- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02299024
Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: 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.
|
|
Eksperimentel: 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.
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Knowledge of medication name
Tidsramme: 4-7 days
|
The primary outcome was the patients ability to identify the medication name of their prescribed opioid pain reliever upon follow-up.
|
4-7 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Knowledge and counseling recall outcomes
Tidsramme: 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
|
Actual Use outcomes
Tidsramme: 4-7 days
|
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
|
Response to the intervention
Tidsramme: 4-7 days
|
Patients in the intervention arm were asked how they liked the intervention using a series of question with a Likert scale.
|
4-7 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Danielle McCarthy, MD MS, Northwestern University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SP0017808
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Opioidbrug, uspecificeret
-
University of MichiganThe Benter FoundationAktiv, ikke rekrutterendeOpioid ordinationForenede Stater
-
matthieu clanetAfsluttet
-
University of MichiganNational Institute on Drug Abuse (NIDA)AfsluttetOpioid ordinationForenede Stater
-
University of North Carolina, Chapel HillNorth Carolina Department of Health and Human ServicesAfsluttetAnalgetika OpioidForenede Stater
-
Purdue Pharma LPAfsluttetOpioid analgesiForenede Stater, Australien, Finland, New Zealand
-
Second Hospital of Shanxi Medical UniversityRekrutteringOpioid analgetisk bivirkningKina
-
St. Louis UniversityAfsluttetOpioid-vedligeholdte gravide kvinder
-
Frederiksberg University HospitalAfsluttet
-
Centre Hospitalier Universitaire DijonAfsluttetOpioidfri anæstesi | Opioid anæstesiFrankrig
-
Centre Hospitalier Universitaire DijonAfsluttetOpioidfri anæstesi | Opioid anæstesiFrankrig
Kliniske forsøg med Additional Opioid Information
-
National Human Genome Research Institute (NHGRI)AfsluttetSund frivilligForenede Stater
-
Meir Medical CenterAfsluttet
-
Asociacion Instituto BiodonostiaRekrutteringUterine cervikale neoplasmer | Angst | Klinisk forsøg | Tidlig opdagelse af kræftSpanien
-
US Department of Veterans AffairsAfsluttetKolorektale neoplasmerForenede Stater
-
Karolinska InstitutetMerck Sharp & Dohme LLCTilmelding efter invitationLivmoderhalskræft | Vulva kræft | Hovedkræft | Kræft i halsen | Kønsvorte | Anus kræft | Penis kræft | Mus papillomaSverige
-
Duke UniversityStanford University; University of North Carolina, Chapel Hill; World BankAfsluttet
-
ThinkWellUniversity of Oxford; Queen's University, Belfast; The BMJAfsluttetTilskyndelseDet Forenede Kongerige
-
Penn State UniversityRekruttering
-
National University of SingaporeAktiv, ikke rekrutterendeAngst | Uddannelsesmæssige problemer | Ægteskab Alder | Fødsel, forsinket | Aldersrelateret kvindelig infertilitetSingapore
-
Assistance Publique - Hôpitaux de ParisIkke rekrutterer endnu