Use of a Nurse Pain Educator for Patients With Chronic Pain

N

NEMA Research

Status

Completed

Conditions

Chronic Pain
Opioid Use
Nurse's Role

Treatments

Other: Opioid Education

Study type

Interventional

Funder types

Industry
Other U.S. Federal agency

Identifiers

NCT03044522
NEMA-SUPeR-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

183 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

183 participants in 2 patient groups

No Nurse Education
No Intervention group
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.
Nurse Education
Other group
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.
Treatment:
Other: Opioid Education

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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