EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
The overall objective of this proposal is to develop and optimize a CDSS, including several nudges, to increase guideline-concordant statin prescribing for CVD risk (Nudge-CVD-CDSS). Potential nudges will be developed, usability tested and refined and then evaluated in a factorial trial. The aim of this trial is to develop, based on a conceptual model of the prescribing process, a set of potential intervention components (EHR-nudges) to promote and support AHA/ACC guideline-concordant statin prescribing. A user-centered design process will be employed. EHR audit log data will be used to identify technical workflows of current provider prescribing patterns. Provider- and patient-directed default, peer comparison, and salient messaging nudges will be developed (5 total). Patient-directed nudges will encourage patients to prompt their providers to prescribe guideline-concordant statins.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Nicole Redfern
- Telefonnummer: 646-501-2501
- E-mail: Nicole.Redfern@nyulangone.org
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10016
- NYU Langone Health
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Providers:
1. Medical doctor, nurse practitioner, and physician assistants practicing at any NYULH Internal or Family Medicine practice.
Patients:
- Age 40-75 years old
- Had a previous visit in the past 12 months with a provider at any NYULH Internal or Family Medicine practice.
- Had blood pressure documented in the last 12 months
- Had LDL results completed in the last 12 months
- Has either a diagnosis of cardiovascular disease, LDL > 190, or ASCVD risk score ≥ 20%
Exclusion Criteria:
Providers - N/A
Patients:
- Pregnant
- Has allergy or contraindication to statin
- Already taking a high-intensity statin
- Has diagnosis of dementia
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Provider
Providers will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
A clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E). |
|
Ingen indgriben: Control
Providers randomized to this arm will receive no EHR nudges. |
|
|
Eksperimentel: Patient
Patients will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
A clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of patients indicated for statin therapy who were prescribed a guideline-approved statin at the correct dose during the study period
Tidsramme: Month 18
|
Month 18
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Safiya Richardson, MD, MPH, NYU Langone Health
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
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
- 23-01349
- 1R01HL171292-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Nicole.Redfern@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD-delingstidsramme
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD-delingsadgangskriterier
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Nicole.Redfern@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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