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

NCT03012087 | Completed

• 1 other identifier: MyHealthyChoices
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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.

Conditions

Prescription Drug Abuse

Outcome Measures

Primary Outcomes (1)

• Change in Self-Reported Preference for Opioid Pain Reliever

  Assessed via questionnaire on a scale of 0-10.

  Baseline and Immediate Post-test

Secondary Outcomes (2)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

MyHealthyChoices

Behavioral: MyHealthyChoices

Control Group

PLACEBO COMPARATOR

Health Risk Assessment

Other: Health Risk Assessment

Interventions

MyHealthyChoices BEHAVIORAL

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.

Intervention Group

Health Risk Assessment OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ED visit for an injury- or pain-related chief complaint
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• West Virginia University: collaborator

Study Sites (2)

Johns Hopkins Hospital Emergency Department

Baltimore, Maryland, 21205, United States

Location

West Virginia University Emergency Department

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 28385954 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Andrea C Gielen, ScD ScM

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 6, 2017
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)