A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing (REDUCE)
4. mars 2020 oppdatert av: University of Pennsylvania
In this study, the investigators will evaluate the effect of a health system initiative aiming to change clinician opioid prescribing behaviors using two behavioral economic interventions - individual audit feedback and peer comparison feedback of clinicians.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Opioid-related abuse and overdose represent a growing national epidemic in the United States.
Clinician practice patterns play an important role: opioid prescriptions impact the likelihood that patients will misuse or become dependent on these medications, with longer prescriptions leading to greater sustained use.
In this study, we will evaluate a Sutter Health System quality improvement initiative using monthly individual audit feedback and/or monthly peer comparison feedback to clinicians to change opioid prescribing patterns.
In partnership with Sutter Health System, this will be conducted using randomization to evaluate its effect.
We will also conduct a process evaluation to understand factors associated with better or worse performance at the clinician level.
Studietype
Intervensjonell
Registrering (Faktiske)
452
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Walnut Creek, California, Forente stater, 94596
- Sutter Heath
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Clinicians
1. Practiced primarily at participating emergency department or urgent care center
Patients
- Presented to a participating emergency department or urgent care center during the study period
- Discharged to home from the visit
Exclusion Criteria:
Clinicians
- Saw less than 100 patients in the prior year
- Practiced primarily at another site that is not in the main trial
- Did not practice at Sutter Health in the prior 90 days
Patients
- Currently pregnant
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Styre
Ingen inngrep
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Eksperimentell: Individual Audit
Clinicians will receive individual audit feedback informing them of their performance.
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Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period.
The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.
|
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Eksperimentell: Peer Comparison
Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers.
|
Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period.
Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a "low prescriber."
|
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Eksperimentell: Individual Audit and Peer Comparison
Clinicians will receive individual audit feedback informing them of their performance and peer comparison feedback informing them of how their performance compares to their peers.
|
Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period.
The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.
Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period.
Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a "low prescriber."
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the mean number of pills per opioid prescription
Tidsramme: Six months
|
The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.
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Six months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in proportion of patient visits with an opioid prescription
Tidsramme: Six months
|
The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.
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Six months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in morphine milligram equivalents per opioid prescription
Tidsramme: Six months
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The change in morphine milligram equivalents per opioid prescription from baseline to the intervention period.
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Six months
|
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Change in mean number of opioid pills per patient-visit
Tidsramme: Six months
|
The change in the mean number of opioid pills per patient-visit from baseline to the intervention period.
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Six months
|
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Change in proportion of patient-visits with non-opioid pain prescription
Tidsramme: Six months
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The change in proportion of patient-visits with non-opioid pain prescriptions (e.g., ibuprofen, acetaminophen, celecoxib, or muscle relaxants such as cyclobenzaprine, baclofen or tizanidine) from baseline to the intervention period.
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Six months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Amol Navathe, MD, PhD, University of Pennsylvania
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. september 2019
Primær fullføring (Faktiske)
2. mars 2020
Studiet fullført (Faktiske)
2. mars 2020
Datoer for studieregistrering
Først innsendt
17. januar 2019
Først innsendt som oppfylte QC-kriteriene
29. januar 2019
Først lagt ut (Faktiske)
31. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 829269
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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