A Patient Portal Tool, E-assist, for Supporting CRC Screening

Colorectal Cancer Clinical Trial

Official title:

A Post-Visit Patient Portal Tool to Promote Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798224
• Other study ID #: LCCC 1624
• Secondary ID: 1R01CA197205
• Status: Completed
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: July 27, 2021

Study information

• Verified date: October 2022
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1826
• Est. completion date: July 27, 2021
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• e-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.
• Healthwise Educational Program
Online access to fact sheets that provide basic information about colorectal cancer and screening.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   UNC Lineberger Comprehensive Cancer Center