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Completed

NCT Number: NCT02032030

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

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.

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Key information

Conditions

Heart Attack Angina Angina Pectoris Apnea Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiac Arrest Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chest Pain Confusion Congestive Heart Failure Deep Vein Thrombosis Delirium Digestive System Diseases Duodenal Diseases Embolism Embolism and Thrombosis Gastrointestinal Bleed Gastrointestinal Diseases Gastrointestinal Hemorrhage Heart Arrest Heart Diseases Heart Failure Hemorrhage Infarction Infections Intestinal Diseases Intraoperative Awareness Intraoperative Complications Ischemia Lung Diseases Mental Disorders Myocardial Infarction Myocardial Ischemia Nausea Necrosis Nerve Injury Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Pneumonia Postoperative Complications Pulmonary Embolism Respiration Disorders Respiratory Arrest Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Signs and Symptoms, Respiratory Stomach Diseases Stomach Ulcer Stroke Surgical Wound Infection Thrombosis Vascular Diseases Venous Thrombosis Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgical and procedural patients who require anesthesia services

Exclusion criteria

  • Patients under the age of 18 years

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Return to Work

    Time frame: 1 year

    Return to work after surgery

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: SATISFY-SOS

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2014
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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