Clinical trial NCT02032030: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: quality of Life
pain
nausea
falls
intraoperative awareness
anesthesia awareness
cognition
activities of daily living
major morbidity
all-cause mortality
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 73952
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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%.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Surgical and procedural patients who require anesthesia services

Exclusion Criteria:

* Patients under the age of 18 years

Primary outcomes:
measure: quality of life
timeFrame: 1 year
measure: functional health
timeFrame: 1 year
measure: falls
timeFrame: 1 year
measure: cognition
timeFrame: 1 year
measure: emotional health
timeFrame: 1 year
measure: mental health
timeFrame: 1 year
measure: physical health
timeFrame: 1 year
measure: pain
timeFrame: 1 year
measure: intraoperative awareness
timeFrame: 30-90 days
measure: all-cause mortality
timeFrame: 1 year
measure: surgical wound infection
timeFrame: 1 year
measure: nerve injury
timeFrame: 30-90 days
measure: stroke
timeFrame: 1 year
measure: delirium
timeFrame: 30-90days
measure: Stomach Ulcer
timeFrame: 30-90 days
measure: Gastrointestinal Bleed
timeFrame: 30-90 days
measure: Pneumonia
timeFrame: 1 year
measure: Respiratory Failure
timeFrame: 1 year
measure: Respiratory Arrest
timeFrame: 1 year
measure: Pulmonary Embolism
timeFrame: 1 year
measure: Deep Vein Thrombosis
timeFrame: 1 year
measure: Angina
timeFrame: 1 year
measure: Atrial Fibrillation
timeFrame: 1 year
measure: Congestive Heart Failure
timeFrame: 1 year
measure: Cardiac Arrest
timeFrame: 1 year
measure: Heart Attack
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Return to Work
timeFrame: 1 year
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael S Avidan, MBBCh, FCASA
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Anshuman Sharma, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Daniel Helsten, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Arbi Ben Abdallah, PhD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Troy Wildes, MD
role: STUDY_DIRECTOR
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