Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
Primary Purpose
Prescription Drug Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyHealthyChoices
Health Risk Assessment
Sponsored by
About this trial
This is an interventional prevention trial for Prescription Drug Abuse
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital Emergency Department
- West Virginia University Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
MyHealthyChoices
Health Risk Assessment
Outcomes
Primary Outcome Measures
Change in Self-Reported Preference for Opioid Pain Reliever
Assessed via questionnaire on a scale of 0-10.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03012087
First Posted
December 13, 2016
Last Updated
August 21, 2017
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT03012087
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
West Virginia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Drug Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
MyHealthyChoices
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Health Risk Assessment
Intervention Type
Behavioral
Intervention Name(s)
MyHealthyChoices
Intervention Description
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 Type
Other
Intervention Name(s)
Health Risk Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Self-Reported Preference for Opioid Pain Reliever
Description
Assessed via questionnaire on a scale of 0-10.
Time Frame
Baseline and Immediate Post-test
Secondary Outcome Measure Information:
Title
Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications
Description
Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.
Time Frame
Baseline and 6 weeks
Title
Self-Reported Prescription Drug Storage and Disposal Behaviors
Description
Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea C Gielen, ScD ScM
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital Emergency Department
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
West Virginia University Emergency Department
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28385954
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.
Results Reference
derived
Learn more about this trial
Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
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