Discharge Medication Use Post-Operatively in GU Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opioid Medication Disposal Education.
- Who it may be relevant to
- Registry conditions: Genitourinary Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The main purpose of this research study is to determine the amount of opioids that are taken after discharge following a cystectomy, nephrectomy (partial or total), or prostatectomy surgeries via a 30-day post- discharge opioid use and disposal survey. We will also evaluate the impact of an opioid disposal education pamphlet on proper disposal of unused opioids.
Detailed description
This prospective, non-therapeutic trial aims to evaluate the amount of prescribed opioid medications GU cancer patients are consuming post-discharge following surgical procedure of cystectomies, nephrectomies, and prostatectomies.
Enrolled participants will complete a 30-day post-discharge survey evaluating the usage of prescribed opioids and opioid disposal habits, as well as a patient satisfaction survey. Furthermore, participants will be offered to complete an optional CAHPS® Surgical Care Survey to assess patients' experiences with surgical care during in hospital stay and outpatient office visits.
Education on opioid medication disposal will be provided in the form of a pamphlet to participants that are enrolled beginning in year 2 (approximately month 13) from when the first participant is enrolled or after a minimum of 100 evaluable participants are enrolled in the pre-education cohort.
Interventions
- Other Opioid Medication Disposal Education
Education on opioid medication disposal will be provided in the form of a pamphlet created by Atrium Health based on FDA resources and will be given to all participants at the time of consent (cystectomy, nephrectomy, prostatectomy) beginning in the second year, approximately 13 months from when the first participant is enrolled or until a minimum of 100 evaluable participants are enrolled in the pre-education cohort, whichever occurs last.
Primary outcome measures
- Discharge opioids consumed in 30 days after discharge [Time frame: 30 days after discharge]
Secondary outcome measures (12)
- Number of participants filling opioid prescription [Time frame: 30 days after discharge]
- Participant-reported reasons for not filling opioid prescription [Time frame: 30 days after discharge]
- Participant-reported reasons for not taking all pills [Time frame: 30 days after discharge]
- Participant-reported pain control after discharge [Time frame: 30 days after discharge]
- Number of participants receiving a refill after discharge [Time frame: 30 days after discharge]
- Participant-reported disposal method for left-over opioids [Time frame: 30 days after discharge]
- Patient Satisfaction Survey Item 1 - "I would recommend this institution to a friend or family for treatment." [Time frame: 30 days after discharge]
- Patient Satisfaction Survey Item 2 - "The staff provided adequate information and education prior to discharge regarding my recovery at home (ex. wound care and pain management)." [Time frame: 30 days after discharge]
- Patient Satisfaction Survey Item 3 - "Prior to my discharge, I or my caregiver clearly understood the timing and purpose for taking each of my medications." [Time frame: 30 days after discharge]
- Patient Satisfaction Survey Item 4 - "During the hospital stay, nurses and doctors treated me with courtesy and respect." [Time frame: 30 days after discharge]
- Patient Satisfaction Survey Item 5 - "Following prostatectomy, I preferred to be discharged the same day." [Time frame: 30 days after discharge]
- CAHPS Surgical Care Survey - Number of patients with top-box ratings of preparation for surgery [Time frame: 30 days after discharge]
Eligibility criteria
Inclusion criteria
- Written informed consent and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of enrollment
- Scheduled to undergo surgical cystectomy, partial or total nephrectomy or prostatectomy for a cancer diagnosis.
- Ability to read and understand the English and/or Spanish language.
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Levine Cancer Institute — Charlotte
Identifiers
NCT: NCT06795087 · IRB00121391 · LCI-GU-PO-NMC-001