Prescription Drug AbuseNCT03012087
Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
A study testing MyHealthyChoices and Health Risk Assessment in people with Prescription Drug Abuse, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prescription Drug Abuse
- What is being tested?
- MyHealthyChoices and Health Risk Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital Emergency Department
Baltimore, Maryland, 21205
West Virginia University Emergency Department
Morgantown, West Virginia, 26506
About this study
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.
Read the 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.
- Conditions
- Prescription Drug Abuse
- Being tested
- MyHealthyChoices, Health Risk Assessment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHealthyChoicesBehavioural
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.
Health Risk AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | MyHealthyChoices Receives: Behavioral: MyHealthyChoices |
| Control Group | Placebo comparator | Health Risk Assessment Receives: Other: Health Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Reported Preference for Opioid Pain Reliever
Assessed via questionnaire on a scale of 0-10.
Measured: 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
Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prescription Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University
- Responsible party
- Sponsor
- Investigators
- Andrea C Gielen, ScD ScM, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012087
- Sponsor's protocol ID
- MyHealthyChoices
- Status last verified
- Aug 2017
- First submitted
- 13 Dec 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28385954
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
- ClinicalTrials.gov ID
- NCT03012087
- Acronym / sponsor ID
- MyHealthyChoices
- Conditions
- Prescription Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- West Virginia University
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: MyHealthyChoicesMyHealthyChoices |
| Control Group | Placebo comparator | Other: Health Risk AssessmentHealth Risk Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyHealthyChoicesMy 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. | Behavioural | Intervention Group |
| Health Risk AssessmentThe 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. | Other | Control Group |
Primary outcome
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.
2 secondary outcomes
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
Self-Reported Prescription Drug Storage and Disposal Behaviors
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 28385954Omaki 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.
- Individual participant dataSharing planned: No
Related trials for Prescription Drug Abuse
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Substance Use, Substance-Related Disorders
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Evaluation of Clinical Decision Support in Opioid Tapering
Medication Abuse, Harm Reduction
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Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Opioid-Related Disorders, Hepatitis C (HCV)
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Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool
Opioid Abuse, Prescription Opioid Abuse
Active, not recruitingObservational study
Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder
Drug Use Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea C Gielen, ScD ScM principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyHealthyChoices and Health Risk Assessment in people with Prescription Drug Abuse, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Reported Preference for Opioid Pain Reliever (time frame: Baseline and Immediate Post-test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03012087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.