Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.

INTRODUCTION AND RATIONALE Endoscopic Retrograde Cholangiopancreatography (ERCP) is a specialized procedure combining upper gastrointestinal endoscopy and x-rays to treat hepatopancreaticobiliary diseases. Patient experiences after ERCP has been relatively understudied.

Patient-reported experience measures (PREMs) using questionnaires have been developed to capture patient experiences during clinical care. Most recent guidelines for performance measures for upper gastrointestinal endoscopy have included patient experiences as an important quality and performance measure. [1] It allows for the identification of areas of improvement, ensures the delivery of the procedure aligns with the patients' expectations while fostering a patient-centered and quality driven healthcare environment. [1] Studies have shown that better patient care experiences are correlated with favourable clinical outcomes and adherence to recommendations for future treatments. [2] The surgical literature has shown that high levels of pre-procedural or preoperative anxiety are strongly associated with poorer clinical outcomes, including increased postoperative pain, higher rates of complications, and longer hospital stays. [3] Many factors can influence preprocedural anxiety including demographic, psychological, medical, and social influences. [4] This prospective study aims to focus on pre-procedural anxiety and PREMs for patients specifically undergoing ERCP with conscious sedation and the impact on quality of the procedure

SUMMARY OF PRELIMINARY DATA The patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) is a validated PREM. [5] In a study assessing patient reported experiences during ERCP, higher PRO-STEP scores were predictive of post procedure complications of pancreatitis and perforation. [6] Karpuzcu and colleagues determined that patient-reported anxiety pre-procedure was significantly associated with poor esophagogastroduodenoscopy outcomes [7]. Bal and colleagues found that state anxiety in patients undergoing diagnostic endoscopies was associated with difficulties in sedation regardless of baseline alcohol, opioid, and benzodiazepine use. [8] Studies are lacking looking specifically at anxiety levels and PREMs for ERCP. This is important as ERCP differs from other endoscopic procedures as it is more technically challenging and associated with higher adverse events. [9]

RESEARCH HYPOTHESIS AND SPECIFIC AIMS We propose to conduct a single-centre prospective cohort study to evaluate the effect of pre-procedural anxiety, measured by the State-Trait Anxiety Inventory (STAI-Y), on the tolerability of ERCP using conscious sedation measured by the patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) and procedure cooperation measured by the Procedural Sedation Assessment Survey (PROSAS).

We hypothesize that higher preprocedural anxiety scores will lead to lower procedure tolerability scores and lower procedure cooperation.

IMPACT AND RELEVANCE This would be the first study looking at anxiety levels and PREMs for patients undergoing ERCP. Measuring anxiety levels before an ERCP could help clinicians identify patients who may struggle with the procedure and may benefit from deeper sedation with anesthesia. This could help improve the quality of the procedure, increase patient comfort, avoid unnecessary repeat procedures, and improve patient care overall.

POTENTIAL IMPACT This would be the first study assessing the impact of pre-procedural anxiety levels on patient-reported experience measures in patients' undergoing ERCP. If our hypothesis is correct, it would have a significant impact for many reasons. It could help clinicians identify patients who may struggle with the procedure and may benefit from deeper sedation upfront. This is important as ERCP is technically challenging procedure with higher adverse events than other endoscopic procedures. Anesthesia support for endoscopic procedures is an extremely limited resource at most centers performing ERCP and this could help select patients who would benefit the most. Lastly, it would lead to further quality improvement research to improve patient-reported experiences in ERCP which is an understudied area.

METHODS This is a single-centre prospective cohort study conducted at Kingston Health Sciences Centre, Kingston, Canada. Consecutive eligible patients undergoing ERCP during the one-year study period will be approached for participation.

A customized patient questionnaire (Supplemental Material 1) will be administered pre-procedurally in person and immediately post-procedure in person The preprocedural questionnaire will assess anxiety via the validated and commonly used State-Trait Anxiety Inventory (STAI-Y) measure. [10] The STAI-Y is a self-reported questionnaire consisting of two 20-item scales providing separate measures of state and trait anxiety. State anxiety is a transitory response to an event perceived as adverse, characterized by feelings of tension, apprehension, nervousness, and worry. Trait anxiety is, instead, a more stable predisposition to perceive stressful situations as dangerous or threatening. [10] Responses are scored on a 4-point Likert scale. Higher scores indicate more severe anxiety.

