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

Not Applicable

Completed

• Conditions: Prescription Drug Abuse
• Interventions: Behavioral: MyHealthyChoices; Other: Health Risk Assessment

• Registration Number: NCT03012087
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	MyHealthyChoices	MyHealthyChoices
Control Group	Health Risk Assessment	Health Risk Assessment

Primary Outcome Measures

Name	Time	Method
Change in Self-Reported Preference for Opioid Pain Reliever	Baseline and Immediate Post-test	Assessed via questionnaire on a scale of 0-10.

Secondary Outcome Measures

Name	Time	Method
Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications	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.
Self-Reported Prescription Drug Storage and Disposal Behaviors	6 weeks	Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.

Trial Locations

Locations (2)

Johns Hopkins Hospital Emergency Department; 🇺🇸 Baltimore, Maryland, United States

West Virginia University Emergency Department; 🇺🇸 Morgantown, West Virginia, United States