Trial Outcomes & Findings for PROUD Study - Preventing Opioid Use Disorders (NCT NCT04766996)

Last Updated: 2023-06-22

Results Overview

Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

57 participants

Primary outcome timeframe

Up to 5 weeks

Results posted on

2023-06-22

Participant Flow

Participants were recruited from the Emory Orthopaedics \& Spine Center in Atlanta, Georgia, USA. Participant enrollment began May 17, 2021 and the final follow-up assessment occurred December 27, 2021.

Participant milestones

Participant milestones
Measure	Prospective Cases Undergoing Non-opioid Drug Regimen Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery. The non-opioid drug regiment includes the following: Guided mindfulness meditation twice daily; Self-administered aromatherapy every 6 hours and at bedtime; Baby aspirin (81mg) twice daily for 6 weeks post surgery; Tylenol/Acetaminophen (1000mg) one pre-operative dose then every 8 hours for three weeks after surgery; Pregabalin twice a day for 2 weeks before surgery and twice a day for 2 weeks after surgery; Prednisone (5mg) Daily for 3 weeks after surgery; Meloxicam (7.5mg) twice a day for 2 weeks before surgery and twice a day, for 2 weeks after surgery; Prilosec (20mg) Daily for 2 weeks before surgery and 2 weeks after surgery; Rescue pain medicine Tramadol (50mg) up to 3 times a day as needed; Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only; Zofran 4 mg pre-operative; Pepcid 20 mg pre-operative; Reglan 10 mg pre-operative; Versed 2 mg pre-operative; Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively; Propofol 10-125 mcg/kg/min intraoperative; Ancef 2-3 gm weight-based dosing intraoperative; Tranexamic Acid (TXA) 2 gm intraoperative; Decadron 10 mg intraoperative; Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative; Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative	Professional Staff Professional staff who participated in the implementation of the opioid free surgical protocol completed surveys seeking their opinion about interprofessional teamwork and communication.
Overall Study STARTED	7	50
Overall Study COMPLETED	6	37
Overall Study NOT COMPLETED	1	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Prospective Cases Undergoing Non-opioid Drug Regimen Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery. The non-opioid drug regiment includes the following: Guided mindfulness meditation twice daily; Self-administered aromatherapy every 6 hours and at bedtime; Baby aspirin (81mg) twice daily for 6 weeks post surgery; Tylenol/Acetaminophen (1000mg) one pre-operative dose then every 8 hours for three weeks after surgery; Pregabalin twice a day for 2 weeks before surgery and twice a day for 2 weeks after surgery; Prednisone (5mg) Daily for 3 weeks after surgery; Meloxicam (7.5mg) twice a day for 2 weeks before surgery and twice a day, for 2 weeks after surgery; Prilosec (20mg) Daily for 2 weeks before surgery and 2 weeks after surgery; Rescue pain medicine Tramadol (50mg) up to 3 times a day as needed; Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only; Zofran 4 mg pre-operative; Pepcid 20 mg pre-operative; Reglan 10 mg pre-operative; Versed 2 mg pre-operative; Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively; Propofol 10-125 mcg/kg/min intraoperative; Ancef 2-3 gm weight-based dosing intraoperative; Tranexamic Acid (TXA) 2 gm intraoperative; Decadron 10 mg intraoperative; Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative; Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative	Retrospective Control Underwent Opioid Drug Regimen A group of retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively was initially intended to be created from medical records of patients who had received this surgery in the time prior to this study started, upon conclusion of data collection for the prospective cases. This study did not complete as anticipated and the retrospective control group was not created prior to the early termination of the study.	Professional Staff Professional staff who participated in the implementation of the opioid free surgical protocol completed surveys seeking their opinion about interprofessional teamwork and communication.
Overall Study Withdrawal by Subject	1	0	13

Baseline Characteristics

Age was not collected for the professional staff to ensure that survey responses were anonymous.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prospective Cases Undergoing Non-opioid Drug Regimen n=7 Participants Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery.	Retrospective Control Underwent Opioid Drug Regimen A group of retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively was initially intended to be created from medical records of patients who had received this surgery in the time prior to this study started, upon conclusion of data collection for the prospective cases. This study did not complete as anticipated and the retrospective control group was not created prior to the early termination of the study.	Professional Staff n=50 Participants Professional staff who participated in the implementation of the opioid free surgical protocol completed surveys seeking their opinion about interprofessional teamwork and communication.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.	—	—	0 Participants n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.
Age, Categorical Between 18 and 65 years	2 Participants n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.	—	—	2 Participants n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.
Age, Categorical >=65 years	5 Participants n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.	—	—	5 Participants n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.
Age, Continuous	70 years STANDARD_DEVIATION 12 • n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.	—	—	70 years STANDARD_DEVIATION 12 • n=7 Participants • Age was not collected for the professional staff to ensure that survey responses were anonymous.
Sex/Gender, Customized Female	7 Participants n=7 Participants	—	25 Participants n=50 Participants	32 Participants n=57 Participants
Sex/Gender, Customized Male	0 Participants n=7 Participants	—	9 Participants n=50 Participants	9 Participants n=57 Participants
Sex/Gender, Customized Other	0 Participants n=7 Participants	—	3 Participants n=50 Participants	3 Participants n=57 Participants
Sex/Gender, Customized Unknown or not reported	0 Participants n=7 Participants	—	13 Participants n=50 Participants	13 Participants n=57 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	—	0 Participants n=50 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants	—	6 Participants n=50 Participants	6 Participants n=57 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	—	0 Participants n=50 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Black or African American	0 Participants n=7 Participants	—	5 Participants n=50 Participants	5 Participants n=57 Participants
Race (NIH/OMB) White	7 Participants n=7 Participants	—	22 Participants n=50 Participants	29 Participants n=57 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	—	0 Participants n=50 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	—	17 Participants n=50 Participants	17 Participants n=57 Participants
Region of Enrollment United States	7 participants n=7 Participants	—	50 participants n=50 Participants	57 participants n=57 Participants

PRIMARY outcome

Timeframe: Up to 5 weeks

Population: This analysis includes participants who completed the study and required post-operative opioid medication.

Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication.

Outcome measures

Outcome measures
Measure	Prospective Cases Undergoing Non-opioid Drug Regimen n=1 Participants Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery.
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen	400 milligrams Standard Deviation 0

SECONDARY outcome

Timeframe: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)

Population: The baseline survey was provided to all perioperative suite professional staff who gave their consent to participate in the study, however, 13 did not complete the survey. The follow-up surveys were to be completed once the full protocol had been implemented on all 60 anticipated patient participants. As the trial was terminated prior to enrolling 60 participants, the follow-up NIPEAS scale scores were not collected.

The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration.

Outcome measures

Outcome measures
Measure	Prospective Cases Undergoing Non-opioid Drug Regimen n=37 Participants Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery.
Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm Baseline	4.35 score on a scale Standard Deviation 0.39

Adverse Events

Prospective Cases Undergoing Non-opioid Drug Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Professional Staff

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

Kelly Wiltse Nicely, MD

Emory University

Phone: 404-727-6946

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place