Evaluation of an Opioid Stewardship Program in Non-Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-79
SponsorKorea University Guro Hospital
About this trial
The objective of this prospective, non-randomized clinical trial is to evaluate the effectiveness of a pharmacist-led Opioid Stewardship Program (OSP) in outpatient adults with chronic non-cancer pain. This study compared OSP implementation with a historical control to determine whether it reduces the incidence of high-risk opioid prescribing and improves patients' awareness, knowledge, and attitudes about opioid use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Outpatients at the Department of Anesthesiology and Pain Medicine or the Department of Physical Medicine & Rehabilitation of the study site who received a prescription for opioid analgesics (oral, transdermal, sublingual, or buccal formulations containing oxycodone, fentanyl, tapentadol, hydrocodone, or morphine) due to chronic non-cancer pain during the study evaluation period (from IRB approval date to September 30, 2025)
Adults aged ≥19 years and <80 years
Patients who voluntarily signed a written informed consent form after receiving a full explanation of the study and understanding its purpose
Disqualifiers
Patients with active cancer
Patients diagnosed with sickle cell disease
Patients diagnosed with a life-limiting illness eligible for hospice or palliative care as defined in Article 2 of the 'ACT ON HOSPICE AND PALLIATIVE CARE AND DECISIONS ON LIFE-SUSTAINING TREATMENT FOR PATIENTS AT THE END OF LIFE'
Pregnant patients
Trial design
Design model
Single group
Treatments tested in this trial
Opioid Stewardship Program
Other interventionThe Opioid Stewardship Program (OSP) includes pain and functional assessments, opioid prescription review and coordination, patient education, and counseling provided by trained pharmacists.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Opioid Stewardship Program Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of potentially high-risk opioid prescriptions
This outcome measures the proportion of potentially high-risk opioid prescriptions based on predefined criteria: * Prescription (Rx) of ER/SR opioids to patients with no prior opioid use * Rx of certain ER/SR opioid dosages to patients who are not opioid-tolerant * Rx of sublingual/buccal fentanyl * Rx exceeding 50 MME/day * Rx exceeding 10 MME/dose or 30 MME/day to patients with no prior opioid use * Rx with no dose adjustments for the elderly or renally impaired with no prior opioid use * ER/SR opioid conversions outside 50-75% of the prior MME/day * Rx of oral ER/SR opioids more than twice daily * Rx of transdermal fentanyl at intervals less than 72 hours * Rx exceeding 30 days supply * Rx without a pain assessment in the past 3 months in long-term opioid users * No opioid dose adjustment in the last 3 Rx despite additional pain interventions and improved pain in long-term users * No opioid dose adjustment in the last 3 Rx despite the lack of pain improvement in long-term users
Time frame
At each outpatient visit during the study evaluation period (up to 4 months per participant)Secondary outcomes
1
Average daily morphine milligram equivalent (MME)
This outcome assesses the clinical effect of the intervention by calculating the average daily MME for each opioid prescription during the study evaluation period.
Time frame
At each outpatient visit during the study evaluation period (up to 4 months per participant)2
Change in opioid knowledge scores after education sessions compared to baseline
This outcome evaluates patient understanding of opioid use. Knowledge scores are measured at baseline (before the first education session) and after each of the education sessions using a validated questionnaire.
Time frame
At each outpatient visit during the study evaluation period (up to 4 months per participant)3
Change in opioid attitude scores after education sessions compared to baseline
This outcome assesses patient attitudes toward opioid use, including concerns about addiction, side effects, and trust in physicians. Attitude scores are measured at baseline and after each of the education sessions using a modified K-PMAQ-14 (Korean version of pain medication attitude questionnaire-14) survey.
Time frame
At each outpatient visit during the study evaluation period (up to 4 months per participant)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Korea University Guro Hospital
Lead sponsor
Korea Hospital Pharmaceutical Education & Research Center
Collaborator
Korea University
Collaborator
Source ClinicalTrials.gov