Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Bowel preparation quality
研究概览
简要总结
Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.
详细描述
This is a prospective, randomized, controlled clinical investigation designed to evaluate the efficacy of enhanced bowel preparation instructions (automated SMS, information website, and pre-recorded phone call) in improving bowel preparation quality in elective colonoscopy.
Subjects from the interventional and control group will receive standard of care bowel preparation instruction.
The interventional group will receive enhanced instructions delivered by automated SMS, information website and pre-recorded phone calls in the 48 hours leading up to the colonoscopy day. The intention is to provide a reminder, to reiterate instruction on clear fluid diet and timing of bowel preparation medication, and to provide additional graphical illustration on the information website.
Subjects in the interventional group must reply "OK" to each automated SMS or press "1" on the keypad at the end of the automated phone call to acknowledge understanding and receipt of instruction. Failure to acknowledge trigger an alert for a booking office staff member to directly call the patient and confirm compliance.
The clinical investigation will be conducted at one hospital in the state of New South Wales, Australia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patient cannot be blinded to the allocation. The colonoscopist (care provider) is blinded to the allocation. The investigator and statistician will remain blinded to the allocation until analysis has been conducted.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective colonoscopy booking at Griffith Base Hospital.
排除标准
- •Emergency colonoscopy
- •Patients who are unable to understand bowel preparation instructions in the following languages: English, Italian, Punjabi, Gujarati, Samoan, Mandarin.
研究组 & 干预措施
Standard Bowel Preparation Instruction
Patients receive the standard-of-care bowel preparation instruction.
Enhanced Bowel Preparation Instruction
Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction.
干预措施: Enhanced bowel preparation instruction (Other)
结局指标
主要结局
Bowel preparation quality
时间窗: Bowel preparation quality is scored once for each patient at the time of colonoscopy completion. We expect to conduct this score in 500 patients over the study period of approximately 12 months.
Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (range 0 to 9, with higher scores indicating better bowel preparation quality)
次要结局
- Polyp detection rate(Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.)
- Colonoscopy cancellation rate(Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.)
- Caecal intubation rate(Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.)
研究者
Dr Minh Pham
Researcher
Griffith Base Hospital