A Randomized Controlled Trial of Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)
Summary
This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).
Detailed description
Eligible adult patients with probable or histologically/cytologically confirmed, primary or recurrent, malignant neoplasms (any stage) scheduled to undergo elective major cancer surgery at FCCC who meet eligibility criteria will be stratified by procedure type and randomized to the Intervention Arm or Control Arm. • Prior to discharge, patients who meet eligibility criteria at Second Registration will be confirmed for study eligibility and randomized. Patients in the Control Arm will receive standard post-discharge surveillance, as deemed appropriate/necessary by the surgeons caring for them at the time of hospital discharge. Patients in the Intervention and Control Arms will be monitored * Through PDD 30 for postoperative deaths and complications (as defined by ACS NSQIP) and/or adverse events (as defined by CTCAE) * Through the end of the index hospitalization for ICU admission, postoperative LOS, return to operating room, and discharge to home. * Through PDD 90 for hospital readmission, QOL, and receipt of anti-neoplastic therapy
Arms & interventions
- ProcedureIntensified post-discharge surveillance
* TCC Nurse Televisit at post-discharge day 1 and 7 * Televisit with APP/Resident/Fellow between post-discharge day 3-5 * Referral for home health nursing evaluation upon discharge
- ProcedureStandard post-discharge surveillance
Patients in the Control Arm will receive standard post-discharge surveillance, as deemed appropriate/necessary by the surgeons caring for them at the time of hospital discharge.
Outcome measures
Primary
30-day rate of readmission/visit to emergency department/death
The primary objective of this trial is to determine if intensified post-discharge surveillance leads to a 7% absolute risk reduction/35% relative risk reduction in the composite endpoint of 30-day rate of readmission/visit to emergency department/death compared to standard post discharge management in patients undergoing elective, high risk cancer operations.
Time frame: 30 days
Secondary
30-day rate of death
Time frame: 30 days
30-day rate of hospital readmission after index surgery
Time frame: 30 days
60-day rate of hospital readmission after index surgery
Time frame: 60 days
90-day rate of hospital readmission after index surgery
Time frame: 90 days
30-day rate of unplanned Emergency Department visits
Time frame: 30 days
Eligibility criteria
Study locations (1)
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497