Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02032030
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : May 9, 2019
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine

Brief 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.

Condition or disease
Heart Attack Cardiac Arrest Congestive Heart Failure Atrial Fibrillation Angina Deep Vein Thrombosis Pulmonary Embolism Respiratory Arrest Respiratory Failure Pneumonia Gastrointestinal Bleed Stomach Ulcer Delirium Stroke Nerve Injury Surgical Wound Infection

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: SATISFY-SOS: Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys
Actual Study Start Date : July 2012
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Primary Outcome Measures :
  1. quality of life [ Time Frame: 1 year ]
  2. functional health [ Time Frame: 1 year ]
  3. falls [ Time Frame: 1 year ]
  4. cognition [ Time Frame: 1 year ]
  5. emotional health [ Time Frame: 1 year ]
  6. mental health [ Time Frame: 1 year ]
  7. physical health [ Time Frame: 1 year ]
  8. pain [ Time Frame: 1 year ]
  9. intraoperative awareness [ Time Frame: 30-90 days ]
  10. all-cause mortality [ Time Frame: 1 year ]
  11. surgical wound infection [ Time Frame: 1 year ]
  12. nerve injury [ Time Frame: 30-90 days ]
  13. stroke [ Time Frame: 1 year ]
  14. delirium [ Time Frame: 30-90days ]
  15. Stomach Ulcer [ Time Frame: 30-90 days ]
  16. Gastrointestinal Bleed [ Time Frame: 30-90 days ]
  17. Pneumonia [ Time Frame: 1 year ]
  18. Respiratory Failure [ Time Frame: 1 year ]
  19. Respiratory Arrest [ Time Frame: 1 year ]
  20. Pulmonary Embolism [ Time Frame: 1 year ]
  21. Deep Vein Thrombosis [ Time Frame: 1 year ]
  22. Angina [ Time Frame: 1 year ]
  23. Atrial Fibrillation [ Time Frame: 1 year ]
  24. Congestive Heart Failure [ Time Frame: 1 year ]
  25. Cardiac Arrest [ Time Frame: 1 year ]
  26. Heart Attack [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Return to Work [ Time Frame: 1 year ]
    Return to work after surgery

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We are attempting to recruit all-comers visiting our preoperative assessment clinic, with current daily enrollment rates approaching 60%.

Inclusion Criteria:

  • Surgical and procedural patients who require anesthesia services

Exclusion Criteria:

  • Patients under the age of 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02032030

Layout table for location contacts
Contact: Sherry L McKinnon, AA
Contact: Michael S. Avidan, MBBCh, FCASA

Layout table for location information
United States, Missouri
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Michael S Avidan, MBBCH, FCA   
Contact: Sherry L McKinnon, AA   
Sponsors and Collaborators
Washington University School of Medicine
Layout table for investigator information
Principal Investigator: Michael S Avidan, MBBCh, FCASA Washington University School of Medicine
Study Director: Anshuman Sharma, MD Washington University School of Medicine
Study Director: Daniel Helsten, MD Washington University School of Medicine
Study Director: Arbi Ben Abdallah, PhD Washington University School of Medicine
Study Director: Troy Wildes, MD Washington University School of Medicine

Additional Information:


Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael Avidan, Director, Institute of Quality Improvement, Research & Informatics (INQUIRI), Washington University School of Medicine Identifier: NCT02032030     History of Changes
Other Study ID Numbers: 201203088
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Keywords provided by Michael Avidan, Washington University School of Medicine:
quality of Life
intraoperative awareness
anesthesia awareness
activities of daily living
major morbidity
all-cause mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Wound Infection
Surgical Wound Infection
Stomach Ulcer
Gastrointestinal Hemorrhage
Respiratory Insufficiency
Pulmonary Embolism
Heart Failure
Atrial Fibrillation
Heart Arrest
Venous Thrombosis
Myocardial Infarction
Surgical Wound
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Signs and Symptoms
Respiration Disorders
Wounds and Injuries
Myocardial Ischemia