Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of a Nurse Pain Educator for Patients With Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044522
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid Use Nurse's Role Other: Opioid Education Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Multicenter Study Comparing the Patient Outcomes Associated With Use of a Nurse Pain Educator for Patients With Chronic Pain
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : September 21, 2017
Actual Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.
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



Primary Outcome Measures :
  1. Change in Opioid Consumption [ Time Frame: 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.

  2. Change Opioid Consumption [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Current Opioid Misuse Measure (COMM) [ Time Frame: 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.

  2. Change in Pain Medicine Questionnaire (PMQ) [ Time Frame: 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.

  3. Change in SF-36 [ Time Frame: 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.

  4. Change in Quality of Life Scale [ Time Frame: 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.


Other Outcome Measures:
  1. Online Pain Assessment Tool [ Time Frame: 6 Months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044522


Locations
Layout table for location information
United States, Florida
Headache and Pain Management Center of SWFL
Fort Myers, Florida, United States, 33912
Gold Coast Research
Plantation, Florida, United States, 33317
United States, Kansas
Mid America Physiatrists
Overland Park, Kansas, United States, 66210
United States, Virginia
Piedmont Family Practice
Warrenton, Virginia, United States, 20186
Sponsors and Collaborators
NEMA Research, Inc.
Food and Drug Administration (FDA)
Investigators
Layout table for investigator information
Principal Investigator: Joseph Pergolizzi, MD NEMA Research, Inc.

Layout table for additonal information
Responsible Party: NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT03044522    
Other Study ID Numbers: NEMA-SUPeR-001
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be presented in a manuscript/publication in a peer-reviewed journal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents