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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.

  Show Detailed Description

  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 November 24, 2014