- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05785780
Mål 3, Optimalisering av CRC-screening hos pasienter med diabetes i sikkerhetsnettets primæromsorgsinnstillinger
Optimalisering av kolorektal kreftscreening blant pasienter med diabetes i sikkerhetsnettets primæromsorgsinnstillinger: Målretting av implementeringsmetoder
This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening for patients with diabetes in primary care safety-net settings.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Aim 3 is a hybrid type 2 effectiveness-implementation pilot study in six primary care safety net clinics. This single-arm study uses a pre-post design to evaluate the targeted implementation strategies impact on: (1) preliminary effectiveness and (2) implementation (i.e., feasibility and acceptability) and a mixed-method comparative case study learning evaluation for safety-net primary care adoption and implementation. Implementation strategies that will be tested were developed through a stakeholder engaged, community-based participatory implementation planning approach. This study uses a tailored combination of implementation strategies that include but are not limited to: identification of patient and practice-level barriers, patient education matierals, patient reminders provider/clinical team education, clinical champions, and audit and feedback. The impact of this evaluation will be measure using mixed methods to assess Exploration, Preparation, Implementation factors related to how organizational and contextual variables affect adoption and implementation for targeting CRC screening among patients with diabetes in safety net clinics at 12 months post intervention. Aim 3 surveys 20 clinicians and staff from 6 clinics (n=120) and conducts key-informant interviews with 8 clinic and staff members at pre- and post-implementation (who have participated in the survey; n=96) and evaluates aggregate data for 30 patients across six clinics (n=180).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
-
New Brunswick, New Jersey, Forente stater, 08903
- RWJBarnabas Health - Robert Wood Johnson University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of diabetes mellitus;
- Participants not up-to-date with CRC screening based on electronic health record (e.g. FOBT/FIT in last year; flexible sigmoidoscopy within four years; or colonoscopy within nine years);
- Age-eligible for CRC screening (50-74 years of age);
- Participants in process of undergoing screening are eligible for participation if they have a FIT/FOBT incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year.
Exclusion Criteria:
• Medical conditions not concordant with standard CRC screening intervals (e.g. prior CRC diagnosis, inflammatory bowel disease, renal failure, etc.).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Targeted CRC Screening Toolkit
Based on national survey data and a community engagement participatory implemention planning group, a tailored combination of widely accepted implementation strategies will be adapted for targeting CRC screening for patients with diabetes. These strategies include but are not limited to: identification of patient and practice-level barriers, patient education, provider reminders, and audit and feedback. |
Strategies in the toolkit include but are not limited to: identification of patient and practice-level barriers, routine tailored patient reminders, provider reminders, & clinic staff feedback. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Colonoscopy uptake
Tidsramme: 12 months
|
Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy |
12 months
|
|
Up-to-date CRC screening
Tidsramme: 12 months
|
Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening |
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes
Tidsramme: 12 months
|
Preliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled) |
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant Acceptability
Tidsramme: 12 months
|
Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants |
12 months
|
|
Implementation Fidelity
Tidsramme: 12 months
|
Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets |
12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Denalee O'Malley, PhD, Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey
Publikasjoner og nyttige lenker
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 002056
- Pro2020002075 (Annen identifikator: Rutgers, The State University of New Jersey)
- R00CA256043 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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