Trial Outcomes & Findings for Opioid Use After Thyroid and Parathyroid Surgeries (NCT NCT04955444)
NCT ID: NCT04955444
Last Updated: 2023-09-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Up to 2 days
Results posted on
2023-09-05
Participant Flow
Participant milestones
| Measure |
Historical Control Group
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
80
|
|
Overall Study
COMPLETED
|
160
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid Use After Thyroid and Parathyroid Surgeries
Baseline characteristics by cohort
| Measure |
Historical Control Group
n=160 Participants
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
|
Post-implementation Group
n=80 Participants
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.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 14 • n=5 Participants
|
57 years
STANDARD_DEVIATION 14 • n=7 Participants
|
57 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
109 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
33 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Opioid use within 1 week prior to surgery
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Surgery performed
Parathyroidectomy
|
82 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Surgery performed
Thyroidectomy
|
90 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 daysProportion 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.
Outcome measures
| Measure |
Historical Control Group
n=160 Participants
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
|
Post-implementation Group
n=80 Participants
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.
|
|---|---|---|
|
New Opioid Discharge Prescriptions
|
128 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 2 daysProportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding the recommended dose of 112.5 oral MMEs
Outcome measures
| Measure |
Historical Control Group
n=160 Participants
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
|
Post-implementation Group
n=80 Participants
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.
|
|---|---|---|
|
Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs)
|
52 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 2 daysProportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy
Outcome measures
| Measure |
Historical Control Group
n=160 Participants
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
|
Post-implementation Group
n=80 Participants
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.
|
|---|---|---|
|
Opioid Discharge Prescriptions Exceeding 5 Days
|
27 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 7 daysProportion 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.
Outcome measures
| Measure |
Historical Control Group
n=160 Participants
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
|
Post-implementation Group
n=80 Participants
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.
|
|---|---|---|
|
New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 daysProportion 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
Outcome measures
| Measure |
Historical Control Group
n=160 Participants
The historical control group underwent a thyroidectomy or parathyroidectomy procedure prior to implementation of the quality improvement bundle.
|
Post-implementation Group
n=80 Participants
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.
|
|---|---|---|
|
Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy
|
9 Participants
|
0 Participants
|
Adverse Events
Historical Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-implementation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place