Trial Outcomes & Findings for EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use (NCT NCT02431793)
NCT ID: NCT02431793
Last Updated: 2019-09-25
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
652 participants
Primary outcome timeframe
7-14 days after enrollment
Results posted on
2019-09-25
Participant Flow
Participant milestones
| Measure |
Usual Care
Employ the standard of care, no intervention
|
EMC2 Strategy
Patients of providers randomized to EMC2 arm will receive educational tool from the Emergency Department (ED) to support the understanding and safe use of opioids.
1. A single-page medication information sheet with content from a patients perspective, following health literacy best practices.
2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both 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 in-system PCP) notifying them of ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription.
|
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) a single-page medication information sheet 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 electronic health record (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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
202
|
243
|
207
|
|
Overall Study
Completed T1 (3-5 Days Post Enrollment)
|
136
|
180
|
143
|
|
Overall Study
Completed T2 (7-14 Days Post Enrollment)
|
95
|
141
|
107
|
|
Overall Study
Completed T3 (30 Days Post Enrollment)
|
85
|
113
|
93
|
|
Overall Study
COMPLETED
|
83
|
109
|
90
|
|
Overall Study
NOT COMPLETED
|
119
|
134
|
117
|
Reasons for withdrawal
| Measure |
Usual Care
Employ the standard of care, no intervention
|
EMC2 Strategy
Patients of providers randomized to EMC2 arm will receive educational tool from the Emergency Department (ED) to support the understanding and safe use of opioids.
1. A single-page medication information sheet with content from a patients perspective, following health literacy best practices.
2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both 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 in-system PCP) notifying them of ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription.
|
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) a single-page medication information sheet 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 electronic health record (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.
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.
|
|---|---|---|---|
|
Overall Study
Ineligible doe to not filling Rx
|
11
|
7
|
8
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
101
|
122
|
104
|
Baseline Characteristics
Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
Baseline characteristics by cohort
| Measure |
Usual Care
n=202 Participants
Employ the standard of care, no intervention
|
EMC2 Strategy
n=243 Participants
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.
|
EMC2 Strategy + SMS Text Reminders
n=207 Participants
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.
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 14.2 • n=202 Participants
|
42.3 years
STANDARD_DEVIATION 14.4 • n=243 Participants
|
41.3 years
STANDARD_DEVIATION 13.3 • n=207 Participants
|
42.2 years
STANDARD_DEVIATION 14.0 • n=652 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=202 Participants
|
135 Participants
n=243 Participants
|
124 Participants
n=207 Participants
|
372 Participants
n=652 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=202 Participants
|
108 Participants
n=243 Participants
|
83 Participants
n=207 Participants
|
280 Participants
n=652 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
95 Participants
n=201 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
110 Participants
n=242 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
100 Participants
n=207 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
305 Participants
n=650 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
|
Race/Ethnicity, Customized
Race · African American
|
66 Participants
n=201 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
71 Participants
n=242 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
63 Participants
n=207 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
200 Participants
n=650 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
|
Race/Ethnicity, Customized
Race · Other
|
40 Participants
n=201 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
61 Participants
n=242 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
44 Participants
n=207 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
145 Participants
n=650 Participants • Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.
|
|
Health Literacy (NVS)
Limited/Marginal Literacy
|
71 Participants
n=202 Participants
|
80 Participants
n=243 Participants
|
68 Participants
n=207 Participants
|
219 Participants
n=652 Participants
|
|
Health Literacy (NVS)
Adequate Literacy
|
131 Participants
n=202 Participants
|
163 Participants
n=243 Participants
|
139 Participants
n=207 Participants
|
433 Participants
n=652 Participants
|
|
Income
< $40,000
|
60 Participants
n=184 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
69 Participants
n=223 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
49 Participants
n=175 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
178 Participants
n=582 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
|
Income
$40,000-$100,000
|
68 Participants
n=184 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
78 Participants
n=223 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
56 Participants
n=175 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
202 Participants
n=582 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
|
Income
>$100,000
|
56 Participants
n=184 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
76 Participants
n=223 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
70 Participants
n=175 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
202 Participants
n=582 Participants • 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.
|
PRIMARY outcome
Timeframe: 7-14 days after enrollmentPopulation: 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.
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).
Outcome measures
| Measure |
Usual Care
n=77 Participants
Employ the standard of care, no intervention
|
EMC2 Strategy
n=107 Participants
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.
|
EMC2 Strategy + SMS Text Reminders
n=86 Participants
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.
|
|---|---|---|---|
|
Safe Medication Dosing (Prescription Understanding)
|
0.67 probability
Interval 0.55 to 0.77
|
0.83 probability
Interval 0.75 to 0.89
|
0.79 probability
Interval 0.69 to 0.87
|
SECONDARY outcome
Timeframe: 7-14 days after enrollmentPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=73 Participants
Employ the standard of care, no intervention
|
EMC2 Strategy
n=113 Participants
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.
|
EMC2 Strategy + SMS Text Reminders
n=125 Participants
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.
|
|---|---|---|---|
|
Medication Knowledge
|
5.48 score on a scale
Interval 5.13 to 5.84
|
5.46 score on a scale
Interval 5.16 to 5.75
|
6.06 score on a scale
Interval 5.71 to 6.41
|
SECONDARY outcome
Timeframe: 10 day medication diaryPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=75 Participants
Employ the standard of care, no intervention
|
EMC2 Strategy
n=98 Participants
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.
|
EMC2 Strategy + SMS Text Reminders
n=85 Participants
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.
|
|---|---|---|---|
|
Proper Medication Use (Medication Diary)
|
0.52 probability
Interval 0.4 to 0.63
|
0.66 probability
Interval 0.56 to 0.75
|
0.65 probability
Interval 0.54 to 0.75
|
SECONDARY outcome
Timeframe: 7-14 days after enrollmentPopulation: 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.
Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.
Outcome measures
| Measure |
Usual Care
n=90 Participants
Employ the standard of care, no intervention
|
EMC2 Strategy
n=131 Participants
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.
|
EMC2 Strategy + SMS Text Reminders
n=90 Participants
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.
|
|---|---|---|---|
|
Current Opioid Misuse Measure (COMM)
|
0.70 probability
Interval 0.58 to 0.79
|
0.78 probability
Interval 0.7 to 0.85
|
0.71 probability
Interval 0.6 to 0.81
|
SECONDARY outcome
Timeframe: 7-14 days after enrollmentPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=88 Participants
Employ the standard of care, no intervention
|
EMC2 Strategy
n=116 Participants
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.
|
EMC2 Strategy + SMS Text Reminders
n=75 Participants
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.
|
|---|---|---|---|
|
Pain Score
|
2.76 score on a scale
Interval 2.21 to 3.31
|
2.47 score on a scale
Interval 2.01 to 2.94
|
2.60 score on a scale
Interval 2.03 to 3.17
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EMC2 Strategy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EMC2 Strategy + SMS Text Reminders
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place