CHAPTER I: REFINEMENT OF A STATE-WIDE EARLY

HEARING DETECTION AND INTERVENTION SYSTEM IN UTAH

1.1 Purpose of Project

When babies with hearing loss are identified early, and provided with appropriate audiological, medical, and educational services, they develop language, cognitive, and social skills at a faster rate, and subsequently do better in school. Recognizing the importance of early identification of hearing loss, Utah has been a leader since the early 1970s in developing innovative strategies for early identification of congenital hearing loss.

Until 1993, the Utah Department of Health operated a birth certificate-based high-risk screening program in which the risk factors for hearing loss recommended by the Joint Committee on Infant Hearing (JCIH) were incorporated as a part of the legally required birth certificate. Parents of babies who had any of these risk factors were contacted by a computer-generated letter and invited to obtain a free audiological diagnosis for their baby. Although often cited as a model program, it was not without its problems. First, it was difficult to get parents to bring their babies back for diagnostic evaluations. Second, research in the 1980s showed that only about half of all children with congenital hearing loss had any of these risk factors. Consequently, in the early 1990s, the Utah Department of Health staff began exploring other options for early identifications of hearing loss.

As technological developments related to the measurement of otoacoustic emissions (OAE) or automated brainstem response (ABR) made hospital-based universal newborn hearing screening feasible, Utah was one of the leaders in evaluating and implementing this new technology. The first universal newborn hearing screening (UNHS) program in Utah using OAE was implemented in June of 1993 shortly following the National Institutes of Health Consensus Development Conference, which recommended that all babies be screened for hearing loss before leaving the hospital. By the end of 1996, approximately 70% of all Utah babies were born in hospitals with UNHS programs. In 1998, the state legislature passed a law requiring all birthing facilities to have UNHS program in operation by July 1, 1999.

It is important to recognize, however, that hospital-based screening is only the first step in a process to identify babies with hearing loss and provide them and their families with timely and appropriate services. Unfortunately, many hospitals in Utah have struggled making these connections. For the benefits of universal newborn hearing screening to be available to babies and their families, screening must be appropriately coordinated and linked with diagnostic and early intervention services in a way that is family-centered and culturally competent. Throughout this proposal, the term "Early Hearing Detection and Intervention Program" will be used to refer to all components from hospital-based hearing screening, to follow-up and tracking, diagnosis, and provision of medical, audiological, and educational services. It also includes the provision of culturally competent family support services and providing for all children to be in a medical home. The purpose of this project is to do a refinement of the existing EHDI System in Utah in a way that ensures that all newborns:

1. Receive physiological hearing screening prior hospital discharge.
2. Receive health care in a medical home.
3. Complete an audiological evaluation by 3 months of age if they do not pass the screening.
4. Are enrolled by six months of age in a program that includes appropriate medical, audiological, and educational services if they are diagnosed with hearing loss.

1.2 Organizational Experience and Capacity

Hearing, Speech, and Vision Services (HSVS) at the Utah Department of Health is responsible for providing state-wide screening, diagnosis, consultation, and education in the area of pediatric hearing, speech, and vision disorders. The mission of HSVS is to assure optimal hearing, speech, language, and vision in Utah children through a collaborative, state-wide system of prevention, early identification, and care coordination. HSVS maintains clinical facilities in five geographically distributed locations within the state, all of which are staffed by licensed and certified speech-language pathologists and/or audiologists. Services are also provided in many rural areas of the state through Child Development Clinics held in cooperation with local Health Departments. Once a problem is identified by HSVS, children are referred to appropriate local resources for continued management.

The Principal Investigator for the project, Dr. Thomas Mahoney, has been involved in early identification of hearing loss for many years. Together with other staff from the Department of Health, he developed the birth certificate-based high-risk screening program referred to above. When new technology became available for hospital-based universal newborn hearing screening, he led the way in implementing this technology in Utah. For eight years he served on the Joint Committee on Infant Hearing, and he has served as the chair for the American Academy of Audiology Task Force on Early Identification of Hearing Loss, and president of the Directors of Speech and Hearing Programs and State Health and Welfare Agencies (DSHPSHWA). Because of these professional experiences, he is particularly well-informed about issues related to early hearing detection and intervention systems and has been instrumental in helping people understand that even though all Utah hospitals new have universal newborn hearing and screening programs, there are still substantial challenges in developing an effective early hearing detection and intervention system.

