Trial Outcomes & Findings for 24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery (NCT NCT04043143)

NCT ID: NCT04043143

Last Updated: 2021-10-27

Results Overview

Prescribed post-discharge opioid doses in oral morphine equivalents from the electronic health record (EHR).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: Date of admission to the hospital up to 60 days after the date of hospital discharge.
• Results posted on: 2021-10-27

Participant Flow

One participant withdrew prior to being randomized.

Participant milestones

Measure	Arm 1 Prescription As Usual At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Overall Study STARTED	29	27
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Arm 1 Prescription As Usual At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Overall Study Lost to Follow-up	5	5
Overall Study screen failure	1	0

Baseline Characteristics

24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery

Baseline characteristics by cohort

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=22 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	19 Participants n=7 Participants	39 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	22 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Date of admission to the hospital up to 60 days after the date of hospital discharge.

Prescribed post-discharge opioid doses in oral morphine equivalents from the electronic health record (EHR).

Outcome measures

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=22 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Prescribed Post-discharge Opioids	55.3 Oral Morphine Equivalent units (OME) Standard Deviation 37.1	62.8 Oral Morphine Equivalent units (OME) Standard Deviation 32.8

SECONDARY outcome

Timeframe: One week after hospital discharge date.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 1 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=22 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1	62.0 T-Score Metric Standard Error 6.4	58.0 T-Score Metric Standard Error 9.6

SECONDARY outcome

Timeframe: Two weeks after hospital discharge date.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 2 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=22 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2	55.2 T-Score Metric Standard Error 9.1	51.9 T-Score Metric Standard Error 8.2

SECONDARY outcome

Timeframe: Three weeks after hospital discharge date.

Population: 2 participants in Arm 2 did not complete the survey.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 3 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=20 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3	50.1 T-Score Metric Standard Error 8.1	48.6 T-Score Metric Standard Error 8.8

SECONDARY outcome

Timeframe: Four weeks after hospital discharge date.

Population: One participant from Arm 1 and two participants from Arm 2 did not complete the survey.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 4 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=22 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=20 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4	47.4 T-Score Metric Standard Error 6.9	46.3 T-Score Metric Standard Error 8.5

SECONDARY outcome

Timeframe: One week after hospital discharge date.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 1 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=22 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1	58.3 T-Score Metric Standard Error 6.4	55.6 T-Score Metric Standard Error 8.1

SECONDARY outcome

Timeframe: Two weeks after hospital discharge date.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 2 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=22 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 2	53.3 T-Score Metric Standard Error 6.5	49.9 T-Score Metric Standard Error 8.0

SECONDARY outcome

Timeframe: Three weeks after hospital discharge date.

Population: 2 participants in Arm 2 did not complete the survey.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 3 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=23 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=20 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 3	48.6 T-Score Metric Standard Error 6.3	45.2 T-Score Metric Standard Error 8.5

SECONDARY outcome

Timeframe: Four weeks after hospital discharge date.

Population: One participant from Arm 1 and two participants from Arm 2 did not complete the survey.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 4 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Outcome measures

Measure	Arm 1 Prescription As Usual n=22 Participants At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge. Arm 1 Prescription As Usual: At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.	Arm 2 Prescription Tool Intervention n=20 Participants At the time of writing the discharge prescription for a patient the provider will be informed by the best practice alert (BPA) Prescription Tool that a patient may be considered for a lower post-discharge opioid dose (no opioids for patients who did not take any opioids in the last 24 hours, and 10 oxycodone 5mg tablets, for patients having taken less than 22.5 MME, e.g. 1-3 oxycodone 5mg tablets in the last 24 hours). Final dosing decisions and drug choices will remain at the discretion of the treating provider and decisions will be tracked. Arm 2 Prescription Tool Intervention: The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 4	45.2 T-Score Metric Standard Error 6.1	43.6 T-Score Metric Standard Error 9.2

Adverse Events

Arm 1 Prescription As Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 Prescription Tool Intervention

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

Karsten Bartels, MD, PhD, MBA

University of Colorado Denver | Anschutz

Phone: 303-724-1111

Email: karsten.bartels@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place