Negating Opioid and Pain Actively Through Intervention (NOPAIN)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Chronic Pain; Opioid Use
• Intervention / Treatment: Behavioral: Pain education with follow up encounters

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Chronic pain or long-acting opioid use; 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.

Behavioral: Pain education with follow up encounters; Patient pain review, counseling and education by pharmacists and physicians in follow up encounters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in opioid prescription strength	Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents	Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in pain as evidenced by decrease in opioid daily dose	Subject will keep a daily opioid calendar to track their opioid daily dose	Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date
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	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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Cardinal Health
• Investigators: Principal Investigator: Huy Le, PharmD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2017
• Primary Completion (ACTUAL): May 17, 2018
• Study Completion (ACTUAL): May 17, 2018

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (ACTUAL): October 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Opioid; Pain education; Drug monitoring
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 5170244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No