PURPOSE

Over the past decade, consensus statements and guidelines have been developed advocating universal newborn hearing screening (UNHS) (NIH, 1993; Joint Committee on Infant Hearing, 1994; American Academy of Pediatrics, 1999; Healthy People 2010 Objectives,1999). Research (Yoshignaga-Itano, 1999) confirms that treatment outcomes are most positive when infant hearing loss is identified and intervention started prior to the seventh month of age. Without UNHS, nearly 50% of newborns with hearing losses will not be diagnosed until at least the second year of life, missing an important therapeutic window (NIH, 1993; JCIH, 1994).

Although not mandated in North Dakota (ND), hospitals in Minot, Grand Forks, and Fargo have adopted UNHS as standard practice. In 1998, these birthing hospitals accounted for approximately 39% of ND’s newborns. The ND Children’s Special Health Services’ (CSHS) UNHS survey (1999) identified barriers preventing expansion of UNHS into other ND hospitals. Health providers cited equipment costs, operating expenses, lack of trained knowledgeable staff, physician acceptance, support services, and low birth numbers as reasons for not pursuing the UNHS program.

The UNHS1999 survey revealed only 57% of those infants failing the initial hearing screening actually received a second screening. Further, one-third of the infants failing a second screening received full audiological evaluations. Inadequate program design and inconsistent protocols contributed to the lack of follow-up.

Implementation of a UNHS program that addresses procedures for appropriate follow-up is a critical need in ND. The proposed ND UNHS program will incorporate features of UNHS programs implemented in several other states (e.g., Colorado, Maryland, Utah, Rhode Island). These programs have been validated and match currently accepted standards of practice. Further, specific features of the Colorado (CO) UNHS program are tailored to the demographic similarities between ND and CO.

All ND birthing hospitals (30) will be provided equipment and training to conduct UNHS. Regional coordinators throughout the state will support these hospitals and health professionals by overseeing all components of the ND UNHS program including screening, follow-up testing, and early intervention. The ND program will require hearing screening at birth, prior to hospital discharge. Testing will be provided by incorporating either auditory brainstem response or evoked otoacoustic emissions. Re-screening will be completed within two to four weeks if the first screening is abnormal. A referral for an audiological evaluation will be completed on children who fail the re-screening before the end of the third month after birth. A referral for early intervention services will also be initiated immediately following identification of a hearing loss.

The proposed project will be a full implementation of UNHS for ND. It will provide physiological hearing screening to over 90% of all newborns in ND before hospital discharge and refer those identified to appropriate early intervention services. Specific referrals will be made to the newborn’s medical home, the appropriate regional Human Service Center, the Family to Family Support Network, and the ND School for the Deaf (NDSD) birth to three agency.

ORGANIZATIONAL EXPERIENCE AND CAPACITY

The North Dakota Children’s Special Health Services division of the Department of Human Services (CSHS) administers the Maternal and Child Block Grant fund dedicated to children with special health care needs. CSHS works in close partnership with the Maternal and Child Division to improve the health and well-being of mothers, infants, and children in ND. As a Title V agency, CSHS has a long history of paying for diagnostic services to identify children with hearing loss as well as the hearing aids required for treatment of eligible children. Through its Birth Review Program, CSHS works collaboratively with other departments to identify as-risk newborns and provide information and referral services to their families. The population served through this program includes infants who have risk factors that may affect hearing abilities. CSHS has named the North Dakota Center for Persons with Disabilities (NDCPD) as the financial and operational agent responsible for the proposed statewide program for universal newborn hearing screening (UNHS). The letter of designation and cooperative agreement are included as Appendix B.

The NDCPD is a University Affiliated Program at Minot State University (MSU) funded by the U.S. Department of Health and Human Services Administration on Developmental Disabilities. One of the missions of the NDCPD is to engage in activities that prevent developmental disabilities. The NDCPD has a state-wide mandate to increase the availability of services to individuals at-risk for disabilities. It engages in a range of research, development, and training activities to serve persons in ND with disabilities.

Faculty at NDCPD are drawn from MSU academic programs including the Communication Disorders, Education of the Deaf, Psychology, Computer Science, and Social Work. The Communication Disorders Department provides the only ND audiology training program which in conjunction with a comprehensive audiology/speech-language clinic. Faculty participate in the operation of the clinic and provide supervision for students completing audiology practica in a variety of community, institutional, clinical, and school settings. Last year, the department’s audiology clinic provided services to over 2,500 individuals.

As an interdisciplinary organization, NDCPD has participated in and facilitated implementation of a variety of statewide programs. The Title V Children’s Special Health Services is administered in North Dakota by the ND Department of Human Services (DHS). NDCPD has worked with several divisions of DHS including Vocational Rehabilitation, Developmental Disabilities, Infant Development, and Children’s Special Health Services to conduct statewide training and program development.

In particular, NDCPD assisted in the initial development and launching of the ND State Assistive Technology Project. It has developed and replicated a state-wide program of child-care support services through the Infant Development Program for infants and toddlers with disabilities. NDCPD currently operates a staff development and training program serving the statewide network of community facilities for adults with mental retardation.

NDCPD has the capacity to manage the proposed project and implement the planned tasks. Over the past six years, NDCPD has operated two large-scale regional projects involving the purchase and deployment of over $2 million in computer and telecommunications equipment to community locations. The faculty and staff at NDCPD have the experience, technical expertise, administrative capacity, and organizational infrastructure to successfully implement the proposed UNHS program.

ADMINISTRATION AND ORGANIZATION

As an interdisciplinary organization, the NDCPD works with academic divisions at MSU, ND service programs, community service providers, and the private sector to develop and implement project activities. Figure 1 provides an organizational chart describing staff, programmatic responsibilities, and supervisory lines for the project. The proposed membership of the project Advisory Panel includes a broad representation of state agencies, community health care facilities, professional organizations representing a variety of disciplines, and consumer/family organizations. Additional stakeholders in ND will have less formal links to the project through the State Implementation Coordinator and the Principal Investigator.

AVAILABLE RESOURCES

Currently ND has no resources directed to carry-out the proposed project. To establish UNHS in ND, additional funding is necessary for equipment acquisitions, staff, faculty to develop and conduct training, and the dissemination of public information materials. The project will rely on the resources of the Minot State University Department of Communication Disorders and Special Education (MSU-CDC), the North Dakota Center for Persons with Disabilities (NDCPD), and the North Dakota Children’s Special Health Services Division (CSHS).

Resources

MSU Department of Communication Disorders and Special Education - The department offers the only audiology training program in the state of ND. The audiology faculty of the department will participate in developing and conducting training on infant hearing screening for other practicing audiologists in the state. They will also provide training for health technicians, nurses, and other support personnel who may be called upon to conduct the UNHS services.

North Dakota Center for Persons with Disabilities - The NDCPD is an organizational unit of MSU. It has access to all of the resources of the University to carry-out the proposed activities. Resources such as MSU’s television studio, computer network, library, statewide Interactive Video Network classrooms, and the Continuing Education Division will be useful for conducting the training and inservice functions of this project. NDCPD has a multimedia Internet design lab with over $1 million worth of computer and media equipment. This facility provides an interdisciplinary environment for faculty, students, and technicians to create virtually any kind of Internet-deliverable media.

North Dakota Children’s Special Health Services Division - The CSHS, funded by the Maternal Child Health Block Grant, is committed to supporting the implementation of UNHS. Staff of CSHS have conducted the initial needs assessment activities and facilitated planning efforts that have helped articulate the broad parameters of the proposed project. The Cooperative Agreement between NDCPD and CSHS (Appendix B) specifies the points of agreement that will make this project a collaborative effort combining the scientific, educational, policy development, and system planning strengths of both organizations.

If funded, project activities will be carried out by MSU-CDC and NDCPD faculty and staff. CSHS will also provide a 5% FTE of one staff member to work on this project.

Personnel

David Williams (Ph.D., CCC-SL/P) - Dr. Williams will serve as Principal Investigator. He is a professor and chair of the Communication Disorders and Special Education Department at MSU, with a specialty in early childhood phonological and language disorders. Dr. Williams will oversee the project and coordinate with stakeholder organizations throughout the state. Specifically, he will work with the staff of the CSHS Division to integrate UNHS into the long-term planning for sustaining the program after the grant. He will work approximately 15% FTE on the project in conjunction with duties at MSU. Dr. Williams has over 25 years of experience directing projects.

Stephanie Martin (Ph.D., CCC-A/SLP) - Dr. Martin is the Director of Audiology at MSU where she is responsible for graduate training and program development. She is dually certified and licensed in audiology and speech/language pathology. Her areas of expertise are pediatric amplification and central auditory processing disorders in children. Dr. Martin will be responsible for the training component of this project and will work 20% FTE.

