Clinical trial NCT04955444: Opioid Use After Thyroid and Parathyroid Surgeries
Official title: Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Parathyroidectomy
Opioid Use
Pain, Postoperative
Keywords: Thyroidectomy
Parathyroidectomy
Opioid
Postoperative pain
Multimodal anesthesia
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Houston
First posted: 2021-07-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: New Opioid Discharge Prescriptions
timeFrame: Up to 2 days
Secondary outcomes:
measure: Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)
timeFrame: Up to 2 days
measure: Opioid Discharge Prescriptions Exceeding 5 Days
timeFrame: Up to 2 days
measure: New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery
timeFrame: Up to 7 days
measure: Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Elsie Rizk, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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