Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05004376 |
| Other study ID # |
00006479 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2022 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
University of Rochester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this project, we intend to conduct a randomized pilot trial of a structured behavioral
intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to
promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening
recommendations. We will also collect qualitative feedback on perceptions of the intervention
to inform its refinement.
Description:
The investigators propose a pilot randomized controlled trial with a prospectively collected
convenience sample of 130 ED patients non-adherent with CRC screening guidelines over a
3-month period. ED Research Associates (EDRAs) will use the EPIC eRecord system to screen
adult patients registered in the ED at URMC and Noyes Memorial Hospital (when an EDRA is
present in that ED) for eligibility. Inclusion criteria will include: 45-75 years and English
or Spanish speaking (costs for interpreting study surveys and patient interactions will be
paid for from PI discretionary research funds). Exclusion criteria will include personal
and/or family history of colorectal cancer, personal history of inflammatory bowel disease,
and a history of abdominal or pelvic radiation to treat a prior cancer. These exclusions were
chosen due to their impact on standard colorectal screening recommendations. After consent,
subjects will complete a ~10-minute questionnaire administered by the EDRA to determine
adherence to current USPSTF guidelines for colorectal cancer screening using validated items
in the CDC's National Health Interview Survey16. The enrollment process will categorize study
participants into three groups: adherent, uncertain, or non-adherent. Subjects found to be
adherent will be notified and their participation will conclude. Subjects found to be in the
uncertain or non-adherent groups will be randomized into the treatment or control condition.
Following intervention, subjects who were non-adherent will be referred to their usual care
provider to discuss options for becoming adherent. Subjects for whom adherence is uncertain
will be referred to their usual care provider to confirm their adherence status. Subjects who
find through their PCP that they are adherent will be treated as screen failures. Sensitivity
analyses will be performed to evaluate estimates of intervention efficacy with and without
inclusion of subjects initially determined uncertain and later categorized as non-adherent.
Following the initial enrollment, randomization, and recommendation to contact their PCPs,
subjects in the intervention condition will receive a series of 6 text messages, sent at
approximately 15 day intervals, presenting theory-based messages aimed at encouraging
colorectal cancer screening uptake. Subjects without a primary care provider will be given
information on how to establish a PCP in Rochester and on cancer screening services
subsidized through the Cancer Services Program (CSP) of the Finger Lakes Region (our current
R01 includes referrals to the CSP). All subjects in the non-adherent and uncertain groups
will receive a follow-up call at 150 days for a ~5-minute survey to determine if they
underwent or scheduled screening, if they learned that they did not require screening, and
what barriers they perceived in getting screened. Qualitative feedback regarding perceptions
of the intervention will also be collected in order to refine the intervention for future
study. Medical chart review will also be conducted to confirm patient self-reports, making
use of UR records and records from the Rochester Regional Health Information Organization
(RHIO; our current R01 has incorporated the RHIO).Completion of a "second-level" consent form
for use of the RHIO for chart review will be required for enrollment. In our cervical cancer
pilot study, we successfully contacted 68% of participants for follow-up, 11 of whom declined
to complete the follow-up interview. Based on lessons learned in our preliminary work, we
have developed several strategies (currently employed in our R01 study), in addition to the
incentive payment for study completion, which we will employ to maximize retention in this
study:
1. Telephone numbers will be confirmed in the ED during enrollment by the EDRA performing
the enrollment by calling the patient's phone to be certain the number is correct.
2. Up to five calls will be made to each study participant during the follow-up window.
3. Each participant will be provided with study team contact information and asked to
notify us in the event that their phone number changes.
4. In addition to their primary cell phone number, alternative contact information will be
sought from each participant to enable attempts at re-engagement, including: a.Secondary
telephone number of participant b.Email address(es) and mailing address.
5. The EHR will be accessed to check for changes in contact information
