Opioid PrescribingNCT07566182
Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina
A study testing Opioid Stewardship Intervention in people with Opioid Prescribing, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
The goal of this stepped-wedge cluster randomized trial is to evaluate whether an opioid stewardship intervention improves post-operative opioid prescribing practices. Participants will include surgeon champions and identified change team members (e.g., pharmacists, hospitalists, nurses, advanced practice providers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Prescribing
- What is being tested?
- Opioid Stewardship Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgeon champions and identified change team members must be currently practicing at one of the sites participating in this study.
- Patient representatives must be:
- Proficient in the English language Prescribed opioids following a qualifying general surgery procedure (inpatient or outpatient laparoscopic appendectomy, inguinal/femoral hernia repair, umbilical hernia, bariatric/weight loss surgery, mastectomy, laparoscopic cholecystectomy, laparoscopic colectomy, lipoma/soft tissue tumor excision, and anal/rectal procedures).
- No patients will be enrolled for this trial. However, claims data will be used to assess the claims based outcome measure (opioid prescribing).
- Patients greater than or equal to 18 at the time of a qualifying general surgery procedure either inpatient or outpatient (laparoscopic appendectomy; umbilical/ventral/inguinal/femoral hernia repair; bariatric/weight loss surgery; mastectomy; laparoscopic cholecystectomy; laparoscopic colectomy; lipoma/soft tissue tumor excision; anal/rectal procedures) based on procedure codes Patients must have continuous insurance coverage (including prescription drug coverage), 6 months before to 60 days post discharge to assess comorbidities and prescription drug fills.
Who cannot join
- Patients with an opioid fill 6 months before the procedure. Patients who undergo a significant operation during the stay associated with their index procedure that would require additional pain management.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Meaghan Hazelet contact
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Jessica Schumacher, PhD, 919-966-4320, Jessica_Schumacher@med.unc.edu
Jessica Schumacher, PhD
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
William Hope, MD, william.hope@novanthealth.org
About this study
Official title: Building an Implementation Science Network to Reduce Post-Operative Opioid Prescribing in Southeastern North Carolina
The goal of this stepped-wedge cluster randomized trial is to evaluate whether an opioid stewardship intervention improves post-operative opioid prescribing practices. Participants will include surgeon champions and identified change team members (e.g., pharmacists, hospitalists, nurses, advanced practice providers, anesthesiologists, etc.) and patient representatives at designated hospital sites in North Carolina.
The main questions it aims to answer are:
Read more
- Does the intervention reduce postoperative opioid prescribing behavior at the surgeon and hospital level? II. Is the intervention acceptable, feasible, and effective for implementation among participating hospitals?
Researchers will compare opioid prescribing and implementation outcomes across sites before and after implementation using a stepped-wedge cluster randomized design, in which sites are randomly assigned to different intervention start times.
Participants will attend educational sessions delivered, introduce the Standard Opioid Prescribing (SOPS) Toolkit into their clinical practice, review benchmarked, deidentified opioid prescribing performance reports that use administrative claims data (secondary data source, data not collected or shared between hospitals), and complete surveys assessing intervention acceptability, feasibility, and effectiveness. Preliminary effectiveness will be assessed through reduction of opioid prescriptions using administrative claims data.
Read the detailed description
A stepped-wedge cluster randomized trial will be conducted across participating hospital sites in Southeastern North Carolina. Sites will transition sequentially from the control condition to the intervention condition based on randomization, until all clusters have completed the opioid stewardship intervention over a 10-week period.
During the control phase, opioid prescribing will continue according to existing practices. During the intervention phase, sites will implement a multi-component site-specific opioid stewardship intervention. The intervention includes dissemination of the Standard Opioid Prescribing (SOPS) Toolkit, quality improvement (QI) educational sessions, and benchmarked opioid prescribing performance reports generated from administrative claims data. These reports provide deidentified surgeon- and site-level prescribing summaries so that sites are able to see their current opioid prescribing levels.
