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Automated Navigation to Improve Outpatient Colonoscopy Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03710213
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Shivan J Mehta, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Adherence, Patient Colonoscopy Text Messaging Behavioral: Text Message-based Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel Preparation
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : September 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
No Intervention: Usual Care
Usual care includes (1) bowel preparation instructions that are delivered via mail or through a secure online messaging portal, (2) a phone call from the endoscopy staff in the week prior to colonoscopy, and (3) the option to call the endoscopy staff during business hours to have any questions answered on demand.
Experimental: Text Message-based Intervention
In addition to usual care, the text message-based intervention consists of the subject receiving text messages per a pre-determined protocol starting 7 days prior to the date of scheduled colonoscopy, in addition to two text messages at the time of enrollment explaining the texting program. Of note, if a patient in the intervention arm cancels or reschedules their colonoscopy after randomization, they will not receive any additional protocol text messages as part of this trial.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710213


Locations
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United States, Pennsylvania
University of Pennsylvania Hospital System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Shivan J Mehta, University of Pennsylvania:
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Responsible Party: Shivan J Mehta, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03710213    
Other Study ID Numbers: 831701
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No