Postoperative Opioid Consumption After Urogyneocologic Surgery
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial is to evaluate whether preoperative opioid
      education will reduce postoperative opioid consumption after urogynecologic surgeries.
      Additionally, the effect of the opioid education on opioid storage and disposal patterns will
      be evaluated. The pattern of opioid consumption 2 and 6 weeks after surgery will be compared
      between patients in the study arms. The rates of prescription refills 12 weeks and 12 months
      after the surgery will be compared between patients in the study arms.
    

Detailed description: 
      The study concept would be introduced to the patients at the prior to or during the
      preoperative visit. If the patient agrees to participation during any of these encounters,
      written consent and HIPPA authorization will be obtained and the patient would be randomized
      to the intervention or control arm using a computerized randomization scheme on REDCap. The
      randomization will be stratified by hospital system the surgery was performed within (UC
      Irvine Medical Center versus Kaiser Permanente Southern California). If the patient is
      randomized to the intervention arm, the first opioid informational pamphlet will be provided
      and reviewed with the patient in addition to standard preoperative instructions. If the
      patient is randomized to the control arm, standard preoperative instructions will be
      provided. Patients within both arms of the study will receive standardized postoperative
      medication prescriptions prior to the surgery. Patients within both arms of the study will
      complete the modified surgical pain score and preoperative opioid education study survey
      prior to surgery.

      After the surgery is completed, the primary surgeon will decide whether to admit the patient
      to the hospital and which postoperative analgesics will be administered within the hospital
      prior to discharge for subjects in both study arms. The patient will follow up for standard
      postoperative clinic visits at 2 weeks and 6 weeks postoperatively. One to two days prior to
      the 2 week postoperative visit, the patients will be contacted via telephone to remind them
      to bring their opioid prescription bottles to the clinic visit.

      Between the surgery date and the 2 week postoperative visit, the electronic medical records
      will be reviewed to evaluate the length of the surgery, intraoperative complications, the
      postoperative date of discharge, the postoperative date of removal of the transurethral foley
      catheter, the total daily morphine equivalents that the patient was prescribed prior to
      discharge from the hospital, and the presence of opioid prescriptions 30 days prior to the
      surgery. Additionally, the CURES 2.0 Database will be queried to evaluate for opioid
      prescriptions 30 days prior to the surgery.

      During the 2 week postoperative visit, the remaining opioid tablets will be counted and
      recorded by a co-investigator. The patient will complete the modified surgical pain score and
      postoperative opioid education study survey. The electronic medical record system and CURES
      2.0 Database will be queried to evaluate for additional opioid prescriptions since the time
      of surgery. Patients randomized to the intervention arm will receive the second opioid
      informational pamphlet, which will be reviewed by a co-investigator.

      During the 6 week the patient will complete the modified surgical pain score and
      postoperative opioid education study survey. The electronic medical record system and CURES
      2.0 Database will be queried to evaluate for additional opioid prescriptions since the time
      of surgery. The patients' electronic medical records will be reviewed after the 6 week
      postoperative visit to evaluate for postoperative complications.

      Twelve week after the surgery, the electronic medical record system and CURES 2.0 Database
      will be queried to evaluate for additional opioid prescriptions since the time of surgery.

      If a patient fails to follow up for a postoperative visit, at least two attempts will be made
      to contact the patient via telephone to collect opioid pill counts and have the patient
      verbally complete the modified surgical pain score and postoperative opioid education study
      survey. Initial statistical analysis will be performed after the 12 week postoperative review
      of the electronic medical records and CURES 2.0 Database have been completed.

      Twelve months after the surgery, the electronic medical record system and CURES 2.0 Database
      will be queried to evaluate for additional opioid prescriptions since the time of surgery.
      Additional statistical analysis will be performed after the 12 month opioid refill
      prescriptions have been evaluated.

      While this is a multi-site trial involving subjects from UC Irvine Medical Center, Kaiser
      Permanente Orange County - Irvine, and Kaiser Permanente Orange County - Anaheim, only
      de-identified data will be uploaded into the REDCap data management system. The lead
      investigator will maintain a separate key containing patient health information for subjects
      from both sites, which will be utilized to evaluate for additional opioid prescriptions 12
      months after the surgery. Co-investigators from both study sites will not have access to
      identifiable data from subjects that were not recruited from their particular study site.
    

Intervention name(s): Opioid-specific educational patient pamphlets
Intervention type(s): Behavioral
Intervention description(s): See prior description
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, non-blinded, controlled trial that will be performed at two sites. Study subjects will be randomized to either the control arm (standard perioperative instructions) or intervention arm (standard perioperative instructions with additional perioperative opioid-specific education) using a randomization program in a 1:1 ratio.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Surgery; Patient Education; Opioid; Medication Storage; Medication Disposal