An interventional study of Probabilistic Risk Communication Tool (PRT) and Narrative Enhanced Risk Tool (NERT) in Opioid Dependence, Communication and Risk Behavior, sponsored by University of Pennsylvania. Completed at 4 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention
To compare the effectiveness of 3 strategies to inform patients of their risks associated with misuse of opioid prescriptions after treatment in the ED from renal colic or musculoskeletal back pain. Randomization will be to 3 arms for the Randomized Practical Control Trial across 3 sites (A) standardized general risk information sheet only (B) standardized general risk information sheet plus a visual probabilistic risk tool (C) standardized sheet plus narrative enhanced probabilistic risk tool.
Amid a devastating public health crisis, in which 19,000 overdose deaths per year in the United States are due to prescription opioids, the investigators ask the following questions: Can risk-informed communication (with or without a narrative-enhanced tool) improve patient-centered outcomes in the domains of knowledge, opioid use, functional outcomes, and patient provider therapeutic alignment? This question has implications for over 17 million patients who present to acute care settings with acute pain from common conditions. Can these goals be accomplished in a real-world setting, for a diverse patient population? The investigators approach to this project includes a practical randomized controlled trial, conducted in nine acute care settings, at three geographically distinct hospital centers, with broad inclusion criteria and a diverse population. Aims: This project aims to compare the effectiveness of 1) a standardized general risk information sheet only; 2 a standardized general risk information sheet plus a probabilistic risk tool; and 3) a standardized sheet plus narrative-enhanced probabilistic risk tool on the following outcomes: * Knowledge as measured by risk awareness and treatment preferences for fewer opioids, particularly among those at higher risk for addiction * Reduced use of opioids as measured by quantity of opioids taken, functional improvement, and repeat use of unscheduled visits for pain at 14 days * Patient provider alignment as measured by concordance between patient preference and finalized prescription plan, and the presence of shared decision making. These aims will be achieved in a multicenter randomized practical clinical trial of 1,300 patients who are planned for discharge from acute care settings after being treated for acute back or acute kidney stone pain. The investigators hypothesize that, compared with patients receiving a generalized risk information sheet or a probabilistic risk communication tool alone, patients with acute renal colic and musculoskeletal back pain randomized to receive narrative-enhanced risk communication, will do the following: (H1) demonstrate greater knowledge, as determined by awareness of risk for opioid dependency; (H2a) select a treatment plan with fewer opioids; (H2b) take fewer opioids for fewer days, while achieving the same degree of pain relief and improved functional status; (H3a) enjoy greater levels of concordance between the patient-preferred and provider-selected treatment plans; and (H3b) engage in greater shared decision making with their providers. How these aims are important to patients: The research question is important to patients because 1) patients are frequently exposed to the potential for either under- or over-treatment of pain; 2) patients have different risk factors for dependency, which may impact the appropriateness of certain medications for pain relief; and 3) opioid dependence and misuse which often begin with prescriptions for acute pain are costly and common, and affect families, communities, and society as a whole.
Exclusion Criteria:
Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.
Probabilistic Risk Communication (PRT): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
Other: Probabilistic Risk Communication Tool (PRT)
Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of \~ 2-minute length and recorded.
Other: Probabilistic Risk Communication Tool (PRT) · Other: Narrative Enhanced Risk Tool (NERT)
The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale around prolonged opioid uses. Narrative videos are developed from actual patients sharing their stories - put into a in a structured format of \~ 2-minute length and recorded.
Risk Awareness and Recall
The primary outcome of this study is for patients to gain an understanding of individual risk using the Opioid Risk Tool (ORT). The ORT is a brief screening tool allowing patients to confidentially enter their own history to determine the probability opioid dependency and addiction. High concordance between measured risk and patient recall might indicate sustained effectiveness (or stickiness) of the risk communication tool. Discordance might indicate a failure of risk communication and knowledge of individualized risk. This outcome is dichotomous, categorized as "Yes" the person correctly recalled their risk category or "No", either they did not correctly recall their risk category or they did not remember their risk category at all. The count of participants is the amount categorized as "Yes", they correctly recalled their risk category.
