Internet-Based Motivational Interviewing for Colonoscopy

Colorectal Neoplasms Clinical Trial

Official title:

Internet-Based Motivational Interviewing for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595904
• Other study ID #: GCO 14-0275
• Secondary ID: K07CA190726
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: May 8, 2020

Study information

• Verified date: June 2021
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Although colonoscopies can prevent CRC, nearly one third of African Americans have not received a screening colonoscopy within the recommended time frame (one colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality. Previous research suggests that a motivational interviewing based intervention may help improve screening colonoscopy uptake. This study will conduct a randomized clinical trial examining the efficacy of a motivational interviewing informed tablet app, called e-Motivate, to improve African Americans' screening colonoscopy uptake. Participants will be African Americans who receive a referral for a screening colonoscopy. Participants (N=200) will be randomly assigned to one of two groups: (1) usual care group (N=100); or (2) e-Motivate app group (N=100). Participants in the usual care group will receive standard clinical care which includes patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will complete the e-Motivate app in the clinic immediately after they receive a referral for the screening colonoscopy. The participants in the e-Motivate app group will also receive usual care. Six months following the initial referral, participants' medical charts will be reviewed to determine whether the participants completed the recommended screening colonoscopy. Secondary outcomes (e.g., bowel prep quality, number of cancellations) will also be analyzed.

Description:

Colorectal cancer (CRC), a largely preventable disease, remains the third leading cause of cancer death in the United States. Compared to other racial groups, African Americans have the highest CRC morbidity and mortality rates. Recent reports have found that African Americans' CRC incidence rates are 20% higher and mortality rates are 45% higher than those of whites. Given these disparities, it is critical to increase African Americans' participation in CRC screenings. Of the recommended CRC screening mechanisms, a colonoscopy is often the preferred method because it allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than 1/3 of African Americans have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality.

A motivational interviewing (MI) intervention can help improve African Americans' screening colonoscopy uptake. MI is a brief patient-centered intervention that increases perceived competence, autonomy, and relatedness in order to promote behavioral change. Extensive research supports the efficacy of MI to promote preventive health screening uptake, including increasing screening colonoscopy rates, and MI has proven efficacious with African Americans across a wide range of diseases.

Traditionally, MI is delivered live, where individuals meet with a professional for a one-on-one intervention. Although efficacious, live-MI is not without limitations. Of greatest concern, live-MI requires both staffing and economic resources, limiting its ability to be widely disseminated. A digital intervention, such a tablet app, may overcome these limitations. By eliminating the need for an on-site professional, a tablet app is a high reach, low cost intervention with the potential to have a significant public health impact.

The primary goal of this study is to conduct a randomized clinical trial (RCT) that examines the efficacy of a tablet app, called e-Motivate, to improve screening colonoscopy rates in African Americans.

The app first underwent iterative field-testing and subsequent modifications to ensure that the app had high usability and acceptability ratings.

The final version of the app, called e-Motivate, will be tested in a randomized clinical trial. African American patients referred for a screening colonoscopy will be recruited to the RCT. Participants (N=200) will be randomly assigned to a usual care group (N=100) or an e-Motivate group (N=100). Participants in the usual care group will receive standard patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will receive standard clinical care and will also complete the e-Motivate app. The app will be a 20-minute tablet app that will include motivational interviewing informed exercises and education. The app will be completed in the clinic immediately after a participant receives a referral for a screening colonoscopy. Six months following the initial referral, participants medical charts will be reviewed to determine whether they completed the recommended screening colonoscopy. It is hypothesized that participants in the e-Motivate group will be more likely to complete the recommended screening colonoscopy.

The study will also explore whether the e-Motivate app can improve secondary outcomes (e.g., bowel prep quality, number of cancellations).

Potential mediators, informed by Self Determination Theory, will be evaluated. Potential moderators (e.g., age, education, family history of CRC) will be explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• self-identified as African American/Black

• received a referral for a screening colonoscopy

• recommended age to begin screening for colorectal cancer (based on current guidelines)

• English speaking

Exclusion Criteria:

• hearing or vision impaired

• participated in the previous iterative field testing

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Behavioral:
• E-Motivate group
Participants in the e-Motivate group will receive standard clinical care which includes patient navigation (e.g., scheduling and reminders). They will also complete a 20-minute, motivational interviewing informed tablet app in the clinic immediately after they receive a referral for a screening colonoscopy. The tablet app consists of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
• Usual Care Group
Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy. In particular, they will receive patient navigation which includes scheduling the colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller SJ, Foran-Tuller K, Ledergerber J, Jandorf L. Motivational interviewing to improve health screening uptake: A systematic review. Patient Educ Couns. 2017 Feb;100(2):190-198. doi: 10.1016/j.pec.2016.08.027. Epub 2016 Aug 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Completed a Screening Colonoscopy	Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy	six months after the initial referral
Secondary	Number of Participants With Adequate Bowel Prep Quality	An adequate prep which is defined as "adequate, excellent or good". An inadequate prep would be defined as "inadequate, poor or fair". Six months following the initial referral, medical charts was reviewed to determine the physician-rated bowel prep quality for participants who completed the screening colonoscopy.	six months after initial referral
Secondary	Number of Participants Who Had Canceled Appointments	Process variable was assessed via medical chart review six months following the initial referral	six months
Secondary	Number of Patients Who Had Rescheduled Appointments	Process variable was assessed via medical chart review six months following the initial referral	six months
Secondary	Number of Participants Who Were No-show Appointments	Process variable was assessed via medical chart review six months following the initial referral	six months