Special Emphasis Notice (SEN): AHRQ Announces Interest in Research on Health Care Associated Infections

Notice Number: NOT-HS-10-007

Key Dates
Release Date:  December 10, 2009

Issued by
Agency for Healthcare Research and Quality

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to improve the quality, safety, efficiency and effectiveness of healthcare for all Americans.  AHRQ achieves this mission, in part, by supporting health services research grants.  In Fiscal Year 2010, AHRQ intends to support research designed to prevent and more effectively manage health care associated infections (HAIs) with an emphasis on ambulatory care settings.  AHRQ will fund R01 grants with the following research priorities: 1) development, implementation and demonstration of the prevention of HAIs; 2) determination of the clinical and cost usefulness of preventative interventions; 3) population level studies on the patient risk factors, sources and disease genotypes of antibiotic resistant organisms that can result in perceived HAIs.  This SEN is based on the distillation of existing, peer reviewed research, case studies and qualitative information resulting from a series of listening sessions that occurred in selected cities across the United States in 2009.1

HAIs are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting.  HAIs include antibiotic resistant organisms, which have complex, often unclear sources.  Examples of diseases that can produce HAIs are summarized at: http://www.cdc.gov/ncidod/dhqp/id.html.  HAIs are associated with a variety of causes, including, but not limited to, the use of medical devices, complications following a surgical procedure, transmission between patients and healthcare workers, or the result of antibiotic use.2,3,4  HAIs exact a significant toll on human life. They are among the leading causes of preventable death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002.5  This is a substantial threat to patient safety and public health.  In addition to the substantial human suffering caused by HAIs, the financial burden attributable to such infections is staggering.  It is estimated that HAIs result in $28 to $33 billion in excess healthcare costs each year.6

It is for these reasons, that the prevention of HAIs is a top priority for the U.S. Department of Health and Human Services.  The Department has published the Action Plan to Prevent Healthcare-Associated Infections, which is available at: http://www.dhhs.gov/ophs/initiatives/hai/index.html.  AHRQ continues to facilitate collaborations across the Department, including funding many of the Action Plan’s tier I efforts, which are summarized at: http://www.ahrq.gov/qual/haiflyer.htm and http://www.ahrq.gov/qual/haify09.htm.  The intent of this SEN is not to replicate this current work.  Rather, the objectives of investigator-initiated research are to foster a rounded portfolio of projects on HAIs.  This SEN focuses on the tier II priority of the Action Plan: ambulatory care.7

Ambulatory care settings are defined as non-acute, non-residential settings including practitioner offices, clinics, outpatient departments of hospitals, large or small group practices, community health centers, emergency departments, ambulatory surgery centers, dialysis centers, home care, dental offices, mental health centers, occupational health centers, school health facilities and inmate health facilities.  Ambulatory care also includes transitions from one care setting to another.

The scope of ambulatory care practice has steadily increased over the past several decades due to rapid changes in technology, financing and organization of health services.  For instance, many medical and surgical procedures that were once provided only in hospitals are now routinely performed in ambulatory settings.  Ambulatory surgical centers (ASCs) are the fastest growing provider type participating in Medicare, increasing in number by more than 61 percent from 2000 to the start of 2009.  Estimates are that these centers performed 14.9 million procedures in 2006, or 43 percent of all same-day surgeries.8  A recent survey conducted by the Centers for Medicare and Medicaid Services (CMS) in collaboration with the Centers for Disease Control and Prevention (CDC) found numerous deficiencies in infection control practices at ASCs.  Many ASCs were also unaware of CMS’s Quality of Care requirements.9

Given these findings and their significant impact on patient safety, health care quality and public health, a tier II priority for ambulatory care are to develop and implement cost effective and repeatable HAI prevention strategies for ASCs.

Second, antibiotic resistant organisms have increased in prevalence within health care, resulting in a substantial and unique HAI challenge.  Such infections have increased in the ambulatory setting by 59 percent and in the emergency department setting by 31 percent.10   The sources and patient risk factors of many of these organisms are yet to be determined with certainty in any health setting and do remain controversial.11,12,13  “The sources and routes of tomorrow’s infections are unknown.  Thus, we must remain vigilant in our monitoring of healthcare-associated infections . . . ”7  It is essential as a tier II priority to objectively understand the sources – health care or otherwise - of these resistant organisms and associated patient risk factors so that we have solid information to better patient and health care worker safety.

