Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers

Conditions
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Prescription Drug Abuse

Intervention / Treatment
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* Behavioral: MyHealthyChoices
* Other: Health Risk Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ED visit for an injury- or pain-related chief complaint 18 years of age or older speak English has a smart phone or email address that is used on a regular basis no previous medical care for the current complaint triage pain score between 7-10 Exclusion Criteria: allergy to pain medications have used a prescription pain medication for more than two days in the past month report renal problems or a history of dialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>MyHealthyChoices | Behavioral: MyHealthyChoices<br>* 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.<br>|
| Placebo Comparator: Control Group<br>Health Risk Assessment | Other: Health Risk Assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |