Colorectal Cancer
Conditions
Keywords
Colorectal Cancer Screening, CRC Screening, Rectum, Colon, Screening, Populations at Risk, CRC, colorectal cancer (CRC)
Brief summary
To compare patient perceptions, intent to screen, and screening use among those using a patient portal with and without a colorectal cancer (CRC) screening decision support tool, e-assist. To evaluate whether the effectiveness of e-assist is moderated by multi-level factors, including patient health literacy, decision-making preference, and CRC screening decision stage. To assess program impact and create an implementation guide for e-assist by combining results from Aims 1 & 2, a program implementation analysis/process evaluation and the perspectives of staff from future diverse implementation sites including small primary care practices, University-based primary practices and federally-qualified health centers.
Detailed description
During initial project period, the content was developed for the online e-assist tool using messages and tools developed under prior NCI-funded applications combined with newly developed messaging specific to this application. Throughout development, the principal investigator will seek input and guidance from a quality improvement team at the Henry Ford Health System (HFHS) (i.e., the local performance site) that is tasked with patient portal innovation for Meaningful Use. Once finalized, the effectiveness of e-assist will be evaluated using a three-arm, practical randomized trial. Trial participants will be randomized to one of the following three groups: 1. e-assist: Colon Health (treatment arm) \[n = 900\] 2. Healthwise Educational Program (active control) \[n = 900\] 3. Usual care control (observational only) \[n = 900\] For the evaluation, the investigators employ an intent-to-treat design with primary effectiveness measured by electronic health record (EHR)-documented CRC screening use. Secondary outcomes of interest include patient-reported CRC screening intent, perceived barriers to and support for CRC screening as well as perceived susceptibility and screening benefits. Results from all analyses will be used to develop an implementation guide for the dissemination and implementation of e-assist among diverse primary care practices.
Interventions
BEHAVIORALe-assist: Colon Health
Online e-assist program uses educational messages and workflow tools. The intent is to reduce mental workload in terms of how to proceed by filtering and presenting information in a usable manner at a time of peaked situational awareness. The program will prompt patients to indicate their decision stage based on the Precaution Adoption Process Model. e-assist users are then prompted to view additional information and logistical assistance personalized for their decision stage.
BEHAVIORALHealthwise Educational Program
Online access to fact sheets that provide basic information about colorectal cancer and screening.
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
-CRC screening recommendation via colonoscopy and/or stool cards at time of primary care appointment. Receiving care in a HFHS primary care clinic and activated MyChart account.
Exclusion criteria
* EHR-documented colonoscopy in the past 10 years, sigmoidoscopy in the past 5 years, or fecal occult blood test (FOBT) or fecal immunochemical test (FIT) in the past 12 months. * Elevated risk for CRC (i.e., personal or family history of CRC, those with prior polyps, or a history of inflammatory bowel disease, familial adenomatous polyposis, or hereditary nonpolyposis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRC Screening use | 1 year | For the evaluation, an intent-to-treat design with primary effectiveness measured by electronic health record (EHR)-documented CRC screening use. Effectiveness will be assessed among all trial enrollees and specific subgroups. Primary outcome is a binary variable reflecting CRC screening use at 12-months post-intervention as documented by the occurrence of any of the following: colonoscopy, flexible sigmoidoscopy, fecal occult blood testing, fecal immunochemical testing, or testing via Cologuard. |
Countries
United States
Outcome results
None listed