Opioid Use After Thyroid and Parathyroid Surgeries

October 24, 2022 updated by: Elsie Rizk, The Methodist Hospital Research Institute

Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgeries

Unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. Published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. The purpose of this quasi-experimental, quality improvement study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) patient education, (2) provider education, and (3) electronic health record (EHR) enhancements. The proportion of patients who receive new opioid discharge prescriptions for pain management following thyroid or parathyroid surgery at Houston Methodist Hospital for up to 6 months following bundle implementation will be compared to a historical control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

BACKGROUND: New and persistent opioid use after minor and major surgery is common, and the duration of opioid use following surgery is associated with opioid dependence, abuse, and overdose. Most patients undergoing thyroid or parathyroid surgery do not require opioid discharge prescriptions for effective pain management. If opioids are prescribed for these surgeries, up to 7% of patients will use opioids 3 to 6 months after surgery. Previously published quality programs that optimized perioperative multimodal analgesia (MMA) regimens, provider education, patient education, and shared decision making successfully reduced the proportion of patients discharged with opioid prescriptions to less than 5% following thyroid and parathyroid surgery.

STUDY DESIGN: This quasi-experimental, quality improvement study compares opioid discharge prescribing practices before and after implementation of the quality improvement bundle. The quality improvement bundle includes patient education, provider education, and EHR enhancements. Patients who undergo a thyroidectomy or parathyroidectomy procedure will be included in the study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 4 to 6 months following bundle implementation. The primary outcome is the proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes the continuation of previous, chronic opioid therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients undergoing a primary thyroidectomy or parathyroidectomy procedure at Houston Methodist Hospital during the study period. Only index surgeries during the study time frame were included.

Exclusion Criteria:

  • Patients with a hospital length of stay after surgery >2 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Historical control group
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
Experimental: Post-implementation group
The post-implementation group will have a thyroidectomy or parathyroidectomy procedure after bundle implementation and will receive care that is enhanced by the quality improvement bundle.
Other: Quality improvement bundle
The quality improvement bundle consists of (1) patient education, (2) provider education, and (3) EHR enhancements including order sets and best practice alerts.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
New Opioid Discharge Prescriptions
Time Frame: Up to 2 days
Proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes continuation of previous, chronic opioid therapy.
Up to 2 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)
Time Frame: Up to 2 days
Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding the recommended dose of 112.5 oral MMEs
Up to 2 days
Opioid Discharge Prescriptions Exceeding 5 Days
Time Frame: Up to 2 days
Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy
Up to 2 days
New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery
Time Frame: Up to 7 days
Proportion of thyroidectomy and parathyroidectomy postoperative patients who receive new opioid prescriptions from the surgeon's office within 7 days of surgery including discharge prescriptions. This outcome excludes continuation of previous, chronic opioid therapy.
Up to 7 days
Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy
Time Frame: Up to 2 days
Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid prescriptions exceeding 50 oral MMEs/day when new, postoperative discharge prescriptions are added to existing opioid therapy
Up to 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Methodist Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elsie Rizk, PharmD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro000023276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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