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

Study Overview
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Brief Summary
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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
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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: e-assist: Colon Health (treatment arm) [n = 900] Healthwise Educational Program (active control) [n = 900] 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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: e-assist: Colon Health
* Behavioral: Healthwise Educational Program


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-assist: Colon Health (treatment arm)<br>Eligible 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. | Behavioral: e-assist: Colon Health<br>* 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.<br>* Other names: experimental treatment;|
| Active Comparator: Healthwise Educational Program (active control)<br>Eligible 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. | Behavioral: Healthwise Educational Program<br>* Online access to fact sheets that provide basic information about colorectal cancer and screening.<br>* Other names: usual care plus;|
| No Intervention: Usual care control (observational only)<br>There 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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRC, Colorectal Cancer Screening, CRC Screening, Rectum, Colon, Screening, Populations at Risk, colorectal cancer (CRC)