As a part of the 1998 legislation requiring all hospitals to do universal newborn hearing screening, a state newborn hearing advisory committee was created. This committee consists of 12 members appointed by the governor, as listed on page 1 of the Appendices. These members represent audiology, early intervention, family practice physicians, pediatricians, neonatology, health insurance companies, public health, and parents. The committee is responsible for advising the Department of Health on all aspects of early hearing detection and intervention.

1.3 Administration and Organization

The project will be conducted by HSVS. The organizational structure showing the organizations within the Department of Health that are relevant to this proposal are shown on page 2 of the Appendices. The Principal Investigator for the project will be Dr. Thomas Mahoney, who directs Hearing, Speech, and Vision Services (HSVS). Other staff on the project will report directly to Dr. Mahoney, as shown on Figure 1. Training and technical support services will be provided by the National Center for Hearing Assessment and Management (NCHAM) at Utah State University. NCHAM staff have worked closely with HSVS for the last 10 years. Vitae for each of the proposed staff at HSVS and NCHAM are included on pages 3 to 8 of the Appendices.

1.4 Available Resources

The basic infrastructure for an effective EHDI system already exists in Utah, but they are not yet appropriately coordinated. As required by the state, all birthing facilities in Utah have screening equipment, have implemented universal newborn hearing screening programs, and receive oversight from a licensed audiologist. A network of pediatric audiologists who are willing, and have the equipment, to do diagnostic audiological evaluations of infants have been identified. A state computer-based data management and tracking system has been implemented, and all but two hospitals in the state submit data monthly via electronic means to the state database. Regional HSVS offices each have a licensed audiologist who is available to provide free diagnostic assessments for babies referred from the screening programs. Furthermore, the Department of Health is the lead agency for Part C programs for infants and toddlers in Utah; therefore, many of the agencies who are relevant to providing early intervention Services to children identified with hearing loss are also located in the Health Department. Even though these basic components are in place, data collected for the Needs Assessment show that there are still significant gaps that need to be addressed.

1.5 Identification of Target Population and Service Availability

The latest report from the National Center for Health Statistics showed that Utah had 43,059 births, of which 85% were Caucasian, 10% were Hispanic, 2.9% were Asian or Pacific Islander, 1.5% were American Indiana, and .6% were African-American. The target population for this project is all babies born in Utah and their families. Of particular interest to this project are infants and families for whom the current system is not working well. These are primarily families living in the rural/remote areas of the state, and ethnic minorities, particularly those where language is a problem. Although hospitals reported that 98.1% of all newborns were screened prior to being discharged from the hospital during the first 11 months of 1999, most hospitals are struggling with connecting babies referred from the screening program with appropriate diagnostic and early intervention services. Culturally competent support for families (such as providing appropriate services to parents of Spanish-speaking children) continues to be a problem and primary care physicians are not sufficiently involved in newborn hearing screening activities.

Although there is almost universal support for the concept of early identification of hearing loss, there are significant weaknesses in the current system. These weaknesses will be addressed through a collaborative effort that involves a wide-range of agencies and groups, including, but not limited to, the Utah Baby Watch Early Intervention Program, the Parent/Infant Program with the Utah State School for the Deaf and Blind, the Department of Health Child Development and Specialty Clinics, the Utah Telehealth Network, the Intermountain Pediatric Society, the University of Utah Medical Center Department of Pediatrics, and the National Center for Hearing Assessment and Management (NCHAM) at Utah State University (see letters of support on pages 7 to 16 of the Appendices).

1.6 Needs Assessment

For the past three years, HSVS has contracted with the National Center for Hearing Assessment and Management (NCHAM) at Utah State University to assist hospitals in implementing UNHS programs, NCHAM staff have conducted workshops, held quarterly meetings for UNHS program coordinators, and provided a toll-free telephone support line for people to ask questions. As a result of data gathered during these activities, and based on telephone interviews with a sample of hospitals conducted in preparation for this grant application, the status of the EHDI program in Utah, with respect to each of the goal areas outlined in CFDA #93.110ZZ, can be summarized as shown in Table 1.

Information from the needs assessment regarding each of these eight goals areas can be summarized as follows. The basic infrastructure for implementing an effective EHDI system in Utah has been developed. The statewide tracking and data management system provides convincing evidence, however, that major gaps exist. Hospitals report that they are screening 98% of births, but comparisons with vital statistics suggests significant under- reporting in many cases. Refer rates at time of discharge are too high and it appears that a substantial number of babies who need follow-up diagnosis and enrollment in early intervention are not receiving these services in a timely way. A strength identified during the needs assessment, is that a data management is in place that provides credible data about these issues. There is, however, much that remains to be done with respect to helping people

Table 1: Current Status of Utah EHDI Program

understand how to use the data management and tracking system and to link it to other public health data basis to achieve more effective services for children and their families.?

There is also evidence that the current EHDI system works least well for families living in the rural/remote parts of the state and for families from ethnic minorities or who do not speak good English. It is clear from the needs assessment that a good tracking and data management system is essential to identifying the areas where problems exist so that activities designed to improve the system can be appropriately targeted. Based on this needs analysis, the primary areas that need to be addressed are:

• improving the quality of UNHS programs,
• linking screening programs to diagnosis and intervention, and
• continued improvement of the data management system.

Important but less urgent areas deal with medical home and family support.

1.7 Collaboration and Coordination

Identifying infants with hearing loss, and providing appropriate services to them and their families, requires participation from many different stakeholders and disciplines. The essential components of this service system are already in place in Utah among state- and community-based agencies, health care providers, and private groups. In some cases, these groups serve a broader constituency, of which children with hearing loss are just one part. In other cases, their efforts are focused specifically on children with hearing loss.

This project will focus on coordinating the efforts of these groups into an effective, statewide EHDI system. Although the number of collaborators will expand as the work of the grant continues, those thought to be most important at this time, and who have provided letters of support (see pages 9-17) to participate in the project activities, are described below.

1.7.1 Baby Watch Early Intervention Program

The Department of Health is the lead agency in Utah for implementing statewide services for children with developmental delays and/or disabilities from birth to age 3, under the Individuals with Disabilities Education Act (1997), Part C. Although a much broader constituency of children is served, any child with a permanent hearing loss qualifies for the program. Services include multidisciplinary evaluation and assessment; service coordination among providers, coordinators, and agencies; provision of specialty and therapy services such as special instruction, nursing, physical therapy, speech therapy, family support; and other related services and strategies to build on family strengths and child potential. Services are available to children and families without cost. These services are coordinated with HSVS, which maintains clinical audiological facilities in Salt Lake City, Cedar City, Ogden, Price, and Vernal, all of which are staffed by licensed and certified speech/language pathologists and/audiologists. Recycled hearing aids are available through HSVS for financially eligible families.

1.7.2 Utah School for the Deaf Parent/Infant Program

A home-based program for parents of 0- to 3-year-old sensory-impaired children is provided through the Utah School for the Deaf. Services are based on the SKI*HI curriculum, which emphasizes development of language, cognitive, and social skills using a systematic, behaviorally oriented curriculum. Parent advisors are available throughout the state to assist with the implementation of the program and participate with the Baby Watch Early Intervention Program in developing and Individualized Family Service Program (IFSP) whenever a child is identified. This IFSP must be developed within 45 days of a referral being made to the Baby Watch program.

1.7.3 Utah Parent Center

Part of the national network of Parent Information and Training Centers, the Utah Parent Center provides information, referral, training, and support for parents of individuals with disabilities, as well as coordination among parents and professionals. Services include workshops on topics such as parents' roles in the educational decision-making process, behavior management, stress management, and coping strategies. Trained parent consultants are available to meet with each family.

1.7.4 Child Development Clinics

The Department of Health sponsor regular Child Development Clinics in all parts of the state to provide multidisciplinary medical and developmental assessment services for children birth to 5 years of age who have developmental disabilities or chronic illness associated with developmental delay. The program also offers case management services to children with multiple disabilities up to 18 years of age. Staff include a nurse, developmental pediatrician, social worker, psychologist, speech pathologist, nutritionist, plus access to many other clinical specialty services. Parent, family, and community education and involvement is emphasized, as is the importance of early identification diagnosis and treatment. The clinics do not provide routine medical care nor treat acute illnesses, but work closely with the clients' health care providers and the Baby Watch Early Intervention Program.

