Medication AdherencePhase 2NCT01770314
Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.
A Phase 2 study testing Experimental in people with Medication Adherence, run by Inflexxion, Inc. at 1 site in United States.
Trial summary
The purpose of this project is to test whether an online pain medication intervention is a feasible and effective way to increase opioid pain medication safety. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be willing and able to provide consent
- Have the ability to read and write English
- Diagnosis of non-cancer chronic pain
- Prescribed opioids and taking consistently for 3 months.
- Over 18 years old
Who cannot join
- Previously visited painACTION
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Safety Pilot Study
The purpose of this project is to test whether an online pain medication intervention is a feasible and effective way to increase opioid pain medication safety.
Read the detailed description
The goal of the study is to test the efficacy of the pain medication safety intervention for increasing safe management of prescription medication opioids. The study will use a randomized, controlled design that compares the intervention (painACTION medication safety lessons) to a waitlist control condition.
The hypotheses related to efficacy are that, as compared to the control group, people in the experimental group will demonstrate:
- Increased self-efficacy for how to safely manage medications (primary outcome)
- Increased behaviors associated with safely managing medication (secondary outcome)
Participants:
Investigators will recruit the first 148 respondents who meet the inclusion criteria and consent to be in the study.
Experimental Group. Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
Control Group. The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
Randomization: Participants will be randomized by gender and age.
Procedure: Participants will be recruited with the help of the participating clinic. Staff members will let people know about the study by giving out informational fliers. The flier will direct people who are interested in participating in the study to an online screener. Those who screen in will automatically be lead to a consent form. Participants randomized to use painACTION will be sent the link to the online program and provided with a code that will serve as a Personal Identification Number (PIN) to access the program and return for subsequent sessions. The codes will also allow research staff to track program activity. The numbers are generated as participants agree to participate in the study and will begin with 0001 and continue to 0140 as the investigators add participants. The Research Coordinator will only provide assistance with the technical aspects of navigating the program. All assessments will be administered online. The battery will take no more than thirty minutes to complete. Several studies have determined that online assessments have many advantages over other modes of data collection (Webb et al., 1999; Yun, 2000). Online administration allows: (1) automation of the data collection process; (2) standardization of administration; (3) the use of personalized e-mail invitations at the precise assessment time points; (4) opportunities for participants to complete questionnaires on their own time and in the setting most comfortable to them; and (5) greater protection of confidentiality and conservation of resources because no written record exists. In addition, a number of studies have demonstrated that participants prefer computer-assisted self-interviews to traditional methods of data collection, and are more honest with computers (Johnston \& Walton, 1995, Paperny et al., 2000). The increase in precision translates to greater power to detect real effect differences and higher confidence in the validity of the data. Information will not be saved if the browser is closed and the questionnaire has not been completed and submitted.
Assessments: Data will be collected from participants at baseline, immediately after the intervention, and one month post intervention.
- Conditions
- Medication Adherence
- Being tested
- Experimental
- Keywords
- Opioid Pain Medication, Medication Safety, Correct storage, Correct disposal, Correct Use
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
Also called painACTION website
Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed. Receives: Behavioral: Experimental |
| Control | No intervention | The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications
Responses are measured on a 4-point Likert scale (1= "Not at all confident" and 4= "Extremely confident"). The total Score range:8=least confident, 32=most confident.
How confident do you feel in your ability to do each of the following activities, today?
- I can recognize side effects that are related to my opioid medicine.
- I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant.
Internal consistency of the items in the pilot measure will be assessed (Cronbach's alpha).
Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest.
Measured: Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention
Secondary outcomes (1)
Satisfaction With the Program
We tested and analyzed participants' satisfaction with the program by asking the question: "Overall, how satisfied were you with the lessons." They answered on a 4 point Likert scale: 1=Not at all satisfied, 2=Somewhat Satisfied, 3=Satisfied, 4 = Very satisfied. Higher values indicate higher satisfaction.
Measured: One-month followup assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication AdherenceStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflexxion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Donovan, Ph. D., Principal investigator, Inflexxion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770314
- Sponsor's protocol ID
- MedSafetyStudy
- Other IDs
- Endo Pharmaceuticals
- Status last verified
- Apr 2014
- First submitted
- 11 Jan 2013
- Last updated
- 19 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Safety Pilot Study
- ClinicalTrials.gov ID
- NCT01770314
- Acronym / sponsor ID
- MedSafetyStudy
- Conditions
- Medication Adherence
- Keywords
- Opioid Pain Medication, Medication Safety, Correct storage, Correct disposal, Correct Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Inflexxion, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Posted 19 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to test whether an online pain medication intervention is a feasible and effective way to increase opioid pain medication safety.
Detailed description
The goal of the study is to test the efficacy of the pain medication safety intervention for increasing safe management of prescription medication opioids. The study will use a randomized, controlled design that compares the intervention (painACTION medication safety lessons) to a waitlist control condition.
The hypotheses related to efficacy are that, as compared to the control group, people in the experimental group will demonstrate:
- Increased self-efficacy for how to safely manage medications (primary outcome)
- Increased behaviors associated with safely managing medication (secondary outcome)
Participants:
Investigators will recruit the first 148 respondents who meet the inclusion criteria and consent to be in the study.
Experimental Group. Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
Control Group. The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
Randomization: Participants will be randomized by gender and age.
Procedure: Participants will be recruited with the help of the participating clinic. Staff members will let people know about the study by giving out informational fliers. The flier will direct people who are interested in participating in the study to an online screener. Those who screen in will automatically be lead to a consent form. Participants randomized to use painACTION will be sent the link to the online program and provided with a code that will serve as a Personal Identification Number (PIN) to access the program and return for subsequent sessions. The codes will also allow research staff to track program activity. The numbers are generated as participants agree to participate in the study and will begin with 0001 and continue to 0140 as the investigators add participants. The Research Coordinator will only provide assistance with the technical aspects of navigating the program. All assessments will be administered online. The battery will take no more than thirty minutes to complete. Several studies have determined that online assessments have many advantages over other modes of data collection (Webb et al., 1999; Yun, 2000). Online administration allows: (1) automation of the data collection process; (2) standardization of administration; (3) the use of personalized e-mail invitations at the precise assessment time points; (4) opportunities for participants to complete questionnaires on their own time and in the setting most comfortable to them; and (5) greater protection of confidentiality and conservation of resources because no written record exists. In addition, a number of studies have demonstrated that participants prefer computer-assisted self-interviews to traditional methods of data collection, and are more honest with computers (Johnston \& Walton, 1995, Paperny et al., 2000). The increase in precision translates to greater power to detect real effect differences and higher confidence in the validity of the data. Information will not be saved if the browser is closed and the questionnaire has not been completed and submitted.
Assessments: Data will be collected from participants at baseline, immediately after the intervention, and one month post intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: ExperimentalParticipants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed. |
| Control | No intervention | –The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be willing and able to provide consent
- Have the ability to read and write English
- Diagnosis of non-cancer chronic pain
- Prescribed opioids and taking consistently for 3 months.
- Over 18 years old
Key exclusion criteria (1 listed)
- Previously visited painACTION
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 |
|---|---|---|
| ExperimentalAlso: painACTION websiteParticipants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed. | Behavioural | Experimental |
Primary outcome
Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications
Time frame: Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention
Responses are measured on a 4-point Likert scale (1= "Not at all confident" and 4= "Extremely confident"). The total Score range:8=least confident, 32=most confident. How confident do you feel in your ability to do each of the following activities, today? 1. I can recognize side effects that are related to my opioid medicine. 2. I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant. Internal consistency of the items in the pilot measure will be assessed (Cronbach's alpha). Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest.
1 secondary outcome
Satisfaction With the Program
Time frame: One-month followup assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth Donovan, Ph. D. principal investigator
Inflexxion, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental in people with Medication Adherence, run by Inflexxion, Inc. at 1 site 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 5 inclusion and 1 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications (time frame: Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2014.