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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
240
Phase
- 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
-
-
Texas
-
Houston, Texas, United States, 77030
- Houston Methodist Hospital
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-
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
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 |
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.
|
|
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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.
|
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
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
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
|
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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.
Collaborators
Investigators
- 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
- Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
- Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773.
- Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.
- Overton HN, Hanna MN, Bruhn WE, Hutfless S, Bicket MC, Makary MA; Opioids After Surgery Workgroup. Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert Panel Consensus. J Am Coll Surg. 2018 Oct;227(4):411-418. doi: 10.1016/j.jamcollsurg.2018.07.659. Epub 2018 Aug 14.
- Jena AB, Goldman D, Karaca-Mandic P. Hospital Prescribing of Opioids to Medicare Beneficiaries. JAMA Intern Med. 2016 Jul 1;176(7):990-7. doi: 10.1001/jamainternmed.2016.2737.
- Lou I, Chennell TB, Schaefer SC, Chen H, Sippel RS, Balentine C, Schneider DF, Moalem J. Optimizing Outpatient Pain Management After Thyroid and Parathyroid Surgery: A Two-Institution Experience. Ann Surg Oncol. 2017 Jul;24(7):1951-1957. doi: 10.1245/s10434-017-5781-y. Epub 2017 Feb 3.
- 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.
- Militsakh O, Lydiatt W, Lydiatt D, Interval E, Lindau R, Coughlin A, Panwar A. Development of Multimodal Analgesia Pathways in Outpatient Thyroid and Parathyroid Surgery and Association With Postoperative Opioid Prescription Patterns. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):1023-1029. doi: 10.1001/jamaoto.2018.0987.
- Shindo M, Lim J, Leon E, Moneta L, Li R, Quintanilla-Dieck L. Opioid Prescribing Practice and Needs in Thyroid and Parathyroid Surgery. JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1098-1103. doi: 10.1001/jamaoto.2018.2427. Erratum In: JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1189.
- Sada A, Ubl DS, Thiels CA, Cronin PA, Dy BM, Lyden ML, Thompson GB, McKenzie TJ, Habermann EB. Optimizing Opioid-Prescribing Practices After Parathyroidectomy. J Surg Res. 2020 Jan;245:107-114. doi: 10.1016/j.jss.2019.07.039. Epub 2019 Aug 12.
- Rizk E, Swan JT, Cheon O, Colavecchia AC, Bui LN, Kash BA, Chokshi SP, Chen H, Johnson ML, Liebl MG, Fink E. Quality indicators to measure the effect of opioid stewardship interventions in hospital and emergency department settings. Am J Health Syst Pharm. 2019 Feb 1;76(4):225-235. doi: 10.1093/ajhp/zxy042.
- Rizk E, Yuan F, Zheng F, Fink E, Kaur N, Tran AT, Iso T, Mohyuddin NG, Thekdi AA, Jackson GL, Wanat MA, Thornton JD, Swan JT. Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgery. Otolaryngol Head Neck Surg. 2023 Jul;169(1):176-184. doi: 10.1177/01945998221121626. Epub 2023 Jan 29.
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)
June 14, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
June 18, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
October 24, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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