Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

Browse trials for

• Pain 2,170
• Chronic Pain 2,917
• Agnosia 1,175

Keywords

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

Study arms

• Experimental
  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.

  Other: Opioid Stewardship Program

Interventions

• OtherOpioid 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.

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)

Individual participant data

Plan to share: No — 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.