1.7.5 Speciality Clinic Program

Where necessary, Child Development Clinics are coordinated with the Speciality Clinic Program, which is responsible for ensuring that children with special health care needs throughout the state, regardless of ability to pay, receive specialty health evaluations, diagnostic testing, follow-up care, and medical equipment. The Speciality Clinic Program services most relevant to this project are those associated with genetics. Recent research shows that approximately half of all permanent hearing loss is genetic, and 80% of genetic hearing loss is non-syndromic and inherited in an autosomal recessive manner. Approximately 50% of childhood non-syndromic recessive hearing loss is caused by mutations in the connexin (cx26) gene (GJB2/DFNB1), making it the most common form of autosomal recessive non-syndromic hearing loss, with a carrier rate estimated to be as high as 2.8%. Recent articles published in Pediatrics and other medical journals, have recommended that all newborns with confirmed hearing should have cx26 testing for purposes of genetic counseling of the parents, as well as helping to understand the etiology of deafness. With a relatively small amount of support from the grant, the Child Development and Speciality Clinics provide these services to Utah children identified with hearing loss.

1.7.5 Community-Based Services Program

Families of children with special health care needs require assistance to coordinate their child's care among multiple specialists, primary care physicians, CSHCN providers, managed care providers, and tertiary care providers. Families in rural areas of the state face even greater challenges accessing and coordinating primary and specialty care. The Department of Health's Community-Based Services helps to meet this need through local Health Department contracts, which provide nurse case managers and clerical support throughout the case. Community-Based Services is already coordinating all CSHCN specialty clinics traveling to rural areas to provide diagnostic and treatment services and is willing to coordinate those Child Development Clinics in which children with hearing loss are involved.

Families of children with hearing loss often need help accessing other community agencies and resources in order to meet their child's non-medical needs, including educational, social, and mental health. Families may also need assistance to obtain services such as child care, transportation, or financial assistance to meet their needs. The local nurse managers and clerical support staff provide information and referrals to agencies and organizations to help meet this essential component for families and children in Utah.

1.7.6 Intermountain Pediatric Society

The Intermountain Pediatric Society has worked closely with the Department of Health over the last several years to promote the concept that all children should have a "medical home." A medical home is an approach to providing health care services, which provides a place where a child and family can receive the medical care they need from someone they trust. A medical home includes the following elements.

• Accessible: care is provided close to the child's home, in the community
• Continuous: the same primary pediatric health care professional from infancy and adolescence is provided.
• Family-centered: recognition that the family is the center for strength and support for children and an active participant in their child's care. Information is shared with the family and providers on an on-going basis.
• Coordinated: Families are linked to support, educational-, and community-based services.
• Compassionate Care: Concern for the well-being of the child and family is expressed.

The Utah Department of Health and the Intermountain Pediatric Society have developed a written plan for expanding and supporting the concept of "medical home" throughout the state and will work with HSVS toward the goal of ensuring that all children with hearing loss are connected to a medical home.

1.7.7 Utah Telehealth Network

Because much of Utah is located in rural/remote areas, the Utah Telehealth Network was established in 1966 by the Tele-Medicine Outreach Program at the University of Utah. Connections can be made to other sites including the Utah Department of Health and various sites around the country via dial-up links. A major project of the Utah Telehealth Network is the telecommunications and information infrastructure program (TIIAP), which has a goal of improving services to rural children with special health care needs through the use of Telehealth technology. This project will supplement services to rural children with special needs using video conference technology currently in place through the Utah Telehealth Network. Staff of TIIAP have agreed to support the Child Development Clinics for hearing impaired children in rural areas with Telehealth technology.

1.7.8 Department of Vital Statistics

One of the weaknesses identified during the needs assessment was the fact that not all live births were being included in the database reported to the stated EHDI management system. Linking the EHDI management system to Vital Statistics would not only eliminate this problem, but it would provide a mechanism for contacting parents of children born at home to inform them of the availability of free newborn hearing screening. The Vital Statistics Electronic Birth Certificate database has already been linked to the metabolic screening program for newborns. The director of Vital Statistics has committed to making a similar link with the EHDI data management program.

