Abuses Over-The-Counter/Prescription Medications, Opioid Use, Pain, Postoperative, Patient Dependence on, Physical Activity
Conditions
Brief summary
This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.
Detailed description
Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education & increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.
Interventions
BEHAVIORALPatient centered pre-op education
To implement a patient centered education intervention to evaluate post-op narcotic use.
BEHAVIORALroutine preop education
To implement routine patient education intervention to evaluate post-op narcotic use.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects are ≥ 18 years of age 2. English or Spanish speaking 3. Patient scheduled for pelvic floor surgery
Exclusion criteria
1. Unable to speak English or Spanish 2. Using long acting opioids (e.g. MS Contin, Fentanyl patch) 3. Primary or Pain Healthcare Provider recommends against study participation (eg. If the patient has a history of opioid use disorder or other confounding problems, we will contact the Primary Care Provider or Pain Healthcare Provider for their recommendations regarding study participation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use at Approximately Two Weeks Post-op | 2 weeks | Morphine milligram equivalents at the two weeks post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use at Approximately Six to Eight Weeks Post-op | 6-8 weeks | Morphine milligram equivalents at the six to eight weeks post-op |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Centered Pre-op Education Patient centered pre-operative education and patient centered post-operative care.
Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use. | 86 |
| Routine Pre-op Education Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics
routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use. | 88 |
| Total | 174 |
Baseline characteristics
| Characteristic | Patient Centered Pre-op Education | Routine Pre-op Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 88 Participants | 174 Participants |
| Age, Continuous | 53 years | 55 years | 54 years |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 11 Participants | 18 Participants |
| Race (NIH/OMB) Asian | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Black or African American | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants | 37 Participants | 82 Participants |
| Race (NIH/OMB) White | 33 Participants | 35 Participants | 68 Participants |
| Sex: Female, Male Female | 86 Participants | 88 Participants | 174 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 88 |
| other Total, other adverse events | 0 / 86 | 0 / 88 |
| serious Total, serious adverse events | 0 / 86 | 0 / 88 |
Outcome results
Primary
Opioid Use at Approximately Two Weeks Post-op
Morphine milligram equivalents at the two weeks post-op
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Centered Pre-op Education | Opioid Use at Approximately Two Weeks Post-op | 15 MME |
| Routine Pre-op Education | Opioid Use at Approximately Two Weeks Post-op | 22.5 MME |
Secondary
Opioid Use at Approximately Six to Eight Weeks Post-op
Morphine milligram equivalents at the six to eight weeks post-op
Time frame: 6-8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Centered Pre-op Education | Opioid Use at Approximately Six to Eight Weeks Post-op | 15 MME |
| Routine Pre-op Education | Opioid Use at Approximately Six to Eight Weeks Post-op | 23 MME |