Negating Opioid and Pain Actively Through Intervention

Not Applicable

Completed

• Conditions: Opioid Use; Chronic Pain; Pain
• Interventions: Behavioral: Pain education with follow up encounters

• Registration Number: NCT03306147
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-10
• Study Start: 2017-10-12
• Primary Completion: 2018-05-17
• Study Completion: 2018-05-17
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic pain or long-acting opioid use	Pain education with follow up encounters	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale	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	Survey will be administered by investigators and completed by the patients before and after the interventions
Reduction in pain as evidenced by decrease in opioid daily dose	Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date	Subject will keep a daily opioid calendar to track their opioid daily dose

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States