1.8 Goals and Objectives

The goal of this project is to refine the existing EHDI system so that an effective EHDI system can be operated in Utah and sufficiently institutionalized by the end of the 4-year grant, that it will be maintained without extramural funding. The specific objectives to be completed by the end of four years are listed in Table 2.

Table 2: Objectives for Project to Refine the Utah EHDI System

Objective

1. 99% of all newborns in Utah will be screened for hearing loss before they are discharged from the hospital.

2. Infants who do not pass the screening test will receive an appropriate audiological evaluation by 3 months of age.

3. Infants identified with a hearing loss will be enrolled in an appropriate intervention before 6 months of age and receive appropriate specialty health care (including genetics counseling where appropriate) before 6 months of age.

4. The EHDI statewide data management system will be linked to other relevant public health databases such as Vital Statistics, Birth Defects, Early Intervention, and WIC, to better coordinate services, reduce the number of children lost to follow-up, and provide better data for public health purposes.

5. Less than 10% of infants who fail the screening process will be lost to follow-up before they complete the diagnostic procedures, and, if appropriate, are enrolled in early intervention programs.

6. All infants screened for hearing loss will be connected with a medical home.

7. Families of all newborns will be provided with culturally competent support as part of the screening, referral, diagnosis, and early intervention enrollment process, as judged by evaluation data collected from a sample of parents.

8. All families of newborns will have adequate private and/or public insurance to pay for newborn hearing screening and any necessary diagnostic and intervention services.

9. EHDI services will be organized so that families can use them easily, can participate in decision making at all levels, and are satisfied with the services they receive as judged by evaluation data collected from a sample of parents.

The specific activities used to address the above objectives are described in section 1.10.

1.9 Resources

Resources from this grant will be used to refine the existing Utah Early Hearing Detection and Intervention (EHDI) system. The project will be conducted by HSVS in the Bureau of Children with Special Health Care Needs at the Utah Department of Health. Grant funds will be used only for the purposes described in this proposal. Necessary fiscal control and accounting procedures already in place for Utah Department of Health activities will be used to ensure that funds are appropriately spent.

1.10 Project Methodology

Based on the needs assessment data collected, the activities of this project will focus on:

• Improving the quality of existing UNHS programs in Utah hospitals
• Linking UNHS screening programs to diagnosis and intervention
• Continued improvement of the statewide EHDI data management system
• Connecting babies to a medical home
• Providing culturally competent family support to all infants participating in the EHDI program

During the first two years of the project, most of the emphasis will be on the first three goals, but since the issues are so intertwined, all five areas will be addressed to some degree. It is also important to note that an effective EHDI data management system underlies the work that will be conducted with regard to improving the quality of UNHS programs, linking screening programs to diagnosis and intervention, and connecting children to medical homes. Therefore, activities related to the data management system will be discussed first.

1.10.1 Improving the EHDI Data Management System

Approximately 12 years ago, the Utah Department of Health made a computer based data management system for EHDI programs available to all hospitals in Utah. This system, known as HI*TRACK (Hearing Identification TRACKing), enables people at the hospital to quickly:

• customize the software through user-defined codes and definitions to reflect the specific audiologists, screeners, physicians, and hospitals that are contributing data to that particular database;
• collect basic demographic information for all newborns screened and link that information to data about diagnostic and referral status for infants who need assessment or follow-up services;
• produce program management tools such as tickler lists of infants who need further screening or diagnostic evaluation, and descriptive summarizes of individual screener's performance;
• produce standard and customized letters that communicate the results of screening and diagnostic procedures to parents and/or physicians; and
• generate reports for any specified time period on the status of the early hearing detection and intervention program, including numbers and percentages of infants screened, missed, or lost during inpatient screening, referred for further audiological assessment, and found to have confirmed hearing loss.

The State Department of Health has this same software, and each hospital is required to submit reports at the beginning of each month to the State Coordinator. This data is used by the State Coordinator to assist with tracking and follow-up and to ensure that all babies referred from the screening program receive timely and appropriate services.

