Effect of Increased Frequency of Resident Ward Rounds on Bowel Preparation Quality in Hospitalized Patients Undergoing Therapeutic Colonoscopy: A Cluster-Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adequate Bowel Preparation Rate
研究概览
简要总结
Adequate bowel preparation is critical for successful colonoscopy, yet inadequate preparation remains a significant clinical challenge, occurring in 20-30% of procedures. In hospitalized patients undergoing therapeutic colonoscopy, suboptimal preparation leads to increased costs, prolonged hospital stay, and potential procedure cancellation or rescheduling. Current standard care involves resident ward rounds twice daily.
This cluster-randomized crossover trial aims to evaluate whether increasing the frequency of structured resident ward rounds from 2 to 4 times per day can improve bowel preparation quality in hospitalized patients scheduled for therapeutic colonoscopy. The enhanced ward round intervention includes standardized checklist review, medication verification, dietary compliance confirmation, adverse event screening, and timely intervention when needed.
Three hospital wards will be randomly assigned to different sequences of intervention and control periods using a crossover design with washout periods. The primary outcome is adequate bowel preparation quality assessed by Boston Bowel Preparation Scale (BBPS ≥6 with each segment ≥2), evaluated by blinded endoscopists. Secondary outcomes include procedure quality metrics (cecal intubation rate, examination duration), safety endpoints (electrolyte disturbances, aspiration events), health economics measures (length of stay, total costs), and healthcare worker burden (nursing workload, night-time call frequency).
Subgroup analyses will examine intervention effects across age groups, cognitive function levels, prior colonoscopy experience, and comorbidity burden to identify populations most likely to benefit from enhanced monitoring.
This pragmatic trial addresses a clinically relevant question using a real-world implementation strategy designed to minimize workflow disruption. Results will inform evidence-based policies regarding optimal ward round frequency for colonoscopy preparation in hospital settings.
详细描述
Background and Rationale Adequate bowel preparation is essential for high-quality colonoscopy. The Boston Bowel Preparation Scale (BBPS) is a validated tool for assessing preparation quality, with scores ≥6 (and each segment ≥2) considered adequate. Studies report inadequate preparation rates of 20-30% in routine practice, leading to missed lesions, prolonged procedures, and increased costs.
Hospitalized patients face unique challenges for bowel preparation including comorbidities, cognitive impairment, medication complexity, and communication barriers. While outpatient preparation often relies on written instructions and telephone reminders, inpatients theoretically benefit from direct medical supervision. However, the optimal frequency and structure of ward rounds during bowel preparation remain undefined.
Current practice at our institution includes twice-daily resident ward rounds (morning and afternoon). We hypothesize that increasing ward round frequency to four times daily (adding midday and evening rounds) with a standardized intervention package will improve preparation quality by:
- Enhanced medication compliance monitoring
- Real-time dietary adherence verification
- Early detection and management of adverse events
- Improved patient education and anxiety reduction
- Timely adjustment of preparation regimens Study Design This is a single-center, cluster-randomized, crossover trial with three hospital wards serving as clusters. Each ward will alternate between intervention and control periods in a balanced sequence with washout periods to minimize carryover effects.
Design Features:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Endoscopists performing colonoscopy and assessing BBPS scores are blinded to patient group assignment. Due to the nature of the ward round intervention, participants and care providers cannot be blinded. Data analysts will remain blinded to group allocation until after primary analysis completion.