The priorities stated are not all inclusive.  For instance, the outpatient dialysis population has increased three-fold since 1988 to 2004.14  It has been known for some time that the type of vascular access impacts infection rates.15,16 What is of particular concern in this setting is the high percentage of methicillin-resistant Staphylococcus aureus (MRSA) and associated high mortality.17  Another area of interest is the contribution of environmental disinfection/microbially clean clinical environments and the rates of antibiotic-resistant bacteria.

Applicants are highly encouraged to submit innovative and unique applications, consistent with the research priorities laid out in this SEN.  All applications must demonstrate that the HAI(s) selected for study affects a reasonable cross-section of the United States’ patient population.

Applicants are encouraged to propose quantitative and/or qualitative approaches that are methodologically sound for assessing the impact of proposed preventative intervention(s).  Health care delivery in all settings is complex, involving many active stakeholders: patients (consumers), health care providers, insurers and public health agencies.  The National listening sessions impressed the equal responsibility these stakeholders play in reducing HAIs.1  Applicants are highly encouraged to propose creative and unique interventions that involve consumers, engage the full spectrum of health care professionals (from executives to environmental services), devise creative approaches to leverage the capacities of public health agencies and finally, that involve the active participation of health insurers.  Emerging safety and quality approaches, like risk-informed design and systems-based solutions is also of interest.  We are exploring the practical usefulness of such approaches to the prevention of HAIs.  Risk-informed designs are quality improvement approaches that use tools like failure mode effects analysis, probabilistic risk assessment, modeling, Bayesian analysis and simulation to identify critical aspects/steps in care and in turn focus quality improvements on these high risk areas.  Systems-based interventions use these and related approaches, like ISO 9000 and similar approaches to implement sustainable quality improvements system-wide.18

The knowledge to be achieved through these research efforts is to identify the practical and effective approaches to preventing HAIs, along with definitive determination on antibiotic resistant organisms and their associated patient risk factors.
 
Further guidance:

Priority Populations.  HAIs impact all populations in the ambulatory setting, regardless of age, gender, ethnicity, or socio-ethnic backgrounds.  However, underlying health conditions, selective environmental pressures and lifestyle habits can result in differential risk of acquiring a HAI.  For instance, Native American communities, select rural areas exhibit strains and age distributions that differ from areas with higher population densities.19,20  In another study, recent residence in a long term care facility, regions whose hospitals are located in rural areas and patients over 65 expressed differential risk.21  These nuanced dynamics are important to appreciate, and AHRQ promotes studies with an emphasis priority populations.

Internal & External Validity/Replicability.  The Agency has a preference for supporting research designs that possess sound internal and external validity so that findings can be attributed to the interventions employed and can be generalized beyond a given organization or institution rather than apply solely to the applicant's particular setting.  Sufficient information needs to be given about any system or organizational context variables, which may have a bearing on dependent measures, that may limit the ability to draw generalizable inferences or that need to be known for purposes of replication or adoption.    

Application Submission.  With this notice, AHRQ is providing information about one of the highest research priorities for investigator-initiated applications for fiscal year 2010, beginning with the February receipt date.  AHRQ will continue to provide regular updates of research priorities as research budget information becomes available.  Applications focused on areas identified in this SEN should be submitted on regular research grant receipt dates and will be reviewed by AHRQ’s standing study sections.  Information about the grant application process, including e-grant applications and the funding mechanism noted above, can be found at http://www.ahrq.gov/fund/ or http://grants.nih.gov/grants/guide/pa-files/PA-09-070.html.

The AHRQ designated contact for this SEN is:

            Robert Borotkanics
            Center for Quality Improvement and Patient Safety
            Phone:  301-427-1799
            E-mail:  robert.borotkanics@ahrq.hhs.gov

Applicants are encouraged to contact the designated AHRQ staff early in the process of preparing applications in order to clarify questions and discuss potential research projects.