The STAI-Y questionnaire can be completed in about 10 minutes. Eligible patients will be booked to procedure approximately 30 minutes earlier than usual to have enough time to go over consent and complete the questionnaire.

The post procedure questionnaire will assess tolerability of the ERCP using the validated patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) score. [5] The PRO-STEP consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and throat pain. All questions are scored on a Likert scale from 0 to 10. With higher scores indicating poorer tolerability.

The physician questionnaire (Supplemental Material 1) will assess patient cooperation and pain during the procedure using the validated Procedural Sedation Assessment Survey (PROSAS) questionnaire. [11]

Inclusion criteria

Participants will be eligible for inclusion if they meet all of the following criteria:

• Adults aged ≥18 years
• Undergoing ERCP for any indication with conscious sedation
• Able to provide informed consent

Exclusion criteria

Participants will be excluded if they meet any of the following criteria:

• Age <18 years
• Inability or refusal to provide informed consent
• Cognitive impairment or language barriers precluding questionnaire completion
• Emergent ERCP where pre-procedural questionnaire administration is not feasible

Screening will occur at the time of scheduling or admission for ERCP. Eligibility will be assessed by the study team based on predefined inclusion and exclusion criteria. All eligible patients will be offered participation to minimize selection bias. If the patient is a candidate for the study, the study coordinator will approach the patient and inform them about the background of the study, the risks, the benefits, and answer questions. The signing of the consent form will take place in either the in-patient's room, a clinic room, or the endoscopy preparation area before the procedure.

ERCP PROCEDURE ERCP will be performed by three experienced advanced endoscopists who have performed over 1000 procedures. All patients will received topical lidocaine spray prior to procedure. The ERCP procedure will follow standard practice for patient preparation, sedation, and intubation of the duodenum. Patients will receive sedation in the form of midazolam, diazepam, fentanyl, and/or dimenhydrinate. Diclofenac will be administered per rectum at the conclusion of the procedure when indicated.

DATA COLLECTION All data will be collected prospectively using a standardized questionnaire and review of electronic medical records, entered into an a priori designed data extraction form.

Baseline demographic and clinical variables will include:

• Age
• Sex
• Body mass index (BMI)
• Charlson Comorbidity Index
• Medical history (cardiovascular, respiratory, neurologic, renal, diabetes, other gastrointestinal/hepatic, malignancy, psychiatric)
• Home medications
• ASA class
• Baseline smoking and alcohol use
• Baseline opioid use
• Recreational drug use
• Prior ERCP history

• Document whether sphincterotomy was performed
• Sedation regimen history for previous ERCP
• Indication for ERCP o Document whether cholangioscopy or EUS performed

Procedural variables will include:

• Sedation used
• Trainee involvement
• Cannulation characteristics
• Total procedure time
• Procedural success
• Early termination
• Adverse events including pancreatitis

PRIMARY OUTCOMES The primary outcome will be the impact of pre-procedural anxiety level measured by the State-Trait Anxiety Inventory (STAI-Y), on the tolerability of ERCP using conscious sedation measured by the patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) and procedure cooperation measured by the Procedural Sedation Assessment Survey (PROSAS).

SECONDARY OUTCOMES

• Identification of baseline demographic, clinical, and procedural factors associated with patient experience domains
• Correlation between patient-reported and physician-reported scores to assess concordance and mismatch in perceived experience.
• Procedural success and early termination rates.
• Predictors (patient-experience metrics) associated with post-procedural outcomes (either patient- or physician-related, or adverse events)

Inclusion criteria

• Adults aged ≥18 years
• Undergoing ERCP for any indication with conscious sedation
• Able to provide informed consent

Exclusion criteria

• Age <18 years
• Inability or refusal to provide informed consent
• Cognitive impairment or language barriers precluding questionnaire completion
• Emergent ERCP where pre-procedural questionnaire administration is not feasible