Clinical trial NCT06795087: Discharge Medication Use Post-Operatively in GU Cancer Patients
Official title: Discharge Medication Use Post-Operatively in GU Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genitourinary Cancer
Keywords: Genitourinary Cancer
Cystectomies
Nephrectomies
Prostatectomies
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2025-01-27
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants ≥ 18 years of age or older who will undergo planned cystectomy, nephrectomy (partial or total), or prostatectomy for a GU cancer diagnosis will be approached to enroll into the study.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information.
2. Age ≥ 18 years at the time of enrollment
3. Scheduled to undergo surgical cystectomy, partial or total nephrectomy or prostatectomy for a cancer diagnosis.
4. Ability to read and understand the English and/or Spanish language.
5. Enrolling investigator plans to prescribe opioids at the time of discharge for post-operative pain.
6. 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

Primary outcomes:
measure: Discharge opioids consumed in 30 days after discharge
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Number of participants filling opioid prescription
timeFrame: 30 days after discharge
measure: Participant-reported reasons for not filling opioid prescription
timeFrame: 30 days after discharge
measure: Participant-reported reasons for not taking all pills
timeFrame: 30 days after discharge
measure: Participant-reported pain control after discharge
timeFrame: 30 days after discharge
measure: Number of participants receiving a refill after discharge
timeFrame: 30 days after discharge
measure: Participant-reported disposal method for left-over opioids
timeFrame: 30 days after discharge
measure: Patient Satisfaction Survey Item 1 - "I would recommend this institution to a friend or family for treatment."
timeFrame: 30 days after discharge
measure: 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)."
timeFrame: 30 days after discharge
measure: 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."
timeFrame: 30 days after discharge
measure: Patient Satisfaction Survey Item 4 - "During the hospital stay, nurses and doctors treated me with courtesy and respect."
timeFrame: 30 days after discharge
measure: Patient Satisfaction Survey Item 5 - "Following prostatectomy, I preferred to be discharged the same day."
timeFrame: 30 days after discharge
measure: CAHPS Surgical Care Survey - Number of patients with top-box ratings of preparation for surgery
timeFrame: 30 days after discharge
measure: CAHPS Surgical Care Survey - Number of patients with top-box ratings of preoperative communication
timeFrame: 30 days after discharge
measure: CAHPS Surgical Care Survey - Number of patients with top-box ratings of day of surgery attentiveness
timeFrame: 30 days after discharge
measure: CAHPS Surgical Care Survey - Patients' rating of surgeon
timeFrame: 30 days after discharge
measure: CAHPS Surgical Care Survey - Patients' rating of anesthesiologist
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen Riggs, MD
role: PRINCIPAL_INVESTIGATOR
References: