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Pharmaceutical Intervention Program at Readmission and User Satisfaction in a Emergency Department

18 aprile 2017 aggiornato da: Matías Fernando Martínez Olguín, University of Chile

Impact of a Pharmaceutical Intervention Program at Readmission and User Satisfaction in a Emergency Department, Randomized Clinical Study

A randomized clinical trial with two parallel groups (control and intervened) in the Emergency Department (ED) at the Clinical Hospital of the University of Chile will take place. The sample will be of 996 patients (498 per group).

The control group will receive hospital care and discharge plan usual, while the intervention group also receive a Program of Pharmaceutical Interventions while in the service and at discharge, which includes an analysis of the therapy recommended by the physician, assessing the safer alternatives for the patient population and the special conditions of their pathology, emphasizing evaluations of effectiveness, safety and tolerability of medication, drug interactions, potential adverse events, dose adjustments as needed according to the patient's condition ; verification that the administration is optimal, including choosing the best route to this and the time when the drugs are infused into the patient.Interventions aimed at patient occur during the stay and at discharge, focusing on clarifying administration regimens, reasons for using drugs, prevent drug-related problems, clarify doubts and educate about pharmacotherapy and make a reinforcement of adherence.

The selection and patient recruitment will take place during the first hour of admission to care box, where they were invited to participate and signed informed consent.

In both groups, a doctor and a pharmacist, blind to treatment assignment, will gather information during the stay, discharge and post-discharge, the latter by telephone 30 days after discharge from the ED, in this second interview also verify the existence of a readmission and / or unscheduled medical consultation. In addition, discharge of each patient satisfaction was measured with respect to the service received by a user satisfaction survey applied by external and impartial staff. In addition, two independent trained evaluators (Emergency Medical and Pharmaceutical Chemistry), blinded to treatment assignment, evaluate the background of each case and by consensus allocated the presence of problems related to drugs, and classified as preventable or not preventable, according severity.

X2 test or Fisher exact test was used to test the hypothesis that the Programme of Pharmaceutical Interventions decreases at least 30% the user dissatisfaction compared with usual care in the ED.

Panoramica dello studio

Descrizione dettagliata

Process:

For the selection of patients, a research team consisting of a Physician and a Pharmaceutical Chemist review the inclusion and exclusion criteria within the first hour after the patient enters the care box. Patients who meet the selection criteria are invited to participate in the study and sign the informed consent form. To standardize the sampling and avoid differences by daily or seasonal variation are included in the study of 6 patients per day.

For each of the included patients, information will be collected that allows the characterization: sociodemographic, which includes: sex, age, foresight, schooling, marital status; Morbid antecedents before, during the care and after the high diagnostic illness, reason of admission and previous hospitalizations; Pharmacotherapeutic which includes medicines used, dosage, self-medication, adherence (Morisky & Green Scale), performed before, during the stay in the emergency department and high and post discharge. In addition, the Triage category and the duration of the stay are recorded.

In both groups, a physician and a pharmacist, blind to the allocation of treatment, collect the demographic, morbid and pharmacotherapeutic antecedents, by means of a file specially designed for the study. The post-discharge evaluation is done through the telephone interview 30 days after the discharge from the US.

All information collected on the follow-up sheets of each study patient will be added to an Excel® database. A project investigator will be responsible for ensuring the monitoring of the study, ensuring that Good Clinical Practices are complied with, as well as the quality and reliability of the information recorded on both the records and the database. Both the database and each of the study collection records will include only a patient identification code, in order to maintain their confidentiality. The list that relates the code to the patient's name will be kept protected with access only to the principal investigator.

In the case of the patients who are part of the intervention group, in addition to the care received by the control group, I received a pharmaceutical care program aimed at improving drug use and patient safety. It includes a finished analysis of the therapy indicated by the physician, evaluating the safer alternatives for the type of patient and the special conditions of his pathology, emphasizing evaluations of the effectiveness, safety and tolerability of the medication, drug interactions, possible events Adverse effects, dose adjustments by sea, patient conditions; Verification of what the sea of optimal management, including the choice of the best route for the shelf and the time in which the medicines are infused to the patient.

The intervention is performed at moments one during the stay in the service where they communicate and educate the patient about all the medications indicated and the relationship, which have their health status, as well as the benefits and expected results with their administration. A second moment just after high medicine, where the same review of medications is done and recommendations are given to the patient on how to administer them, promoting adherence to treatment. In addition to all the knowledge he has about his pathology and treatment.

To see that the patient started therapy, the last 7 days after discharge / transfer of the Emergency Service, a member of the team communicated by telephone with the patient. In case you have not started looking for the factors that affected your behavior.

At 30 days after discharge / transfer, an independent external evaluator, blinded to pharmaceutical care, who will not know the group to which the patient belongs, will be contacted by telephone and evaluated again, in addition to consulting medical prescriptions Received and medications purchased to evaluate hospital readmissions or unscheduled medical consultations.

If an error is detected in the control group, it will be communicated to the health team

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1001

Fase

  • Non applicabile

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

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients admitted to the emergency department of clinical hospital of the University of Chile
  • Patients who sign the informed consent form
  • Patients in triage categories C2, C3, C4 and C5

Exclusion Criteria:

  • Patients with inability to communicate and don't have a responsible caregiver to provide reliable information about the patient's therapy
  • Patients who are participating in another study
  • Patients not taking drugs regularly and who don't receive them during care in the ED

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: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control
The control group will receive the usual hospital care. In addition, an interview that allows the characterization of the sample and the measurement of variables such as adherence, problems related to medication and user satisfaction.
Sperimentale: Intervened

The intervention group will receive a Pharmaceutical Intervention Program during their stay in the Service and discharge.

In addition, an interview that allows the characterization of the sample and the measurement of variables such as adherence, problems related to medication and user satisfaction.

patient education/ recommendations to the health team

The intervention group will receive a Pharmaceutical Intervention Program during their stay in the Service and discharge that includes an analysis of the therapy indicated by the physician, evaluating the safer alternatives for the type of patient and the special conditions of their pathology, with emphasis on Assessments of effectiveness, safety and tolerability of medication, drug interactions, possible adverse events, dose adjustments as necessary according to patient conditions; Verification that the administration is optimal, including the choice of the best route for this and the time in which the drugs are infused to the patient.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
User satisfaction
Lasso di tempo: 4 months
4 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Readmission
Lasso di tempo: 4 months
4 months
Drug Related Problem
Lasso di tempo: 4 months
4 months
Adherence measured by four question Morisky-Green test
Lasso di tempo: 5 months
If the patient answers all question "NO", the patient is adherent. Measured in two times in the study. The proportion of adherent patients will be measured with respect to the total of them.
5 months
Proportion of recommendations to the health team accepted
Lasso di tempo: 4 months
Recommendations made by a clinical pharmacist can be accepted or rejected. The measurement will be (accepted recommendations/total of recommendations) x100
4 months

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Matías Martínez, Msc, University of Chile

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)

1 marzo 2015

Completamento primario (Effettivo)

1 dicembre 2015

Completamento dello studio (Effettivo)

1 dicembre 2015

Date di iscrizione allo studio

Primo inviato

6 aprile 2017

Primo inviato che soddisfa i criteri di controllo qualità

11 aprile 2017

Primo Inserito (Effettivo)

17 aprile 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 aprile 2017

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UCh2015

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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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