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Use of a Nurse Pain Educator for Patients With Chronic Pain

NCT ID: NCT03044522

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2017-11-21

Brief Summary

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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

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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.

Conditions

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Chronic Pain Opioid Use Nurse's Role

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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No Nurse Education

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Nurse Education

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.

Group Type OTHER

Opioid Education

Intervention Type OTHER

Interventions

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Opioid Education

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

NEMA Research, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Pergolizzi, MD

Role: PRINCIPAL_INVESTIGATOR

NEMA Research, Inc.

Locations

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Headache and Pain Management Center of SWFL

Fort Myers, Florida, United States

Site Status

Gold Coast Research

Plantation, Florida, United States

Site Status

Mid America Physiatrists

Overland Park, Kansas, United States

Site Status

Piedmont Family Practice

Warrenton, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NEMA-SUPeR-001

Identifier Type: -

Identifier Source: org_study_id