Larry Martin (M.S., CCC-A) - Mr. Martin is a licensed and certified audiologist practicing at Trinity Hospital in Minot, ND. In June 2000 he will receive a Doctorate of Audiology (Au.D.) from the University of Florida. Prior to receiving a Master’s Degree, Mr. Martin specialized as a consultant in the technological side of audiology as a special instrument distributor. He developed and implemented the first UNHS program in ND in 1996 at Trinity Health. Mr. Martin will work 20% FTE and will oversee its technological aspects of the project. He will also work with the Advisory Panel task force in developing the overall protocols to be used by the UNHS program.

Sue Burns (R.N., B.S.N.) - Ms. Burns specializes in newborn and pediatric nursing. She is employed by ND CSHS and is the Maternal Child Health (MCH) State Hearing contact for ND. Ms. Burns has been instrumental in conducting the needs survey and initial planning meetings that have set the broad goals for this project. She will serve as the state implementation coordinator, working 5% FTE on this project in conjunction with her other duties. She will facilitate planning and integration of the UNHS program with state and local disability prevention, early intervention, and health and family support activities. She is in a unique position to assist in facilitating the planning and activities to sustain the UNHS program long after the current grant funding expires.

Bryce Fifield, Ph.D. - Dr. Fifield is the Executive Director of the NDCPD. Over the past seven years, Dr. Fifield has designed and managed large statewide data sets on longitudinal research studies. Dr. Fifield will work 5% FTE on the project. He will assist project staff in designing data reporting and management systems for conducting the evaluation activities. He will also assist the project in developing cost-benefit analyses to be used in planning for long-term maintenance of UNHS in ND.

IDENTIFICATION OF TARGET POPULATION AND SERVICE AVAILABILITY

The target population for the proposed project is every newborn in ND. Date from 1998 showed that 9,156 (resident and non-resident) infants were born in ND. The state has 32 birthing hospitals and clinics. Among the special service populations in the state are three American Indian Reservations served by Indian Health Services and two Air Force bases served by military clinics. As with many ‘frontier’ states, the majority of ND’s population lives in a few larger communities including Fargo, Grand Forks, Bismarck, Minot, and Dickinson. These communities are currently served by seven comprehensive medical facilities. Together, these facilities serve approximately 60% of the state’s population.

Several rural communities are served by small hospitals. The communities of Williston, Jamestown, Belcourt, and Devils Lake serve an additional 10% to 15% of the state’s population. The remainder of the state’s population reside in small and isolated communities served by rural health clinics, most of which are satellites to the larger referral hospitals.

The most recent ND survey assessing the impact of newborn hearing screening was conducted by CSHS (1999). This survey revealed, of the 1998 births, 3,588 received an objective hearing screening prior to hospital discharge. Only three of a possible 32 medical centers provided newborn hearing screenings. All three hospitals utilized evoked otoacoustic emissions or auditory brainstem evoked response audiometry (ABR). While the efforts of these three medical centers were impressive, no other hospitals have initiated universal newborn hearing screening programs. Statewide UNHS has not been realized in ND at this time.

Barriers and Problems Associated with UNHS Programs

Respondents to the survey conducted by CSHS (1999) identified the most common problems associated with UNHS was equipment costs and lack of funds. Additionally, survey data indicate that physicians, audiologists, and technicians employed by hospitals were either not available or trained to conduct newborn hearing screening.

Low birth rates in rural hospitals suggest that equipment purchases and personnel for UNHS programs may not be cost effective. Finally, survey respondents were concerned about inadequate physician. While this barrier withers under the glare of scientific data demonstrating the cost effectiveness and programmatic benefits of UNHS, the importance and impact of physician and public education should not be underestimated.

Existing Services and Support

Three community hospitals are currently providing UNHS services in strategic geographic areas in the state and promote statewide standards of practice. Additional support in the state is present through expertise provided by the audiology program at MSU, the NDCPD, and the ND CSHS. There is interest and support for UNHS in the state legislature. During the last legislative session, a bill supporting UNHS was narrowly defeated in the ND House of Representatives. This project will advocate for legislative support for UNHS. Additionally, an outpouring of support for the project from across the state has been evident from the number of professionals, agencies and consumer groups that have enthusiastically responded to the idea of a UNHS. The Marion Downs National Center for Infant Hearing (see Appendix C) has agreed to provide professional consultation towards implementation and continued support of this UNHS program. Additional structuring of this program has occurred with the web page support of agencies such as American Hearing-Speech-Language Association (ASHA), Center for Infant Hearing (MDNCIH), and the National Center for Hearing Assessment and Management, Utah State University (NCHAH) as well as other support web sites.

