Clinical trial NCT03306147: Negating Opioid and Pain Actively Through Intervention
Official title: Negating Opioid and Pain Actively Through Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Chronic Pain
Opioid Use
Keywords: Pain
Opioid
Drug monitoring
Pain education
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Cardinal Health
First posted: 2017-10-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Decrease in opioid prescription strength
timeFrame: Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date
Secondary outcomes:
measure: Reduction in pain as evidenced by decrease in opioid daily dose
timeFrame: Change in daily opioid use between date of subject enrollment and 90 days after subject enrollment date
measure: Improvement in quality of life score as measured by the PEG pain screening tool by units on a scale
timeFrame: 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
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Huy Le, PharmD
role: PRINCIPAL_INVESTIGATOR
References: