Colorectal CancerNCT02798224
A Patient Portal Tool, E-assist, for Supporting CRC Screening
A study testing e-assist: Colon Health and Healthwise Educational Program in people with Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- e-assist: Colon Health and Healthwise Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,826 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2017to 27 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Post-Visit Patient Portal Tool to Promote Colorectal Cancer Screening
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.
Read the 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:
- 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.
- Conditions
- Colorectal Cancer
- Being tested
- e-assist: Colon Health, Healthwise Educational Program
- Keywords
- Colorectal Cancer Screening, CRC Screening, Rectum, Colon, Screening, Populations at Risk, CRC, colorectal cancer (CRC)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-assist: Colon HealthBehavioural
Also called e-assist, treatment, experimental treatment
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 ProgramBehavioural
Also called active control, usual care plus
Online access to fact sheets that provide basic information about colorectal cancer and screening.
| Study group | Role | What they receive |
|---|---|---|
| e-assist: Colon Health (treatment arm) | Experimental | 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. Receives: Behavioral: e-assist: Colon Health |
| Healthwise Educational Program (active control) | Active comparator | 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. Receives: Behavioral: Healthwise Educational Program |
| Usual care control (observational only) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start14 Jun 2017
- Primary completion25 Sep 2020
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,826 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Elston Lafata, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798224
- Sponsor's protocol ID
- LCCC 1624
- Other IDs
- 1R01CA197205
- Status last verified
- Oct 2022
- First submitted
- 3 Jun 2016
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30617102Dyer 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.
PubMed 30554975
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Visit Patient Portal Tool to Promote Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT02798224
- Acronym / sponsor ID
- LCCC 1624
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Screening, CRC Screening, Rectum, Colon, Screening, Populations at Risk, CRC, colorectal cancer (CRC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,826 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| e-assist: Colon Health (treatment arm) | Experimental | Behavioral: e-assist: Colon HealthEligible 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 comparator | Behavioral: Healthwise Educational ProgramEligible 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 intervention | –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). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-assist: Colon HealthAlso: e-assist, treatment, experimental treatmentOnline 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. | Behavioural | e-assist: Colon Health (treatment arm) |
| Healthwise Educational ProgramAlso: active control, usual care plusOnline access to fact sheets that provide basic information about colorectal cancer and screening. | Behavioural | Healthwise Educational Program (active control) |
Primary outcome
CRC Screening use
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 30617102Lafata 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.
- Derived from this study: PubMed 30554975Dyer 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.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Elston Lafata, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-assist: Colon Health and Healthwise Educational Program in people with Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRC Screening use (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.