Trial Outcomes & Findings for The Life STORRIED Study (NCT NCT03134092)
NCT ID: NCT03134092
Last Updated: 2025-07-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1302 participants
Primary outcome timeframe
Day 14
Results posted on
2025-07-14
Participant Flow
Participant milestones
| Measure |
Generalized Risk Communication (GRC)
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)
Probabilistic Risk Communication Tool (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.
|
Narrative Enhanced Risk Tool (NERT)
Narrative Enhanced Risk Tool (NERT): Participants assigned to this arm will receive the PRT described above but will also be instructed to watch two narrative videos. This video intervention will include a brief narrative video of an individuals' experience with pain and/or pain treatment with opioids. Narrative videos were developed from actual patient stories - put into a in a structured format of \~ 2-minute length and recorded.
|
|---|---|---|---|
|
Overall Study
STARTED
|
434
|
435
|
433
|
|
Overall Study
COMPLETED
|
434
|
435
|
433
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Life STORRIED Study
Baseline characteristics by cohort
| Measure |
Generalized Risk Communication (GRC)
n=434 Participants
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)
n=435 Participants
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.
\\
|
Narrative Enhanced Risk Tool (NERT)
n=433 Participants
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.
|
Total
n=1302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.2 Years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
41.72 Years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
40.32 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
40.59 Years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
224 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
692 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
210 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
607 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/AA
|
175 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
498 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
180 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
556 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other/Multi-racial
|
76 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
434 Participants
n=5 Participants
|
435 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
1302 Participants
n=4 Participants
|
|
Educational Attainment
Less than high school
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Educational Attainment
High School/GED
|
131 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Educational Attainment
Some college/2-year degree
|
137 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
395 Participants
n=4 Participants
|
|
Educational Attainment
Bachelor's degree
|
88 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Educational Attainment
Graduate or Professional school
|
47 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Educational Attainment
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: The control group was never made aware of their risk score as determined by the ORT. Additionally, there were participants who did not fill out the follow-up survey on Day 14, which is why their recall was not analyzed.
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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=304 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=295 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Risk Awareness and Recall
|
118 Participants
|
129 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: There were some participants who did not complete the Day 14 survey, which is why not all participants were analyzed.
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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=317 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=301 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=294 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Patient Reported Use of Opioid Medication
|
42 Participants
|
31 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Days 1-2, days 4-6Population: Data for this patient-reported outcome is not reliable. The question was not asked appropriately in order to accurately measure milligrams/dosage of prescription.
A second outcome is measuring patient reported opioid medication use by Total morphine equivalents.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1-2Patient reported total pills taken in the first 48 hours after baseline enrollment.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=243 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=243 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=242 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Patient Reported Use of Opioid Medication
1-2 opioid tablets taken
|
35 Participants
|
26 Participants
|
26 Participants
|
|
Patient Reported Use of Opioid Medication
No opioids taken
|
180 Participants
|
167 Participants
|
182 Participants
|
|
Patient Reported Use of Opioid Medication
3-6 opioid tablets taken
|
24 Participants
|
39 Participants
|
27 Participants
|
|
Patient Reported Use of Opioid Medication
>6 opioid tablets taken
|
4 Participants
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 14, 3 MonthsPopulation: The number of participants analyzed differs from day 14 and day 90 because the total number analyzed is the number of participants still taking opioids at that time.
Frequency of use
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=42 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=31 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=31 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Patient Reported Use of Opioid Medication
14 days · Daily
|
13 Participants
|
19 Participants
|
13 Participants
|
|
Patient Reported Use of Opioid Medication
14 days · 1-3 times a week
|
10 Participants
|
2 Participants
|
6 Participants
|
|
Patient Reported Use of Opioid Medication
14 days · >3 times a week
|
11 Participants
|
7 Participants
|
6 Participants
|
|
Patient Reported Use of Opioid Medication
14 days · <1 time a week
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Patient Reported Use of Opioid Medication
90 days · Daily
|
9 Participants
|
5 Participants
|
4 Participants
|
|
Patient Reported Use of Opioid Medication
90 days · >3 times a week
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Patient Reported Use of Opioid Medication
90 days · 1-3 times a week
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Patient Reported Use of Opioid Medication
90 days · <1 time a week
|
6 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.Patient reported days to no longer taking opioids
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=164 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=162 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=148 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Patient Reported Use of Opioid Medication
|
6 Days
Interval 4.0 to 14.0
|
5 Days
Interval 4.0 to 14.0
|
4 Days
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Days 1, day 14, 3 MonthsPopulation: The number of participants analyzed changes at each time point based on the number of participants who filled out the surveys.
