- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02299024
Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Recent studies indicate that emergency department (ED) discharge processes - including written and spoken communications - are inadequate, and patients often leave without the knowledge necessary to properly care for themselves. In the context of opioid pain relievers, this lack of knowledge is potentially dangerous, as patients may not possess the requisite knowledge for safe use of their medication or an awareness of the dangers of medication misuse.
The aim of this study was to evaluate the impact of an opioid information sheet and spoken counseling on patient knowledge about opioids and safe use behaviors. The investigators conducted a randomized controlled pilot test of a dual-modality educational intervention (written information sheet and spoken counseling about opioids) to assess if the intervention can increase patient knowledge about opioid pain relievers. These activities were intended to guide future modification of educational interventions and the future development of best practices for emergency physician spoken counseling about opioid pain relievers.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- prescribed an opioid pain reliever
- English Speaking
Exclusion Criteria:
- Non-English Speaking
- Clinically unstable, psychologically impaired or intoxicated as judged by the research staff member.
- Chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days.
- admitted to hospital
- unable to complete follow up phone interview in 4 - 7 days.
Piano di studio
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 |
|---|---|
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Nessun intervento: Control
Patients in this arm are discharged from the Northwestern Emergency Department with standard communication about their prescribed opioid pain medication from their care providers.
They are called for a follow up survey 4-7 days after their visit.
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Sperimentale: Dual Modality Educational Intervention
Patients in this arm are discharged from the ED with an additional information sheet about their prescribed opioid pain medication, via the intervention titled "Additional Opioid Information".
The sheet is read aloud to them by a research assistant.
They are called 4-7 days later for a follow up survey.
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Patients receiving this intervention are given additional information about the opioid pain medication that they are receiving in the form of a one page handout.
The hand out was written in a health-literacy appropriate manner.
A research assistant read the handout to them out loud, and they were given a copy to take home with them.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Knowledge of medication name
Lasso di tempo: 4-7 days
|
The primary outcome was the patients ability to identify the medication name of their prescribed opioid pain reliever upon follow-up.
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4-7 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Knowledge and counseling recall outcomes
Lasso di tempo: 4-7 days
|
In addition to the outcome of medication name patients were asked additional knowledge and recall questions including: active ingredients in the medication, knowledge about safe daily dose of acetaminophen, side effects, recall of counseling about activities to avoid (drinking alcohol, driving vehicle), knowledge about addictive potential of the medication.
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4-7 days
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Actual Use outcomes
Lasso di tempo: 4-7 days
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Patients were queried about their home use of the medication including: pain score at home, average number of tabs per day, and satisfaction with pain reduction.
Additionally they were asked about the timing of any alcohol consumption or driving in relation to the timing of medication dosing.
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4-7 days
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Response to the intervention
Lasso di tempo: 4-7 days
|
Patients in the intervention arm were asked how they liked the intervention using a series of question with a Likert scale.
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4-7 days
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Danielle McCarthy, MD MS, Northwestern University
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 (Effettivo)
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
- SP0017808
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 .