Trial record 3 of 16 for:    Open Studies | "Stomach Ulcer"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02032030
First received: January 7, 2014
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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
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

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • functional health [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • falls [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • cognition [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • emotional health [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • mental health [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • physical health [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • intraoperative awareness [ Time Frame: 30-90 days ] [ Designated as safety issue: No ]
  • all-cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • surgical wound infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • nerve injury [ Time Frame: 30-90 days ] [ Designated as safety issue: No ]
  • stroke [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • delirium [ Time Frame: 30-90days ] [ Designated as safety issue: No ]
  • Stomach Ulcer [ Time Frame: 30-90 days ] [ Designated as safety issue: No ]
  • Gastrointestinal Bleed [ Time Frame: 30-90 days ] [ Designated as safety issue: No ]
  • Pneumonia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Respiratory Failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Respiratory Arrest [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pulmonary Embolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Deep Vein Thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Angina [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Atrial Fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Congestive Heart Failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cardiac Arrest [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Heart Attack [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Return to Work [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Return to work after surgery


Estimated Enrollment: 36000
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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%.

Criteria

Inclusion Criteria:

  • Surgical and procedural patients who require anesthesia services

Exclusion Criteria:

  • Patients under the age of 18 years
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032030

Contacts
Contact: Sherry L McKinnon, AA mckinnos@anest.wustl.edu
Contact: Michael S. Avidan, MBBCh, FCASA avidanm@anest.wustl.edu

Locations
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Michael S Avidan, MBBCH, FCA       avidanm@anest.wustl.edu   
Contact: Sherry L McKinnon, AA       mckinnos@anest.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Michael S Avidan, MBBCh, FCASA Washington University School of Medicine
Study Director: Anshuman Sharma, MD Washington University Early Recognition Center
Study Director: Daniel Helsten, MD Washington University Early Recognition Center
Study Director: Arbi Ben Abdallah, PhD Washington University Early Recognition Center
Study Director: Troy Wildes, MD Washington University Early Recognition Center
Study Director: Anke Winter, MD, MSc Washington University Early Recognition Center
  More Information

Publications:

Responsible Party: Michael Avidan, Director, Institute of Quality Improvement, Research & Informatics (INQUIRI), Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02032030     History of Changes
Other Study ID Numbers: 201203088
Study First Received: January 7, 2014
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
quality of Life
pain
nausea
falls
intraoperative awareness
anesthesia awareness
cognition
activities of daily living
major morbidity
all-cause mortality

Additional relevant MeSH terms:
Stomach Ulcer
Apnea
Atrial Fibrillation
Delirium
Embolism
Gastrointestinal Hemorrhage
Heart Arrest
Heart Failure
Myocardial Infarction
Pneumonia
Pulmonary Embolism
Stroke
Surgical Wound Infection
Thrombosis
Ulcer
Venous Thrombosis
Wound Infection
Respiratory Insufficiency
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 18, 2014