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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inflexxion, Inc.
ClinicalTrials.gov Identifier:
NCT01770314
First received: January 11, 2013
Last updated: April 21, 2014
Last verified: April 2014
  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

Further study details as provided by Inflexxion, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Satisfaction With the Program [ Time Frame: One-month followup assessment ] [ Designated as safety issue: No ]
    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.


Enrollment: 176
Study Start Date: September 2012
Study Completion Date: September 2013
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770314

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

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
Results First Received: September 30, 2013
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Inflexxion, Inc.:
Opioid Pain Medication
Medication Safety
Correct storage
Correct disposal
Correct Use

ClinicalTrials.gov processed this record on September 16, 2014