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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03710213
Other study ID # 831701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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