Clinical trial NCT02798224: A Patient Portal Tool, E-assist, for Supporting CRC Screening
Official title: A Post-Visit Patient Portal Tool to Promote Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer Screening
CRC Screening
Rectum
Colon
Screening
Populations at Risk
CRC
colorectal cancer (CRC)
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-14
Enrollment: 1826
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: CRC Screening use
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Elston Lafata, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lafata JE, Shin Y, Flocke SA, Hawley ST, Jones RM, Resnicow K, Schreiber M, Shires DA, Tu SP. Randomised trial to evaluate the effectiveness and impact of offering postvisit decision support and assistance in obtaining physician-recommended colorectal cancer screening: the e-assist: Colon Health study-a protocol study. BMJ Open. 2019 Jan 7;9(1):e023986. doi: 10.1136/bmjopen-2018-023986.
citation: Dyer KE, Shires DA, Flocke SA, Hawley ST, Jones RM, Resnicow K, Shin Y, Lafata JE. Patient-Reported Needs Following a Referral for Colorectal Cancer Screening. Am J Prev Med. 2019 Feb;56(2):271-280. doi: 10.1016/j.amepre.2018.08.017. Epub 2018 Dec 13.