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Opioid Use After Thyroid and Parathyroid Surgeries

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ClinicalTrials.gov Identifier: NCT04955444
Recruitment Status : Completed
First Posted : July 8, 2021
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
University of Houston
Information provided by (Responsible Party):
Elsie Rizk, The Methodist Hospital Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thyroidectomy Parathyroidectomy Opioid Use Pain, Postoperative Other: Quality improvement bundle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study consists of 2 groups: (1) the historical control group and (2) the post-implementation group. The historical control group includes 160 patients who underwent a thyroidectomy or a parathyroidectomy procedure from January 2018 to December 2019 (20 patients randomly sampled from each quarter prior to bundle implementation). The quality improvement bundle will be implemented at Houston Methodist Hospital in June 2021. The post-implementation group will include the first 80 eligible patients accrued over 4 to 6 months following bundle implementation. An estimated sample size of 80 patients in the post-implementation group and 160 patients in the historical control group will provide 80% power to detect an absolute decrease of 20% in the primary endpoint using a two-sided alpha of 0.05.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgeries
Actual Study Start Date : June 14, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04955444


Locations
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United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital Research Institute
University of Houston
Investigators
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Principal Investigator: Elsie Rizk, PharmD The Methodist Hospital Research Institute
Publications:

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Responsible Party: Elsie Rizk, Pharmacy Administrative Specialist in Clinical Research Program Director, Clinical Pharmacy Fellowship in Outcomes Research, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04955444    
Other Study ID Numbers: Pro000023276
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elsie Rizk, The Methodist Hospital Research Institute:
Thyroidectomy
Parathyroidectomy
Opioid
Postoperative pain
Multimodal anesthesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations