Use of a Nurse Pain Educator for Patients With Chronic Pain

Not Applicable

Completed

• Conditions: Opioid Use; Chronic Pain; Nurse's Role
• Interventions: Other: Opioid Education

• Registration Number: NCT03044522
• Lead Sponsor: NEMA Research, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-11-14
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-07
• Primary Completion: 2017-09-21
• Study Completion: 2017-11-21
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse Education	Opioid Education	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.

Primary Outcome Measures

Name	Time	Method
Change Opioid Consumption	6 Months	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.
Change in Opioid Consumption	6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life Scale	6 Months	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.
Change in Current Opioid Misuse Measure (COMM)	6 Months	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.
Change in Pain Medicine Questionnaire (PMQ)	6 Months	Assess Safe and Appropriate Use of Opioids by measuring change in Pain Medicine Questionnaire from baseline to end of study and at each month.
Change in SF-36	6 Months	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.

Trial Locations

Locations (4)

Piedmont Family Practice; 🇺🇸 Warrenton, Virginia, United States

Headache and Pain Management Center of SWFL; 🇺🇸 Fort Myers, Florida, United States

Gold Coast Research; 🇺🇸 Plantation, Florida, United States

Mid America Physiatrists; 🇺🇸 Overland Park, Kansas, United States