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| Name | Class |
|---|---|
| University of Houston | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Historical control group | No Intervention | The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle. | |
| Post-implementation group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality improvement bundle | Other | The quality improvement bundle consists of (1) patient education, (2) provider education, and (3) EHR enhancements including order sets and best practice alerts. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Opioid Discharge Prescriptions Exceeding 5 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elsie Rizk, PharmD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28403427 | Background | 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. | |
| 29343479 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Historical Control Group | The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle. |
| FG001 | Post-implementation Group | The post-implementation group underwent a thyroidectomy or parathyroidectomy procedure after bundle implementation and received care that is enhanced by the quality improvement bundle. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Historical Control Group | The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle. |
| BG001 | Post-implementation Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 2 days |
|
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Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elsie Rizk | The Methodist Hospital Research Institute | 7134412557 | erizk@houstonmethodist.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Oct 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
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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 | 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 | 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 |
| 27294595 | Background | 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. |
| 28160140 | Background | 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. |
| 31356280 | Background | 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. |
| 29049548 | Background | 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. |
| 30027221 | Background | 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. |
| 30422170 | Background | 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. |
| 31415931 | Background | 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. |
| 30118896 | Background | 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. |
| 30715186 | Background | 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. |
| 36040827 | Result | 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. |
The post-implementation group underwent a thyroidectomy or parathyroidectomy procedure after bundle implementation and received care that is enhanced by the quality improvement bundle.
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.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Opioid use within 1 week prior to surgery | Count of Participants | Participants |
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| Surgery performed | Count of Participants | Participants |
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| 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 | Posted | Count of Participants | Participants | Up to 2 days |
|
|
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| Secondary | Opioid Discharge Prescriptions Exceeding 5 Days | Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy | Posted | Count of Participants | Participants | Up to 2 days |
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| 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. | Posted | Count of Participants | Participants | Up to 7 days |
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| 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 | Posted | Count of Participants | Participants | Up to 2 days |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Post-implementation Group | The post-implementation group underwent a thyroidectomy or parathyroidectomy procedure after bundle implementation and received care that is enhanced by the quality improvement bundle. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |