Breast Cancer, Breast Reconstruction
Conditions
Brief summary
The study will assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. This trial is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care). This will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription.
Detailed description
Opioids are widely overprescribed and overused after surgery, contributing to the current opioid misuse crisis which affects more than 10 million Americans annually. In the breast reconstruction after mastectomy population, studies report as many as 47% of patients go on to become prolonged users of opioids. The primary goal is to assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. The proposed study is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care). This project is directly relevant to the mission of the AHRQ to improve health care patient safety and to provide a 360-degree view of the patient. Specifically, this will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription. Patients will be randomized to an opioid video vs. no opioid video cohort by a block randomization scheme based on a predefined computer-generated sequence (six blocks, six numbers per block) in a 1:1 intervention: no intervention ratio. Patients in the opioid video cohort will watch a 3-minute education video on proper opioid use preoperatively. The video includes information on (1) how to consume appropriate over-the-counter pain medication alongside opioids for optimal pain control, (2) how prescribed opioids should be used only to treat pain related to the surgery, and (3) the proper disposal of unused opioids. The video was created through the University of Utah Office of Patient Experience. Feedback regarding the educational content was provided by surgeons, pain management physicians, and pharmacists throughout the process.
Interventions
BEHAVIORALOpioid Educational Video
The video includes information on (1) how to consume appropriate over-the-counter pain medication alongside opioids for optimal pain control, (2) how prescribed opioids should be used only to treat pain related to the surgery, and (3) the proper disposal of unused opioids. The video was created through the University of Utah Office of Patient Experience. Feedback regarding the educational content was provided by surgeons, pain management physicians, and pharmacists throughout the process.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients will be randomized to a opioid video vs. no opioid video cohort by a block randomization scheme based on a predefined computer-generated sequence (six blocks, six numbers per block) in a 1:1 intervention: no intervention ratio.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients 18 years of age or older * Patients undergoing abdominally based autologous free flap breast reconstruction after mastectomy for breast cancer or cancer prophylaxis
Exclusion criteria
* Patients undergoing reoperations such as autologous breast reconstruction as a revision procedure following failed implant-based reconstruction * Patients undergoing multiple procedures such as mastectomy and immediate reconstruction * Patients with documented chronic opioid use prior to procedure, chronic pain condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | up to 2 weeks postoperative | Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs). |
| Days to Opioid Cessation | up to 2 weeks postoperative | Total number of days until ceasing opioid use from breast reconstruction surgery to 2 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days to Non-Opioid Analgesics Cessation | up to 2 weeks postoperative | Total number of days until ceasing of non-opioid analgesics from breast reconstruction surgery to 2 weeks. |
| Opioids Prescribed Consumed | up to 2 weeks postoperative | This outcome measure will report the percentage of opioids prescribed consumed from breast reconstruction surgery up to 2 weeks. |
| Complication Types | up to 2 weeks postoperative | This outcome measure will report the frequency of the following breast reconstruction complications: * Poor wound healing: skin necrosis, dehiscence of wound * Seroma/ Hematoma * Infection * Takeback to the operating room pre-discharge * Unplanned readmission * Emergency Department visit for any reason * Reoperation |
| Patient-reported Daily Pain Scores | up to 2 weeks postoperative | Patient-reported daily pain scores from breast reconstruction surgery to 2 weeks. Pain Scores are numerical ratings of self-reported pain intensity from 0-10. Lower scores indicate less pain, and higher score indicate more pain. This outcome measure will report the mean Patient-reported Daily Pain Scores. |
| Non-Opioid Analgesics Consumed | up to 2 weeks postoperative | This outcome measure will report the amount and type of non-opioid analgesics consumed from breast reconstruction surgery to 2 weeks. |
Countries
United States
Contacts
Primary ContactJay Agarwal, MD
Backup ContactEthan Lester
Outcome results
None listed