Opioid Use, Unspecified Clinical Trial
— EMC2Official title:
EHR‐Based Medication Complete Communication Strategy to Promote Safe Opioid Use
Verified date | September 2019 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 652 |
Est. completion date | September 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | 7-14 days after enrollment | |
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. | 7-14 days after enrollment | |
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. | 10 day medication diary | |
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. | 7-14 days after enrollment | |
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. | 7-14 days after enrollment |
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