Clinical trial NCT03044522: Use of a Nurse Pain Educator for Patients With Chronic Pain
Official title: A Multicenter Study Comparing the Patient Outcomes Associated With Use of a Nurse Pain Educator for Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Use
Nurse's Role
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2017-02-07
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Opioid Consumption
timeFrame: 6 Months
measure: Change Opioid Consumption
timeFrame: 6 Months
Secondary outcomes:
measure: Change in Current Opioid Misuse Measure (COMM)
timeFrame: 6 Months
measure: Change in Pain Medicine Questionnaire (PMQ)
timeFrame: 6 Months
measure: Change in SF-36
timeFrame: 6 Months
measure: Change in Quality of Life Scale
timeFrame: 6 Months
Other outcomes:
measure: Online Pain Assessment Tool
timeFrame: 6 Months
Locations:
city: Fort Myers
country: United States
facility: Headache and Pain Management Center of SWFL
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research
state: Florida
city: Overland Park
country: United States
facility: Mid America Physiatrists
state: Kansas
city: Warrenton
country: United States
facility: Piedmont Family Practice
state: Virginia
Study officials:
affiliation: NEMA Research, Inc.
name: Joseph Pergolizzi, MD
role: PRINCIPAL_INVESTIGATOR
References: