- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03825549
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing (REDUCE)
4 mars 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
452
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
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Walnut Creek, California, Förenta staterna, 94596
- Sutter Heath
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollera
Inget ingripande
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|
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Experimentell: 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.
|
|
Experimentell: 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."
|
|
Experimentell: 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."
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in the mean number of pills per opioid prescription
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in proportion of patient visits with an opioid prescription
Tidsram: 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.
|
Six months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in morphine milligram equivalents per opioid prescription
Tidsram: Six months
|
The change in morphine milligram equivalents per opioid prescription from baseline to the intervention period.
|
Six months
|
|
Change in mean number of opioid pills per patient-visit
Tidsram: Six months
|
The change in the mean number of opioid pills per patient-visit from baseline to the intervention period.
|
Six months
|
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Change in proportion of patient-visits with non-opioid pain prescription
Tidsram: Six months
|
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.
|
Six months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Amol Navathe, MD, PhD, University of Pennsylvania
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 september 2019
Primärt slutförande (Faktisk)
2 mars 2020
Avslutad studie (Faktisk)
2 mars 2020
Studieregistreringsdatum
Först inskickad
17 januari 2019
Först inskickad som uppfyllde QC-kriterierna
29 januari 2019
Första postat (Faktisk)
31 januari 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 mars 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 mars 2020
Senast verifierad
1 mars 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 829269
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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