Postoperative Opt-In Narcotic Treatment Study

NCT04710069 | Completed

• 1 other identifier: 19-001702
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

pills go unused, generating waste and leaving an opportunity for misuse and abuse. In a recent study, researchers let patients choose what medications to go home with after surgery. After their thyroid or parathyroid surgery, 96% of patients declined narcotic pain medication. They preferred to manage their pain with acetaminophen instead. Giving patients counseling and empowering them to choose significantly reduces the amount of opioids prescribed and wasted. The aim of our study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids). We would elaborate upon the aforementioned study by studying patient pain scores on a more granular level once they return home. Our study will be designed as a randomized, controlled trial. When adult patients consent for a thyroid or parathyroid surgery, they will be asked to participate in the study. Patients who are currently using narcotics would be excluded. We would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, such as acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested. We will assess patient pain scores and medication use in the recovery area using the electronic medical record. We will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. We will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, we will track their opioid consumption.

Conditions

Postoperative Pain; Narcotic Use; Analgesia; Endocrine Surgery; Opioid Use; Opioid Abuse

Keywords

Postoperative Pain; Narcotic Use; endocrine surgery

Outcome Measures

Primary Outcomes (2)

• Postoperative pain scores

  Pain scores will be compared using regression analysis and t-tests.

  Postoperative Day 0-7

• oral morphine equivalents consumed

  Possible predictors for narcotic use or higher pain scores will be assessed, including age, sex, type of surgery and preoperative questionnaire (PHQ-9) score using a mixed-effects model.

  Postoperative Day 0-7

Secondary Outcomes (1)

• Postoperative Day 0-7

  Postoperative Day 7

Study Arms (2)

Control/Usual Care

NO INTERVENTION

standard treatment of postoperative pain, which involves automatic prescription of a narcotic pain medication regimen after surgery,

Opt-in/POINT

EXPERIMENTAL

An opt-in program (POINT), which requires the patient to consent to receiving a prescription for narcotics

Behavioral: POINT

Interventions

POINT BEHAVIORAL

Patients randomized to the POINT program will be given preoperative counseling on adverse effects of opioids and expectations will be set that most patients do not require opioids for pain control after endocrine surgery, they will receive the info in writing afterwards as well. These patients will also be shown a short instructional video reiterating the counseling provided in the preoperative clinic visit. Information in the video will pertain to the expected pain after surgery, the over-the-counter options for pain control, the risks and side effects of using opioids, and reassurances that opioids may be prescribed at any time after discharge if pain is unmanageable. After the video, the patient will be provided with paperwork, requiring patient consent/signature to receive opioids if they opt into narcotic treatment. They will not be provided with a narcotic prescription if consent is not explicitly provided.

Also known as: Opt-in

Opt-in/POINT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility for outpatient parathyroidectomy, thyroidectomy or neck dissection Patients aged 18 or older English-speaking: Our provided materials (video instruction, written instructions, survey material) will be in English and we want to ensure clear communication with our study subjects. Once we have demonstrated feasibility of such an opt-in policy with our English-speaking subjects, we will expand our materials to additional languages.

You may not qualify if:

• Prior history of narcotic use Inpatient admission after surgery

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Ruffolo LI, Jackson KM, Juviler P, Kaur R, Chennell T, Glover DM, Linehan DC, Moalem J. Narcotic Free Cervical Endocrine Surgery: A Shift in Paradigm. Ann Surg. 2021 Aug 1;274(2):e143-e149. doi: 10.1097/SLA.0000000000003443.

  PMID: 31356280 BACKGROUND

• Zhu CY, Schumm MA, Hu TX, Nguyen DT, Kim J, Tseng CH, Lin AY, Yeh MW, Livhits MJ, Wu JX. Patient-Centered Decision-making for Postoperative Narcotic-Free Endocrine Surgery: A Randomized Clinical Trial. JAMA Surg. 2021 Nov 1;156(11):e214287. doi: 10.1001/jamasurg.2021.4287. Epub 2021 Nov 10.

  PMID: 34495283 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• James Wu, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Michael W Yeh, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Attending surgeons are not aware of participant treatment arm until after the participant undergoes their operation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. James Wu

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: June 26, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)