This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
880
* 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
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.
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITING30-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
30-day rate of death
Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 30-day rate of death
Time frame: 30 days
30-day rate of hospital readmission after index surgery
Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 30-day rate of hospital readmission after index surgery
Time frame: 30 days
60-day rate of hospital readmission after index surgery
Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 60-day rate of hospital readmission after index surgery
Time frame: 60 days
90-day rate of hospital readmission after index surgery
Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 90-day rate of hospital readmission after index surgery
Time frame: 90 days
30-day rate of unplanned Emergency Department visits
Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 30-day rate of unplanned Emergency Department visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 30 days