Clinical trial NCT03710213: Automated Navigation to Improve Outpatient Colonoscopy Adherence
Official title: Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Patient
Colonoscopy
Text Messaging
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Outpatient colonoscopy adherence is negatively impacted by poor communication and challenges with bowel preparation. We plan to perform a randomized controlled trial at the Pennsylvania Presbyterian Medical Center to (1) provide text message-based educational and reminder messages to patients regarding a scheduled colonoscopy, and (2) evaluate the impact of the texting intervention on colonoscopy show rate and bowel preparation.

Detailed description: Colorectal cancer (CRC) is the second leading cause of cancer death in the US, yet there are effective screening and treatment strategies that allow for early detection and treatment. CRC screening is recommended for all individuals aged 50-75, which could include stool testing or colonoscopy, but national rates are still suboptimal at 59-65%. Colonoscopy is an essential component of CRC screening, as it is also required if stool testing is positive. However, colonoscopy requires a complex process to identify an escort, purchase the preparation, take a day off from work, adhere to a clear liquid diet, and complete the split-dose preparation as recommended. This results in a significant no-show and cancellation rate, along with suboptimal preparation quality, which can lead to non-adherence and incomplete screening.

Current approaches to engaging patients include having nurses call patients before the procedure or patient navigators. However, it is often difficult to get patients on the phone, and these interventions can be costly, making it less scalable for clinical practices. Other interventions such as videos or mobile apps have been limited by poor user experience or limited engagement with the patient. There is an opportunity to leverage an automated text message navigation intervention using the Way to Health (WTH) platform to improve patient engagement prior to colonoscopy completion. The WTH platform is a Penn Medicine platform that is hosted on site at the University of Pennsylvania. The platform allows custom text messages to automatically be sent to patients, in addition to bidirectional message capabilities. WTH is protected by a secure firewall and is a HIPAA compliant platform.

In the past year, our team conducted a quality improvement pilot initiative using WTH that tested the feasibility and impact of a one-week text messaging protocol for patients who were scheduled for outpatient colonoscopy. The text messages sent to patients contained information about the preparation process and instructions, expectations about the procedure, and reminders about location and timing. Among the 21 patients enrolled in the pilot, we found high user acceptability and higher colonoscopy show rates as compared to baseline values at Pennsylvania Presbyterian Medical Center. As such we believe that the texting intervention is feasible for testing in the context of a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Scheduled for outpatient colonoscopy at Pennsylvania Presbyterian Medical Center
* Subject has a cell phone with enabled text messaging capability

Exclusion Criteria:

* Fewer than 14 days between the time of enrollment and time of scheduled colonoscopy
* Subject is non-English speaking requiring a translator
* Subject is not the primary individual receiving the text messages

Primary outcomes:
measure: Colonoscopy show rate with good or excellent bowel prep
timeFrame: Assessed on day of colonoscopy
Secondary outcomes:
measure: Colonoscopy show rate
timeFrame: Assessed on day of colonoscopy
measure: Bowel preparation quality
timeFrame: Assessed on day of originally-scheduled colonoscopy
measure: Colonoscopy cancellation rate
timeFrame: Assessed on day of originally-scheduled colonoscopy
measure: Colonoscopy reschedule rate
timeFrame: Assessed on day of originally-scheduled colonoscopy
measure: Colonoscopy no-show rate
timeFrame: Assessed on day of originally-scheduled colonoscopy
measure: Timing of advance cancellation notification (in days)
timeFrame: Assessed on day of originally-scheduled colonoscopy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital System
state: Pennsylvania
Study officials:
References:
citation: Mahmud N, Asch DA, Sung J, Reitz C, Coniglio MS, McDonald C, Bernard D, Mehta SJ. Effect of Text Messaging on Bowel Preparation and Appointment Attendance for Outpatient Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2034553. doi: 10.1001/jamanetworkopen.2020.34553.