Colorectal Neoplasms
Conditions
Keywords
colorectal neoplasms, colonoscopy, African Americans, Telemedicine
Brief 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.
Detailed 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.
Interventions
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).
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.
Sponsors
Study design
Masking description
The outcome assessor will be blinded to the participants' assigned study group.
Intervention model description
Participants are randomly assigned to one of two groups (1:1).
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed a Screening Colonoscopy | six months after the initial referral | Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adequate Bowel Prep Quality | six months after initial referral | 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. |
| Number of Participants Who Had Canceled Appointments | six months | Process variable was assessed via medical chart review six months following the initial referral |
| Number of Patients Who Had Rescheduled Appointments | six months | Process variable was assessed via medical chart review six months following the initial referral |
| Number of Participants Who Were No-show Appointments | six months | Process variable was assessed via medical chart review six months following the initial referral |
Countries
United States
Participant flow
Recruitment details
Recruitment sites: Primary care and Gastroenterology clinics in the Mount Sinai Health System. Enrollment started in November 2017 through November 2019.
Participants by arm
| Arm | Count |
|---|---|
| E-Motivate Group Participants completed a 20-minute tablet app, called e-Motivate and received usual care. In particular, participants in the e-motivate group completed a 20-minute, motivational interviewing informed tablet app in the clinic after they received a physician referral for a screening colonoscopy. The tablet app consisted of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary). | 29 |
| Usual Care Group Participants in the usual care group received standard clinical care for patients referred for a screening colonoscopy. In particular, they received patient navigation (e.g., assistance scheduling the screening colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions). | 34 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 halt in non-essential appointments during 6 month follow up | 2 | 1 |
| Overall Study | Deemed medically ineligible for direct access colonoscopy | 4 | 3 |
| Overall Study | Insurance complications | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 1 |
Baseline characteristics
| Characteristic | Usual Care Group | Total | E-Motivate Group |
|---|---|---|---|
| Age, Continuous | 59.15 years STANDARD_DEVIATION 7.02 | 58.87 years STANDARD_DEVIATION 7.16 | 58.55 years STANDARD_DEVIATION 7.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 60 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 58 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 26 Participants | 44 Participants | 18 Participants |
| Sex: Female, Male Male | 8 Participants | 19 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 34 |
| other Total, other adverse events | 0 / 29 | 0 / 34 |
| serious Total, serious adverse events | 0 / 29 | 0 / 34 |
Outcome results
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
Time frame: six months after the initial referral
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Motivate Group | Number of Participants Who Completed a Screening Colonoscopy | 19 Participants |
| Usual Care Group | Number of Participants Who Completed a Screening Colonoscopy | 19 Participants |
Number of Participants Who Had Canceled Appointments
Process variable was assessed via medical chart review six months following the initial referral
Time frame: six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Motivate Group | Number of Participants Who Had Canceled Appointments | 5 Participants |
| Usual Care Group | Number of Participants Who Had Canceled Appointments | 11 Participants |
Number of Participants Who Were No-show Appointments
Process variable was assessed via medical chart review six months following the initial referral
Time frame: six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Motivate Group | Number of Participants Who Were No-show Appointments | 0 Participants |
| Usual Care Group | Number of Participants Who Were No-show Appointments | 2 Participants |
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.
Time frame: six months after initial referral
Population: Data only available for those participants with bowel prep quality ratings.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Motivate Group | Number of Participants With Adequate Bowel Prep Quality | 12 Participants |
| Usual Care Group | Number of Participants With Adequate Bowel Prep Quality | 13 Participants |
Number of Patients Who Had Rescheduled Appointments
Process variable was assessed via medical chart review six months following the initial referral
Time frame: six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| E-Motivate Group | Number of Patients Who Had Rescheduled Appointments | 0 Participants |
| Usual Care Group | Number of Patients Who Had Rescheduled Appointments | 6 Participants |