Opioid Use, Unspecified
Conditions
Keywords
Opioids
Brief summary
The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.
Detailed description
Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge. The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume \>85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.
Interventions
BEHAVIORALEMC2 Strategy
Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
BEHAVIORALSMS Text Reminders
In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria: 1. Patient age 18 years and older 2. English language speaking 3. prescribed pill form of hydrocodone-acetaminophen opioid pain reliever 4. own a cell phone with text messaging capabilities 5. the patient is the person primarily responsible for administering medication
Exclusion criteria
* Subjects will be excluded from the study if any of the following conditions are met: 1. Aged \<18 2. non-English speaking 3. clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician 4. chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days 5. admitted to hospital 6. unable to complete follow up phone interviews 7. pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safe Medication Dosing (Prescription Understanding) | 7-14 days after enrollment | Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Knowledge | 7-14 days after enrollment | The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire. Patients will be asked about each of the above via structured, open-ended items. Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included. The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10. A higher score on the scale represents better patient knowledge. |
| Proper Medication Use (Medication Diary) | 10 day medication diary | Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use. |
| Current Opioid Misuse Measure (COMM) | 7-14 days after enrollment | Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids. |
| Pain Score | 7-14 days after enrollment | Pain scores through structured questions about use in the past 24 hours were collected from participants. Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Employ the standard of care, no intervention | 202 |
| EMC2 Strategy Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.
1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.
2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.
3. Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed on the prescription. | 243 |
| EMC2 Strategy + SMS Text Reminders In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
EMC2 Strategy: Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
Short Message Service (SMS) Text Reminders: In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days. | 207 |
| Total | 652 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible doe to not filling Rx | 11 | 7 | 8 |
| Overall Study | Lost to Follow-up | 101 | 122 | 104 |
| Overall Study | Withdrawal by Subject | 7 | 5 | 5 |
Baseline characteristics
| Characteristic | Total | EMC2 Strategy + SMS Text Reminders | Usual Care | EMC2 Strategy |
|---|---|---|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 14 | 41.3 years STANDARD_DEVIATION 13.3 | 43.3 years STANDARD_DEVIATION 14.2 | 42.3 years STANDARD_DEVIATION 14.4 |
| Health Literacy (NVS) Adequate Literacy | 433 Participants | 139 Participants | 131 Participants | 163 Participants |
| Health Literacy (NVS) Limited/Marginal Literacy | 219 Participants | 68 Participants | 71 Participants | 80 Participants |
| Income >$100,000 | 202 Participants | 70 Participants | 56 Participants | 76 Participants |
| Income < $40,000 | 178 Participants | 49 Participants | 60 Participants | 69 Participants |
| Income $40,000-$100,000 | 202 Participants | 56 Participants | 68 Participants | 78 Participants |
| Race/Ethnicity, Customized Race African American | 200 Participants | 63 Participants | 66 Participants | 71 Participants |
| Race/Ethnicity, Customized Race Other | 145 Participants | 44 Participants | 40 Participants | 61 Participants |
| Race/Ethnicity, Customized Race White | 305 Participants | 100 Participants | 95 Participants | 110 Participants |
| Sex: Female, Male Female | 372 Participants | 124 Participants | 113 Participants | 135 Participants |
| Sex: Female, Male Male | 280 Participants | 83 Participants | 89 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 202 | 0 / 243 | 0 / 207 |
| other Total, other adverse events | 0 / 202 | 0 / 243 | 0 / 207 |
| serious Total, serious adverse events | 0 / 202 | 0 / 243 | 0 / 207 |
Outcome results
Primary
Safe Medication Dosing (Prescription Understanding)
Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).
Time frame: 7-14 days after enrollment
Population: The population for this analysis includes anyone who completed the demonstrated dosing task at T2 (7-14 days post enrollment). The reported results represent the predicted probability of correctly demonstrating dosing, adjusting for health literacy and physician inter-correlation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Safe Medication Dosing (Prescription Understanding) | 0.67 probability |
| EMC2 Strategy | Safe Medication Dosing (Prescription Understanding) | 0.83 probability |
| EMC2 Strategy + SMS Text Reminders | Safe Medication Dosing (Prescription Understanding) | 0.79 probability |
Secondary
Current Opioid Misuse Measure (COMM)
Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.
Time frame: 7-14 days after enrollment
Population: The population for this analysis includes anyone who answered select COMM questions at T2 (7-14 days post enrollment). The reported results represent those who safely took their opioid medications, adjusting for health literacy, income, race and physician inter-correlation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Current Opioid Misuse Measure (COMM) | 0.70 probability |
| EMC2 Strategy | Current Opioid Misuse Measure (COMM) | 0.78 probability |
| EMC2 Strategy + SMS Text Reminders | Current Opioid Misuse Measure (COMM) | 0.71 probability |
Secondary
Medication Knowledge
The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire. Patients will be asked about each of the above via structured, open-ended items. Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included. The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10. A higher score on the scale represents better patient knowledge.
Time frame: 7-14 days after enrollment
Population: The population for this analysis includes anyone who answered the knowledge questions at T2 (7-14 days post enrollment). The reported results represent the mean knowledge score (0-10), adjusting for health literacy, income, race and physician inter-correlation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Medication Knowledge | 5.48 score on a scale |
| EMC2 Strategy | Medication Knowledge | 5.46 score on a scale |
| EMC2 Strategy + SMS Text Reminders | Medication Knowledge | 6.06 score on a scale |
Secondary
Pain Score
Pain scores through structured questions about use in the past 24 hours were collected from participants. Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores.
Time frame: 7-14 days after enrollment
Population: The population for this analysis includes anyone who answered the pain score questions at T2 (7-14 days post enrollment). The reported results represent the mean pain score (0-10), adjusting for health literacy, income, race and physician inter-correlation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Pain Score | 2.76 score on a scale |
| EMC2 Strategy | Pain Score | 2.47 score on a scale |
| EMC2 Strategy + SMS Text Reminders | Pain Score | 2.60 score on a scale |
Secondary
Proper Medication Use (Medication Diary)
Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use.
Time frame: 10 day medication diary
Population: The population for this analysis includes anyone who returned their medication diary with medication information filled out. The reported results represent the predicted probability of correctly using medication (without errors), adjusting for physician inter-correlation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Proper Medication Use (Medication Diary) | 0.52 probability |
| EMC2 Strategy | Proper Medication Use (Medication Diary) | 0.66 probability |
| EMC2 Strategy + SMS Text Reminders | Proper Medication Use (Medication Diary) | 0.65 probability |