About this trial
This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years at diagnosis
ECOG performance status 0, 1, or 2, defined as
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
Disqualifiers
Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.
Post
Elective (curative or palliative) major cancer surgery (as listed in 4.1.4 above) at the time of the index surgery (patient may have undergone more than one of these procedures) OR
Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)
Trial design
Parallel
Treatments tested in this trial
Intensified post-discharge surveillance
Procedure/Surgery* 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
Standard post-discharge surveillance
Procedure/SurgeryPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
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
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
Sponsors and contacts
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