Use of a Nurse Pain Educator for Patients With Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044522
• Other study ID #: NEMA-SUPeR-001
• Status: Completed
• Phase: N/A
• First received: February 1, 2017
• Last updated: December 7, 2017
• Start date: November 14, 2016
• Est. completion date: November 21, 2017

Study information

• Verified date: December 2017
• Source: NEMA Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: November 21, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Nurse's Role
• Opioid Use

Intervention

Other:
• Opioid Education

Locations

Country	Name	City	State
United States	Headache and Pain Management Center of SWFL	Fort Myers	Florida
United States	Mid America Physiatrists	Overland Park	Kansas
United States	Gold Coast Research	Plantation	Florida
United States	Piedmont Family Practice	Warrenton	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
NEMA Research, Inc.	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Online Pain Assessment Tool	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	6 Months
Primary	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
Primary	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	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.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months