Negating Opioid and Pain Actively Through Intervention

Pain Clinical Trial

— NOPAIN  

Official title:

Negating Opioid and Pain Actively Through Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306147
• Other study ID #: 5170244
• Status: Completed
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: May 17, 2018

Study information

• Verified date: February 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 17, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Cardinal Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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