An interventional study of Pain education with follow up encounters in Pain, Chronic Pain and Opioid Use, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Loma Linda University · Not applicable, Interventional, and Supportive care
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.
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 33 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Loma Linda University is the lead sponsor of 305 studies on the registry; 48 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
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Exclusion Criteria:
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
Patient pain review, counseling and education by pharmacists and physicians in follow up encounters
Decrease in opioid prescription strength
Opioid usage will be measured by changes in prescription strength of morphine milligram equivalents
Time frame: Change in prescription strength between date of subject enrollment and 90 days after subject enrollment date
Reduction in pain as evidenced by decrease in opioid daily dose
Subject will keep a daily opioid calendar to track their opioid daily dose
Time frame: 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
Survey will be administered by investigators and completed by the patients before and after the interventions
Time frame: 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
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in May 2018, 7 months.
Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 7 months is below that.
Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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