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OpenTrials
Completed

NCT Number: NCT03710213

Automated Navigation to Improve Outpatient Colonoscopy Adherence

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Hospital System

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text message-based intervention

Behavioral

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.

Primary outcomes

  1. Colonoscopy show rate with good or excellent bowel prep

    Time frame: Assessed on day of colonoscopy

    The proportion of patients who show up to their scheduled colonoscopy appointment and have a good or excellent prep

Secondary outcomes

  1. Colonoscopy show rate

    Time frame: Assessed on day of colonoscopy

    The proportion of patients who show up to their scheduled colonoscopy appointment

  2. Bowel preparation quality

    Time frame: Assessed on day of originally-scheduled colonoscopy

    The grading of bowel preparation quality (poor, fair, adequate, good, excellent) among those patients who show to their scheduled colonoscopy

  3. Colonoscopy cancellation rate

    Time frame: Assessed on day of originally-scheduled colonoscopy

    The proportion of patients who cancel their originally scheduled colonoscopy appointment

  4. Colonoscopy reschedule rate

    Time frame: Assessed on day of originally-scheduled colonoscopy

    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

  5. Colonoscopy no-show rate

    Time frame: Assessed on day of originally-scheduled colonoscopy

    The proportion of patients who do not show for their scheduled colonoscopy appointment and who have not canceled

  6. Timing of advance cancellation notification (in days)

    Time frame: Assessed on day of originally-scheduled colonoscopy

    The number of days in advance that a patient cancels their scheduled colonoscopy

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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