The primary outcomes are the acceptability, feasibility, and effectiveness of the intervention assessed during and after implementation as determined from semi-structured interviews and surveys. Secondary outcomes include additional provider and patient opioid prescribing outcomes related to post-operative opioid fills by patients. This information will be obtained from administrative claims data. No patient information will be collected and no patient will be enrolled int eh study. These measures evaluate whether tailoring the opioid stewardship intervention to each hospital improves routine clinical practice and provider opioid prescribing.
- Conditions
- Opioid Prescribing
- Being tested
- Usual Care, Opioid Stewardship Intervention
- Keywords
- Opioid Stewardship, Postoperative opioid prescribing, Cluster randomized trial, Implementation science, Audit and feedback, Performance reporting, Quality Improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.
Opioid Stewardship InterventionBehavioural
A multi component intervention consisting of dissemination of the Standard Opioid Prescribing (SOPS) Toolkit, quality improvement educational sessions for clinicians, and benchmarked opioid prescribing performance reports generated from administrative claims data. Reports provide deidentified surgeon and site level summaries of opioid prescribing patterns.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Control Period) | Other | During the control phase of the stepped wedge cluster randomized trial, participating hospitals continue opioid prescribing according to existing local practices. Clinicians do not receive any components of the opioid stewardship intervention during this period. Each hospital contributes data to this arm prior to crossing over to the intervention phase based on randomized timing. Receives: Other: Usual Care |
| Opioid Stewardship Intervention (Intervention Period) | Experimental | During the intervention phase, hospitals implement a multi component opioid stewardship intervention after crossing over from the control condition according to randomized start time. Clinician participants at each site engage in the intervention for approximately 10 weeks. All hospitals eventually receive the intervention as part of the stepped wedge design. Receives: Behavioral: Opioid Stewardship Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members)
Acceptability will be assessed qualitatively using themes derived from semi-structured interviews conducted with change team members. Interviews will explore perceptions of the intervention and its fit within the hospital context. Themes identified after the 10-week implementation period will be compared with themes identified prior to implementation.
Measured: From enrollment through 6 months after completion of the 10-week intervention period
Proportion of training and learning sessions attended (Feasibility Measure 1)
Proportion of training and learning sessions attended by change team members
Measured: From enrollment through 6 months after completion of the 10-week intervention period
percentage of change team member providers that completed pre- and post- assessments (Feasibility Measure 2)
percentage of change team member providers that completed pre- and post- assessments
Measured: From enrollment through 6 months after completion of the 10-week intervention period
change team's ability to start the trial as randomized (Feasibility Measure 3)
change team's ability to start the trial as randomized (yes/no)
Measured: From enrollment through 6 months after completion of the 10-week intervention period
proportion of intervention components implemented (Feasibility Measure 4)
proportion of intervention components implemented using themes gathered from semi-structured interviews (intervention fidelity)
Measured: From enrollment through 6 months after completion of the 10-week intervention period
Change in Organizational Readiness to Change (ORIC) Measure (Effectiveness Measure 1- survey)
Change in ORIC score from pre- to post intervention. Change team members will complete the survey before the intervention start phase and after intervention completion.
Measured: From enrollment through 6 months after completion of the 10-week intervention period)
Audit and feedback effectiveness as assessed by learning sessions and semi structured interviews (Effectiveness Measure 2)
Audit and feedback effectiveness is defined as the extent change team members feel ownership and agreement, can make sense of the information provided, are motivated by the social influence that reviewing their performance shows (e.g., comparing their performance to other hospitals), and accept accountability for the proposed changes.
Measured: Intervention Period
Change in Milligram equivalents (MME) of the first post-operative fill pre- and post-intervention using administrative claims data (Effectiveness Measure 3).
Change in Milligram equivalents (MME) of the first opioid prescription filled (outpatient) by patients -3 days before admission for their qualifying procedure through 7 days post-discharge during the pre- and post-intervention time periods.
Measured: Comparing pre (6 months before enrollment) and 6 month period starting at the end of the 10-week intervention period.