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
- •Hospitalized patients (inpatients)
- •Scheduled for therapeutic colonoscopy (polypectomy, endoscopic mucosal resection [EMR], endoscopic submucosal dissection [ESD], or biopsy for diagnosis)
- •Time from admission to scheduled colonoscopy ≥48 hours (allowing adequate preparation time)
- •Patient or legal representative able to provide written informed consent
- •Able to understand and follow bowel preparation instructions (with assistance from caregivers if needed)
排除标准
- •Emergency gastrointestinal conditions: bowel obstruction, acute lower gastrointestinal bleeding requiring urgent intervention, suspected or confirmed perforation
- •Emergency or same-day colonoscopy (scheduled <24 hours after admission)
- •History of total colectomy or current colostomy/ileostomy
- •Severe cognitive impairment (Mini-Cog score 0-1 or MMSE <18) without available caregiver
- •Severe cardiopulmonary disease: New York Heart Association (NYHA) Class IV heart failure, chronic kidney disease (CKD) stage 4-5 (eGFR <30 ml/min/1.73m²) unable to tolerate PEG-based preparation
- •Known or suspected pregnancy, currently breastfeeding
- •Previous severe allergic reaction to PEG or bowel preparation agents
- •Current participation in another interventional clinical trial
- •Unable to provide informed consent and no legal representative available
- •Patient or legal representative declines participation
研究组 & 干预措施
Enhanced Ward Rounds (Intervention)
Residents conduct ward rounds 4 times daily (morning, midday, afternoon, evening) with each visit lasting ≥10 minutes. Standardized intervention package includes: (1) medication verification and adherence check, (2) dietary compliance review, (3) adverse event screening for electrolyte disturbances and aspiration risk, (4) clinical decision support with timely interventions, and (5) patient education assessment. Electronic check-in required at each visit with time-stamped checklist completion.
干预措施: Enhanced Frequency Ward Rounds with Standardized Intervention Package (Behavioral)
Standard Ward Rounds
Standard care with residents conducting ward rounds 2 times daily (morning and afternoon). Patients receive routine clinical assessment and verbal confirmation of bowel preparation instructions. All other aspects of care remain identical to intervention group including PEG preparation regimen, dietary protocol, patient education materials, and rescue protocols.
干预措施: Standard Frequency Ward Rounds (Behavioral)
结局指标
主要结局
Adequate Bowel Preparation Rate
时间窗: Assessed during colonoscopy procedure (Day 0, examination day)
Proportion of patients achieving adequate bowel preparation defined as Boston Bowel Preparation Scale (BBPS) total score ≥6 points AND each colonic segment score ≥2 points. BBPS is a validated 0-9 point scale (3 segments × 0-3 points each) assessing preparation quality during colonoscopy. Endoscopist records BBPS score for each segment (right colon, transverse colon, left colon) after cleansing maneuvers during colonoscopy. Adequate preparation requires both: (1) total score ≥6 and (2) no segment with score \<2. Endoscopists remain blinded to patient group assignment.
次要结局
- Boston Bowel Preparation Scale (BBPS) Total Score(Assessed during colonoscopy procedure (Day 0))
- Cecal Intubation Rate(Assessed during colonoscopy procedure (Day 0))
- Cecal Intubation Time(Assessed during colonoscopy procedure (Day 0))
- Total Examination Duration(Assessed during colonoscopy procedure (Day 0))
- Adenoma Detection Rate (ADR)(Assessed at time of pathology report (within 2 weeks post-procedure))
- Preparation-Related Adverse Events(From initiation of bowel preparation (Day -1) through colonoscopy completion (Day 0), approximately 24-36 hours)
- Procedure Rescheduling Rate(Within 7 days of originally scheduled procedure)
- Length of Hospital Stay(From admission until discharge, expected average of 5-10 days)
- Total Hospitalization Costs(From admission until discharge, expected average of 5-10 days)
- Patient Satisfaction Score(Within 24 hours after colonoscopy completion (Day 0))
- Patient Preparation Tolerance(Within 24 hours after colonoscopy completion (Day 0))
- Night-time Nurse Call Frequency(Night before colonoscopy (Day -1 evening to Day 0 morning), approximately 10 hours)
- Nursing Workload Score(Assessed at end of preparation period, within 24 hours after colonoscopy (Day 0))
- Patient Knowledge Score(Evening before colonoscopy (Day -1, approximately 18:00-22:00))
研究者
Zhaofeng Chen
Pro
LanZhou University