Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina
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:
I. 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jessica Schumacher, PhD
- Número de teléfono: (919) 966-4320
- Correo electrónico: Jessica_Schumacher@med.unc.edu
Copia de seguridad de contactos de estudio
- Nombre: Meaghan Hazelet
- Correo electrónico: meaghan.hazelet@med.unc.edu
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- University of North Carolina at Chapel Hill
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Contacto:
- Jessica Schumacher, PhD
- Número de teléfono: 919-966-4320
- Correo electrónico: Jessica_Schumacher@med.unc.edu
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Investigador principal:
- Jessica Schumacher, PhD
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Wilmington, North Carolina, Estados Unidos, 28401
- Novant Health New Hanover Regional Medical Center
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Contacto:
- William Hope, MD
- Correo electrónico: william.hope@novanthealth.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
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).
Inclusion criteria for the claims analysis includes:
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.
Exclusion Criteria:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Usual Care (Control Period)
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.
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Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.
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Experimental: Opioid Stewardship Intervention (Intervention Period)
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members)
Periodo de tiempo: From enrollment through 6 months after completion of the 10-week intervention period
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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.
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From enrollment through 6 months after completion of the 10-week intervention period
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Proportion of training and learning sessions attended (Feasibility Measure 1)
Periodo de tiempo: From enrollment through 6 months after completion of the 10-week intervention period
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Proportion of training and learning sessions attended by change team members
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From enrollment through 6 months after completion of the 10-week intervention period
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percentage of change team member providers that completed pre- and post- assessments (Feasibility Measure 2)
Periodo de tiempo: From enrollment through 6 months after completion of the 10-week intervention period
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percentage of change team member providers that completed pre- and post- assessments
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From enrollment through 6 months after completion of the 10-week intervention period
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change team's ability to start the trial as randomized (Feasibility Measure 3)
Periodo de tiempo: From enrollment through 6 months after completion of the 10-week intervention period
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change team's ability to start the trial as randomized (yes/no)
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From enrollment through 6 months after completion of the 10-week intervention period
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proportion of intervention components implemented (Feasibility Measure 4)
Periodo de tiempo: From enrollment through 6 months after completion of the 10-week intervention period
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proportion of intervention components implemented using themes gathered from semi-structured interviews (intervention fidelity)
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From enrollment through 6 months after completion of the 10-week intervention period
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Change in Organizational Readiness to Change (ORIC) Measure (Effectiveness Measure 1- survey)
Periodo de tiempo: From enrollment through 6 months after completion of the 10-week intervention period)
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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.
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From enrollment through 6 months after completion of the 10-week intervention period)
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Audit and feedback effectiveness as assessed by learning sessions and semi structured interviews (Effectiveness Measure 2)
Periodo de tiempo: Intervention Period
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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.
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Intervention Period
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Change in Milligram equivalents (MME) of the first post-operative fill pre- and post-intervention using administrative claims data (Effectiveness Measure 3).
Periodo de tiempo: Comparing pre (6 months before enrollment) and 6 month period starting at the end of the 10-week intervention period.
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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.
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Comparing pre (6 months before enrollment) and 6 month period starting at the end of the 10-week intervention period.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Second opioid fill within 60-days of discharge (yes/no) using administative claims data
Periodo de tiempo: From enrollment through 6 months after completion of the 10-week intervention period
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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
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From enrollment through 6 months after completion of the 10-week intervention period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jessica Schumacher, PhD, University of North Carolina, Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 25-1636
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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