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Use of a Nurse Pain Educator for Patients With Chronic Pain

Primary Purpose

Chronic Pain, Opioid Use, Nurse's Role

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid Education
Sponsored by
NEMA Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Headache and Pain Management Center of SWFL
  • Gold Coast Research
  • Mid America Physiatrists
  • Piedmont Family Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

No Nurse Education

Nurse Education

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 1, 2017
Last Updated
December 7, 2017
Sponsor
NEMA Research, Inc.
Collaborators
Food and Drug Administration (FDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03044522
Brief Title
Use of a Nurse Pain Educator for Patients With Chronic Pain
Official Title
A Multicenter Study Comparing the Patient Outcomes Associated With Use of a Nurse Pain Educator for Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
November 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NEMA Research, Inc.
Collaborators
Food and Drug Administration (FDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Use, Nurse's Role

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Nurse Education
Arm Type
No Intervention
Arm Description
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.
Arm Title
Nurse Education
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Opioid Education
Primary Outcome Measure Information:
Title
Change in Opioid Consumption
Description
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
Title
Change Opioid Consumption
Description
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
Secondary Outcome Measure Information:
Title
Change in Current Opioid Misuse Measure (COMM)
Description
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
Title
Change in Pain Medicine Questionnaire (PMQ)
Description
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
Title
Change in SF-36
Description
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
Title
Change in Quality of Life Scale
Description
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
Other Pre-specified Outcome Measures:
Title
Online Pain Assessment Tool
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Pergolizzi, MD
Organizational Affiliation
NEMA Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Headache and Pain Management Center of SWFL
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Gold Coast Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Mid America Physiatrists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Piedmont Family Practice
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be presented in a manuscript/publication in a peer-reviewed journal.

Learn more about this trial

Use of a Nurse Pain Educator for Patients With Chronic Pain

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