NEEDS ASSESSMENT

In 1999, CSHS conducted a survey of the status of UNHS in ND. Of 9,156 (resident and non-resident) births in 1998, only 3,588 (39%) received hearing screening before hospital discharge. Only 3 of 32 birthing hospitals in the state conduct universal newborn hearing screening. The survey also found that follow-up screenings are problematic for hospitals conducting UNHS programs. Of the 493 infants who required a rescreen after the initial UNHS before discharge, only 281 (57%) returned for the recommended follow-up screening. Further, 21 (7.5%) of the newborns did not pass the second screening, but only seven (30% of those failing a second screening) were referred for a complete hearing evaluation. Clearly, the value of UNHS will be severely limited if adequate procedures for follow-up and referral are not developed.

Poor follow-up may be affected by inadequate infant tracking systems and limited support for a UNHS. Even though the community hospitals have chosen to implement UNHS programs, they have done so without proper communication with one another. Each of the current three programs are operating independently of one another. Each has chosen their own method of implementation. This lack of communication and mix match of programs provides a greater probability of inconsistencies and restricts implementation of a uniform statewide UNHS program. Specifically, no statewide plans are in place which provide UNHS database information, guidelines or technical assistance for medical centers providing newborn hearing screening services. Without a UNHS database, medical centers cannot effectively assess program effectiveness, costs, or coordinate services with early intervention professionals, and the child’s medical home or family support networks.

Along with the barriers identified by the 1998 survey (ND CSHS, 1999), the rural nature of ND is also problematic. Due to the lack of expertise, financial constraints, and the long distances between rural medical centers, UNHS programs are not present in any rural birthing hospitals.

Finally, most audiology practices are largely comprised of adult populations due to the large aging population in ND. As a result, few audiologists in the state are trained to use clinical tools such as evoked otoacoustic emissions or auditory evoked response audiometry for newborn hearing screenings. Consequently, less than a dozen ND audiologists are qualified to properly screen, assess, and fit amplification on infants by three months of age. Clearly, systematic education will be needed for all audiologists in the state who are linked with UNHS programs. Strategies resulting in the development of continuity of services between audiologists, the medical home, the NDSD, and other relevant agencies are greatly needed.

Current successful strategies at the state and national level

A number of national models are present which provide successful blueprint to initiate and sustain a UNHS program. These programs include the Rhode Island project (White et. al, 1992), and more recently a 19 state UNHS consortium (Arehart et. al., 1998). The Rhode Island project is significant as it provides the basic framework for UNHS protocols and offers scientific data regarding sensitivity and specificity. Additionally, one of the UNHS consortium states is Colorado which has many demographic similarities to ND regarding rural health issues. Moreover, Colorado initiated its UNHS in the early 1990's (Mehl, 1998) and therefore has considerable experience in providing a rural statewide UNHS program.

In addition to the presence of applicable state UNHS screening models, there are excellent resource centers nationwide for UNHS. Both the Marion Downs National Center (MDNC) and the National Center for Hearing Assessment and Management at Utah State University offer tremendous resources for initiating and sustaining a successful UNHS. Our project will contract services with Marion Downs National Center for Infant Hearing for technical assistance (see letters of support in Appendix C).

COLLABORATION AND COORDINATION

The proposed project will be a collaborative effort between the NDCPD and CSHS to establish UNHS as the prevailing standard of care in ND. To achieve this end, the project will coordinate its activities with a variety of stakeholders. A memorandum of agreement (see Appendix B) between NDCPD and CSHS has already been established. Letters of support and commitment to participate in the project’s Advisory Panel are included in Appendix C from individuals and stakeholders.

The Advisory Panel will consist of 15 to 20 representatives from agencies, programs, professional organizations, consumer, and family groups. The Panel will include broad representation of the professional disciplines, administrative organizations, health care industries, and consumer groups likely to be affected by the project. Care has been taken during the initial recruitment of participants for the Advisory Panel to balance representation from the population centers, rural communities, and broad geography of ND as well as traditionally underserved and unserved groups in our state.