Secondary outcomes (1)
Second opioid fill within 60-days of discharge (yes/no) using administative claims data
For patients with one or more post-operative opioids filled, the proportion that filled a second prescription within 60 days of discharge from the qualifying procedure
Measured: From enrollment through 6 months after completion of the 10-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid PrescribingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Schumacher, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566182
- Sponsor's protocol ID
- 25-1636
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Claims data use are governed by separate data use agreements with data vendors and cannot be shared per those agreements. There is no plan to share qualitative or survey data as sharing risks identifying the small number of hospitals that are participating in the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building an Implementation Science Network to Reduce Post-Operative Opioid Prescribing in Southeastern North Carolina
- ClinicalTrials.gov ID
- NCT07566182
- Acronym / sponsor ID
- 25-1636
- Conditions
- Opioid Prescribing
- Keywords
- Opioid Stewardship, Postoperative opioid prescribing, Cluster randomized trial, Implementation science, Audit and feedback, Performance reporting, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this stepped-wedge cluster randomized trial is to evaluate whether an opioid stewardship intervention improves post-operative opioid prescribing practices. Participants will include surgeon champions and identified change team members (e.g., pharmacists, hospitalists, nurses, advanced practice providers, anesthesiologists, etc.) and patient representatives at designated hospital sites in North Carolina.
The main questions it aims to answer are:
- Does the intervention reduce postoperative opioid prescribing behavior at the surgeon and hospital level? II. Is the intervention acceptable, feasible, and effective for implementation among participating hospitals?
Researchers will compare opioid prescribing and implementation outcomes across sites before and after implementation using a stepped-wedge cluster randomized design, in which sites are randomly assigned to different intervention start times.
Participants will attend educational sessions delivered, introduce the Standard Opioid Prescribing (SOPS) Toolkit into their clinical practice, review benchmarked, deidentified opioid prescribing performance reports that use administrative claims data (secondary data source, data not collected or shared between hospitals), and complete surveys assessing intervention acceptability, feasibility, and effectiveness. Preliminary effectiveness will be assessed through reduction of opioid prescriptions using administrative claims data.
Detailed description
A stepped-wedge cluster randomized trial will be conducted across participating hospital sites in Southeastern North Carolina. Sites will transition sequentially from the control condition to the intervention condition based on randomization, until all clusters have completed the opioid stewardship intervention over a 10-week period.
During the control phase, opioid prescribing will continue according to existing practices. During the intervention phase, sites will implement a multi-component site-specific opioid stewardship intervention. The intervention includes dissemination of the Standard Opioid Prescribing (SOPS) Toolkit, quality improvement (QI) educational sessions, and benchmarked opioid prescribing performance reports generated from administrative claims data. These reports provide deidentified surgeon- and site-level prescribing summaries so that sites are able to see their current opioid prescribing levels.
The primary outcomes are the acceptability, feasibility, and effectiveness of the intervention assessed during and after implementation as determined from semi-structured interviews and surveys. Secondary outcomes include additional provider and patient opioid prescribing outcomes related to post-operative opioid fills by patients. This information will be obtained from administrative claims data. No patient information will be collected and no patient will be enrolled int eh study. These measures evaluate whether tailoring the opioid stewardship intervention to each hospital improves routine clinical practice and provider opioid prescribing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Control Period) | Other | Other: Usual CareDuring the control phase of the stepped wedge cluster randomized trial, participating hospitals continue opioid prescribing according to existing local practices. Clinicians do not receive any components of the opioid stewardship intervention during this period. Each hospital contributes data to this arm prior to crossing over to the intervention phase based on randomized timing. |
| Opioid Stewardship Intervention (Intervention Period) | Experimental | Behavioral: Opioid Stewardship InterventionDuring the intervention phase, hospitals implement a multi component opioid stewardship intervention after crossing over from the control condition according to randomized start time. Clinician participants at each site engage in the intervention for approximately 10 weeks. All hospitals eventually receive the intervention as part of the stepped wedge design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Surgeon champions and identified change team members must be currently practicing at one of the sites participating in this study.
- Proficient in the English language Prescribed opioids following a qualifying general surgery procedure (inpatient or outpatient laparoscopic appendectomy, inguinal/femoral hernia repair, umbilical hernia, bariatric/weight loss surgery, mastectomy, laparoscopic cholecystectomy, laparoscopic colectomy, lipoma/soft tissue tumor excision, and anal/rectal procedures).
