Trial Outcomes & Findings for Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery (NCT NCT03805386)

NCT ID: NCT03805386

Last Updated: 2021-02-21

Results Overview

Percent utilization of opioids consumed (consumed/prescribed)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 65 participants
• Primary outcome timeframe: 6 weeks postop
• Results posted on: 2021-02-21

Participant Flow

Ambulatory Gynecologic Surgery Clinic

Participant milestones

Measure	Standard of Care Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.	Patient Directed Care Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
Overall Study STARTED	32	33
Overall Study COMPLETED	32	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

Baseline characteristics by cohort

Measure	Standard of Care n=32 Participants Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.	Patient Directed Care n=33 Participants Subject directed arm will be prescribed the number of opioids that the patient decides based on a shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.	Total n=65 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	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	59.5 years n=5 Participants	52 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants
BMI	26.3 kg/m2 n=5 Participants	28.3 kg/m2 n=7 Participants	26.9 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks postop

Percent utilization of opioids consumed (consumed/prescribed)

Outcome measures

Measure	Standard of Care n=32 Participants Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.	Patient Directed Care n=33 Participants Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
# of Opioid Pills Consumed	26.7 % oxycodone used Standard Error 0.91	38.4 % oxycodone used Standard Error 1.08

SECONDARY outcome

Timeframe: preoperative visit

Number of opioids prescribed

Outcome measures

Measure	Standard of Care n=32 Participants Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.	Patient Directed Care n=33 Participants Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
Opioid Pills Prescribed	30 pills Interval 30.0 to 30.0	15 pills Interval 12.0 to 24.0

SECONDARY outcome

Timeframe: 6 weeks post-operative

Patients were asked if they were satisfied with the # of oxycodone pills prescribed.

Outcome measures

Measure	Standard of Care n=32 Participants Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.	Patient Directed Care n=33 Participants Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
Patient Satisfaction	27 Participants	29 Participants

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Directed Care

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

Principal Investigator, Dr Johnny Yi

Mayo Clinic Arizona

Phone: 14803420612

Email: yi.johnny@mayo.edu

Results disclosure agreements

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