The Advisory Panel will establish task forces or workgroups as necessary to develop the ND UNHS state protocol (the overall system of how UNHS operates), procedures for making and following-up on referrals to early intervention agencies, and public awareness and evaluation activities. A workgroup will also be developed to design procedures for medical centers and birthing hospitals to use as they implement the ND UNHS state protocol. Task forces and workgroups may solicit participation of experts in and out of the state who are not Advisory Panel members.

During the first couple of years, the project staff and Advisory Panel members will make presentations about UNHS to civic and business groups, agency personnel, consumer groups, and a wide range of health professional organizations. In particular, we plan on targeting physician organizations such as the ND Academy of Pediatrics, the ND Family Practitioners, otolylaryngologists, general practitioners, and OB/GYNs. Presentations will also be made to other ND organizations representing allied health care disciplines such as physician assistants, public health nurses, nurse practitioners, physical and occupational therapists, and hospital administrators.

GOALS AND OBJECTIVES

Goal 1 Equipment needed to conduct universal infant hearing screening in ND will be available at all of the state’s birthing hospitals.

Objective 1.1 Establish pediatric referral facilities for people who live in all of ND.

Activity 1.1.1 Establish an agreement with at least four healthcare facilities to serve as regional referral centers. Each referral center must agree to provide the equipment and expertise needed to function as a pediatric audiology referral agency. Referral centers will have clinical OAE equipment and clinical diagnostic ABR systems with frequency specific and bone conduction capabilities.

Objective 1.2 All of the state’s birthing hospitals will have the equipment necessary to conduct UNHS.

Activity 1.2.1 Identify birthing hospitals that do not have the equipment needed to conduct UNHS.

Activity 1.2.2 Provide otoacoustic emission screening devices (e.g. Madsen Echo Screen) to hospitals and birthing hospitals in ND according to the following schedule.

Year 1: Programs that have more than 300 births per year.

Year 2: Programs that have 50 to 300 births per year.

Year 3: Programs that have 1 to 50 births per year.

Objective 1.3 Develop manuals for ND UNHS.

Activity 1.3.1 Manuals that describe the project, protocols for screenings, referral, and diagnostic assessment, as well as data and reporting systems will be developed.

Activity 1.3.2 ND UNHS manuals will be distributed to each participating birthing center and pediatric audiology referral center.

Goal 2 Establish a statewide data system for collecting, managing, tracking, and reporting the progress of UNHS.

Objective 2.1 Convene a task force that is made up of members of the state Advisory Panel and other stakeholders as necessary to review existing systems for managing statewide screening data (e.g., HI*TRACK and SIMS).

Activity 2.1.1 Obtain documentation and pricing information from publishers of the major software programs (NCHAM and OZ) .

Activity 2.1.2 Have data system task force establish minimum features needed for the statewide data system.

Activity 2.1.3 The task force will make a recommendation to the Advisory Panel regarding preferred data system.

Objective 2.2 Implement statewide reporting of UNHS results.

Activity 2.2.1 Purchase software licenses or client packages for participating birthing clinics.

Activity 2.2.2 Provide software training for clerical staff, or other birthing center personnel assigned to UNHS data reporting.

Activity 2.2.3 Train project staff to use the state data system to develop reports for the Advisory Panel and other ND stakeholders.

Goal 3 Develop the protocols for conducting the UNHS, making referrals, and reporting the results to the state data system.

Objective 3.1 Determine the UNHS protocols for screening and referral. These protocols will be based on validated models from states where UNHS is already in place.

Activity 3.1.1 Review the Colorado, Rhode Island, Utah, Hawaii, Maryland and Texas models for screening and referral.

Activity 3.1.2 Choose or develop a model that is likely to work in ND.

Goal 4 ND will have an adequate supply of personnel who are qualified to conduct UNHS, use UNHS data to make appropriate referrals, and report UNHS data .

Objective 4.1 The project will train at least eight audiologists to conduct and supervise infant hearing screenings consistent with the Joint Committee on Infant Hearing 1994 position statement and Healthy People 2010 goals.

