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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
324
Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
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.
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.
Hospital Sibu
Sibu, Sarawak, Malaysia
RECRUITINGAdequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
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.
Time frame: On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)
Polyp Detection Rate
Proportion of participants with at least one polyp detected during colonoscopy. Documented as yes/no and number of polyps.
Time frame: During colonoscopy procedure
Cecal Intubation Time
Time in minutes from colonoscope insertion to identification of cecal landmarks.
Time frame: During colonoscopy procedure
Colonoscopy Withdrawal Time
Time in minutes from initiation of scope withdrawal to scope exit at rectum, excluding biopsy/therapeutic time.
Time frame: During colonoscopy procedure
Procedure Cancellation Rate
Proportion of participants whose colonoscopy was cancelled and reason for cancellation.
Time frame: On day of scheduled colonoscopy
Repeat Colonoscopy Rate
Proportion requiring repeat colonoscopy due to inadequate initial preparation.
Time frame: Within 6 months of initial colonoscopy
Patient Tolerance to Bowel Preparation
atient self-reported tolerability using five-point scale: Very Easy, Easy, Neutral, Difficult, Very Difficult.
Time frame: Pre-procedure on day of colonoscopy
Procedure-Related Complications
Occurrence of procedure-related complications including perforation, bleeding, post-polypectomy syndrome, or other adverse events. Outcome is dichotomous: Yes (complication occurred) or No (no complications). Lower occurrence rate indicates better outcome.
Time frame: During procedure and within 7 days post-procedure
Patient-Reported Clarity of Instructions
Patient perception of clarity using Five-Point Likert Scale (minimum=1 "Strongly Disagree", maximum=5 "Strongly Agree"). Statement: "The instructions were clear." Higher scores indicate greater perceived clarity of instructions (better outcome).
Time frame: Pre-procedure on day of colonoscopy
Patient Anxiety Assessment
Patient self-reported anxiety on Visual Analog Scale for Anxiety (VAS-A), 0-10 scale (0=no anxiety, 10=extremely anxious).
Time frame: Pre-procedure on day of colonoscopy
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