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Clinical Trials/NCT03306147
NCT03306147
Completed
Not Applicable

Negating Opioid and Pain Actively Through Intervention

Loma Linda University1 site in 1 country33 target enrollmentOctober 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Loma Linda University
Enrollment
33
Locations
1
Primary Endpoint
Decrease in opioid prescription strength
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2017
End Date
May 17, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Huy Le

Medication Safety/Pharmacy Quality Management Coordinator

Loma Linda University

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

Outcomes

Primary Outcomes

Decrease in opioid prescription strength

Time Frame: 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 Outcomes

  • 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)
  • 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)

Study Sites (1)

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