitfenster: Within one week after discharge.
The patient's journal will be searched for information regarding help with medication at home.
Within one week after discharge.
Number of enquiries.
Zeitfenster: Directly after the patient received drug counseling.
Patient enquiries will be classified to one of the predefined categories: adverse effects, choice of therapy, dosage and administration, interactions, product information, storage and handling, indication or other.
Directly after the patient received drug counseling.
Number of potentially prevented drug-related problems.
Zeitfenster: Directly after the patient received drug counseling.
The pharmacist that performed the drug counseling assessed whether the drug counseling had potentially prevented a drug-related problem.
Directly after the patient received drug counseling.
Cause of hospitalization.
Zeitfenster: Within one week after discharge.
The patient's journal will be searched for cause of hospitalization.
Within one week after discharge.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Region Hovedstadens Apotek

Mitarbeiter

The Hospitals Pharmacies' and Amgros' Research Development Foundation

Ermittler

  • Hauptermittler: Tim E Vejborg, M.Sc.Pharm, Region Hovedstadens Apotek

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Juli 2018

Primärer Abschluss (Tatsächlich)

3. Juni 2019

Studienabschluss (Tatsächlich)

3. Juni 2019

Studienanmeldedaten

Zuerst eingereicht

22. Januar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Februar 2019

Zuerst gepostet (Tatsächlich)

4. Februar 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2019

Zuletzt verifiziert

1. Juni 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • H-18003889

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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