Opioid Cessation
Conditions
Brief summary
The purpose of this study is to evaluate the relative efficacy of enhanced usual care versus motivational interviewing and guided opioid tapering support to promote opioid cessation after total hip or knee replacement surgery.
Interventions
BEHAVIORALMotivational 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.
BEHAVIORALEnhanced 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planning to undergo surgery * English speaking * Ability and willingness to complete questionnaires and assessments * Scheduled for total hip, knee, or shoulder replacement * Preoperative opioid use and opioid use 14 days after surgery to increase the likelihood of delayed opioid cessation. * Not under the care of a current pain management provider
Exclusion criteria
* Any conditions causing inability to complete assessments * Known pregnancy * Elevated suicidality * Enrollment in conflicting perioperative trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Opioid Cessation | Through study completion, an average of 1 year | Time to opioid cessation between the two groups will be analyzed using survival analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 87 |
| 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. | 92 |
| Total | 179 |
Baseline characteristics
| Characteristic | Motivational Interviewing and Guided Opioid Tapering Support | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 14 | 57.2 years STANDARD_DEVIATION 23.2 | 59.4 years STANDARD_DEVIATION 19.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 86 Participants | 165 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Numeric Rating Scale of Pain | 3.3 units on a scale STANDARD_DEVIATION 2.9 | 2.8 units on a scale STANDARD_DEVIATION 2.8 | 3.0 units on a scale STANDARD_DEVIATION 2.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 68 Participants | 76 Participants | 144 Participants |
| Sex: Female, Male Female | 55 Participants | 64 Participants | 119 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 92 |
| other Total, other adverse events | 0 / 87 | 0 / 92 |
| serious Total, serious adverse events | 0 / 87 | 0 / 92 |
Outcome results
Primary
Time to Opioid Cessation
Time to opioid cessation between the two groups will be analyzed using survival analysis
Time frame: Through study completion, an average of 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Motivational Interviewing and Guided Opioid Tapering Support | Time to Opioid Cessation | 28 days |
| Enhanced Usual Care | Time to Opioid Cessation | 25 days |
Secondary
Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9)
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.
Time frame: Through study completion, 1 year after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interviewing and Guided Opioid Tapering Support | Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9) | 20 Participants |
| Enhanced Usual Care | Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9) | 17 Participants |