Pre-operative Education Modalities to Decrease Opioid Use

Study Overview
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Brief Summary
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This is a triple-armed, randomized, controlled, non-blinded trial to study the effect of preoperative patient education in conjunction with a limited opioid peri-operative analgesia program on post-operative opioid use following radical prostatectomy. Patients will be randomized into three education arms: usual care (variable provider-dependent education), text handout, or text handout and pre-recorded video. The impact of patient education on outcomes of in-hospital, post-discharge, and persistent opioid use will be studied.

Detailed Description
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This is a triple-armed, randomized, controlled, non-blinded trial that will be conducted at Virginia Mason Medical Center (VMMC). Men of age 18 or older undergoing robotic assisted radical prostatectomy (RARP) for prostate cancer will be approached to participate in the study. Recruited patients will be randomized into three main groups based upon opioid education given to the patient before surgery: usual care group, text handout group, and text handout with pre-recorded video group. During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider. The study group will receive additional standardized pre-operative education including the topics of: Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction. Patients in both usual care and study groups will receive standardized multimodal analgesia program with minimal opioids used. Primary outcomes measured will include in-hospital and post-discharge opioid use, pain levels and time to return of bowel function. Secondary outcomes will include daily measures of patient satisfaction and quality of life, feeling of preparedness to manage post-operative pain, as well as incidence of prolonged opioid use at 90 days after surgery.

Official Title
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Evaluation of Pre-operative Education Modalities to Decrease Opioid Use in Prostate Cancer Patients: A Prospective Randomized Control Trial

Conditions
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Prostatectomy, Opioid-Related Disorders

Intervention / Treatment
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* Behavioral: Pre-operative Opioid Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Undergoing RARP at VMMC Consent to participate in the study Exclusion Criteria: Long-term opioid use defined as use of opioids on most days for >3 months History of drug or alcohol dependence Concurrent surgery during radical prostatectomy History of allergy to opioid analgesics, NSAIDs, acetaminophen or local anesthetics Inability or unwillingness to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Triple-armed randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider. | |
| Experimental: Text Handout<br>This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout. | Behavioral: Pre-operative Opioid Education<br>* The pre-operative education in the text handout and pre-recorded video will include the topics of: Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.<br>|
| Experimental: Text handout and Pre-recorded Video<br>This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video. | Behavioral: Pre-operative Opioid Education<br>* The pre-operative education in the text handout and pre-recorded video will include the topics of: Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital opioid use | Morphine equivalents used in the hospital will be calculated. | Immediately after the intervention/procedure/surgery | 
| Post-discharge opioid use | Patient-reported number of opioid pills used after discharge (daily questionnaire). | Immediately after the intervention/procedure/surgery | 
| Post-operative pain | Average pain over the course of today. (0=no pain, 5=moderate pain, 10=severe pain) | Immediately after the intervention/procedure/surgery | 
| Return of bowel function | Patient-reported return of bowel function as time in days to first flatus and first bowel movement. | Immediately after the intervention/procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with undergoing the surgery | Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied) | Immediately after the intervention/procedure/surgery | 
| Quality of life after undergoing surgery | Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL) | Immediately after the intervention/procedure/surgery | 
| Prolonged post-operative opioid use | Incidence of prolonged postoperative opioid use defined by the American Society of Interventional Pain Physicians Guidelines as continued use beyond the normal and expected time of 90 days for surgical healing. | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid Education, Post-operative Opioid Use