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

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Completed
CT.gov ID
NCT03012087
Collaborator
West Virginia University (Other)
123
Enrollment
2
Locations
2
Arms
9
Actual Duration (Months)
61.5
Patients Per Site
6.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MyHealthyChoices
  • Other: Health Risk Assessment
 N/A

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
Actual Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

MyHealthyChoices

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.
Placebo Comparator: Control Group

Health Risk Assessment

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Self-Reported Preference for Opioid Pain Reliever [Baseline and Immediate Post-test]

    Assessed via questionnaire on a scale of 0-10.

Secondary Outcome Measures

  1. Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications [Baseline and 6 weeks]

    Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.

  2. Self-Reported Prescription Drug Storage and Disposal Behaviors [6 weeks]

    Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Hospital Emergency Department Baltimore Maryland United States 21205
2 West Virginia University Emergency Department Morgantown West Virginia United States 26506

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • West Virginia University

Investigators

  • Principal Investigator: Andrea C Gielen, ScD ScM, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT03012087
Other Study ID Numbers:
  • MyHealthyChoices
First Posted:
Jan 6, 2017
Last Update Posted:
Aug 22, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Substance-Related Disorders

Study Results

No Results Posted as of Aug 22, 2017