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Completed

NCT Number: NCT03044522

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid Education

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NEMA Research, Inc.

Industry

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2017
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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