Communication, Narrative Medicine, Opioid Dependence, Risk Behavior
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERProbabilistic 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.
OTHERNarrative 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 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.
Sponsors
Patient-Centered Outcomes Research Institute
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years to 70 years old * Experiencing back pain or renal colic * Text messaging and internet access including email capabilities or access to a smartphone * Anticipated discharge within 24 hours
Exclusion criteria
* Patients who take opioids for chronic pain or cancer treatments * Patients who have taken opioids in the past month with the exception of patients who have taken opioids in the previous 48 hours before arriving at the ED for their presenting condition based on provider assessment * Patients who are pregnant, in police custody, intoxicated, cognitively impaired, or otherwise unable to fully consent and participate * Patients who are hemodynamically compromised, in respiratory distress, or in severe emotional or physical distress. * Patients older than 70 or younger than 18 * Patients who will be admitted to hospital or deemed to have a critical illness based on provider assessment * Patients who are cognitively impaired * Patients who are suicidal or homicidal ideation by chart review and clinician assessment. * Patients with evidence of aberrant behavior based on clinical assessment * Patients who do not have a phone, text messaging OR email address * Patients under police arrest at ED visit * Patients who are non-English or Spanish speaking * Patients previously enrolled * Patient with any current contraindications for NSAIDs or opioid medications including allergies, chronic kidney disease (GFR60, if measured)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk Awareness and Recall | Day 14 | 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. |
| Patient Reported Use of Opioid Medication | Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Ability/Return to Usual Activities | At Baseline and 3 Months (referred to as 3 M below) | 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. |
| Patient Reported Shared Decision Making | Day 1 | 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. |
| Satisfaction With Pain Treatment | Days 1 and 7, Day 14, 3 Months | 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. |
| Trust in Provider | Day 7 | 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. |
| Patient Reported Use of Opioid Medication | Days 1-2, days 4-6 | A second outcome is measuring patient reported opioid medication use by Total morphine equivalents. |
| Treatment Plan Agreement Between Patient Preference and Provider Decision | At Baseline | 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. |
| Self-Report Additional Provider Visits | Day 14 and 3 Month | Self-Report additional provider visits to measure follow-up visits for pain |
| Current Opioid Misuse Measure (COMM) | 3 months | The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids. |
| Patient Preference for Treatment Plan | At Baseline | 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. |
| Reported Use of Non Opioid Pain Medication | Days 1, day 14, 3 Months | Patient reported use and dose of NSAIDs and acetaminophen |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 434 |
| Probabilistic Risk Communication (PRT) 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.
\\ | 435 |
| 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. | 433 |
| Total | 1,302 |
Baseline characteristics
| Characteristic | Total | Generalized Risk Communication (GRC) | Narrative Enhanced Risk Tool (NERT) | Probabilistic Risk Communication (PRT) |
|---|---|---|---|---|
| Age, Continuous | 40.59 Years STANDARD_DEVIATION 13.9 | 40.2 Years STANDARD_DEVIATION 13.9 | 40.32 Years STANDARD_DEVIATION 13.8 | 41.72 Years STANDARD_DEVIATION 16.6 |
| Educational Attainment Bachelor's degree | 272 Participants | 88 Participants | 89 Participants | 95 Participants |
| Educational Attainment Graduate or Professional school | 162 Participants | 47 Participants | 56 Participants | 59 Participants |
| Educational Attainment High School/GED | 385 Participants | 131 Participants | 137 Participants | 117 Participants |
| Educational Attainment Less than high school | 85 Participants | 29 Participants | 31 Participants | 25 Participants |
| Educational Attainment Some college/2-year degree | 395 Participants | 137 Participants | 119 Participants | 139 Participants |
| Educational Attainment Unknown | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/AA | 498 Participants | 175 Participants | 167 Participants | 156 Participants |
| Race/Ethnicity, Customized Other/Multi-racial | 243 Participants | 76 Participants | 80 Participants | 87 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 556 Participants | 180 Participants | 185 Participants | 191 Participants |
| Region of Enrollment United States | 1302 Participants | 434 Participants | 433 Participants | 435 Participants |
| Sex/Gender, Customized Female | 692 Participants | 224 Participants | 239 Participants | 229 Participants |
| Sex/Gender, Customized Male | 607 Participants | 210 Participants | 193 Participants | 204 Participants |
| Sex/Gender, Customized Other | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 434 | 0 / 435 | 0 / 433 |
