An interventional study of Opioid Education in Chronic Pain, Opioid Use and Nurse's Role, sponsored by NEMA Research, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-11.
Sponsored by NEMA Research, Inc. · Not applicable, Interventional, and Supportive care
This multicenter randomized (block randomization) controlled parallel arm pilot study comparing the incorporation vs no incorporation of a Nurse Pain Educator into clinics that treat chronic non cancer pain patients with opioid analgesics. Subjects who are either opioid naïve or opioid experienced will be enrolled into the study.
The Nurse Pain Educator arm shall have two phases: a Pre-Teaching Phase and a Teaching/Knowledge Maintenance Phase. During the Pre-Teaching Phase, all subjects who are enrolled will complete different baseline assessments and will be prescribed an opioid. Subjects will then enter the Teaching/Knowledge Maintenance Phase. Subject enrolled into the Nurse Pain Educator arm will be educated on different opioid pain management topics with a focus on safe and appropriate use and consumption of opioid analgesics. Subjects will meet monthly with the Nurse Educator for up to 5 months for reinforcement of their training and to assess their use of their medication, their quality of life and their physical and mental well-being.
Subjects who are enrolled into the study arm with no Nurse Pain Educator will be monitored every month to assess their use of their medication, their quality of life and their physical and mental well-being. No intervention will be conducted with these subjects beyond that of standard of care at the facility. Subjects will be evaluated monthly but primary differences in outcomes will compare baseline to 6 months.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 183 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →NEMA Research, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who are enrolled into study arm with no Nurse Pain Educator will be monitored every month to assess their use of their medication, quality of life, physical and mental well-being. No intervention will be conducted with these subjects beyond that of standard of care at the facility.
Subject enrolled into the Nurse Pain Educator arm will be educated (Opioid Education) on different opioid pain management topics with a focus on safe and appropriate use and consumption of opioid analgesics.
Other: Opioid Education
Change in Opioid Consumption
Difference between opioid consumption in subjects with and without education by a Nurse Pain Educator as measured by Total Morphine Sulfate Equivalent of Prescription from change in baseline to end of study and at each month.
Time frame: 6 Months
Change Opioid Consumption
Difference between opioid consumption in subjects with and without education by a Nurse Pain Educator as measured by a Qualitative Assessment of Opioid consumption from change in baseline to end of study and at each month.
Time frame: 6 Months
Change in Current Opioid Misuse Measure (COMM)
Assess Safe and Appropriate Use of Opioids by measuring change in Currenet Opioid Misuse Measure from baseline to end of study and at each month.
Time frame: 6 Months
Change in Pain Medicine Questionnaire (PMQ)
Assess Safe and Appropriate Use of Opioids by measuring change in Pain Medicine Questionnaire from baseline to end of study and at each month.
Time frame: 6 Months
Change in SF-36
Assess Quality of Life and Daily Function by measuring the change in the SF-36 Health Outcomes survey from baseline to end of study and at each month.
Time frame: 6 Months
Change in Quality of Life Scale
Assess Quality of Life and Daily Function by measuring the change in the 11 point Quality of Life Scale from baseline to end of study and at each month.
Time frame: 6 Months
Online Pain Assessment Tool
Assess ease of use and outcomes of the Online Pain Assessment Tool from change in baseline to end of study in the Online Pain Assessment Tool scores
Time frame: 6 Months
Plan to share: No — The data will be presented in a manuscript/publication in a peer-reviewed journal.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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NEMA Research, Inc.