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

Prescription Drug Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012087
• Other study ID #: MyHealthyChoices
• Status: Completed
• Phase: N/A
• First received: December 13, 2016
• Last updated: August 21, 2017
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prescription Drug Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• MyHealthyChoices
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.

Other:
• Health Risk Assessment
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital Emergency Department	Baltimore	Maryland
United States	West Virginia University Emergency Department	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-Reported Preference for Opioid Pain Reliever	Assessed via questionnaire on a scale of 0-10.	Baseline and Immediate Post-test
Secondary	Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications	Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.	Baseline and 6 weeks
Secondary	Self-Reported Prescription Drug Storage and Disposal Behaviors	Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.	6 weeks