| other Total, other adverse events | 0 / 434 | 0 / 435 | 0 / 433 |
| serious Total, serious adverse events | 0 / 434 | 0 / 435 | 0 / 433 |
Outcome results
Primary
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
Population: There were some participants who did not complete the Day 14 survey, which is why not all participants were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 42 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 31 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 31 Participants |
Primary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Risk Awareness and Recall | 118 Participants |
| Narrative Enhanced Risk Tool (NERT) | Risk Awareness and Recall | 129 Participants |
Secondary
Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Current Opioid Misuse Measure (COMM) | 17 Participants |
| Narrative Enhanced Risk Tool (NERT) | Current Opioid Misuse Measure (COMM) | 9 Participants |
| Narrative Enhanced Risk Tool (NERT) | Current Opioid Misuse Measure (COMM) | 9 Participants |
Secondary
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)
Population: Not all participants answered this question at both timepoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Functional Ability/Return to Usual Activities | 5.45 RAND Health score change baseline to 3 M |
| Narrative Enhanced Risk Tool (NERT) | Functional Ability/Return to Usual Activities | 5.10 RAND Health score change baseline to 3 M |
| Narrative Enhanced Risk Tool (NERT) | Functional Ability/Return to Usual Activities | 4.26 RAND Health score change baseline to 3 M |
Secondary
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)
Population: Not all participants answered the question at both time points.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Functional Ability/Return to Usual Activities | 4.46 APO score change baseline to 3 M |
| Narrative Enhanced Risk Tool (NERT) | Functional Ability/Return to Usual Activities | 4.82 APO score change baseline to 3 M |
| Narrative Enhanced Risk Tool (NERT) | Functional Ability/Return to Usual Activities | 4.67 APO score change baseline to 3 M |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Patient Preference for Treatment Plan | 143 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Preference for Treatment Plan | 123 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Preference for Treatment Plan | 112 Participants |
Secondary
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
Population: There were participants that did not fill out the Day 1 survey and were therefore not analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Patient Reported Shared Decision Making | 6.826797 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Shared Decision Making | 7.070968 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Shared Decision Making | 7.220430 score on a scale |
Secondary
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
Population: Data for this patient-reported outcome is not reliable. The question was not asked appropriately in order to accurately measure milligrams/dosage of prescription.
Secondary
Patient Reported Use of Opioid Medication
Frequency of use
Time frame: Day 14, 3 Months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 14 days | Daily | 13 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 14 days | >3 times a week | 11 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 14 days | 1-3 times a week | 10 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 14 days | <1 time a week | 8 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 90 days | Daily | 9 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 90 days | >3 times a week | 4 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 90 days | 1-3 times a week | 5 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 90 days | <1 time a week | 6 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | 1-3 times a week | 2 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | 1-3 times a week | 2 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | <1 time a week | 3 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | Daily | 5 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | >3 times a week | 7 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | Daily | 19 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | >3 times a week | 7 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | <1 time a week | 5 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | 1-3 times a week | 6 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | >3 times a week | 6 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | Daily | 13 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 14 days | <1 time a week | 6 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | 1-3 times a week | 4 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | >3 times a week | 5 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | Daily | 4 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 90 days | <1 time a week | 3 Participants |
Secondary
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 6 Days |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 5 Days |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 4 Days |
Secondary
Patient Reported Use of Opioid Medication
Patient reported total pills taken in the first 48 hours after baseline enrollment.
