Opioid Use After Thyroid and Parathyroid Surgeries

Pain, Postoperative Clinical Trial

Official title:

Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955444
• Other study ID #: Pro000023276
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Parathyroidectomy
• Thyroidectomy

Intervention

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.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute	University of Houston

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;16 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Opioid Discharge Prescriptions	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	Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)	Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding the recommended dose of 112.5 oral MMEs	Up to 2 days
Secondary	Opioid Discharge Prescriptions Exceeding 5 Days	Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy	Up to 2 days
Secondary	New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery	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
Secondary	Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy	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