Opioid Stewardship Intervention for Opioid Prescribing

Not yet recruiting at 1 trial location
JS
MH
Overseen ByMeaghan Hazelet
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Opioid Stewardship Intervention can help doctors prescribe fewer opioids after surgery. The focus is on improving opioid prescription practices at hospitals in North Carolina. Researchers will compare current practices with those using the new intervention to assess its effectiveness and ease of use. Ideal participants include hospital staff involved in patient care, such as surgeons and nurses, and patient representatives who have undergone certain surgeries and are proficient in English. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance patient care and safety.

Do I have to stop taking my current medications for this trial?

The trial does not specify whether participants need to stop taking their current medications. It focuses on evaluating opioid prescribing practices rather than changing participants' medication regimens.

What prior data suggests that this opioid stewardship intervention is safe for improving opioid prescribing practices?

Research has shown that programs like the opioid stewardship interventions under study are generally safe for people. Several studies have found that these programs can reduce opioid prescriptions without harming patients' health. For example, one study found that these efforts led to fewer opioid prescriptions and shorter use of opioids by patients, without negatively affecting their overall health.

Another study demonstrated that these programs can help manage pain effectively and safely. By improving pain management, they ensure patients receive necessary care without unnecessary risks. Overall, evidence suggests that opioid stewardship interventions are well-tolerated and do not cause major side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Opioid Stewardship Intervention because it aims to transform how opioids are prescribed in hospitals, focusing on safer and more effective opioid use. Unlike standard practices that vary widely and may not always prioritize reduction in opioid use, this intervention provides a structured approach that includes best practices and guidelines to optimize prescribing habits. By implementing this stewardship program, hospitals can potentially reduce opioid misuse while still managing patient pain effectively, a significant advancement in the landscape of opioid prescribing.

What evidence suggests that the Opioid Stewardship Intervention is effective for improving opioid prescribing practices?

Research has shown that programs to manage opioid use can effectively reduce opioid prescriptions. One study found nearly a 40% drop in prescriptions due to these programs. Another study demonstrated that 14 out of 15 medical procedures experienced significant decreases in prescribed opioids, with reductions ranging from 37.1% to 89.6%. These programs aim to reduce unnecessary opioid use without compromising patient care. In this trial, participating hospitals will implement the Opioid Stewardship Intervention to evaluate its effectiveness in promoting safer prescribing habits. Evidence suggests that such programs can work well in healthcare settings.12346

Who Is on the Research Team?

JS

Jessica Schumacher, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for surgeons, healthcare team members, and patient representatives at certain North Carolina hospitals. Patients must be adults who had specific general surgeries, have steady insurance coverage before and after surgery, speak English, and were prescribed opioids post-surgery. People already using opioids or needing major extra surgery are excluded.

Inclusion Criteria

Surgeon champions and identified change team members must be currently practicing at one of the sites participating in this study
I am at least 18 and had continuous insurance before and after my surgery.
I speak English and was prescribed opioids after a qualifying general surgery.

Exclusion Criteria

Patients with an opioid fill 6 months before the procedure
I had a major surgery during my hospital stay that needs extra pain management.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Hospitals continue opioid prescribing according to existing local practices without receiving any components of the opioid stewardship intervention.

Varies based on randomization

Intervention Phase

Hospitals implement a multi-component opioid stewardship intervention, including the SOPS Toolkit, educational sessions, and performance reports.

10 weeks
Educational sessions and performance reviews

Follow-up

Participants are monitored for the effectiveness of the intervention through surveys and interviews assessing acceptability, feasibility, and effectiveness.

6 months after intervention completion

What Are the Treatments Tested in This Trial?

Interventions

  • Opioid Stewardship Intervention

Trial Overview

The study tests if an opioid stewardship program—using education sessions, a prescribing toolkit, performance feedback reports, and surveys—can help hospital teams reduce unnecessary opioid prescriptions after surgery compared to usual care. Hospitals start the intervention at different times by random assignment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Usual Care (Control Period)Experimental Treatment1 Intervention
Group II: Opioid Stewardship Intervention (Intervention Period)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

Citations

The Effect of Opioid Stewardship Interventions on Key Outcomes

The evidence is low to moderate that OS efforts decrease numbers of opioid prescriptions, proportion of patients on long-term opioids, or days' supply. Six of 7 ...

The effectiveness of opioid stewardship interventions in ...

Selected opioid stewardship interventions may be effective for reducing opioid prescribing without adversely affecting clinical outcomes.

The effectiveness of opioid stewardship interventions in ...

Conclusions: Selected opioid stewardship interventions may be effective for reducing opioid prescribing without adversely affecting clinical outcomes.

Opioid Stewardship - Making Healthcare Safer IV - NCBI - NIH

The MHS III report concluded that overall, SOE for significant reductions in opioid dosage was moderate; for clinical outcomes, only two studies evaluated ...

Implementation of opioid stewardship programs (OSPs) in ...

Nine studies included data on patient safety measures, including adverse events such as return emergency room visits, need for naloxone ...

Assessment of an Opioid Stewardship Program

This quality improvement study involves comparison of opioid prescription data before and after implementation of an opioid stewardship ...