N/A
Completed N=419
Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations
Source: ClinicalTrials.gov NCT01853774 ↗Enrolled (actual)
419
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Primary Outcome is Clinic Attendance — 64; 17 Participants
Summary
The purpose of this study is to test the effectiveness of a two-phase intervention using "community-to-clinic navigators" to guide individuals from an especially hard-to-reach, multicultural, and underinsured population into primary care clinics and, subsequently, to track effects of the intervention on completion of colorectal cancer (CRC) screening in clinics. A cost-effectiveness analysis will lay the foundation for further implementation and dissemination research.
Aim 1: Test effectiveness of community group education + tailored navigation versus community group education only in increasing clinic attendance among low-income, multicultural Arizona residents, aged 50 to 75 yrs.
Hypothesis 1: Individuals receiving group education classes + tailored navigation will show higher rates of clinic attendance than those receiving only group education.
* As a separate critical step for those who make clinic appointments, the investigators will examine the effect on follow through to screening, using initial group assignment as a control variable in analysis. Patients making clinic appointments will receive referral for screening and tailored navigation as usual care.
Aim 2: Track outcomes of the Phase I intervention on CRC screening test completion among low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.
Hypothesis 2: Individuals receiving group classes and tailored navigation during Phase I will have higher rates of CRC screening test completion than those receiving classes only, (however this outcome will be primarily due to clinic attendance).
Aim 3: Determine the cost-effectiveness of each phase of the interventions on increasing CRC screening completion among low-income, multicultural Arizona residents aged 50 to 75 years.
Exploratory Aim 4: Examine the levels of program dissemination from community to clinic to final screenings using the RE-AIM model.
Research Question 2: What is the degree of Reach, Efficacy, Adoption, Implementation, and Maintenance of the community-to-clinic navigation, and clinic-to-screening outcomes?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome is Clinic Attendance |
64; 17 | — |
| SECONDARY The Secondary Outcome is Participant Completion of a CRC Screening Test. |
56; 14 | — |
Eligibility Criteria
Inclusion Criteria
Phase I Inclusion criteria:
- participants will be aged 50-75,
- speak either English or Spanish,
- live in low-income neighborhoods (including a range of race and ethnicity),
- are due for CRC screening,
- may be at average or high risk for CRC,
- either will not identify a regular clinic they attend or will be registered (or identify) with one of the clinic systems engaged in our study. Those who do identify a clinic home, however, will also be encouraged to join the study as long as they are due for screening.
Phase II Inclusion criteria:
- Participants who keep their clinic appointment from Phase I will be enrolled in the study by clinic navigators and the Phase I inclusion criteria (above) will be re-confirmed.
Exclusion Criteria
- Individuals who are compliant with CRC screening guidelines will not be eligible.
While we will not intentionally exclude any specific racial/ethnic group, our study materials are offered in Spanish and English. As such, anyone who does cannot speak, read, and write English or Spanish will not be eligible to participate in the study.
Data sourced from ClinicalTrials.gov (NCT01853774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.