References:

  1. Reducing Healthcare-Associated Infections: Report on Stakeholder Meetings.  Prepared by The Keystone Center.  2009.
  2. Williams IT, Perz JF, Bell BP.  Viral Hepatitis Transmission in Ambulatory Health Care Settings.  Healthcare Epidemiology, 2004; 38:1592-1598.
  3. Herwaldt LA, Smith SD, Carter CD.  Infection Control in the Outpatient Setting.  Infection Control and Hospital Epidemiology, 1998; 19: 41-74.
  4. Levy DG, Stergachis A, McFarland LV, et al.  Antibiotics and Clostridium difficile Diarrhea in the Ambulatory Care Setting.  Clinical Therapeutics, 2000; 22: 91-102,
  5. Klevens RM, Edwards J, Richards C, Horan T, Gaynes R, Pollock D, Cardo D. Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002. Public Health Reports 2007; 122:160-166.
  6. Scott Rd. The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention, 2009. Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, February 2009.
  7. Wright D.  Testimony Before the House Committee on Appropriations Subcommittee on Labor, Health, and Human Services, Education, and Related Agencies, United States House of Representatives.  April 1, 2009.
  8. CMS Survey & Certification (S&C) Providing Data Quickly (PDQ) Database.
  9. ASC Pilot Survey Project.  Presentation given to the HHS Steering Committee by the Survey & Certification Group.  April 28, 2009.
  10. McCaig LF, McDonald LC, Mandal S, Jernigan DB.  Staphylococcus aureus-Associated Skin and Soft Tissue Infections in Ambulatory Care.  Emerging Infectious Diseases 2006;12:1715-1723.
  11. Seybold U, Kourbatova EV, Johnson JG, Halvosa SJ, et al.  Emergence of Community-Associated methicillin-Resistant Staphylococcus aureus USA300 Genotype as a Major Cause of health Care-Associated Blood Stream Infections.  Clinical Infectious Diseases 2006; 42:647-56.
  12. Liu C, Graber CJ, Karr M, et al.  A Population-Based Study of the Incidence and Molecular Epidemiology of Methicillin-Resistant Staphylococcus aureus Disease in San Francisco, 2004-2005.  Clinical Infectious Disease 2008; 46:1637-1646.
  13. Klevens RM, Morrison MA, Nadle J.  Invasive methicillin-Resistant Staphylococcus aureus Infections in the United States.  Journal of the American Medical Association 2007; 298:1763-71.
  14. United States Renal Data System.  United States Renal Data System 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States.  2006  Bethesda, MD: US Department of Health and Human Services, National Institutes of Health.
  15. Tokars JL, Miller ER, Stein G.  New national Surveillance System for Hemodialysis-Associated Infections: Initial Results.  American Journal of Infection Control  2002; 32 :288-95.
  16. Stevenson KB, Adcox MJ, Mallea MC, et al.  Standardized Surveillance of Hemodialysis Vascular Access Infections: 18-Month Experience at an Outpatient, Multifacility Hemodialysis Center 2000; 21: 200-03.
  17. Invasive Methicillin-Resistant Staphylococcus aureus Infections Among Dialysis Patients, United Sates, 2005.  Morbidity and Mortality Weekly Report 2007; 56:197-199.
  18. Reid PP, Compton WD, Grossman JH, Fanjiang G (Eds.).  Building a better delivery system: a new engineering/health care partnership.  2005  National Academies Press: Washington, DC.
  19. Shukla SK, Stemper ME, Ramaswamy SV, et al.  Molecular characteristics of nosocomial and native American community-associated methicillin-resistant Staphylococcus aureus clones from rural Wisconsin.  Journal of Clinical Microbiology 2004; 42: 3752-57.
  20. David MZ, Rudolph KM, Hennessy TW, et al.  Molecular epidemiology of methicillin-resistant Staphylococcus aureus, Rural Southwestern Alaska.  Emerging Infectious Diseases 2008; 14: 1693-99.
  21. Polgreen PM, Beekmann SE, Chen YY, et al.  Epidemiology of methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus in a rural state 2006; 27: 252-6.


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