E-CIRVE: Exploratory Center for Interdisciplinary Research in Vaccinology

Exploratory Center for Interdisciplinary Research in Vaccinology at Emory
(E-CIRVE)
Pilot Projects – Influenza Vaccine Policy

Project Lead: Walter A. Orenstein, MD, Director, Emory Program for Vaccine Policy and Development; Associate Director, Emory Vaccine Center; and Associate Director, Southeastern Center for Emerging Biologic Threats (SECEBT)

Research Lead: Julie A. Gazmararian, PhD, Research Associate Professor, Emory Center on Health Outcomes and Quality, Rollins School of Public Health

Research Assistant: Mila Prill, MSPH Student, Rollins School of Public Health

Working Group: Centers for Disease Control and Prevention, Georgia State Health Department

Background

Annual influenza epidemics are a major cause of serious morbidity and mortality. Despite the availability of a safe and effective vaccine, approximately 36,000 persons die from influenza and about 114,000 are hospitalized during a typical epidemic. About 90% of the deaths occur in adults who are 65 years of age or older. Current immunization policy is targeted to those who are at greatest risk of complications from influenza, including all persons older than 64 years of age. While annual vaccination coverage in this age group has more than tripled in the past two decades, now approaching 70%, the estimated number of deaths associated with influenza disease has actually doubled. The reasons for this increase in deaths are unclear, but one concern is the decreased efficacy of vaccine in the frail elderly (30-40%) compared to an efficacy of 70-90% among younger healthy adults.

For many years, Japan had a policy of vaccinating school-aged children, which was later terminated. A retrospective ecologic study reported that the health burden from influenza was substantially reduced in the elderly during the period of vaccination of school-aged children, suggesting that vaccinating such children, by decreasing transmission of disease, indirectly protected the high risk groups. Children often have the highest attack rates for influenza. Mathematical modeling studies, performed at Emory University, support the concept that vaccination of school-aged children, with present influenza vaccines, may be the best way of reducing the substantial health burden from influenza. As a result of the problems encountered in controlling influenza, a major question is whether the current policy recommending vaccination of high risk groups only should be changed to include vaccination of all children. This would represent one of the most radical changes ever made in immunization policy. For example, vaccination of children ages 5 through 18 years could make 56 million children eligible for vaccination, during a two month period, annually.

Changing policy will require evidence that full implementation of vaccination of children would actually be more effective at reducing burden and would be safe. Information needed includes the magnitude, duration, and quality of the immune response to the virus as well as the protection induced, not only against the homologous strain in the vaccine, but also against heterologous strains that could become prevalent. A change in policy would also require evidence that such vaccination was feasible, that it would be economically justifiable, and that it would be ethical to vaccinate one group when the major benefits would be obtained by another. Further, the policy would be more acceptable if there was buy-in from key stakeholders for a change prior to a decision and if there were data on what information and interventions were likely to lead to high levels of implementation.

Reducing the risk of exposure to influenza of persons at high risk of complications of disease through vaccination of their contacts has been an influenza vaccination policy for many years. Health care workers (HCW), because of their contacts both with patients with influenza as well as those at risk of complications should be vaccinated annually. However, coverage among HCW has been low and many have the same misconceptions about disease and vaccine as the general public. Understanding the reasons for the failure of HCW vaccination programs and designing effective interventions may have benefit not only for HCW targeted efforts but for general population vaccination efforts too.

The pilot projects undertaken by E-CIRVE address many of these key issues to assist with implementation of a change in policy to vaccinate all children. The overall goal of these pilot projects is to determine the potential effectiveness and feasibility of mass vaccination of the United States population against influenza. Results from the pilot projects will allow us to better evaluate the logistics, problems, and costs involved in effectively implementing a broader influenza vaccination policy. A description and status report of each project is described below.

AFIX – Assessing Immunization Practices, Coverage, and Costs

Objectives

Specific objectives of this pilot project include to:

Determine the feasibility and best practices for providing influenza vaccine to children; and

Assess current influenza immunization practices of clinicians who care for children and correlating those practices with actual immunization coverage levels.

Study Design

Each year the Georgia Immunization Program visits all public (n=213) and half of the private hospitals and clinics (n=948) that participate in the federal program, Vaccines For Children (VFC). They conduct evaluations and surveys for the assessment-feedback portion of the AFIX program, in addition to collecting influenza coverage data.

Our interdisciplinary workgroup developed a questionnaire to compliment the information already being collected. Some practices completed a long version of this questionnaire while other completed an abbreviated version. The survey asked questions to help us better understand the logistics of providing influenza vaccines to children, which policies help achieve the highest immunization coverage rates, the attitudes of medical staff toward expanded vaccination recommendations, and the barriers to more extensive use of influenza vaccines for more children such as those enrolled in school. Furthermore, information is being collected to conduct a cost analysis. Our collaborators with expertise in health economics and industrial engineering are leading the cost analysis.

Progress to Date

This survey has been completed, and the analysis is being prepared for publication.

Stakeholders

Objectives

Specific objectives of this pilot project include to:

Evaluate underlying knowledge, concerns, and beliefs of key stakeholder groups;

Assess whether there is buy-in from key stakeholders for a change prior to a decision; and

Collect data on what information and interventions are likely to lead to high levels of implementation.

Study Design

This project utilizes qualitative methodology, both focus group discussions and in-depth interviews with key stakeholders, to obtain important information to guide future research and policy directions. Each of these methodologies will be described below.

