Clinical trial NCT03012087: Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
Official title: Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prescription Drug Abuse
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: West Virginia University
First posted: 2017-01-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Self-Reported Preference for Opioid Pain Reliever
timeFrame: Baseline and Immediate Post-test
Secondary outcomes:
measure: Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications
timeFrame: Baseline and 6 weeks
measure: Self-Reported Prescription Drug Storage and Disposal Behaviors
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital Emergency Department
state: Maryland
city: Morgantown
country: United States
facility: West Virginia University Emergency Department
state: West Virginia
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Andrea C Gielen, ScD ScM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omaki E, Castillo R, Eden K, Davis S, McDonald E, Murtaza U, Gielen A; My Healthy Choices Decision Aid Study Team. Using m-health tools to reduce the misuse of opioid pain relievers. Inj Prev. 2019 Aug;25(4):334-339. doi: 10.1136/injuryprev-2017-042319. Epub 2017 Apr 6.