EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

Employ the standard of care, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

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 automatically on the prescription.

Group Type EXPERIMENTAL

EMC2 Strategy

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

EMC2 Strategy

Intervention Type BEHAVIORAL

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.

SMS Text Reminders

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No