Focus Groups

We plan to conduct about nine focus group discussions among mothers of children enrolled in elementary schools in the metro-Atlanta area. Each group will consist of 6-8 individuals and will reflect diverse demographic characteristics. We plan to limit the focus groups to mothers since studies have shown that they are the primary decision makers regarding childhood vaccinations. Groups will also reflect different racial/ethnic and socioeconomic characteristics. Total enrollment in the focus groups is estimated at between 54 to 72 individuals depending upon the size of each group.

We have contracted with a professional facilitator who will coordinate the recruitment process and conduct the focus group discussions. The focus group sessions will be audio taped and later transcribed from the tapes. The focus groups will be conducted in facilities that have one-way mirrors so the research team will also be able to observe the discussions. A meal will be served during the focus group discussion and we plan to provide a $75 gift (e.g., gift certificate) to thank participants for their time and input. We will also provide a one-page information fact sheet about current influenza recommendations at the end of the focus group discussions to each participant.

In-Depth Interviews

We will conduct a series of in-depth interviews which will target representative members of specific populations – practicing physicians and their office staff, third party payors of health care, school authorities in the regions from which the focus groups were recruited, and public health officials from states both with and without anti-thimerosal legislation. We anticipate conducting between 24 to 34 in-depth interviews.

The in-depth interviews will be audio taped and later transcribed. We will send our interview guide to each respondent prior to the interview to help them prepare their responses. The interviews may be conducted in person or by phone . We plan to provide a meal during the interview as well as a $50 gift to thank each respondent for their time and input. We will also provide a one-page information fact sheet about current influenza recommendations at the end of the interview.

For both the focus group discussions and in-depth interviews, we will discuss topics such as: knowledge of influenza and vaccination policy; beliefs about influenza vaccination; attitudes toward influenza vaccination policy; and current and future influenza vaccination behaviors.

Progress to Date

We have finalized the screener for focus group participants and plan to begin recruiting during the first week of February. We anticipate conducting the focus group discussions in mid-February and have begun drafting the facilitator’s guide. For the in-depth interviews, we have developed our list of potential interviewees and are beginning to further develop our interview guide. The study has received IRB approval.

Healthcare Workers Study (funded by Chiron Foundation)

Background

Annual vaccination of health care workers against influenza has been recommended by the Advisory Committee on Immunization Practices (ACIP) for many years. - These recommendations are designed to protect health care workers who may care for patients with influenza, to decrease employee absenteeism during the influenza season, and to prevent health care workers from transmitting influenza to their patients and their families. Despite the evidence that influenza vaccine is effective in preventing illness among Health Care Workers (HCWs) and that vaccination of HCWs can help protect their patients, annual vaccination rates for HCWs have remained low, typically at less than 45%. ,

Objectives

We are proposing a three phase project with the overall goal of improving influenza vaccine coverage rates among health care workers in hospital settings in the Atlanta area. Phases II and III are contingent upon additional funding. The specific objectives of the first phase are to:

evaluate influenza vaccination policies and practices for health care workers;

obtain data on recent vaccination coverage (2004-2005 season) for health care workers;

determine if particular policies and practices are associated with higher coverage rates.

There are no studies which compare and contrast influenza vaccination coverage rates among different acute care facilities in a single community nor data on the differences in policies that might account for differences in coverage rates. Information obtained during phase I will help guide the development of a survey to identify barriers and potential interventions to increase influenza vaccine coverage rates among health care workers (phase II). The information from phase II will be used to develop an intervention program to increase vaccination rates (phase III). Collection and dissemination of information on influenza vaccination policies and coverage rates in multiple institutions in a given community has the potential to improve coverage in all institutions by documenting which policies appear to be most effective and by showing the poorer performers that success can be achieved.

Study Design

The study population for phase one includes 12 hospitals in the metro-Atlanta area. Data for phase I was collected by in-person interviews with the Directors of Infection Control Programs and Directors of Employee Health Programs at each of the targeted hospitals. We developed an interview guide (see Appendix B) and sent this to our target interviewees at each hospital to review prior to our in-person interview.

Progress to Date

We completed 15 interviews representing all twelve facilities. Both the Director of Infection Control and Director of Employee Health were contacted at each facility. For most of the facilities, the Directors indicated who would be the most appropriate person to complete the interview; in many situations, only one person completed the survey. Several of the facilities are under the same employee health/infection control departments, so, only ten facilities are actually represented in the preliminary data tables. These facilities represent 38,568 beds in the Metro Atlanta area.

Integration of Disciplines:

For all of our projects, we have been working closely with an interdisciplinary group from Emory University, the Centers for Disease Control and Prevention, and the Georgia State Health Department. The working group represents expertise in behavioral sciences, epidemiology, industrial engineering, communications, clinicians, and health economics.

1 CDC. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2003;52(RR-8):1-34.

2 CDC. Immunization of health-care workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee. MMWR. 1997;46(RR-18):1-45.

3 Boylard EQ, Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchmann SD. Guideline for infection control in healthcare personnel, 1998. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1998;19(6):407-63.

4 CDC. Estimated influenza vaccination coverage among adults and children – United States, September 1- November 30, 2004. MMWR. 2004; 53(49): 1147-1153.

5 Dash GP, Fauerbach L, Pfeiffer J, et al. APIC position paper: Improving health care worker influenza immunization rates. Am J Infect Control 2004;32(3): 123-125.