Skip to main content
Clinical Trials/NCT03012087
NCT03012087CompletedNot Applicable

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

Johns Hopkins Bloomberg School of Public Health2 sites in 1 country123 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
123
Locations
2
Primary Endpoint
Change in Self-Reported Preference for Opioid Pain Reliever

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention Group

Experimental

MyHealthyChoices

Intervention: MyHealthyChoices (Behavioral)

Control Group

Placebo Comparator

Health Risk Assessment

Intervention: Health Risk Assessment (Other)

Outcomes

Primary Outcomes

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

  • Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications(Baseline and 6 weeks)
  • Self-Reported Prescription Drug Storage and Disposal Behaviors(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials