Negating Opioid and Pain Actively Through Intervention (NOPAIN)
Primary Purpose
Pain, Chronic Pain, Opioid Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain education with follow up encounters
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Pain, Opioid, Drug monitoring, Pain education
Eligibility Criteria
Inclusion Criteria:
- at least 18 years of age
- history of opioid use for 3 or more months or
- currently prescribed and are using long-acting or extended release opioids
Exclusion Criteria:
- substance use
- oncology patients
- hematology patients
Sites / Locations
- Loma Linda University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chronic pain or long-acting opioid use
Arm Description
Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician.
Outcomes
Primary Outcome Measures
Decrease in opioid prescription strength
Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents
Secondary Outcome Measures
Reduction in pain as evidenced by decrease in opioid daily dose
Subject will keep a daily opioid calendar to track their opioid daily dose
Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale
Survey will be administered by investigators and completed by the patients before and after the interventions
Full Information
NCT ID
NCT03306147
First Posted
October 4, 2017
Last Updated
February 8, 2019
Sponsor
Loma Linda University
Collaborators
Cardinal Health
1. Study Identification
Unique Protocol Identification Number
NCT03306147
Brief Title
Negating Opioid and Pain Actively Through Intervention
Acronym
NOPAIN
Official Title
Negating Opioid and Pain Actively Through Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
May 17, 2018 (Actual)
Study Completion Date
May 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
Collaborators
Cardinal Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic pain is one of the most prevalent and debilitating medical conditions and opioid analgesics are a commonly prescribed class of medications in the United States. Opioid efficacy has been proven in terms of managing acute and chronic pain; however, opioid overdose deaths, addictions, and diversions have all continued to increase over the years. The purpose of this study is to increase patient engagement in pain management and education, and to decrease opioid use by 10% over the study period. This study will also help present opportunities for future studies to obtain insight regarding the chronic use of opioids.
Detailed Description
The institutional review board has approved this prospective single-center study at a large 900-bed academic university medical center. The electronic medical record system will identify 300 patients, who are at least 18 years of age, with a history of opioid use for 3 or more months, or who are currently prescribed and are using long-acting or extended release opioids. Procedures by student pharmacists, pharmacy residents, and pharmacists will include reviewing medical records and prescription drug monitoring programs for the use of opioids, evaluating baseline pain, quality of life, and satisfaction via questionnaires and assessment questions, and performing thorough medication consultations on current opioid regimens. Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician. Opioid usage, pain, quality of life, and patient satisfaction will be assessed. The primary outcome measured will be a decrease in opioid usage in morphine milligram equivalents. Secondary outcomes include change in quality of life and patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Opioid Use
Keywords
Pain, Opioid, Drug monitoring, Pain education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chronic pain or long-acting opioid use
Arm Type
Experimental
Arm Description
Education of pain and promotion of adjunct and non-pharmacologic alternative therapies will be completed to engage patients in assessing their pain and seeing the effectiveness of their treatment. Patients will receive 3 follow-up interventions: 2 phone calls with a pharmacist or student pharmacist at weeks 2 and 6, and a follow-up visit with a pain or primary care physician.
Intervention Type
Behavioral
Intervention Name(s)
Pain education with follow up encounters
Intervention Description
Patient pain review, counseling and education by pharmacists and physicians in follow up encounters
Primary Outcome Measure Information:
Title
Decrease in opioid prescription strength
Description
Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents
Time Frame
Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date
Secondary Outcome Measure Information:
Title
Reduction in pain as evidenced by decrease in opioid daily dose
Description
Subject will keep a daily opioid calendar to track their opioid daily dose
Time Frame
Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date
Title
Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale
Description
Survey will be administered by investigators and completed by the patients before and after the interventions
Time Frame
Change in quality of life score as measured by the PEG pain screening tool by units on a scale between date of subject enrollment and 90 days after subject enrollment date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least 18 years of age
history of opioid use for 3 or more months or
currently prescribed and are using long-acting or extended release opioids
Exclusion Criteria:
substance use
oncology patients
hematology patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huy Le, PharmD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Negating Opioid and Pain Actively Through Intervention
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