Knowledge, Attitudes, Practice, Medication Adherence, Opioid Use, Pain, Postoperative, Risk Reduction Behavior
Conditions
Brief summary
Legitimate prescription opioid use during adolescence has been associated with later prescription opioid misuse and substance use disorder symptoms during adulthood. Thus, primary prevention interventions for older adolescents and young adults (15-24 yrs) at the time of prescribing are imperative. The goal of our research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition and informed decision-making among 15-24 year olds who are prescribed these agents for home use. Young adults and older adolescents who manage their own prescription pain medicines need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief. The proposed research will evaluate new strategies to help subjects learn about opioid risks and make safe and effective analgesic decisions. 355 subjects who are undergoing an elective surgical procedure will be recruited. Subjects will be randomized to receive the new educational routine information. Subjects' knowledge and perceptions will be evaluated at baseline and at critical times after surgery.
Detailed description
The goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed decision-making including misuse among 15-24 year olds who are prescribed these agents for home use. This is a randomized, controlled study design. The investigators will enroll emerging adults (aged 15-24 yrs) who are scheduled to undergo a surgical procedure and will be prescribed an opioid as part of their routine postoperative care. Comprehensive informed consent will be obtained. No medical treatments will be altered for the purposes of this educational study. All participants will complete baseline surveys to assess their pain medicine familiarity, their opioid risk knowledge and perceptions, and their analgesic self-efficacy and their pain relief/ risk avoidance preferences. Participants will also be presented (via the survey platform) with several hypothetical (mock) scenarios and will be asked to make hypothetical decisions about how they would treat pain for each. The Intervention group will receive tailored feedback and guidance after each scenario (i.e., the Scenario Tailored Opioid Messages) and the Control group will receive only routine analgesic risk and benefit information. Participants will complete the post-scenario/feedback surveys to re-assess opioid risk perceptions and self-efficacy and will complete brief health literacy surveys. On days 7, 14 and at 1 and 3 months, participants will be resurveyed (via emailed qualtrics survey link or paper -whichever is preferred) about their opioid risk knowledge, perceptions, scenario decision making, analgesic self-efficacy and pain relief/risk avoidance preferences. All surveys and datasheets will contain unique identifiers only. Identifiers will be maintained separately from survey data (linked only by unique identifier) to maintain privacy. Participants will receive up to $50 for participation.
Interventions
BEHAVIORALEducational Intervention
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
Sponsors
University of Michigan
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Group assignment will be coded for subjects and data collectors. Subjects will be blinded to whether the information they receive is the Intervention vs. Control. Group assignment will coded on data entry and unblinded after analyses.
Intervention model description
randomized, controlled, factorial design
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing an elective surgical procedure for which it is expected they will receive a prescription pain medicine for management of pain during recovery at home.
Exclusion criteria
* Undergoing non-elective procedure * Cognitive impairment precluding self-reporting of pain * Hematologic/oncologic condition * Liver of kidney conditions precluding usual analgesic prescription patters (opioid plus a non-opioid) * Use of opioids for prolonged pain pre-operatively (\<2 weeks)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Risk Perception | Baseline, day 14, 3 months post intervention | Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Misuse Intention Decisions | 3 months post intervention | Number of participants with opioid misuse intentions and behaviors |
Countries
United States
Participant flow
Recruitment details
Subjects recruited from 11/2019 through May 2021 from surgical clinic rosters at University of Michigan
Pre-assignment details
Enrollment number includes all who Started by signing the consent and were assigned to study groups. Completed indicates those who were analyzed. Not completed includes those withdrawn after signing consent but prior to analyses. Reasons incomplete are indicated below (reasons included; alterations in surgical procedure or no opioid prescription dispensed).
Participants by arm
| Arm | Count |
|---|---|
| Education Intervention This group will receive the scenario-tailored STOMP educational feedback
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises. | 258 |
| Control This group will receive only standard of care information. | 201 |
| Total | 459 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | incomplete baseline; surgical complication; no opioid prescription | 24 | 20 |
Baseline characteristics
| Characteristic | Control | Total | Education Intervention |
|---|---|---|---|
| Age, Continuous | 19.1 years STANDARD_DEVIATION 2.8 | 19.1 years STANDARD_DEVIATION 2.7 | 19.1 years STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 23 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 194 Participants | 436 Participants | 242 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 31 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 35 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 163 Participants | 370 Participants | 207 Participants |
| Sex: Female, Male Female | 104 Participants | 238 Participants | 134 Participants |
| Sex: Female, Male Male | 97 Participants | 221 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 258 | 0 / 201 |
| other Total, other adverse events | 0 / 258 | 0 / 201 |
| serious Total, serious adverse events | 9 / 258 | 6 / 201 |
Outcome results
Primary
Opioid Risk Perception
Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)
Time frame: Baseline, day 14, 3 months post intervention
Population: All who completed at least one follow-up measurement of risk perception.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Intervention | Opioid Risk Perception | Baseline | 31.4 score on a scale | Standard Deviation 0.85 |
| Education Intervention | Opioid Risk Perception | Day 14 | 32.8 score on a scale | Standard Deviation 0.65 |
| Education Intervention | Opioid Risk Perception | Month 3 | 31.0 score on a scale | Standard Deviation 0.62 |
| Control | Opioid Risk Perception | Baseline | 31.1 score on a scale | Standard Deviation 1.01 |
| Control | Opioid Risk Perception | Day 14 | 30.02 score on a scale | Standard Deviation 1.12 |
| Control | Opioid Risk Perception | Month 3 | 29.8 score on a scale | Standard Deviation 1.21 |
Comparison: Hypothesis was tested using multivariable regression models (generalized estimating equation)p-value: 0.00195% CI: [0.86, 3.4]Regression, Linear
Secondary
Opioid Misuse Intention Decisions
Number of participants with opioid misuse intentions and behaviors
Time frame: 3 months post intervention
Population: Rest of the sample lost to follow-up at months 1-3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Education Intervention | Opioid Misuse Intention Decisions | Misuse Intentions | 47 Participants |
| Education Intervention | Opioid Misuse Intention Decisions | Misuse behavior | 18 Participants |
| Control | Opioid Misuse Intention Decisions | Misuse Intentions | 38 Participants |
| Control | Opioid Misuse Intention Decisions | Misuse behavior | 12 Participants |
Comparison: Logistic regression model examined the effect of the intervention on the outcome (collapsed intentions/behaviors)p-value: 0.53495% CI: [0.72, 1.9]Regression, Logistic