Needs assessment data show that although hospital staff have been able to use the software effectively for reporting information to the state about babies who have been screened, they are not using it to its full capacity with regard to ensuring that babies receiving diagnostic evaluations and are enrolled in early intervention programs. Therefore, hospital staff will be assisted during the first year to help them understand and use all of the capabilities of the HI*TRACK system.

One of the current problems is that hospitals are not entering all babies into the system. Thus, the percentage of babies screened looks more positive than it really is (see recent report from the EHDI data management system on pages 18-20 of the appendices). The Director of the Department of Vital Statistics in Utah has already agreed to assist with linking to link the Vital Statistics database to the EHDI database so that the State Coordinator can identified exactly which babies have been missed in each hospital. We have also discussed the possibility of developing a unique medical identification number for all babies born in the state. This will be done in conjunction with the metabolic newborn screening program. The pilot test of this system will be implemented in May 2000.

Once the linkage is accomplished with Vital Statistics, there will be a way of offering hearing screening services to children born at home by matching children in Vital Statistics with the EHDI database. A letter will be sent to parents of all home births and staff at the existing regional offices of HSVS will be available as necessary to follow-up with these parents to offer newborn hearing screening services.

In Years 2-4, project staff will work with other agencies in the Department of Health to link the EHDI database with other systems such as the Birth Defect Registry, Early intervention, WIC, and the Immunization Registry. The advantages of such linkages are substantial. For example, the Birth Defects Registry contains a database of medical and demographic information on about 3% of all babies born in Utah with some type of birth defect. Very little is known about the cause of many birth defects, but it is clear that they are often correlated. By linking information about other birth defects with information about congenital hearing loss we will be able to substantially expand our understanding of the etiology of hearing loss. Another example, the Utah WIC database keeps track of all participants in the federally funded WIC program for supplemental food/nutrition and education to pregnant, breast feeding women of infants, and children up to 5 years of age. Almost half of the newborns in Utah qualify for WIC supplements. Even parents who are unlikely to return for follow-up hearing screening or diagnostic appointments often come back for WIC appointments. Therefore, WIC provides an excellent contact point to remind parents about the need for follow-up to hospital-based newborn hearing screening procedures.

The linkages of the EHDI database to these other data systems provides an excellent opportunity for tracking children who are lost midway through the diagnostic process. The project will be assisted in these efforts by the Community-Based Services Program, who has committed resources to helping find parents who are lost part way through the process. By the end of the 4-year grant, we expect to not only refine the EHDI data management system and to link to Vital Statistics, but to have accomplished linkages with several other databases.

1.10.2 Improving the Quality of Existing UNHS Programs in Utah Hospitals

As shown by pages 18-20 in the Appendices, the state Data Management system provides excellent information about the areas in which UNHS programs need to improve. Some of this improvement will probably happen simply as a result of generating these reports each month and distributing them to hospitals. In other cases, on-site visits and individualized assistance will be necessary. HSVS has set the following goals:

• All babies will be screened prior to discharge
• at least 90% of the babies will pass the hearing screening prior to hospital discharge.
• at least 90% of the babies who need them, will complete an outpatient screening.

This project provides the resources necessary to systematically help hospitals in achieving these goals. The project coordinator will be assisted in these efforts by staff from NCHAM. Quarterly meetings will be held with staff from each of the hospitals in each of four regions of the state. Previously, state-wide meetings have been held, but attendance has not been as good as desired, because some hospitals had to travel so far. The resources of this grant will enable us to hold those meetings on a regional basis.

Experiences of NCHAM staff suggest that hands-on training is often necessary to assist people in achieving reasonable refer rates for both the in-patient and the out-patient screen. Because many of the hospitals who are struggling in achieving these goals are located in rural areas of the state, it is expensive and time-consuming to make on-site visits. During the first year of the project, we will explore using Telehealth links through the University of Utah for doing this hands-on training. In other words, a person can be in their hospital in Blanding, Utah (several hundred miles from the University of Utah) and receive hands-on instruction with a live baby regarding their screening techniques. If such telemedicine procedures prove to be effective, they will be expanded to other sites during subsequent years.

