Contemporary clinical trials · 2022
PRescribing Interventions for Chronic pain using the Electronic health record (PRINCE): Study protocol.
СтатьяПоддержка службы здравоохранения СШАПоддержка NIH: внешняя программаПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Vock David M, Neprash Hannah T, Hanson Alexandra V, Elert Brent A, Satin David J, Rothman Alexander J, Short Sonja, Karaca-Mandic Pinar, Markowitz Rebecca, Melton Genevieve B, Golberstein Ezra
Аннотация
BACKGROUND: Primary care is a frequent source of pain treatment and opioid prescribing. The objective of the Prescribing Interventions for Chronic Pain using the Electronic health record (PRINCE) study is to assess the effects of two behavioral economics-informed interventions embedded within the electronic health record (EHR) on guideline-concordant pain treatment and opioid prescribing decisions in primary care settings.
METHODS: Setting: The setting for this study is 43 primary care clinics in Minnesota.
DESIGN: The PRINCE study uses a cluster-randomized 2 × 2 factorial design to test the effects of two interventions. An adaptive design allows for the possibility of secondary randomization to test if interventions can be titrated while maintaining efficacy.
INTERVENTIONS: One intervention alters the "choice architecture" within the EHR to nudge clinicians toward non-opioid treatments for opioid-naïve patients and toward tapering for patients currently receiving a "high risk" opioid. The other intervention integrates the prescription drug monitoring program (PDMP) directly within the EHR.
OUTCOME: The primary outcome for opioid-naïve patients is whether an opioid is prescribed in a primary care visit without a non-opioid alternative pain treatment. The primary outcome for current opioid-using patients is whether opioid prescriptions were tapered with a documented rationale.
DISCUSSION: The PRINCE study will provide real-world evidence on two approaches to improving pain treatment in primary care using the EHR. The adaptive study design strikes a balance between establishing intervention efficacy and testing whether efficacy varies with intervention intensity.
METHODS: Setting: The setting for this study is 43 primary care clinics in Minnesota.
DESIGN: The PRINCE study uses a cluster-randomized 2 × 2 factorial design to test the effects of two interventions. An adaptive design allows for the possibility of secondary randomization to test if interventions can be titrated while maintaining efficacy.
INTERVENTIONS: One intervention alters the "choice architecture" within the EHR to nudge clinicians toward non-opioid treatments for opioid-naïve patients and toward tapering for patients currently receiving a "high risk" opioid. The other intervention integrates the prescription drug monitoring program (PDMP) directly within the EHR.
OUTCOME: The primary outcome for opioid-naïve patients is whether an opioid is prescribed in a primary care visit without a non-opioid alternative pain treatment. The primary outcome for current opioid-using patients is whether opioid prescriptions were tapered with a documented rationale.
DISCUSSION: The PRINCE study will provide real-world evidence on two approaches to improving pain treatment in primary care using the EHR. The adaptive study design strikes a balance between establishing intervention efficacy and testing whether efficacy varies with intervention intensity.