Patient reported use and dose of NSAIDs and acetaminophen
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=433 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Reported Use of Non Opioid Pain Medication
Day 14 · Opioids and NSAIDs
|
27 Participants
|
20 Participants
|
23 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 90 · No pain medication
|
154 Participants
|
163 Participants
|
171 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 90 · NSAIDs only
|
103 Participants
|
105 Participants
|
98 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 1 · No pain medication
|
47 Participants
|
55 Participants
|
64 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 1 · NSAIDs only
|
193 Participants
|
170 Participants
|
167 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 1 · Opioids only
|
15 Participants
|
20 Participants
|
16 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 1 · Opioids and NSAIDs
|
42 Participants
|
54 Participants
|
49 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 14 · No pain medication
|
144 Participants
|
142 Participants
|
147 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 14 · NSAIDs only
|
131 Participants
|
130 Participants
|
117 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 14 · Opioids only
|
15 Participants
|
11 Participants
|
8 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 90 · Opioids only
|
9 Participants
|
9 Participants
|
3 Participants
|
|
Reported Use of Non Opioid Pain Medication
Day 90 · Opioids and NSAIDs
|
15 Participants
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: At Baseline and 3 Months (referred to as "3 M" below)Population: Not all participants answered this question at both timepoints.
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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=433 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Functional Ability/Return to Usual Activities
|
5.45 RAND Health score change baseline to 3 M
Interval 1.29 to 9.62
|
5.10 RAND Health score change baseline to 3 M
Interval 1.01 to 9.2
|
4.26 RAND Health score change baseline to 3 M
Interval 0.14 to 8.37
|
SECONDARY outcome
Timeframe: Baseline, Days 1 and 7, Day 14, 3 Months (referred to as "3 M" below)Population: Not all participants answered the question at both time points.
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)
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=433 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Functional Ability/Return to Usual Activities
|
4.46 APO score change baseline to 3 M
Interval 3.69 to 5.23
|
4.82 APO score change baseline to 3 M
Interval 4.06 to 5.59
|
4.67 APO score change baseline to 3 M
Interval 3.7 to 5.24
|
SECONDARY outcome
Timeframe: Day 1Population: There were participants that did not fill out the Day 1 survey and were therefore not analyzed.
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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=306 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=310 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=310 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Patient Reported Shared Decision Making
|
6.826797 score on a scale
Interval 6.5662 to 7.0873951
|
7.070968 score on a scale
Interval 6.812057 to 7.3298782
|
7.220430 score on a scale
Interval 6.96152 to 7.4793413
|
SECONDARY outcome
Timeframe: Days 1 and 7, Day 14, 3 MonthsPopulation: A different number of participants filled out the surveys at each time point. Therefore, the number above, overall participants analyzed, reflects the overall numbers randomized to each arm.
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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=435 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=433 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Satisfaction With Pain Treatment
Day 1
|
6.57 score on a scale
Interval 6.21 to 6.93
|
6.58 score on a scale
Interval 6.22 to 6.94
|
7.25 score on a scale
Interval 6.89 to 7.61
|
|
Satisfaction With Pain Treatment
Day 7
|
6.50 score on a scale
Interval 6.12 to 6.88
|
6.49 score on a scale
Interval 6.11 to 6.87
|
6.92 score on a scale
Interval 6.54 to 7.3
|
|
Satisfaction With Pain Treatment
Day 14
|
6.58 score on a scale
Interval 6.2 to 6.96
|
6.56 score on a scale
Interval 6.17 to 6.95
|
6.82 score on a scale
Interval 6.43 to 7.21
|
|
Satisfaction With Pain Treatment
Month 3
|
6.58 score on a scale
Interval 6.18 to 6.98
|
6.81 score on a scale
Interval 6.41 to 7.21
|
7.17 score on a scale
Interval 6.77 to 7.57
|
SECONDARY outcome
Timeframe: Day 7The 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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=300 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=298 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=296 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Trust in Provider
|
76.23 score on a scale
Standard Deviation 21.91
|
73.62 score on a scale
Standard Deviation 23.93
|
75.20 score on a scale
Standard Deviation 21.06
|
SECONDARY outcome
Timeframe: At BaselinePatients 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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=432 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Patient Preference for Treatment Plan
|
143 Participants
|
123 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: At BaselinePatient 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.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=433 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=432 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Treatment Plan Agreement Between Patient Preference and Provider Decision
|
286 Participants
|
300 Participants
|
303 Participants
|
SECONDARY outcome
Timeframe: Day 14 and 3 MonthPopulation: The number of participants analyzed changes at each time point based on the number of participants who filled out the surveys.
Self-Report additional provider visits to measure follow-up visits for pain
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=434 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=433 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Self-Report Additional Provider Visits
Day 14
|
125 Participants
|
127 Participants
|
121 Participants
|
|
Self-Report Additional Provider Visits
Day 90
|
113 Participants
|
128 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.
Outcome measures
| Measure |
Probabilistic Risk Communication (PRT)
n=24 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=19 Participants
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.
|
Narrative Enhanced Risk Tool (NERT)
n=16 Participants
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.
Probabilistic Risk Communication Tool (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 infor
|
|---|---|---|---|
|
Current Opioid Misuse Measure (COMM)
|
17 Participants
|
9 Participants
|
9 Participants
|
Adverse Events
Generalized Risk Communication (GRC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Probabilistic Risk Communication (PRT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Narrative Enhanced Risk Tool (NERT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Zachary Meisel
University of Pennsylvania Perelman School of Medicine
Phone: 215-746-5618
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place