Time frame: Days 1-2
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | No opioids taken | 180 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 1-2 opioid tablets taken | 35 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | 3-6 opioid tablets taken | 24 Participants |
| Probabilistic Risk Communication (PRT) | Patient Reported Use of Opioid Medication | >6 opioid tablets taken | 4 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | >6 opioid tablets taken | 11 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | No opioids taken | 167 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 3-6 opioid tablets taken | 39 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 1-2 opioid tablets taken | 26 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | >6 opioid tablets taken | 7 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 1-2 opioid tablets taken | 26 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | 3-6 opioid tablets taken | 27 Participants |
| Narrative Enhanced Risk Tool (NERT) | Patient Reported Use of Opioid Medication | No opioids taken | 182 Participants |
Secondary
Reported Use of Non Opioid Pain Medication
Patient reported use and dose of NSAIDs and acetaminophen
Time frame: Days 1, day 14, 3 Months
Population: The number of participants analyzed changes at each time point based on the number of participants who filled out the surveys.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 90 | Opioids only | 9 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 90 | No pain medication | 154 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 14 | NSAIDs only | 131 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 1 | Opioids only | 15 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 14 | Opioids and NSAIDs | 27 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 14 | Opioids only | 15 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 1 | No pain medication | 47 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 1 | NSAIDs only | 193 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 90 | NSAIDs only | 103 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 1 | Opioids and NSAIDs | 42 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 90 | Opioids and NSAIDs | 15 Participants |
| Probabilistic Risk Communication (PRT) | Reported Use of Non Opioid Pain Medication | Day 14 | No pain medication | 144 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | Opioids only | 11 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | No pain medication | 55 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | NSAIDs only | 170 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | Opioids only | 20 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | Opioids and NSAIDs | 54 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | No pain medication | 142 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | NSAIDs only | 130 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | Opioids and NSAIDs | 20 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | No pain medication | 163 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | NSAIDs only | 105 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | Opioids only | 9 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | Opioids and NSAIDs | 10 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | No pain medication | 64 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | No pain medication | 171 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | Opioids only | 16 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | Opioids and NSAIDs | 49 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | NSAIDs only | 98 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 1 | NSAIDs only | 167 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | Opioids and NSAIDs | 13 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | Opioids only | 8 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | NSAIDs only | 117 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 90 | Opioids only | 3 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | Opioids and NSAIDs | 23 Participants |
| Narrative Enhanced Risk Tool (NERT) | Reported Use of Non Opioid Pain Medication | Day 14 | No pain medication | 147 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Probabilistic Risk Communication (PRT) | Satisfaction With Pain Treatment | Day 1 | 6.57 score on a scale |
| Probabilistic Risk Communication (PRT) | Satisfaction With Pain Treatment | Day 7 | 6.50 score on a scale |
| Probabilistic Risk Communication (PRT) | Satisfaction With Pain Treatment | Day 14 | 6.58 score on a scale |
| Probabilistic Risk Communication (PRT) | Satisfaction With Pain Treatment | Month 3 | 6.58 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Month 3 | 6.81 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Day 1 | 6.58 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Day 14 | 6.56 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Day 7 | 6.49 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Month 3 | 7.17 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Day 7 | 6.92 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Day 14 | 6.82 score on a scale |
| Narrative Enhanced Risk Tool (NERT) | Satisfaction With Pain Treatment | Day 1 | 7.25 score on a scale |
Secondary
Self-Report Additional Provider Visits
Self-Report additional provider visits to measure follow-up visits for pain
Time frame: Day 14 and 3 Month
Population: The number of participants analyzed changes at each time point based on the number of participants who filled out the surveys.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Probabilistic Risk Communication (PRT) | Self-Report Additional Provider Visits | Day 14 | 125 Participants |
| Probabilistic Risk Communication (PRT) | Self-Report Additional Provider Visits | Day 90 | 113 Participants |
| Narrative Enhanced Risk Tool (NERT) | Self-Report Additional Provider Visits | Day 14 | 127 Participants |
| Narrative Enhanced Risk Tool (NERT) | Self-Report Additional Provider Visits | Day 90 | 128 Participants |
| Narrative Enhanced Risk Tool (NERT) | Self-Report Additional Provider Visits | Day 14 | 121 Participants |
| Narrative Enhanced Risk Tool (NERT) | Self-Report Additional Provider Visits | Day 90 | 124 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probabilistic Risk Communication (PRT) | Treatment Plan Agreement Between Patient Preference and Provider Decision | 286 Participants |
| Narrative Enhanced Risk Tool (NERT) | Treatment Plan Agreement Between Patient Preference and Provider Decision | 300 Participants |
| Narrative Enhanced Risk Tool (NERT) | Treatment Plan Agreement Between Patient Preference and Provider Decision | 303 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probabilistic Risk Communication (PRT) | Trust in Provider | 76.23 score on a scale | Standard Deviation 21.91 |
| Narrative Enhanced Risk Tool (NERT) | Trust in Provider | 73.62 score on a scale | Standard Deviation 23.93 |
| Narrative Enhanced Risk Tool (NERT) | Trust in Provider | 75.20 score on a scale | Standard Deviation 21.06 |