Trial Outcomes & Findings for Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid Cessation (NCT NCT03659734)

NCT ID: NCT03659734

Last Updated: 2025-01-17

Results Overview

Time to opioid cessation between the two groups will be analyzed using survival analysis

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 179 participants
• Primary outcome timeframe: Through study completion, an average of 1 year
• Results posted on: 2025-01-17

Participant Flow

Participant milestones

Measure	Motivational Interviewing and Guided Opioid Tapering Support Motivational Interviewing and Guided Opioid Tapering Support: Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.	Enhanced Usual Care Enhanced Usual Care: Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
Overall Study STARTED	87	92
Overall Study COMPLETED	87	92
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid Cessation

Baseline characteristics by cohort

Measure	Motivational Interviewing and Guided Opioid Tapering Support n=87 Participants Motivational Interviewing and Guided Opioid Tapering Support: Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.	Enhanced Usual Care n=92 Participants Enhanced Usual Care: Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.	Total n=179 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 14.0 • n=5 Participants	57.2 years STANDARD_DEVIATION 23.2 • n=7 Participants	59.4 years STANDARD_DEVIATION 19.3 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	64 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	86 Participants n=7 Participants	165 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	76 Participants n=7 Participants	144 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Numeric Rating Scale of Pain	3.3 units on a scale STANDARD_DEVIATION 2.9 • n=5 Participants	2.8 units on a scale STANDARD_DEVIATION 2.8 • n=7 Participants	3.0 units on a scale STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 1 year

Time to opioid cessation between the two groups will be analyzed using survival analysis

Outcome measures

Measure	Motivational Interviewing and Guided Opioid Tapering Support n=87 Participants Motivational Interviewing and Guided Opioid Tapering Support: Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.	Enhanced Usual Care n=92 Participants Enhanced Usual Care: Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
Time to Opioid Cessation	28 days Interval 14.0 to 49.0	25 days Interval 15.0 to 51.0

SECONDARY outcome

Timeframe: Through study completion, 1 year after surgery

Assessed by total score on the Current Opioid Misuse Measure (COMM). The Current Opioid Misuse Measure is a self-report measure of risk for aberrant medication related behavior among persons who are prescribed opioids for pain. The COMM contains 17 items rated from 0="never" to 4="very often" . The 17 items are summed to create a total score with a minimum of 0 to a maximum of 68. Higher scores represent a higher risk of potential opioid medication misuse (worse outcome). Patients exhibiting opioid misuse (binary outcome) were defined as those reporting a postoperative COMM score greater than or equal to 9.

Outcome measures

Measure	Motivational Interviewing and Guided Opioid Tapering Support n=87 Participants Motivational Interviewing and Guided Opioid Tapering Support: Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.	Enhanced Usual Care n=92 Participants Enhanced Usual Care: Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9)	20 Participants	17 Participants

Adverse Events

Motivational Interviewing and Guided Opioid Tapering Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual 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

Dr. Jennifer Hah

Stanford University

Phone: 650-723-4000

Email: map_pain_study@stanford.edu

Results disclosure agreements

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