Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

NCT ID: NCT07102446

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Chronic Pain Opioid Analgesia Opioid Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Opioid Stewardship Program Intervention Group

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.

Group Type EXPERIMENTAL

Opioid Stewardship Program

Intervention Type OTHER

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

Interventions

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Opioid Stewardship Program

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Hospital Pharmaceutical Education & Research Center

UNKNOWN

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role collaborator

Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lee, So Hyun

Chief of Pharmacy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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So Hyun Lee, MS

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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So Hyun Lee, MS

Role: CONTACT

+82-2-2626-1611

Kyungim Kim, Ph.D.

Role: CONTACT

+82-44-860-1624

Facility Contacts

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So Hyun Lee, MS

Role: primary

+82-2-2626-1611

Other Identifiers

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2025GR0258

Identifier Type: -

Identifier Source: org_study_id

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