Use of a Nurse Pain Educator for Patients With Chronic Pain

NCT03044522 | Completed

• 1 other identifier: NEMA-SUPeR-001
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Pain; Opioid Use; Nurse's Role

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Current Opioid Misuse Measure (COMM)

  6 Months

• Change in Pain Medicine Questionnaire (PMQ)

  6 Months

• Change in SF-36

  6 Months

• Change in Quality of Life Scale

  6 Months

Other Outcomes (1)

• Online Pain Assessment Tool

  6 Months

Study Arms (2)

No Nurse Education

NO INTERVENTION

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

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

Interventions

Opioid Education OTHER

Nurse Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NEMA Research, Inc.: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (4)

Headache and Pain Management Center of SWFL

Fort Myers, Florida, 33912, United States

Location

Gold Coast Research

Plantation, Florida, 33317, United States

Location

Mid America Physiatrists

Overland Park, Kansas, 66210, United States

Location

Piedmont Family Practice

Warrenton, Virginia, 20186, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Pergolizzi, MD

  NEMA Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 7, 2017
• Study Start: November 14, 2016
• Primary Completion: September 21, 2017
• Study Completion: November 21, 2017
• Last Updated: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)