Time frame: Day 14
Patient Reported Use of Opioid Medication
Taking opioid medication at Day 14. This outcome is dichotomous. "Yes" if they were taking opioids at Day 14, or "No" if they were not taking opioids at Day 14.
Time frame: Day 14
Patient Reported Use of Opioid Medication
A second outcome is measuring patient reported opioid medication use by Total morphine equivalents.
Time frame: Days 1-2, days 4-6
Patient Reported Use of Opioid Medication
Patient reported total pills taken in the first 48 hours after baseline enrollment.
Time frame: Days 1-2
Patient Reported Use of Opioid Medication
Frequency of use
Time frame: Day 14, 3 Months
Patient Reported Use of Opioid Medication
Patient reported days to no longer taking opioids
Time frame: Time from emergency department visit to ceasing opioid use. We assessed at days 1-2, 4-6, 14, and month 3, data up to 3 months reported.
Reported Use of Non Opioid Pain Medication
Patient reported use and dose of NSAIDs and acetaminophen
Time frame: Days 1, day 14, 3 Months
Functional Ability/Return to Usual Activities
The RAND health- 20 questionnaire will be used to measure functional ability. We report the domain of "Role Function". Scores for this domain are reported on a scale of 0% to 100%, with 0% representing the worst possible score in that domain and 100% the best possible score.
Time frame: At Baseline and 3 Months (referred to as "3 M" below)
Functional Ability/Return to Usual Activities
The American Pain Outcome questionnaire will be used to measure functional ability. We report the change in the score for "In the last 24 hours how much has pain interfered/prevented you from... Doing activities such as walking, sitting, or standing" between Baseline and 3 months. (scale: 0 = 0% of the time, 10 = 100% of the time)
Time frame: Baseline, Days 1 and 7, Day 14, 3 Months (referred to as "3 M" below)
Patient Reported Shared Decision Making
The CollaboRATE93 scale- a brief, patient reported measure of shared decision making after a clinical encounter will be used. The scale will be adapted to reflect the context of an acute pain clinical encounter in the emergency department. There are three questions scored 0-9 with higher values meaning more collaboration. The average score of the three questions was calculated.
Time frame: Day 1
Satisfaction With Pain Treatment
Participants are asked "How satisfied were you with the results of your pain treatment while in the hospital?" with 0 = extremely dissatisfied and 10 = extremely satisfied.
Time frame: Days 1 and 7, Day 14, 3 Months
Trust in Provider
The Trust in Physician scale, will be used to measure the patient's their trust in their provider. Allows Patient to report their perception of their provider. Patients are more likely to be adherent to medical care when they trust their physicians. We report the "Trust in lead clinician" item. Score 0-100, where higher indicates more trust.
Time frame: Day 7
Patient Preference for Treatment Plan
Patients will be provided options for pain treatment for discharge treatment plan. We are reporting out on patients who indicated they preferred any type of opioid.
Time frame: At Baseline
Treatment Plan Agreement Between Patient Preference and Provider Decision
Patient preference will be linked to electronic medical record data. Discordance between risk informed patient preferences and provider selection may indicate failure to achieve an optimized patient centered outcome. We report overall alignment.
Time frame: At Baseline
Self-Report Additional Provider Visits
Self-Report additional provider visits to measure follow-up visits for pain
Time frame: Day 14 and 3 Month
Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.
Time frame: 3 months
| Milestone | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Started | 434 | 435 | 433 |
| Completed | 434 | 435 | 433 |
| Not completed | 0 | 0 | 0 |
The primary outcome of this study is for patients to gain an understanding of individual risk using the Opioid Risk Tool (ORT). The ORT is a brief screening tool allowing patients to confidentially enter their own history to determine the probability opioid dependency and addiction. High concordance between measured risk and patient recall might indicate sustained effectiveness (or stickiness) of the risk communication tool. Discordance might indicate a failure of risk communication and knowledge of individualized risk. This outcome is dichotomous, categorized as "Yes" the person correctly recalled their risk category or "No", either they did not correctly recall their risk category or they did not remember their risk category at all. The count of participants is the amount categorized as "Yes", they correctly recalled their risk category.
| Participants | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|
| Risk Awareness and Recall | 118 | 129 |
Taking opioid medication at Day 14. This outcome is dichotomous. "Yes" if they were taking opioids at Day 14, or "No" if they were not taking opioids at Day 14.
