Use of a Nurse Pain Educator for Patients With Chronic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Use; Nurse's Role
• Intervention / Treatment: Other: Opioid Education

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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Headache and Pain Management Center of SWFL
    • Plantation, Florida, United States, 33317
      • Gold Coast Research
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Mid America Physiatrists
  • Virginia
    • Warrenton, Virginia, United States, 20186
      • Piedmont Family Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Nurse Education; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 Months

Collaborators and Investigators

• Sponsor: NEMA Research, Inc.
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Joseph Pergolizzi, MD, NEMA Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2016
• Primary Completion (Actual): September 21, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: NEMA-SUPeR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be presented in a manuscript/publication in a peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No