Negating Opioid and Pain Actively Through Intervention

NCT03306147 | Completed

• 1 other identifier: 5170244
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Chronic Pain; Opioid Use

Keywords

Pain; Opioid; Drug monitoring; Pain education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

Chronic pain or long-acting opioid use

EXPERIMENTAL

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

Interventions

Pain education with follow up encounters BEHAVIORAL

Patient pain review, counseling and education by pharmacists and physicians in follow up encounters

Chronic pain or long-acting opioid use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• substance use
• oncology patients
• hematology patients

Sponsors & Collaborators

• Loma Linda University: lead
• Cardinal Health: collaborator

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huy Le, PharmD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medication Safety/Pharmacy Quality Management Coordinator

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: October 12, 2017
• Primary Completion: May 17, 2018
• Study Completion: May 17, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)