Chronic Pain, Nurse's Role, Opioid Use
Conditions
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.
Interventions
OTHEROpioid Education
Sponsors
Food and Drug Administration (FDA)
NEMA Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Opioid Consumption | 6 Months | 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. |
| Change in Opioid Consumption | 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Medicine Questionnaire (PMQ) | 6 Months | Assess Safe and Appropriate Use of Opioids by measuring change in Pain Medicine Questionnaire from baseline to end of study and at each month. |
| Change in Quality of Life Scale | 6 Months | 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. |
| Change in SF-36 | 6 Months | 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. |
| Change in Current Opioid Misuse Measure (COMM) | 6 Months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Online Pain Assessment Tool | 6 Months | 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 |
Countries
United States
Outcome results
None listed