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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03012087
Enrollment
123
Registered
2017-01-06
Start date
2016-09-30
Completion date
2017-06-30
Last updated
2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prescription Drug Abuse

Brief summary

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

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.

Interventions

BEHAVIORALMyHealthyChoices

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.

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.

Sponsors

West Virginia University
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ED visit for an injury- or pain-related chief complaint 2. 18 years of age or older 3. speak English 4. has a smart phone or email address that is used on a regular basis 5. no previous medical care for the current complaint 6. 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-Reported Preference for Opioid Pain RelieverBaseline and Immediate Post-testAssessed via questionnaire on a scale of 0-10.

Secondary

MeasureTime frameDescription
Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain MedicationsBaseline and 6 weeksAssessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.
Self-Reported Prescription Drug Storage and Disposal Behaviors6 weeksAssessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026