- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02584881
Safe Opioid Prescription Practice for Patients Discharged From Trauma Services (SOPP)
Safe Opioid Prescription Practice for Patients Discharged From Trauma Services With a Prescription for Opioids
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Prescribing opioids to injured patients who are discharged from an inpatient trauma admission is almost ubiquitous; however up to 26% of patients prescribed opioids for chronic pain abuse them leaving them at an increased risk of overdose and overdose fatality. Addressing this problem through an institutional level approach involving both patients and providers, including changes in physician prescription behaviors and directly intervening with the patients to increase knowledge of risks of opioid misuse and overdose, affords us the best opportunity to address this escalating public health concern.
Using a quasi-experimental design the investigators will compare the effect of adopting and implementing a Safe Opioid Prescription Practice (SOPP) protocol within a Level 1 trauma service team compared to a Level 1 trauma service team implementing standard care. Providers at both sites will complete web-based surveys to assess baseline knowledge, attitudes and barriers related to safe prescription practices. The intervention site will complete technical assistance activities to lead to the adoption and implementation of a SOPP protocol. The control site will continue to offer standard care to trauma patients throughout all phases. To measure institutional level changes, chart reviews will be conducted at both sites using a blinded medical review of discharged trauma service patients at baseline, early implementation, implementation and maintenance phases. To measure patient level changes, the investigators will assess patient perception of the discharge experience at both sites during the adoption phase (Cohort 1=100); implementation phase (Cohort 2=100) and maintenance phase (Cohort 3=100) via telephone interview within 7 days post discharge. Three month interviews will also be conducted with Cohort 2 to assess patient opioid usage, pain management strategies and Naloxone usage among Cohort 2. The aims of the proposed research study are to 1) examine and measure the adoption, implementation and maintenance of the SOPP protocol in the intervention site compared to standard care site and 2) to assess patient level outcomes of the SOPP protocol. The secondary aim of this study is to assess the effect the SOPP protocol on provider prescribing practices comparing the average dosage (in morphine milligram equivalents) and duration of dose from the chart review at baseline to the early implementation, implementation and maintenance phases of the study. The findings from this study will allow us to better understand the translation of a safe opioid prescription practice and has the potential to impact best practices for patient discharge within Level 1 trauma centers.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age ≥ 18 years
- Discharged to home from in-patient trauma services with a prescription for opioids
- Responsible for own medication.
- Cognitively capable of giving informed consent, can be contacted by telephone
Exclusion Criteria:
- < 18 years
- Discharged to rehabilitative or nursing home care
- Not discharged with prescribed opioids
- Not responsible for own medication
- No English speaking
- Under arrest at time of in-patient care
- Cannot be contacted by phone.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervention
A safe opioid prescription protocol will be implemented with these trauma patients
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When indicated a prescription for naloxone will be given to patients discharged with prescription opioids from the trauma services.
All patients will receive information on safe opioid use and storage and methods for pain management.
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Nessun intervento: Control
Standard care at discharge will be implemented with these trauma patients
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The frequency of implementation of the SOPP checklist in the intervention site compared to standard care site
Lasso di tempo: Up to 18 months
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Up to 18 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- U01CE002516-01 (Sovvenzione/contratto NIH degli Stati Uniti)
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 .