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| Name | Class |
|---|---|
| Korea Hospital Pharmaceutical Education & Research Center | UNKNOWN |
| Korea University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of potentially high-risk opioid prescriptions | This outcome measures the proportion of potentially high-risk opioid prescriptions based on predefined criteria:
| At each outpatient visit during the study evaluation period (up to 4 months per participant) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At each outpatient visit during the study evaluation period (up to 4 months per participant) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| So Hyun Lee, MS | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Recruiting | Seoul | Seoul | 08308 | South Korea |
The decision not to share individual participant data (IPD) is based on the possibility that the research data may contain personally identifiable information. Informed consent was not obtained from participants for the sharing of their individual data with third parties.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| 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. |
| 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 | 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. | At each outpatient visit during the study evaluation period (up to 4 months per participant) |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |