Based on limited published epidemiological data, up to an alarming 1 in 50 surgical inpatients die within 30 postoperative days. Based on our own data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and 1-year mortality among high-risk surgical patients may be as high as 10%. Short- and intermediate-term postoperative mortality is therefore a pressing public health concern. Similarly, postoperative major morbidity - including delirium, stroke, myocardial infarction, atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia, respiratory failure, loss of functionality, and chronic pain - occurs commonly and affects a substantial proportion of surgical patients, critically ill patients and patients undergoing procedures for chronic pain. Many factors associate strongly and independently with postoperative mortality and major morbidity: patient age, functional status, comorbid medical conditions, and duration and invasiveness of surgery, among others. It is a strategic priority to identify pre- and intraoperative risk factors that are subject to modification.

Population

We are attempting to recruit all-comers visiting our preoperative assessment clinic, with current daily enrollment rates approaching 60%.

Brief Title

Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys

Official Title

SATISFY-SOS: Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys

Brief Summary

Based on limited published epidemiological data, up to an alarming 1 in 50 surgical <br /> inpatients die within 30 postoperative days. Based on our own data from the B-Unaware <br /> (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality <br /> among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and 1-year <br /> mortality among high-risk surgical patients may be as high as 10%. Short- and <br /> intermediate-term postoperative mortality is therefore a pressing public health concern. <br /> Similarly, postoperative major morbidity - including delirium, stroke, myocardial infarction, <br /> atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia, respiratory <br /> failure, loss of functionality, and chronic pain - occurs commonly and affects a substantial <br /> proportion of surgical patients, critically ill patients and patients undergoing procedures <br /> for chronic pain. Many factors associate strongly and independently with postoperative <br /> mortality and major morbidity: patient age, functional status, comorbid medical conditions, <br /> and duration and invasiveness of surgery, among others. It is a strategic priority to <br /> identify pre- and intraoperative risk factors that are subject to modification.

Detailed Description

The overarching purpose of SATISFY-SOS is to implement a rigorous process to assess
short-term and intermediate-term outcomes of surgical and procedural patients who receive
anesthesia services at Barnes-Jewish Hospital facilities, located in St. Louis, Missouri.
Specifically, patients will be followed for major morbidity events, for mortality, and for
quality of life up to a year following their procedures. Patients receiving anesthesia
services will provide informed consent to participate in SATISFY-SOS. Each patient will have
the opportunity to respond to a baseline quality of life survey as well as to two
comprehensive post-procedure surveys. These surveys are conducted by either email, mail or
via a telephone interview at 30-90 days post-procedure and again at one year. The survey
questions are primarily comprised of standardized, validated, non-proprietary survey tools
covering the following topics: general health, mental health, emotional health, physical
health, pain, falls, major morbidity, and cognition.

In addition to collecting patient-reported outcomes, comprehensive medical record information
for each patient beginning with the preoperative assessment and spanning throughout the
surgery or procedure, hospitalization period, time spent in intensive care and follow-up
clinic visits is incorporated into the database. Additionally, mortality data including cause
of death for all patients will be ascertained via the National Death Index and from
information in hospital records. This allows for meaningful, comprehensive electronic data
query capabilities. Under the umbrella of the SATISFY-SOS initiative, we intend to implement
specific evidence-based and patient-centered quality improvement programs, and to ensure that
they are effective when implemented in routine clinical care. Additionally, future
IRB-approved research projects can utilize de-identified SATISFY-SOS data.

All electronic data are collected from existing clinical records. The primary SATISFY-SOS
database is hosted on a firewall-secured, HIPAA-compliant server within the Department of
Anesthesiology at Washington University School of Medicine and maintained and managed by the
departmental IT team. Access to the SATISFY-SOS data is restricted from web access and
limited to only the project Informaticist, Data Manager, and Director.

Regular internal auditing of the data are conducted for validity and completeness on a
monthly basis. On an annual basis, the consent process is audited. The data entered early in
the registry are compared with data entered subsequently. Sensitivity analyses are performed
to determine whether data are missing at random. It is planned to compare the data obtained
from patient-reported outcomes against a sample of data in the medical records and against
data obtained from a sample of patients contacted again by telephone. A data dictionary for
key data fields is currently being compiled. Standard operating procedures have been
developed for registry operations, patient recruitment, data collection, data management and
data analysis. No adverse events attributable to this activity are envisioned. Multiple
outcomes are being tracked; no specific sample size has been calculated. Sensitivity analyses
are planned for missing or unavailable data. No imputation is currently planned. The
statistical analyses will depend on the variables and outcomes of interest. This registry is
currently IRB-approved for total enrollment of 36,000 patients. This is subject to subsequent
expansion, pending IRB approval.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.