Chronic Pain Post-Procedural, Opioid Use
Conditions
Brief summary
This is a pilot study designed to assess the feasibility of using a novel, video-based opioid education tool for opioid naïve ambulatory surgery patients in the perioperative period.
Detailed description
Patients will be randomized to a video or no video prior to surgery then administered a phone questionnaire at post-op day 7, 30, and 90. The Arkansas Prescriptions Drug Monitoring Database will also be accessed for information on opioid prescription refills. The overall goal of the study is to evaluate the effect that video-based opioid education has on narcotic intake after outpatient surgery. The duration of the study will be approximately 3 months, plus a single 1-hour long focus group if desired by the patient.
Interventions
OTHERVideo
A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women 18 years or older * Not chronically receiving opioid analgesics * Patients who have not taken opioids 30 days pre-operatively * Undergoing surgical procedure not requiring overnight hospital stay
Exclusion criteria
* Non-English speaking * Legally deaf or blind * On opiate contract * Has taken oral narcotic in the past 30 days * Unable to operate a telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Post Operative Opioids | 7 days | Knowledge of Post operative Opioids after surgery via 7 day post operative phone call. Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge. |
| Number of Patients Who Discontinued Opioids by 3 Months | Up to 3 months | Post-operative pain control as determined by opioid utilization at three months. This is the number of patients that have discontinued opioids at the 3 month mark. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Chronic Opioid Use | 90-150 days | Feasibility of collecting data on the percentage of patients who develop chronic opioid use. This is measured as the number of patients who received an opioid prescription per the Arkansas prescription drug monitoring database during the 90-150 day period post operatively. |
| Number of Total Days to Opioid Cessation | Up to 3 months | Feasibility of collecting data on the number of days until opioid cessation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Video Patients are not shown the informational video on the safe usage of opioids. | 53 |
| Video Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown. | 50 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | patient required admission so no longer fit study exclusion criteria of ambulatory surgery | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | No Video | Video | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 11 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 39 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 53 Participants | 50 Participants | 103 Participants |
| Sex: Female, Male Female | 29 Participants | 34 Participants | 63 Participants |
| Sex: Female, Male Male | 24 Participants | 16 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 50 |
| other Total, other adverse events | 0 / 53 | 0 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 50 |
Outcome results
Primary
Knowledge of Post Operative Opioids
Knowledge of Post operative Opioids after surgery via 7 day post operative phone call. Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Video | Knowledge of Post Operative Opioids | 8.32 units on a scale | Standard Deviation 2.5 |
| Video | Knowledge of Post Operative Opioids | 9.36 units on a scale | Standard Deviation 1.2 |
Primary
Number of Patients Who Discontinued Opioids by 3 Months
Post-operative pain control as determined by opioid utilization at three months. This is the number of patients that have discontinued opioids at the 3 month mark.
Time frame: Up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Video | Number of Patients Who Discontinued Opioids by 3 Months | 47 Participants |
| Video | Number of Patients Who Discontinued Opioids by 3 Months | 38 Participants |
Secondary
Development of Chronic Opioid Use
Feasibility of collecting data on the percentage of patients who develop chronic opioid use. This is measured as the number of patients who received an opioid prescription per the Arkansas prescription drug monitoring database during the 90-150 day period post operatively.
Time frame: 90-150 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Video | Development of Chronic Opioid Use | 12 Participants |
| Video | Development of Chronic Opioid Use | 5 Participants |
Secondary
Number of Total Days to Opioid Cessation
Feasibility of collecting data on the number of days until opioid cessation
Time frame: Up to 3 months
Population: Days until opioid cessation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Video | Number of Total Days to Opioid Cessation | 13.9 days | Standard Deviation 17 |
| Video | Number of Total Days to Opioid Cessation | 13.9 days | Standard Deviation 20.9 |