Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting

Официальное название

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

Обзор

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.

Подробное описание

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:

Hospital Sibu Endoscopy Unit, Sarawak, Malaysia. Colonoscopies performed by qualified surgeons or registrars under supervision; all endoscopists undergo refresher training on Boston Bowel Preparation Scale (BBPS) scoring for consistency.

STUDY ARMS (INTERVENTIONS):

Arm A (Control): Usual care. Physician/nurse-delivered verbal instructions plus standard pharmacy instructions for bowel preparation solution (split-dose PEG 3L).

Arm B (Written): Tri-lingual (Malay/English/Chinese), plain-language educational leaflet reviewed by health literacy expert, plus brief verbal explanation. Arm C (Visual): Short, structured instructional videos accessible via smartphone QR code, reviewed by health literacy expert, plus brief verbal explanation.

SAMPLE SIZE AND STATISTICAL ANALYSIS:

N=324 (108 per arm). Primary analysis: Intent-to-treat chi-square test comparing adequate vs inadequate BBPS across three arms. Pairwise comparisons with Bonferroni adjustment. Multivariable logistic regression adjusts for prespecified covariates (age, sex, BMI, diabetes, education, language, constipation, study arm).

PRIMARY OUTCOME:

Adequate versus inadequate bowel preparation on Boston Bowel Preparation Scale (BBPS). Adequate = total ≥6 with all segments ≥2.

SECONDARY OUTCOMES:

Polyp detection rate; cecal intubation and withdrawal times; cancellation and repeat rates; patient tolerance; complications; patient-reported clarity and helpfulness; anxiety (VAS-A); demographic predictors.

Вмешательства

• Поведенческое Verbal Counseling
  Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
• Поведенческое Tri-lingual Educational Pamphlet
  Structured written educational material in Malay, English, and Chinese languages detailing complete bowel preparation instructions, timing, dietary guidance, what to expect, and troubleshooting tips. Provided to participant with brief verbal explanation.
• Поведенческое QR-Linked Instructional Videos
  Short, professionally produced instructional videos accessible via smartphone QR code link. Videos present step-by-step bowel preparation instructions, timing, dietary guidance, common concerns, and what to expect during procedure. Participant scans QR code to access video(s) on their smartphone.

Первичные конечные точки

• Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS) [Срок оценки: On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)]

Вторичные конечные точки (9)

• Polyp Detection Rate [Срок оценки: During colonoscopy procedure]
• Cecal Intubation Time [Срок оценки: During colonoscopy procedure]
• Colonoscopy Withdrawal Time [Срок оценки: During colonoscopy procedure]
• Procedure Cancellation Rate [Срок оценки: On day of scheduled colonoscopy]
• Repeat Colonoscopy Rate [Срок оценки: Within 6 months of initial colonoscopy]
• Patient Tolerance to Bowel Preparation [Срок оценки: Pre-procedure on day of colonoscopy]
• Procedure-Related Complications [Срок оценки: During procedure and within 7 days post-procedure]
• Patient-Reported Clarity of Instructions [Срок оценки: Pre-procedure on day of colonoscopy]
• Patient Anxiety Assessment [Срок оценки: Pre-procedure on day of colonoscopy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Малайзия · 1 центр

• Hospital Sibu — Sibu

Идентификаторы

NCT: NCT07685652 · RSCH-25-05992-BBX · NMRR-25-04038-EOB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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