~ CIRAR PILOT UPDATE ~

Public Health Law and State Reporting of Healthcare-Associated Infections
Kristine Gebbie, RN, DrPH
Patricia Stone, RN, PhD, MPH
Benjamin Mason Meier, JD, LLM, MPhil

Pictured left to right: Dr. Patricia Stone, Dr. Kristine Gebbie, and Mr. Ben Meier. 

This project documents and analyzes current state public health legislation and regulation regarding mandatory reporting of healthcare associated infections (HAI).  HAI are a major source of multiple drug resistant organisms (MDRO), and consequently, the study of HAI has become a focus of the Center for Interdisciplinary Research on Antimicrobial Resistance (CIRAR), which funded the current study.  Through their work at the Center for Health Policy at Columbia University School of Nursing, Drs. Kristine Gebbie and Patricia Stone (also members of CIRAR), and Mr. Benjamin Meier are using a systematic interdisciplinary approach for this study that blends the research methods of law, public health policy, and political science along with expertise in infection control processes and resulting HAI to answer the following significant questions about the mandatory reporting on HAI:

• Which states require reporting of HAI, and if so, is this done by legislation or administrative regulation?

• Are the specific HAI to be reported identified in state law or are these HAI considered to be diseases “of public health importance,” with reporting specified by administrative regulation?

• Whether in law or regulation, what reporting policies and procedures are detailed in law (e.g., who is required to report, at what level of detail, and to whom (if anyone) beyond the public health authority will institutionally identifiable information be released)?

The data collected for each state reporting process have been categorized on the basis of (1) general or specific legislative authority, (2) organisms included (i.e., case/intervention definition), (3) required hospital reporter, (4) detail in the report (aggregate for hospital vs. individual case report), and (5) the extent to which reports are released to the public. The research team is exploring, through analysis of the collected information, the degree to which states that have modernized their respective public health laws to approach mandatory reporting by way of general legislation regarding “matters of public health importance” and subsequent detailed administrative regulation to specify those matters. This project is creating a web-based system amenable to regular updating as regulations are promulgated, communicating its results and analysis to CIRAR staff and the public health community through publications and project reports. 

The following link provides an overview of the HAI Reporting Guidelines (current as of August 27, 2007). 

CIRAR Pilot Studies

In the past 3 years, CIRAR has funded 12 pilot studies:

2007

• Development and Evaluation of an e-Portfolio for Documenting Interdisciplinary Research Competency Development
• Public Health Law and State Reporting of Healthcare-Associated Infections
• A Pilot Study of an Intervention to Improve Antimicrobial Prescribing Practices in the Neonatal ICU

2005

• Antibiotic Resistance Determinants in Oral Bacteria 
• Specification of Competencies Necessary for Effective Interdisciplinary Research
• Computer-Mediated HIV Adherence Counseling
• Identifying Risk Factors for MRSA Infection within the Prison Population: The Staph Infection in Prisons Pilot Study (SIPPS)
• Antimicrobial Resistance and Hospital Compliance with Evidence-based Guidelines

• Impact of Guidelines for Empiric Antibiotic Use: Costs, Resistance, and Clinical Outcomes

• Interdisciplinary Study on the Impact of Rapid Detection of Antimicrobial Resistant Pathogens

• Patterns of Antiretroviral Resistance among HIV Isolates in the Dominican Republic and New York City

• Improving Infection Control for Chronic Diseases: Using the Interdisciplinary Care Team for Patients with Cystic Fibrosis as a Model

PI: Suzanne Bakken (CIRAR Executive Committee Member)

Abstract

The precepts of adult learning as self-directed, problem-focused, experiential, and relevant have been generally accepted for more than 30 years. However, not all pre- and post-doctoral research training meets these educational standards and most training still occurs within the constraints of disciplinary silos.  In the grants that comprise the Center for Interdisciplinary Research in Antimicrobial Resistance (CIRAR) Consortium, we have provided arguments to support the contention that innovative solutions for the globally-significant problem of antimicrobial resistance cannot be designed without knowledge development that crosses disciplinary borders. The Training in Interdisciplinary Research in Antimicrobial Resistance (TIRAR) grant (T-90 in U54) delineates an innovative curriculum for interdisciplinary pre- and post-doctoral training research training in antimicrobial resistance.  The R25 application, Web-based Interdisciplinary Research Education (WIREd) Collaboration, proposes to augment the substantive innovations in the TIRAR curriculum through creative application of leading edge information and communication technologies.  The resources developed through WIREd Collaboration will provide a scaffold to support trainee learning that is tied to a particular course in the TIRAR curriculum and trainee learning across courses and throughout the TIRAR training period.  In this pilot study, we propose to conduct preliminary work related to Aim 1 of the R25: Design and implement WIREd Collaboration, an e-learning approach for enhancing interdisciplinary research competency development and facilitating interdisciplinary communication and collaboration related to the topic of antimicrobial resistance.  Specifically, the aims of this pilot are to: 1) Define the functional requirements for an e-portfolio that supports documentation of interdisciplinary research competency development; and 2) Develop the e-portfolio prototype and evaluate its usability.

PI: Kristine Gebbie (CIRAR Executive Committee Member)

Abstract

The purpose of this pilot project is to document and analyze current state public health legislation and regulation regarding mandatory reporting of healthcare associated infections (HAI).  HAI are a major source of multiple drug resistant organisms (MDRO), and consequently, the study of HAI has become one of the major grants included in the Center for Interdisciplinary Research on Antimicrobial Resistance (CIRAR) Consortium through the Study on Effectiveness of Antimicrobial Resistance Reduction Procedures in Hospitals (SEARCH) project.  Given the dearth of research on the effect of mandatory hospital reporting systems on rates of infection, the SEARCH project is intended to assess the effect of mandatory reporting of infection rates on infection control departments’ practices and their consequent effect on HAI rates.  The proposed study will develop data essential to this planned CIRAR research, developing a resource on state-based laws for mandatory HAI reporting that will be of general use to the field of infection control and can be used in the principal SEARCH study to evaluate the costs of reporting and impact on rates of MDRO. 

This proposed pilot study will use a systematic interdisciplinary approach that blends the research methods of law, public health policy, and political science along with expertise in infection control processes and resulting HAI to answer the following significant questions about the mandatory reporting on HAI:

• Which states require reporting of HAI, and if so, is this done by legislation or administrative regulation?

• Are the specific HAI to be reported identified in state law or are these HAI considered to be diseases “of public health importance,” with reporting specified by administrative regulation?

• Whether in law or regulation, what reporting policies and procedures are detailed in law (e.g., who is required to report, at what level of detail, and to whom (if anyone) beyond the public health authority will institutionally identifiable information be released)?

PI: Lisa Saiman (CIRAR Expert Liaison)

Abstract

In 2002, the CDC launched “The 12-Step Campaign to Prevent Antimicrobial Resistance” to educate clinicians about antimicrobial resistance and to provide strategies to improve antimicrobial prescribing practices.  To date, the efforts of this campaign have been largely educational and publications have focused on development and dissemination of the campaign’s messages.  In focus groups conducted among pediatricians, one of the 12 steps recognized as most critical to reduce antimicrobial resistance was ‘target the pathogen’, i.e., treating a patient with the narrowest spectrum antimicrobial agent appropriate when a pathogen is identified.  In a study that reviewed antimicrobial treatment of 540 hospitalized adults, inappropriate usage was characterized by the CDC 12-Step Campaign.  Overall, 37% of antibiotic courses were considered inappropriate and failure to ‘target the pathogen’ was a common violation.  Thus far, the applicability of The 12-Step Campaign to Prevent Antimicrobial Resistance in Hospitalized Children has not been studied in any pediatric population including the neonatal intensive care unit (NICU), a population which has a high rate of antibiotic utilization.

 The Specific Aims of this pilot proposal are:

• To measure the relative frequency of inappropriate antibiotic-days for infants hospitalized in 4 study NICUs and determine the proportion of inappropriate antibiotic-days that can be attributed to failure to ‘target the pathogen’ as defined by the CDC 12-Step Campaign.
• To develop a focused educational intervention for NICU staff to improve antibiotic utilization by appropriately ‘targeting the pathogen’ and field test the intervention.

PI: Seok-Woo Lee, DDS, MS, PhD, Associate Professor, Division of Periodontics, College of Dental Medicine, Columbia University

Abstract

Antibiotic resistance is well documented in oral bacteria.  Numerous resistant bacteria have been isolated from the oral cavity, cultivated, and their resistance to antimicrobials has been characterized.  A great number of resistance genes have thus been identified and characterized from these microorganisms.  Recent data, however, indicate that novel resistance determinants from uncultivable oral bacteria may remain undiscovered using these techniques, since it was estimated that only half of the total of more than 500 oral bacteria have been cultivated.  The hypothesis of this study is that resistance determinants from uncultivable oral bacteria may remain unidentified using conventional methodologies.

Therefore, a novel metagenomics approach will be adopted to identify and characterize antibiotic resistance determinants from oral bacteria including species that do not grow in the laboratory.  Instead of identifying and assessing resistance determinants from specific resistant bacteria that are grown in vitro, the sequences of resistant determinants will be directly obtained from a complex mixture of oral biofilms.

The purpose of this pilot study is to 1) identify both known and unknown antibiotic resistance determinants from oral bacteria, and 2) globally assess the diversity and distribution of antibiotic resistance determinants among different oral bacterial populations.  The results obtained from this study may contribute to the development of new antibiotic drugs specifically designed to inhibit novel resistance mechanisms.  In addition, this study will provide a global view of the genetic diversity of antimicrobial resistance among different oral biofilms.

PI: Kristine Gebbie (CIRAR Executive Committee Member)

Abstract

Objective: A statement of competencies necessary for a researcher to successfully participate in interdisciplinary research.

Background: The CIRAR has identified a definition of interdisciplinary research, based on extensive review of relevant literature and expert opinion of researchers with experience in interdisciplinary research.  The CIRAR further plans to develop and submit a proposal to support the training of new researchers in interdisciplinary research.  In order for the training to be most effective, it should be competency based.  However, the competencies specific to successful participation in interdisciplinary research have not been specified.

Specific Proposal: The PI will use an established method (a Delphi panel approach)  for identification and specification of competencies in an emerging area of practice to propose and validate competencies in this area.  The necessary steps are:

• draft candidate competencies based on review of literature
• create First Draft Candidate Competencies for outside review, based on comments from CIRAR investigators
• establish external review panel by invitation to other NIH-funded interdisciplinary centers, seeking a mix of disciplines and experience
• obtain feedback on First Draft from panel, identify potential edits, additions and deletions
• develop Second Draft Candidate Competencies based on feedback
• obtain feedback on Second Draft from panel, asking same questions
• draft final statement of competencies for review by CIRAR team and expert panel
• publish final competency statement

Use of these competencies in educational programs should then be evaluated, for potential revisions in 3 to 5 years.

PIs: Suzanne Bakken (CIRAR Executive Committee Member) and Rita Kukafka (CIRAR Expert Liaison)

Abstract

Funds are being requested to support a pilot study for a grant submission to NIH under CIRAR that will further develop the patient adherence module of an interactive decision support system called HIV TIPS.  HIVTIPS, a web based decision support system, offers providers online access to current national guidelines for administering anti-retroviral therapies to HIV+ adults and adolescents. The software has programmed a set of interactive algorithms that generates guidelines for medicating patients given specific patient parameters. It also includes a patient education module to assist clinicians in developing plans to help their patients adhere to prescribed medications.   Antiretroviral regimens are complex, have serious side effects, and therefore pose difficulty with adherence.  Nonadherence or subobtimal levels of adherence carry serious potential consequences for the development of viral resistance.

The proposed study, which this pilot study will provide background information for, will test the efficacy of computer-based adherence counseling interventions for HIV positive individuals.  The counseling interventions will be delivered in three ways: by a counselor (care as usual), by computer (care as usual and patient interaction with HIV TIPS), and by a counselor aided by computer (counselor interaction with HIV TIPS integrated into care as usual).

The pilot study is to conduct semi-structured interviews of counseling staff working with HIV patients. The target population includes social workers, case managers, nurses, peer educators, and other counselors working at HIV clinics.  The survey sample will be recruited from the clinics currently participating in the HIV TIPS study and through the New York/New Jersey AIDS Education and Training Center. Based on findings from the ongoing HIV TIPS study, this population of counselors is receptive to the idea of using a computer based tool in their work.  They represent a diverse group in terms of educational and training background, and do not generally use any well defined guidelines and procedures for their counseling interactions with clients. In order to design an effective intervention for this group of counselors, more information is needed on their current counseling practices and training background, and their specific needs for tools. This survey will provide such background information.

The counselors will be asked about their work practices, especially focusing on the following specific areas: mental health assessment, substance abuse assessment, counseling for HIV medication adherence, and counseling for HIV risk behaviors. The interview will also assess the counselors’ educational and training background and the degree to which their work practices are based on models grounded in theory and research. Finally, the interview protocol will include a needs assessment of how the counselors would benefit from computer based tools for different areas of their work.

PIs: Elaine Larson (CIRAR Director) & Frank Lowy (CIRAR Co-Director)

Abstract

This pilot study aims to examine risk factors for carriage of MRSA among prisoners in one representative maximum security prison intake facility (Sing Sing, New York).  It will allow us to examine logistics, test the validity and acceptability of our questionnaire and data extraction, and assess feasibility for a larger proposal examining prospective risk factors for S. aureus and MRSA carriage and infection with S. aureus and MRSA. 

Goals for the pilot study are to:

• Assess the prevalence of risk factors for carriage of MRSA among a small sample of prisoners at intake
• Test the feasibility and validity of our questionnaire instrument
• Assess the intake process in order to gather information on logistics and implementation of the interview
• Extract specific risk factor data from the New York State Department of Correctional Services (NYCDOC) medical screening reception form
• Test laboratory protocols for testing nasal cultures

PIs: Patricia Stone & Lisa Saiman (CIRAR Expert Liaisons)

Abstract

In the last 6 years, the Center for Diseases and Prevention (CDC) has developed 5 separate infection control guidelines to assist hospitals with reducing the problem of antimicrobial resistance.  However, little is known about the extent to which hospitals follow these guidelines as well as the overall everyday effectiveness of these practices. Guided by Donabedian’s structure, process and outcomes theory of quality, the specific aims of the larger (i.e., R01) study are to:  1) Estimate the extent to which hospital policies are consistent with the evidence-based practice (i.e., CDC’s IA recommendations); 2) Determine hospital characteristics (e.g., size, teaching status, region, staffing) that predict consistency with evidence-based practice; and 3) Estimate the extent that hospital characteristics and compliance with evidence-based practices predicts antimicrobial resistant hospital associated infection rates. The purposes of this pilot project are to 1) develop a web based survey to assess whether hospital policies are consistent with the evidence-based practice recommendations; and 2) pilot test the survey to assess reliability and validity.

The R01 study will use a cross-sectional design. Hospitals will be recruited from the Center for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN, formerly know as the National Nosocomial Infection Surveillance [NNIS] system), which will provide consistent antimicrobial resistant data across hospitals.  Support for this method of hospital recruitment has been obtained from the CDC. The American Hospital Association (AHA) database will be used to determine hospital organizational characteristics.

Evidence-based practice policies will be determined using the survey developed and tested in this pilot study.  Based on the CDC IA recommendations from the 5 infection control guidelines, a web based survey will be developed. The survey will be reviewed for content validity by an expert advisory board. We hope to recruit representatives from the CDC, APIC, SHEA, JCAHO and IHI. Pilot testing of the survey will be completed by infection control professionals at 5 local hospitals. Test-retest reliability will be assessed by asking subjects to retake the survey at a 2 week interval. Criterion-referenced reliability will be assessed by: 1) assessing the hospitals policies to compare with survey responses; and 2) visiting hospitals and observing specific behaviors to compare with survey responses. Kappa statistics will be computed.
 

PI: E. Yoko Furuya, Clinical Fellow, Division of Infectious Diseases, Columbia University Medical Center

Abstract

At the Columbia University Medical Center (CUMC), formulary restrictions requiring prior approval for certain antibiotics were instituted several years ago. This program and the concurrent introduction of piperacillin/tazobactam to the Formulary led to a decrease in third-generation cephalosporin use and an associated decrease in rates of vancomycin-resistant enterococci and organisms with extended-spectrum beta-lactamases (ESBL’s). However, this has not slowed the overall progression of antimicrobial resistance, especially among gram-negative organisms, as antibiotics continue to be used in abundant quantity, specifically those with a broad spectrum of activity. In particular, resistance of gram-negative organisms to fluoroquinolones has been steadily rising over the last 5 years, with inpatient Escherichia coli isolates reported only 66% susceptible to levofloxacin in 2004. More recently, we have experienced an outbreak of multiply-resistant Klebsiella pneumoniae that is susceptible only to colistin. While this outbreak was partially due to an influx of colonized patients from other hospitals and chronic care facilities, it prompted a major reevaluation of our current practices in antimicrobial use.

One activity that emerged from this event was the creation of institution-specific guidelines for the empiric use of antibiotics in adult patients at CUMC, based on local susceptibility and antibiotic use data. These guidelines were created through a collaboration between the Division of Infectious Diseases, the Department of Pharmacy, the Department of Epidemiology, and the Department of Microbiology. The purpose of these guidelines is partially to serve as an educational tool for the medical staff to prompt more uniform and rational use of empiric antibiotics, but perhaps more importantly to encourage the use of more narrow-spectrum antibiotics and to limit their duration. We hypothesize that the utilization of these guidelines will lead to less overall antibiotic use, particularly of broad-spectrum antibiotics, and potentially impact antimicrobial costs, antimicrobial resistance, and unnecessary drug toxicities without negative effects on patient outcomes. We would like to conduct an ongoing evaluation of the impact of these guidelines by comparing outcome measures before and after implementation. Specific aims of the project include the following:

Aim 1:  Assess the medical staff’s perception of antimicrobial resistance, provide education about resistance and the impact of antibiotics, and subsequently evaluate their adherence to the guidelines.
Aim 2:  Evaluate changes in antibiotic use within the institution following implementation of these guidelines.
Aim 3:  Evaluate the impact of these guidelines on antimicrobial resistance patterns within the institution.
Aim 4:  Evaluate the impact of the antibiotic use guidelines on patient outcomes.

If we can use this project to demonstrate a decrease in antibiotic utilization and an improvement in antibiotic resistance without adversely affecting patient outcomes, then we will be able to validate our concept of the ASP. The old model of a smaller, simpler ASP will be replaced with a newer model where a more multidisciplinary team comprised of hospital epidemiology, infectious diseases, pharmacy, microbiology, and biomedical informatics will design and evaluate multi-pronged approaches to combatting the problem of antimicrobial resistance, and additional interventions expanding on the goals of the current empiric antibiotic guidelines will be possible. 
 

PI: Richard C. Huard, PhD, Clinical Scientist, Clinical Microbiology Service, New York-Presbyterian Hospital and Columbia University

Abstract 

Antimicrobial resistance presents a growing threat that may be best addressed through an interdisciplinary collaborative research approach.  The objective of this pilot study proposal is to demonstrate how molecular tools, in particular real-time PCR technology, can be adapted to improve rapid detection and characterization of antimicrobial resistant pathogens by the Clinical Microbiology Service of the Columbia University Medical Center, New York Presbyterian Hospital, and be integrated into a larger interdisciplinary research approach that translates molecular data into improved health outcomes - with overall reduced antimicrobial resistance as the long-term goal.  To provide the proof of principle we will develop rapid molecular identification methods to i) discriminate Mycobacterium abscessus from Mycobacterium chelonae (in conjunction with a molecular assay to predict clarithromycin resistance), ii) differentiate Candida albicans from Candida krusei and Candida glabrata, and iii) identify toxin-producing and/or community-associated drug resistant Staphylococcus aureus (CA-MRSA) strains.  We intend to monitor whether the early reporting of myocbacterial and yeast species with predictable intrinsic drug resistance results in the administration of appropriate species-specific empiric therapy.  We also intend to use the derived molecular data to infer the carriage of virulence factor-producing and/or CA-MRSA in a cohort of pregnant women from out local community. Overall, we expect these studies to provide a solid basis upon which other, more expansive, interdisciplinary studies may be predicated.
 

PI: Jonathan K. Joseph, Clinical Fellow, Division of Infectious Diseases, Columbia University Medical Center

Abstract 

Introduction: The Division of Infectious Diseases, HIV clinic at Columbia University Medical Center (CUMC) has been treating HIV in the predominantly Dominican neighborhood of Washington Heights since the epidemic began.  In 2003 the CUMC HIV clinic staff began a collaborative effort to scale-up HIV treatment at sites in Santo Domingo.  During the process of evaluation and planning, conditions known to be risks for the development of drug resistant HIV were discovered including the uncontrolled availability of antiretroviral medicines.

Methods: We propose a pilot study to sample prevalence and patterns of drug resistance in 50 treatment naïve patients and 50 patients with prior treatment histories from each city.  Each patient tested will undergo a series of questions administered by a social worker or educator in each site.   The patients will be questioned about their travel from one city to another, their knowledge of and participation in the transfer of antiretroviral medicines from New York to Santo Domingo, and other risks associated with the development of drug resistance. 

Conclusion: This pilot study may suggest some links between the development of drug resistant HIV in Santo Domingo and resistance in Dominican based communities in the US.  This may further lead to future extensive and detailed analysis of the amount of drug resistance being generated in Santo Domingo, and the risks of transfer of those resistance patterns to the Dominican Community in New York, or other cities with significant Dominican Populations.
 

PI: Samiya Razvi, DCH, Clinical Pediatric Pulmonology Fellow, Columbia University Medical Center

Abstract 

Despite comprehensive medical guidelines for many diseases, healthcare workers' (HCWs) adherence to guidelines is often suboptimal.  This may be due to Knowledge, Attitude and Practice (KAP) barriers that may include lack of knowledge; disagreement with guideline content; and/or lack of administrative support, self-confidence or time to implement guidelines.  Today as healthcare for chronic diseases shifts from inpatient to outpatient and non-healthcare settings, patients assume responsibility for prescribed home therapies, but little data exist on patients' perspectives regarding medical guidelines.

Cystic fibrosis (CF) serves as an ideal model for exploring patient-centered perspectives on medical guideline.  CF is characterized by frequent respiratory infections with progressively antibiotic resistant pathogens and requires self-administration of several therapies in the home.  Appropriate infection control may delay acquisition of pathogens and the development of antimicrobial resistance.  Contemporary CF care is provided by an interdisciplinary team comprised of physicians, nurses, social workers, physical and respiratory therapists which may serve as a unique tool for assessing CF patients' perspectives on infection control guidelines.

This study aims to develop and administer a KAP survey to CF patients and their families to identify barriers that limit adherence to infection control strategies and compare these barriers with those perceived by their HCWs.  We will utilize the skills and expertise of the interdisciplinary team to obtain comprehensive information from patients and their families.  Through this pilot study we aim to develop a model for improving infection control using an interdisciplinary approach that will serve as the basis for a multi-center study.