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Patient Reported Use of Opioid Medication | 42 | 31 | 31 |
A second outcome is measuring patient reported opioid medication use by Total morphine equivalents.
No measurements were reported for this outcome.
Patient reported total pills taken in the first 48 hours after baseline enrollment.
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| No opioids taken | 180 | 167 | 182 |
| 1-2 opioid tablets taken | 35 | 26 | 26 |
| 3-6 opioid tablets taken | 24 | 39 | 27 |
| >6 opioid tablets taken | 4 | 11 | 7 |
Frequency of use
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| 14 days — Daily | 13 | 19 | 13 |
| 14 days — >3 times a week | 11 | 7 | 6 |
| 14 days — 1-3 times a week | 10 | 2 | 6 |
| 14 days — <1 time a week | 8 | 3 | 6 |
| 90 days — Daily | 9 | 5 | 4 |
| 90 days — >3 times a week | 4 | 7 | 5 |
| 90 days — 1-3 times a week | 5 | 2 | 4 |
| 90 days — <1 time a week | 6 | 5 | 3 |
Patient reported days to no longer taking opioids
| Days | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Patient Reported Use of Opioid Medication | 6 (4 to 14) | 5 (4 to 14) | 4 (2 to 6) |
Patient reported use and dose of NSAIDs and acetaminophen
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Day 1 — No pain medication | 47 | 55 | 64 |
| Day 1 — NSAIDs only | 193 | 170 | 167 |
| Day 1 — Opioids only | 15 | 20 | 16 |
| Day 1 — Opioids and NSAIDs | 42 | 54 | 49 |
| Day 14 — No pain medication | 144 | 142 | 147 |
| Day 14 — NSAIDs only | 131 | 130 | 117 |
| Day 14 — Opioids only | 15 | 11 | 8 |
| Day 14 — Opioids and NSAIDs | 27 | 20 | 23 |
| Day 90 — No pain medication | 154 | 163 | 171 |
| Day 90 — NSAIDs only | 103 | 105 | 98 |
| Day 90 — Opioids only | 9 | 9 | 3 |
| Day 90 — Opioids and NSAIDs | 15 | 10 | 13 |
The RAND health- 20 questionnaire will be used to measure functional ability. We report the domain of "Role Function". Scores for this domain are reported on a scale of 0% to 100%, with 0% representing the worst possible score in that domain and 100% the best possible score.
| RAND Health score change baseline to 3 M | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Functional Ability/Return to Usual Activities | 5.45 (1.29 to 9.62) | 5.10 (1.01 to 9.20) | 4.26 (0.14 to 8.37) |
The American Pain Outcome questionnaire will be used to measure functional ability. We report the change in the score for "In the last 24 hours how much has pain interfered/prevented you from... Doing activities such as walking, sitting, or standing" between Baseline and 3 months. (scale: 0 = 0% of the time, 10 = 100% of the time)
| APO score change baseline to 3 M | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Functional Ability/Return to Usual Activities | 4.46 (3.69 to 5.23) | 4.82 (4.06 to 5.59) | 4.67 (3.70 to 5.24) |
The CollaboRATE93 scale- a brief, patient reported measure of shared decision making after a clinical encounter will be used. The scale will be adapted to reflect the context of an acute pain clinical encounter in the emergency department. There are three questions scored 0-9 with higher values meaning more collaboration. The average score of the three questions was calculated.
