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

Stroke Clinical Trial

— SATISFY-SOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032030
• Other study ID #: 201203088
• Status: Completed
• Start date: July 2012
• Est. completion date: October 21, 2020

Study information

• Verified date: June 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73952
• Est. completion date: October 21, 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgical and procedural patients who require anesthesia services

Exclusion Criteria:

• Patients under the age of 18 years

Related Conditions & MeSH terms

• Angina
• Atrial Fibrillation
• Cardiac Arrest
• Congestive Heart Failure
• Deep Vein Thrombosis
• Delirium
• Embolism
• Gastrointestinal Bleed
• Gastrointestinal Hemorrhage
• Heart Arrest
• Heart Attack
• Heart Failure
• Myocardial Infarction
• Nerve Injury
• Pneumonia
• Pulmonary Embolism
• Respiratory Arrest
• Respiratory Failure
• Respiratory Insufficiency
• Stomach Ulcer
• Stroke
• Surgical Wound
• Surgical Wound Infection
• Thrombosis
• Venous Thrombosis
• Wound Infection

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Return to Work	Return to work after surgery	1 year
Primary	quality of life		1 year
Primary	functional health		1 year
Primary	falls		1 year
Primary	cognition		1 year
Primary	emotional health		1 year
Primary	mental health		1 year
Primary	physical health		1 year
Primary	pain		1 year
Primary	intraoperative awareness		30-90 days
Primary	all-cause mortality		1 year
Primary	surgical wound infection		1 year
Primary	nerve injury		30-90 days
Primary	stroke		1 year
Primary	delirium		30-90days
Primary	Stomach Ulcer		30-90 days
Primary	Gastrointestinal Bleed		30-90 days
Primary	Pneumonia		1 year
Primary	Respiratory Failure		1 year
Primary	Respiratory Arrest		1 year
Primary	Pulmonary Embolism		1 year
Primary	Deep Vein Thrombosis		1 year
Primary	Angina		1 year
Primary	Atrial Fibrillation		1 year
Primary	Congestive Heart Failure		1 year
Primary	Cardiac Arrest		1 year
Primary	Heart Attack		1 year