1.10.3 Improve the System for Referral and Audiological Diagnosis

As shown on page 20 of the Appendix, most babies who need an audiological diagnostic evaluation are lost to follow-up.. Newborn hearing and screening is only beneficial if babies who do not pass are provided with timely and appropriate audiological diagnosis. Unfortunately, this has been a serious problem for all parts of the country, including Utah.

To address this problem, we have recently implemented a pilot project based on procedures used successfully in the Mississippi statewide program. Specifically, newborn hearing screening staff in all UNH hospitals will be asked to complete a standard form for babies who do not pass the hearing screen (estimated to be .5% to 1% of all births). The form will contain contact information about the baby, the baby's primary care physician, information about the audiologist the parent has chosen to do the audiological evaluation, and permission by the parent for the hospital and the audiologist to share information on the results of the diagnostic evaluation with the state coordinating office (an example of the form used in this pilot project is included on pages 21 to 22 of the Appendices).

The form will be completed on quadruplicate carbonless paper, with copies for the parent, the audiologist, the hospital, and the state coordinator. The back of the parent and audiologist's copies will have a space for the audiologist to report the results of the diagnostic evaluation. HSVS has recently assembled a list of all audiologists in Utah who have appropriate equipment and are interested in doing infant diagnostic assessments. To be listed as a member of this pediatric audiological network, audiologists had to agree to submit this form to the state coordinator's office within 10 days of completing a diagnostic evaluation for babies. Because a copy of the form is submitted to the state coordinator at the time the baby fails the second-stage screen, the coordinator will be able to identify any babies who have not received a diagnostic evaluation by the time they are 2 months old. In that case, the tracking and follow-up specialist on the project will contact the audiologist to whom the baby was refer and/or the parents to assist in completing an audiological evaluation for that baby. The audiologist at the regional HSVS office will also be available to assist with the location and follow-up efforts.

The data from the pilot test of this system is positive. During the first year of the project, the procedures will be implemented in other Utah hospitals to reduce the number of babies lost to follow-up before a diagnostic evaluation is completed.

Another difficulty with diagnostic evaluations is that there is no protocol with which everyone agrees for conducting these evaluations. This has been identified by the state Newborn Hearing Screening Task Force as a priority. During the first year of the project, a task force of audiologists who have experience with infant diagnostics will be assembled to review protocols already developed by other states (e.g., Texas, Colorado), and to develop a protocol for Utah. This protocol will be used during the second year of the project to assess the quality of the diagnostic evaluations that are being completed for infants. Based on the results of that assessment, it is expected that in-service training and workshops in pediatric diagnostic procedures will be needed. These hands-on training workshops will be organized by the project using expertise from the University of Utah, Utah State University, and Brigham Young University. By the end of the project, audiologists who are interested in participating in the pediatric audiologist network will have to demonstrate that they have appropriate competencies and equipment to evaluate babies. These training courses will provide a mechanism for people who do not yet have those competencies to develop them.

The potential of using the Telehealth Network in the process of certifying audiologists in outlying areas will also be explored. In other words, it is theoretically feasible for someone in Salt Lake to participate in a visual reinforcement audiometry session being conducted in Richfield, Utah, which is several hundred miles away. People at the Telehealth program have expressed their interest in exploring these kinds of applications.

1.10.4 Linking Screening and Diagnostic Evaluations to Early Intervention Programs

There are well-established procedures for referring babies who are diagnosed with a hearing loss to the Baby Watch Early Intervention Program and for those babies to receive services through the Parent Infant Program at the School for the Deaf. Needs assessment data information collected in preparation for this grant, however, suggests that many parents with a newly identified baby with hearing loss are not receiving adequate multidisciplinary assistance through the existing mechanism. In other words, the personnel who are responsible for visiting the family to collect assessment information for the early intervention program often do not have the expertise or experience necessary to deal with the complex issues associated with having a baby with hearing loss.

One way to improve this system is to invite these parents to participate in the Child Development Clinics, which are held regularly throughout the state. These clinics involve a multidisciplinary team (usually a pediatrician, psychologist or social worker, and early interventionist) in which medical and developmental assessments are made and a service plan developed for the family. During Year 1, a sample of parents would be invited to participate in these Child Development Clinics as a part of the IFSP development process and the outcome for these babies would be compared to outcomes for other babies.

