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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nicole Redfern
- Telefonnummer: 646-501-2501
- E-post: Nicole.Redfern@nyulangone.org
Studiesteder
-
-
New York
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New York, New York, Forente stater, 10016
- NYU Langone Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 inngripen: Control
Providers randomized to this arm will receive no EHR nudges. |
|
|
Eksperimentell: 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). |
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Safiya Richardson, MD, MPH, NYU Langone Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 23-01349
- 1R01HL171292-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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