Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting: A Single-Center, Endoscopist-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
研究概览
简要总结
High cancellation rates and suboptimal bowel preparation increase patient discomfort, drive economic waste, and compromise clinical outcomes. Despite guideline emphasis on adequate preparation quality, there is no standard on how or when instructions should be delivered. This study compares three common patient education modalities-usual care verbal counseling, written tri-lingual pamphlet, and visual media via smartphone QR code-to determine which yields the best bowel preparation quality as assessed by the Boston Bowel Preparation Scale (BBPS) in an outpatient endoscopy setting.
详细描述
BACKGROUND AND RATIONALE:
Non-pharmacological factors, especially the modality of patient education, may influence bowel preparation quality, yet are underexplored and likely context-dependent based on local staffing, patient characteristics, and practice norms.
STUDY DESIGN:
Prospective, single-endoscopist-blinded, three-arm randomized controlled trial (RCT) with intention-to-treat (ITT) primary analysis. Allocation 1:1:1 using computer-generated random numbers. Endoscopist and endoscopy nurses are blinded to group assignment; participants cannot be blinded due to the nature of the intervention.
SETTING:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Endoscopist and endoscopy nurses blinded to participant group allocation during procedure and BBPS assessment. Participants and education staff unblinded due to nature of educational intervention. Outcome assessors record BBPS before any bowel cleansing attempts.
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
- •Age 18 years or older
- •Outpatients scheduled for elective colonoscopy at Hospital Sibu Endoscopy Unit
- •Ability to provide written informed consent
- •Access to smartphone or computer with functional internet connectivity
排除标准
- •History of non-compliance with prescribed medical regimens
- •Cognitive impairment, dementia, or significant mental health disorder compromising informed consent
- •Illiteracy or inability to read materials in provided languages
- •Prior colonic resection or colostomy
- •Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
- •Significant physical disability (bed-bound or wheelchair-dependent)
- •Contraindication to polyethylene glycol (PEG) bowel preparation
- •Severe Chronic Kidney Disease (Stage IV or V; eGFR <15 mL/min/1.73m²)
- •Significant cardiac comorbidities (unstable angina, severe heart failure, MI within 6 months)
- •Inability or unwillingness to comply with study protocol
- •Refusal to provide informed consent
研究组 & 干预措施
Usual Care (Verbal Counseling)
Standard physician/nurse-delivered verbal instructions and standard pharmacy information sheet for bowel preparation solution (split-dose PEG 3L, Fortrans) according to hospital protocol. Timing and dietary guidance aligned with standard of care. No additional written or visual materials provided.
干预措施: Verbal Counseling (Behavioral)
Written Educational Pamphlet
Tri-lingual (Malay, English, Chinese) plain-language educational pamphlet detailing step-by-step bowel preparation instructions, plus brief verbal explanation. Pamphlet reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm.
干预措施: Tri-lingual Educational Pamphlet (Behavioral)
Visual Media (QR Code Video)
Short, structured instructional videos accessible via smartphone QR code explaining bowel preparation procedure step-by-step, plus brief verbal explanation. Videos reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm.
干预措施: QR-Linked Instructional Videos (Behavioral)
结局指标
主要结局
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
时间窗: On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)
Primary outcome dichotomized as adequate versus inadequate bowel preparation. Adequate = total BBPS score ≥6 with all three colon segments (left, transverse, right) scoring ≥2 each (scale 0-3 per segment; range 0-9). Inadequate = total \<6 or any segment \<2. Assessment performed before any bowel cleansing/lavage.
次要结局
- Polyp Detection Rate(During colonoscopy procedure)
- Cecal Intubation Time(During colonoscopy procedure)
- Colonoscopy Withdrawal Time(During colonoscopy procedure)
- Procedure Cancellation Rate(On day of scheduled colonoscopy)
- Repeat Colonoscopy Rate(Within 6 months of initial colonoscopy)
- Patient Tolerance to Bowel Preparation(Pre-procedure on day of colonoscopy)
- Patient Anxiety Assessment(Pre-procedure on day of colonoscopy)
- Procedure-Related Complications(During procedure and within 7 days post-procedure)
- Patient-Reported Clarity of Instructions(Pre-procedure on day of colonoscopy)