Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

NCT07102446 | Recruiting

• 1 other identifier: 2025GR0258
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Chronic Pain; Opioid Analgesia; Opioid Use

Keywords

Pharmacist; Pain Management; Opioid Stewardship; Non-Cancer Pain

Outcome Measures

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

  At each outpatient visit during the study evaluation period (up to 4 months per participant)

Secondary Outcomes (3)

• Average daily morphine milligram equivalent (MME)

  At each outpatient visit during the study evaluation period (up to 4 months per participant)

• Change in opioid knowledge scores after education sessions compared to baseline

  At each outpatient visit during the study evaluation period (up to 4 months per participant)

• Change in opioid attitude scores after education sessions compared to baseline

  At each outpatient visit during the study evaluation period (up to 4 months per participant)

Study Arms (1)

Opioid Stewardship Program Intervention Group

EXPERIMENTAL

Participants in this arm are adult outpatients with chronic non-cancer pain who receive a pharmacist-led Opioid Stewardship Program (OSP) for their chronic opioid use.

Other: Opioid Stewardship Program

Interventions

Opioid Stewardship Program OTHER

The Opioid Stewardship Program (OSP) includes pain and functional assessments, opioid prescription review and coordination, patient education, and counseling provided by trained pharmacists.

Opioid Stewardship Program Intervention Group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients who were prescribed opioid analgesics within the past month for postoperative pain management
• Patients who were prescribed opioid analgesics within the past month for newly developed pain
• Patients with communication difficulties
• Patients who were prescribed buprenorphine for the treatment of opioid use disorder
• Patients who are deemed inappropriate for study participation at the discretion of the investigator

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Korea Hospital Pharmaceutical Education & Research Center: collaborator
• Korea University: collaborator

Study Sites (1)

Korea University Guro Hospital

Seoul, Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Pain; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• So Hyun Lee, MS

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Hyun Lee, MS

CONTACT

+82-2-2626-1611; pharm23@kumc.or.kr

Kyungim Kim, Ph.D.

CONTACT

+82-44-860-1624; kim_ki@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pharmacy Department

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: June 27, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)