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临床试验/NCT03710213
NCT03710213已完成不适用

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

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 752 人开始时间: 2018年11月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
752
试验地点
1
主要终点
Colonoscopy show rate with good or excellent bowel prep

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Usual Care

No Intervention

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.

Text Message-based Intervention

Experimental

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.

干预措施: Text Message-based Intervention (Behavioral)

结局指标

主要结局

Colonoscopy show rate with good or excellent bowel prep

时间窗: Assessed on day of colonoscopy

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

次要结局

  • Colonoscopy cancellation rate(Assessed on day of originally-scheduled colonoscopy)
  • Colonoscopy reschedule rate(Assessed on day of originally-scheduled colonoscopy)
  • Colonoscopy no-show rate(Assessed on day of originally-scheduled colonoscopy)
  • Timing of advance cancellation notification (in days)(Assessed on day of originally-scheduled colonoscopy)
  • Colonoscopy show rate(Assessed on day of colonoscopy)
  • Bowel preparation quality(Assessed on day of originally-scheduled colonoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shivan J Mehta

Assistant Professor of Medicine

University of Pennsylvania

研究点 (1)

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