In addition, resources from this grant will be used during the first year to explore the feasibility and value of including a geneticist in these Child Development Clinics. Where appropriate, this will allow infants to be screened for mutations in the connexin (cx26) gene (GJB2/DFNB1) and information from this genetic analysis will be used in counseling parents. During the first year, we will pilot test this approach with about 30 parents. If the service is viewed as valuable for parents, the inclusion of genetic screening in the Child Development Clinics will be expanded in Years 2-4.

For parents living in the more remote parts of the state, it may be necessary to pay for travel costs for them to participate in these clinics. In other cases, where English is not the primary language, a translator will need to be added to the team. Ongoing evaluation data will be collected to decide how well this system is working and whether it is cost-efficient.

1.10.5 Improving Family Support

As a part of providing universal newborn hearing services, all hospitals in Utah are required to provide materials to parents prior to the time screening is done, to keep parents informed about the results of the screening, and to make a certain number of attempts to make contact during follow-up. There is a general feeling that the program has been family friendly. But, in fact, there is little data upon which to base this assumption.

During the first year of the project, a systematic assessment of how parents feel about the participation in EHDI programs will be conducted by NCHAM. Based on the results of that evaluation, it is expected that additional activities will be necessary during Years 2-4. For example, a website could be completed, similar to what has been done in Texas, to allow easier access of information and family support materials. Of course, other distribution methods will need to be explored for those families who do not have access to the Internet. For example, although scattered materials to support families exist, they have not been pulled together in a way that makes them easily available to all families. Such a resource manual needs to be developed and needs to be available in at least English and Spanish.

It is also important to explore the degree to which health insurance plays a role in parents' lack of participation in follow-up screening and diagnosis. The objective for this part of the project is to spend the first year doing a systematic assessment, and based on that assessment to development strategies in conjunction with the collaborating agencies and the Newborn Hearing Screening Committee members to respond to the needs identified. As a part of this assessment, a determination will be made about how many families feel that they have a medical home for their child and what the characteristics are which distinguish between parents who feel that they have a medical home and those who don't. This information will be shared with the people at the Intermountain Pediatric Society and the Department of Health, who have been developing strategies and materials to increase the number of babies connected with a medical home.

1.10.6 The Project Activities Time Allocation and Personnel Allocation Charts

These charts are included on pages 33 and 34.

1.11 Plan for Evaluation

The National Center for Hearing Assessment and Management (NCHAM) at Utah State University will conduct an external evaluation of the project each year. Based on information from the three components described below, this evaluation will specifically address each of the objectives listed in Section 1.8.

1.11.1 Analysis of Data from Hospital and State Database

All hospitals will be using the HI*TRACK data management and tracking program. Each hospital will submit data on their program to the Program Coordinator at the beginning of each month. NCHAM staff will work with the Program Coordinator and Data Analysis Specialist to regularly review these data to target technical assistance and training needs. In addition, quarterly reports will be provided for the Consortium meetings related to coverage, referral rates, timeliness and completeness of diagnostic evaluations, and enrollment in early intervention programs. Monthly reports will also be used by the Program Coordinator to identify and respond quickly to specific needs in individual hospitals.

1.11.2 Onsite Visits

Each year, NCHAM staff will conduct onsite visits to a random sample of four or more hospitals in Utah to review the procedures they are using, identify difficulties they are having, assess the support they receive from the State Coordinator's office, and determine the degree to which the objectives of the project are being met by that hospital. A report of these onsite visits will be submitted at the end of each year to the project staff and to the State Newborn Hearing Screening Advisory Committee.

1.11.3 Questionnaires and Interviews

At the end of the first year, and again at the end of the project period, questionnaires and interviews will be used to collect information from parents, hospital screening staff, hospital administrators, physicians, and audiologists regarding the various objectives of the project that cannot be addressed from the HI*TRACK database. Questionnaires will be based on similar evaluations NCHAM staff have done for the Ohio Department of Health, Idaho Department of Health, Hawaii Department of Health, and Rhode Island Department of Health over the past 10 years. Data collection instruments will be designed to take a minimum amount of time from these stakeholders, consistent with gathering the information needed.