Promoting Equity for Cancer Screening and Follow-up
Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Colorectal cancer (CRC) is the third leading cause of cancer-related death in the United States, and screening has been shown to reduce mortality from CRC. Screening is underutilized in the United States, particularly in some communities such as Blacks/African Americans, American Indians/Alaskan Natives, and rural populations, contributing to disparities in mortality.
For CRC screening, mt-sDNA testing is one of several tests that are recommended by the United States Preventive Services Task Force (USPSTF). As part of a quality improvement program at our institution, those who are due for CRC screening are identified using a validated electronic algorithm and a kit is mailed directly to each patient. Our intervention is initiated on non-respondents to the mailed mt-sDNA outreach by testing the use of a technology-enabled reminder system.
Thirty days after being mailed a mt-sDNA kit, patients who have not completed the screening will be randomized to receive a reminder to complete the mt-sDNA screening by one of three mechanisms (time 0):
- Automated reminder using the EHR patient portal messaging system.
- Automated reminder using a customized interactive voice response (IVR) system
- Personalized reminder phone calls from the clinical team
This will allow for an empirical test of processes that can be employed to improve delivery of CRC screening and reduce preventable deaths in populations that are underserved with evidence-based interventions.
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic in Rochester
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adults, between 50 to 75 years old.
- Due for colorectal cancer screening based on not having a record of a colonoscopy within 10 years, sigmoidoscopy, or CT colonography within 5 years, mt-sDNA within 3 years, or FIT within 1 year.
- Asymptomatic for colorectal cancer such as rectal bleeding or reported abdominal mass.
Exclusion Criteria:
- For the intervention study, patients will be restricted to those aged 50 to 75 years and are due for colorectal cancer screening.
- We will exclude any patient who has:
- Had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, mt-sDNA within 3 years, CT colonography within 5 years, and FOBT/FIT within twelve months of inclusion into the study;
- A diagnosis of CRC or other GI cancer;
- History of confirmed Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis) or other colitis;
- Had a colectomy, partial or total;
- A diagnosis of Lynch Syndrome;
- A diagnosis of Familial Adenomatous Polyposis (FAP);
- Iron deficiency anemia;
- Lower GI bleeding;
- A metastatic (Stage IV) blood or solid tumor cancer;
- End stage renal disease;
- A first degree relative with CRC prior to age 50 or 2+ first degree relatives diagnosed at any age.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: IVR Reminder
Participants will receive an interactive voice reminder
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Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.
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Aktiv komparator: Personalized Phone Call Reminder
Participants will receive a personalized phone call
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Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21.
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Aktiv komparator: Portal Message Only
Participants will receive a online patient portal message reminder
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Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Primary Endpoint (intention-to-treat)
Tidsramme: Completion by 6 months post randomization
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The completion rate of mt-sDNA among eligible patients.
The primary comparison will be the return rate compared across intervention arms.
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Completion by 6 months post randomization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Secondary Outcome (per protocol analysis)
Tidsramme: Completion by 6 months post randomization
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The completion rate of mt-sDNA among eligible patients.
The comparison will be the return rate compared across intervention arms, excluding participants who received an alternative intervention due to not having appropriate portal access.
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Completion by 6 months post randomization
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Chyke Doubeni, MBBS, MPH, Mayo Clinic
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20-012010
Plan for individuelle deltakerdata (IPD)
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