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Effect of Pharmacist Provided Drug Information Services After Hospital Discharge

4 giugno 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control group
Participants in the control group received the normal care following the Danish standard procedure.
Comparatore attivo: 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.
Altro: Drug counseling
Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sense of security regarding drug treatment and satisfaction with drug counseling.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of medications by admission.
Lasso di tempo: Within one week after discharge.
Number of medications will be read in admission report.
Within one week after discharge.
Number of medications by discharge.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: Within one week after discharge.
The patient's journal will be searched for cause of hospitalization.
Within one week after discharge.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Region Hovedstadens Apotek

Collaboratori

The Hospitals Pharmacies' and Amgros' Research Development Foundation

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 luglio 2018

Completamento primario (Effettivo)

3 giugno 2019

Completamento dello studio (Effettivo)

3 giugno 2019

Date di iscrizione allo studio

Primo inviato

22 gennaio 2019

Primo inviato che soddisfa i criteri di controllo qualità

1 febbraio 2019

Primo Inserito (Effettivo)

4 febbraio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • H-18003889

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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