| score on a scale | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Patient Reported Shared Decision Making | 6.826797 (6.566200 to 7.0873951) | 7.070968 (6.812057 to 7.3298782) | 7.220430 (6.961520 to 7.4793413) |
Participants are asked "How satisfied were you with the results of your pain treatment while in the hospital?" with 0 = extremely dissatisfied and 10 = extremely satisfied.
| score on a scale | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Day 1 | 6.57 (6.21 to 6.93) | 6.58 (6.22 to 6.94) | 7.25 (6.89 to 7.61) |
| Day 7 | 6.50 (6.12 to 6.88) | 6.49 (6.11 to 6.87) | 6.92 (6.54 to 7.30) |
| Day 14 | 6.58 (6.20 to 6.96) | 6.56 (6.17 to 6.95) | 6.82 (6.43 to 7.21) |
| Month 3 | 6.58 (6.18 to 6.98) | 6.81 (6.41 to 7.21) | 7.17 (6.77 to 7.57) |
The Trust in Physician scale, will be used to measure the patient's their trust in their provider. Allows Patient to report their perception of their provider. Patients are more likely to be adherent to medical care when they trust their physicians. We report the "Trust in lead clinician" item. Score 0-100, where higher indicates more trust.
| score on a scale | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Trust in Provider | 76.23 ± 21.91 | 73.62 ± 23.93 | 75.20 ± 21.06 |
Patients will be provided options for pain treatment for discharge treatment plan. We are reporting out on patients who indicated they preferred any type of opioid.
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Patient Preference for Treatment Plan | 143 | 123 | 112 |
Patient preference will be linked to electronic medical record data. Discordance between risk informed patient preferences and provider selection may indicate failure to achieve an optimized patient centered outcome. We report overall alignment.
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Treatment Plan Agreement Between Patient Preference and Provider Decision | 286 | 300 | 303 |
Self-Report additional provider visits to measure follow-up visits for pain
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Day 14 | 125 | 127 | 121 |
| Day 90 | 113 | 128 | 124 |
The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.
| Participants | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) |
|---|---|---|---|
| Current Opioid Misuse Measure (COMM) | 17 | 9 | 9 |
Collected over Through study completion, an average of 4 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Generalized Risk Communication (GRC) | 0/434 (0%) | 0/434 (0%) | 0/434 (0%) |
| Probabilistic Risk Communication (PRT) | 0/435 (0%) | 0/435 (0%) | 0/435 (0%) |
| Narrative Enhanced Risk Tool (NERT) | 0/433 (0%) | 0/433 (0%) | 0/433 (0%) |
| Age, Continuous(Years) | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) | Total |
|---|---|---|---|---|
| Mean | 40.2 ± 13.9 | 41.72 ± 16.6 | 40.32 ± 13.8 | 40.59 ± 13.9 |
| Sex/Gender, Customized(Participants) | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) | Total |
|---|---|---|---|---|
| Female | 224 | 229 | 239 | 692 |
| Male | 210 | 204 | 193 | 607 |
| Other | 0 | 2 | 1 | 3 |
| Race/Ethnicity, Customized(Participants) | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) | Total |
|---|---|---|---|---|
| Black/AA | 175 | 156 | 167 | 498 |
| White | 180 | 191 | 185 | 556 |
| Other/Multi-racial | 76 | 87 | 80 | 243 |
| Unknown | 3 | 1 | 1 | 5 |
| Region of Enrollment(Participants) | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) | Total |
|---|---|---|---|---|
| United States | 434 | 435 | 433 | 1302 |
| Educational Attainment(Participants) | Generalized Risk Communication (GRC) | Probabilistic Risk Communication (PRT) | Narrative Enhanced Risk Tool (NERT) | Total |
|---|---|---|---|---|
| Less than high school | 29 | 25 | 31 | 85 |
| High School/GED | 131 | 117 | 137 | 385 |
| Some college/2-year degree | 137 | 139 | 119 | 395 |
| Bachelor's degree | 88 | 95 | 89 | 272 |
| Graduate or Professional school | 47 | 59 | 56 | 162 |
| Unknown | 2 | 0 | 1 | 3 |
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