Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.

• ClinicalTrials.gov Identifier: NCT01770314
• Recruitment Status: Completed
• First Posted: January 17, 2013
• Results First Posted: May 19, 2014
• Last Update Posted: May 19, 2014
• Sponsor: Inflexxion, Inc.
• Information provided by (Responsible Party): Inflexxion, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Medication Adherence	Behavioral: Experimental	Phase 2

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:

1. Increased self-efficacy for how to safely manage medications (primary outcome)
2. 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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Medication Safety Pilot Study
• Study Start Date: September 2012
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Satisfaction With the Program [ Time Frame: One-month followup assessment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Locations

United States, Massachusetts

Inflexxion Inc

Newton, Massachusetts, United States, 02464

Sponsors and Collaborators

Inflexxion, Inc.

Investigators

• Principal Investigator: Elizabeth Donovan, Ph. D.; Inflexxion, Inc.

More Information

• Responsible Party: Inflexxion, Inc.
• ClinicalTrials.gov Identifier: NCT01770314
• Other Study ID Numbers: MedSafetyStudy; Endo Pharmaceuticals ( Other Identifier: Endo Pharmaceuticals )
• First Posted: January 17, 2013
• Results First Posted: May 19, 2014
• Last Update Posted: May 19, 2014
• Last Verified: April 2014

Keywords provided by Inflexxion, Inc.:

Opioid Pain Medication; Medication Safety; Correct storage; Correct disposal; Correct Use