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OpenTrials
Completed

NCT Number: NCT03012087

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

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.

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Key information

Conditions

Prescription Drug Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital Emergency Department, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Self-Reported Preference for Opioid Pain Reliever

    Time frame: Baseline and Immediate Post-test

    Assessed via questionnaire on a scale of 0-10.

Secondary outcomes

  1. Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications

    Time frame: Baseline and 6 weeks

    Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.

  2. Self-Reported Prescription Drug Storage and Disposal Behaviors

    Time frame: 6 weeks

    Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • West Virginia University

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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