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Trial record 1 of 1 for:    NCT03012087
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Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03012087
First Posted: January 6, 2017
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
West Virginia University
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
  Purpose
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 Intervention
Prescription Drug Abuse Behavioral: MyHealthyChoices Other: Health Risk Assessment

Study Type: Interventional
Study Design: 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

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Change in Self-Reported Preference for Opioid Pain Reliever [ Time Frame: Baseline and Immediate Post-test ]
    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 [ Time Frame: 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.

  • Self-Reported Prescription Drug Storage and Disposal Behaviors [ Time Frame: 6 weeks ]
    Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.


Enrollment: 123
Actual Study Start Date: September 2016
Study Completion Date: June 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012087


Locations
United States, Maryland
Johns Hopkins Hospital Emergency Department
Baltimore, Maryland, United States, 21205
United States, West Virginia
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
  More Information

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03012087     History of Changes
Other Study ID Numbers: MyHealthyChoices
First Submitted: December 13, 2016
First Posted: January 6, 2017
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Acetaminophen
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics