- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04873609
Electronic Record Assimilation and Subsequent Eradication of Hepatitis C (ERASE-C)
Targeted Electronic Patient Portal Messaging Increases Hepatitis C Virus Screening in Primary Care: a Randomized Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The Centers for Disease Control and Prevention (CDC) and the United States Preventative Services Taskforce (USPSTF) recommend a one-time hepatitis C infection (HCV) screen in individuals born 1945-65 (baby boomer birth cohort) and in others with risk factors for infection. National adherence to this Grade B recommendation-carrying the same strength of evidence as mammography, and screening for depression, alcohol abuse, and type 2 diabetes-is estimated to be 13.8%. Efforts to increase screening and linkage to HCV care, and also to understand barriers to screening and linkage are therefore warranted.
One such intervention, direct-to-patient messages via electronic medical record (EMR), has been demonstrated to improve adherence in influenza and pneumococcal vaccination, colon cancer screening, immunosuppression after transplantation, among others, but has not been studied as a strategy to improve HCV screening rates within health systems.
Our institution, Stanford Health Care, comprises 86 distinct clinical sites with approximately 1.25 million outpatient visits per year. All clinical sites are linked with an EMR (Epic Systems Corp.) and patients are encouraged to opt-in to receive and send health-related messages through a secure internet and smartphone portal, MyHealth. Approximately 60% of patients at our institution are enrolled in MyHealth.
MyHealth additionally allows bulk-messaging of patients meeting specific characteristics, e.g. patients due for influenza vaccination. Bulk messages can be coupled with laboratory or radiology requisitions. Messages are delivered through the online portal, text message, e-mail, and/or smartphone application notification, depending on patient preference. Laboratory and radiology results are routed automatically to patients' primary care physicians for review.
The investigators propose to conduct a randomized study comparing the effectiveness of a direct-to-patient electronic health message on HCV screening coupled with a lab requisition, versus HCV screening initiated by primary care clinicians as part of routine clinical care alone.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Palo Alto, California, Forente stater, 94305
- Stanford University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- persons born between 1945-1965
- having an activated patient portal to receive secure messages (MyHealth)
- no prior HCV antibody test within our EHR (electronic health record), including externally accessible results
Exclusion Criteria:
- documented HCV viral load in our EHR
- diagnosis of chronic HCV in their problem list
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: No primary care provider (PCP) appointment, No patient outreach
400 patients that did not have an upcoming PCP appointment in 6 months were randomly assigned to control group and did not receive a patient portal message with order for HCV antibody screening
|
|
|
Aktiv komparator: No PCP appointment, Patient outreach
400 patients that did not have an upcoming PCP appointment in 6 months were randomly assigned to receive a patient portal message with order for HCV antibody screening
|
Direct-to-patient message via the electronic patient portal (MyHealth) with HCV antibody lab order directed to their preferred laboratory
Andre navn:
|
|
Ingen inngripen: PCP appointment, No patient outreach
400 patients that had an upcoming PCP appointment in 6 months were randomly assigned to control group and did not receive a patient portal message with order for HCV antibody screening
|
|
|
Aktiv komparator: PCP appointment, Patient outreach
400 patients that had an upcoming PCP appointment in 6 months were randomly assigned to receive a patient portal message with order for HCV antibody screening
|
Direct-to-patient message via the electronic patient portal (MyHealth) with HCV antibody lab order directed to their preferred laboratory
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of HCV antibody test completion
Tidsramme: 6 months
|
completion of HCV antibody test
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of positive HCV antibody or positive HCV RNA referred for treatment
Tidsramme: 8 months
|
referral to subspecialty for treatment of chronic HCV infection
|
8 months
|
|
Rate of subspecialty visit completion
Tidsramme: 3 months
|
attended subspecialty visit for treatment
|
3 months
|
|
Rate of HCV treatment initiation
Tidsramme: 10 months
|
chronic HCV treatment started
|
10 months
|
|
Rate of sustained virologic response
Tidsramme: 10 months
|
HCV cured
|
10 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Aparna Goel, MD, Stanford University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- eP46287
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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