Use of a Nurse Pain Educator for Patients With Chronic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter Study Comparing the Patient Outcomes Associated With Use of a Nurse Pain Educator for Patients With Chronic Pain

Conditions
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Chronic Pain, Opioid Use, Nurse's Role

Intervention / Treatment
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* Other: Opioid Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to read, understand, and provide written informed consent Male or Female patients ≥ 18 years of age Diagnosed with non-cancer pain for >3 months Ability to meet study requirements (i.e., can attend monthly visits, able to complete questionnaires, etc.) Prescribed an oral opioid that will last duration of the study period Provide a completed Opioid Patient Prescriber Agreement Exclusion Criteria: Diagnosed with chronic cancer pain Personal or family history of alcohol or drug abuse in the past 5 years Personal or family history of major mental illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Nurse Education<br>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. | |
| Other: Nurse Education<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 6 Months |