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| Name | Class |
|---|---|
| West Virginia University | OTHER |
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The aim of this study is to pilot test a web-based, patient-centered educational program that encourages the patient to have an informed discussion about pain medication options with their emergency department (ED) provider.
This multi-site, randomized trial will evaluate an m-health program designed to aid the patient in making an informed decision about their pain treatment. Patients reporting to the ED with an injury-related chief complaint who agree to participate are randomized to receive the intervention program, My Healthy Choices, or an attention-matched control. My Healthy Choices pairs tailored education with a patient decision aid to describe what opioid and non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse effects, and produce a tailored report that patients are encouraged to share with their doctor. Data are collected through surveys at three time points during the ED encounter (baseline, immediately after the intervention, and just before discharge), and at a 6-week follow-up survey. The primary outcomes are whether the patient prefers an opioid pain reliever (OPR) and whether the patient takes an OPR. The investigators hope this program will facilitate patient-provider communication, as well as reduce the number of prescriptions written for OPRs and thus the number of patients exposed to prescription opioids and the associated risks of addiction and overdose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | MyHealthyChoices |
|
| Control Group | Placebo Comparator | Health Risk Assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyHealthyChoices | Behavioral | My Healthy Choices explains what opioid pain medications are, assesses and explains the patient's risk factors related to taking opioids, assesses patient preferences about pain medications, and produces a tailored patient report based on the answers. The patient is encouraged to show the report to the treating ED clinician so they can discuss medication options for treating the patient's pain. Following discharge from the ED, intervention group participants discharged with a prescription pain reliever receive messages about safe medication use, storage, and disposal and access to an educational web portal that contains more information on prescription pain medications and safety. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Reported Preference for Opioid Pain Reliever | Assessed via questionnaire on a scale of 0-10. | Baseline and Immediate Post-test |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications | Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea C Gielen, ScD ScM | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital Emergency Department | Baltimore | Maryland | 21205 | United States | ||
| West Virginia University Emergency Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28385954 | Derived | Omaki E, Castillo R, Eden K, Davis S, McDonald E, Murtaza U, Gielen A; My Healthy Choices Decision Aid Study Team. Using m-health tools to reduce the misuse of opioid pain relievers. Inj Prev. 2019 Aug;25(4):334-339. doi: 10.1136/injuryprev-2017-042319. Epub 2017 Apr 6. |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018570 | Risk Assessment |
| ID | Term |
|---|---|
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
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|
| Health Risk Assessment | Other | The WellSource health risk assessment content focuses on general health promotion, and the participant's overall health and wellness. A summary report based on the participants' answers is sent to their email address. |
|
| Self-Reported Prescription Drug Storage and Disposal Behaviors |
Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups. |
| 6 weeks |
| Morgantown |
| West Virginia |
| 26506 |
| United States |
| D008919 |
| Investigative Techniques |
| D012308 | Risk Management |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |