Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Medication Adherence |
Behavioral: Experimental |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Medication Safety Pilot Study |
- Self-efficacy [ Time Frame: 2 months ] [ Designated as safety issue: No ]Self-efficacy for Managing Opioid Medications - This seven-item measure taps into key concepts associated with confidence for managing opioid medications. An example of an item is "I can keep my opioid medicine in a place where other people can't get to it." Responses are measured on a 4-point Likert scale (1= "Strongly Disagree" and 4= "Strongly Agree"). (Primary outcome)
| Estimated Enrollment: | 148 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: 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.
Other Name: painACTION website
|
|
No Intervention: Control
The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previously visited painACTION
Contacts and Locations| Contact: Kim McHugh, BA | 617-614-0373 | kmchugh@inflexxion.com |
| United States, Massachusetts | |
| Inflexxion Inc | Recruiting |
| Newton, Massachusetts, United States, 02464 | |
| Contact: Kim L McHugh, BA 617-614-0373 kmchugh@inflexxion.com | |
| Principal Investigator: Elizabeth Donovan, Ph. D. | |
| Principal Investigator: | Elizabeth Donovan, Ph. D. | Inflexxion, Inc. |
More Information
No publications provided
| Responsible Party: | Inflexxion, Inc. |
| ClinicalTrials.gov Identifier: | NCT01770314 History of Changes |
| Other Study ID Numbers: | MedSafetyStudy, Endo Pharmaceuticals |
| Study First Received: | January 11, 2013 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Inflexxion, Inc.:
|
Opioid Pain Medication Medication Safety Correct storage Correct disposal Correct Use |
Additional relevant MeSH terms:
|
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 18, 2013