- No patients will be enrolled for this trial. However, claims data will be used to assess the claims based outcome measure (opioid prescribing).
- Patients greater than or equal to 18 at the time of a qualifying general surgery procedure either inpatient or outpatient (laparoscopic appendectomy; umbilical/ventral/inguinal/femoral hernia repair; bariatric/weight loss surgery; mastectomy; laparoscopic cholecystectomy; laparoscopic colectomy; lipoma/soft tissue tumor excision; anal/rectal procedures) based on procedure codes Patients must have continuous insurance coverage (including prescription drug coverage), 6 months before to 60 days post discharge to assess comorbidities and prescription drug fills.
Key exclusion criteria (1 listed)
- Patients with an opioid fill 6 months before the procedure. Patients who undergo a significant operation during the stay associated with their index procedure that would require additional pain management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareExisting opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities. | Other | Usual Care (Control Period) |
| Opioid Stewardship InterventionA multi component intervention consisting of dissemination of the Standard Opioid Prescribing (SOPS) Toolkit, quality improvement educational sessions for clinicians, and benchmarked opioid prescribing performance reports generated from administrative claims data. Reports provide deidentified surgeon and site level summaries of opioid prescribing patterns. | Behavioural | Opioid Stewardship Intervention (Intervention Period) |
Primary outcome
Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members)
Time frame: From enrollment through 6 months after completion of the 10-week intervention period
Acceptability will be assessed qualitatively using themes derived from semi-structured interviews conducted with change team members. Interviews will explore perceptions of the intervention and its fit within the hospital context. Themes identified after the 10-week implementation period will be compared with themes identified prior to implementation.
Proportion of training and learning sessions attended (Feasibility Measure 1)
Time frame: From enrollment through 6 months after completion of the 10-week intervention period
Proportion of training and learning sessions attended by change team members
percentage of change team member providers that completed pre- and post- assessments (Feasibility Measure 2)
Time frame: From enrollment through 6 months after completion of the 10-week intervention period
percentage of change team member providers that completed pre- and post- assessments
change team's ability to start the trial as randomized (Feasibility Measure 3)
Time frame: From enrollment through 6 months after completion of the 10-week intervention period
change team's ability to start the trial as randomized (yes/no)
proportion of intervention components implemented (Feasibility Measure 4)
Time frame: From enrollment through 6 months after completion of the 10-week intervention period
proportion of intervention components implemented using themes gathered from semi-structured interviews (intervention fidelity)
Change in Organizational Readiness to Change (ORIC) Measure (Effectiveness Measure 1- survey)
Time frame: From enrollment through 6 months after completion of the 10-week intervention period)
Change in ORIC score from pre- to post intervention. Change team members will complete the survey before the intervention start phase and after intervention completion.
Audit and feedback effectiveness as assessed by learning sessions and semi structured interviews (Effectiveness Measure 2)
Time frame: Intervention Period
Audit and feedback effectiveness is defined as the extent change team members feel ownership and agreement, can make sense of the information provided, are motivated by the social influence that reviewing their performance shows (e.g., comparing their performance to other hospitals), and accept accountability for the proposed changes.
Change in Milligram equivalents (MME) of the first post-operative fill pre- and post-intervention using administrative claims data (Effectiveness Measure 3).
Time frame: Comparing pre (6 months before enrollment) and 6 month period starting at the end of the 10-week intervention period.
Change in Milligram equivalents (MME) of the first opioid prescription filled (outpatient) by patients -3 days before admission for their qualifying procedure through 7 days post-discharge during the pre- and post-intervention time periods.
1 secondary outcome
Second opioid fill within 60-days of discharge (yes/no) using administative claims data
Time frame: From enrollment through 6 months after completion of the 10-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. Claims data use are governed by separate data use agreements with data vendors and cannot be shared per those agreements. There is no plan to share qualitative or survey data as sharing risks identifying the small number of hospitals that are participating in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meaghan Hazelet contact
Jessica Schumacher, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Stewardship Intervention in people with Opioid Prescribing, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Schumacher, PhD ((919) 966-4320, Jessica_Schumacher@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members) (time frame: From enrollment through 6 months after completion of the 10-week intervention period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.