Automated Navigation to Improve Outpatient Colonoscopy Adherence

Colonoscopy Clinical Trial

Official title:

Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710213
• Other study ID #: 831701
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: September 18, 2019

Study information

• Verified date: January 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Colonoscopy
• Text Messaging

Intervention

Behavioral:
• Text Message-based Intervention
The intervention consists of a series of educational and reminder text messages that a patient will receive in the week prior to a scheduled colonoscopy, in addition to two text messages at the time of enrollment explaining the texting program.

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonoscopy show rate with good or excellent bowel prep	The proportion of patients who show up to their scheduled colonoscopy appointment and have a good or excellent prep	Assessed on day of colonoscopy
Secondary	Colonoscopy show rate	The proportion of patients who show up to their scheduled colonoscopy appointment	Assessed on day of colonoscopy
Secondary	Bowel preparation quality	The grading of bowel preparation quality (poor, fair, adequate, good, excellent) among those patients who show to their scheduled colonoscopy	Assessed on day of originally-scheduled colonoscopy
Secondary	Colonoscopy cancellation rate	The proportion of patients who cancel their originally scheduled colonoscopy appointment	Assessed on day of originally-scheduled colonoscopy
Secondary	Colonoscopy reschedule rate	The proportion of patients who cancel and reschedule (for a future date) on the same day, at least one day prior to the originally scheduled colonoscopy appointment date	Assessed on day of originally-scheduled colonoscopy
Secondary	Colonoscopy no-show rate	The proportion of patients who do not show for their scheduled colonoscopy appointment and who have not canceled	Assessed on day of originally-scheduled colonoscopy
Secondary	Timing of advance cancellation notification (in days)	The number of days in advance that a patient cancels their scheduled colonoscopy	Assessed on day of originally-scheduled colonoscopy