A Patient Portal Tool, E-assist, for Supporting CRC Screening
A Post-Visit Patient Portal Tool to Promote Colorectal Cancer Screening
2 other identifiers
interventional
1,826
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jun 2017
Typical duration for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedStudy Start
First participant enrolled
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedOctober 25, 2022
October 1, 2022
3.3 years
June 3, 2016
October 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CRC Screening use
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.
1 year
Study Arms (3)
e-assist: Colon Health (treatment arm)
EXPERIMENTALEligible patients identified will receive a prompt (via email) to log into portal for an important health message. Once eligible patient initiates portal session, continuing past IRB consent screen, patient is enrolled.
Healthwise Educational Program (active control)
ACTIVE COMPARATOREligible patients identified will receive a prompt (via email) to log into portal for an important health message. Once eligible patient initiates portal session, continuing past IRB consent screen, patient is enrolled.
Usual care control (observational only)
NO INTERVENTIONThere will be no participant contact in this arm. We will use existing data sources only (e.g., EHRs) to obtain information on participants in this arm (i.e., an observational data review only).
Interventions
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.
Online access to fact sheets that provide basic information about colorectal cancer and screening.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (2)
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.
PMID: 30617102DERIVEDDyer 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.
PMID: 30554975DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Elston Lafata, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2016
First Posted
June 14, 2016
Study Start
June 14, 2017
Primary Completion
September 25, 2020
Study Completion
July 27, 2021
Last Updated
October 25, 2022
Record last verified: 2022-10