Trial Outcomes & Findings for Internet-Based Motivational Interviewing for Colonoscopy (NCT NCT03595904)
NCT ID: NCT03595904
Last Updated: 2021-07-08
Results Overview
Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
six months after the initial referral
Results posted on
2021-07-08
Participant Flow
Recruitment sites: Primary care and Gastroenterology clinics in the Mount Sinai Health System. Enrollment started in November 2017 through November 2019.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
COMPLETED
|
29
|
34
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Deemed medically ineligible for direct access colonoscopy
|
4
|
3
|
|
Overall Study
Insurance complications
|
1
|
0
|
|
Overall Study
COVID-19 halt in non-essential appointments during 6 month follow up
|
2
|
1
|
Baseline Characteristics
Internet-Based Motivational Interviewing for Colonoscopy
Baseline characteristics by cohort
| Measure |
E-Motivate Group
n=29 Participants
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).
|
Usual Care Group
n=34 Participants
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).
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.55 years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
59.15 years
STANDARD_DEVIATION 7.02 • n=7 Participants
|
58.87 years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six months after the initial referralSix months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy
Outcome measures
| Measure |
E-Motivate Group
n=29 Participants
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).
|
Usual Care Group
n=34 Participants
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).
|
|---|---|---|
|
Number of Participants Who Completed a Screening Colonoscopy
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: six months after initial referralPopulation: Data only available for those participants with bowel prep quality ratings.
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.
Outcome measures
| Measure |
E-Motivate Group
n=22 Participants
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).
|
Usual Care Group
n=19 Participants
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).
|
|---|---|---|
|
Number of Participants With Adequate Bowel Prep Quality
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: six monthsProcess variable was assessed via medical chart review six months following the initial referral
Outcome measures
| Measure |
E-Motivate Group
n=29 Participants
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).
|
Usual Care Group
n=34 Participants
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).
|
|---|---|---|
|
Number of Participants Who Had Canceled Appointments
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: six monthsProcess variable was assessed via medical chart review six months following the initial referral
Outcome measures
| Measure |
E-Motivate Group
n=29 Participants
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).
|
Usual Care Group
n=34 Participants
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).
|
|---|---|---|
|
Number of Patients Who Had Rescheduled Appointments
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: six monthsProcess variable was assessed via medical chart review six months following the initial referral
Outcome measures
| Measure |
E-Motivate Group
n=29 Participants
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).
|
Usual Care Group
n=34 Participants
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).
|
|---|---|---|
|
Number of Participants Who Were No-show Appointments
|
0 Participants
|
2 Participants
|
Adverse Events
E-Motivate Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sarah Miller
Icahn School of Medicine at Mount Sinai
Phone: 212-824-7783
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place