Activity 4.1.1 At least eight of ND’s licensed audiologists will participate in a three-day training seminar. The seminar will teach the audiologists to use ND’s protocols for newborn and infant hearing screening. In addition, the seminar will teach audiologists to use the screening data to make appropriate referrals to regional pediatric audiology centers. Finally, the seminar will teach the audiologists uniform procedures for conducting a pediatric audiological assessment including techniques for the interpretation of OAEs (screening and diagnostic), ABRs (threshold testing, frequency specific and bone conduction), as well as, other behavioral tests that are appropriate for this population.

Activity 4.1.2 Ongoing support and training will be provided as needed through seminar, teleconferencing, videoconferencing, Internet support, etc.

Objective 4.2 Train at least 15 audiologists to interpret screening data and make appropriate referrals.

Activity 4.2.1 At least 15 more licensed audiologists will receive a one day seminar on current, nationally accepted protocols for interpretation of newborn and infant OAE hearing screening data. The seminar will also include specific instruction on ND UNHS’ procedures and protocols.

Activity 4.2.2 Ongoing support and training will be provided as needed through seminar, teleconferencing, videoconferencing, Internet support, etc.

Objective 4.3 Train personnel to operate the infant screening equipment and report the results to the state.

Activity 4.3.1 At least three staff members from each of the ND birthing hospitals will receive on-site training in the use of ND UNHS’ OAE screening equipment. The participants will learn how to perform the screening, follow the protocols, and report results. Training will be conducted according to the following schedule:

Year 1: Programs that have more than 300 births per year.

Year 2: Programs that have 50 to 300 births per year.

Year 3: Programs that have 1 to 50 births per year.

Objective 4.4 The project will train clerical staff to enter data in the program’s online data system.

Activity 4.4.1 At least three clerical staff from each ND birthing center will be trained to use the software system selected as a result of Goal 2 Activities. Training will follow this schedule:

Year 1: Programs that have more than 300 births per year.

Year 2:Programs that have 50 to 300 births per year.

Year 3: Programs that have 1 to 50 births per year.

Activity 4.4.2 Ongoing support and training will be provided as needed through seminars, teleconferencing, videoconferencing, Internet support, etc.

Goal 5 During the grant period, the professional and clerical staff implementing ND’s infant screening program will have access to timely and helpful technical support.

Objective 5.1 Personnel conducting infant screening will have access to both online and telephone-based technical support.

Activity 5.1.1 The project will establish an Internet-based support system for audiologists who will conduct ND’s infant OAE screening. When the web page is complete people conducting tests will have access to 24-hour information and solutions. During normal office hours (8:00 - 5:30 Central M - F) people conducting ND’s infant OAE screening will have access to a telephone consultation hot line for technical support.

Objective 5.2 Audiologists interpreting screening results and making referrals will have access to both online and telephone-based technical support.

Activity 5.2.1 Project staff will provide both online and telephone-based technical support for field-based audiologists who interpret screening data and make referrals to audiological centers.

Objective 5.3 Clerical personnel using the online system to enter data will have access to both online and telephone-based technical support.

Activity 5.3.1 Project staff will use an Internet-based web site as well as telephone systems to provide technical support for clerical personnel who report screening data from ND birthing hospitals.

Objective 5.4 Aggregate UNHS data will be available on-line to ND professionals, and decision makers both online and telephone-based technical support will be available to help these individuals with UNHS data searches.

Activity 5.4.1 Project staff will provide both online and telephone-based technical support for individuals who need to access UNHS data. It should be noted that no patient-specific information will be available.

Objective 5.5 High quality screening and referral services will be provided by ND UNHS.

Activity 5.5.1 Project staff will provide ongoing monitoring from all sites to ensure statewide practices are consistent with national standards. Results of monitoring will be used to refine training materials and improve technical support services.

Goal 6 North Dakotans will be aware of ND’s UNHS and, when appropriate, have access to program data.

Objective 6.1 Parents will know the results of their child’s hearing screening.

Activity 6.1.1 All parents of infants receiving newborn screening will receive a brochure describing infant hearing screening. This brochure will provide consumer information regarding the importance of follow-up and additional testing. Certification of each child’s participation will also be mailed to parents after all tests have been completed. Finally, parents will be notified within one week if a referral or additional testing needs to be made.

Objective 6.2 The results of the infant hearing screening will be recorded in the hospitals’ newborn birthing records.

Activity 6.2.1 A copy of the data generated by the screening test, as well as an audiologist’s signed dictation interpreting those data will be included in each infant’s birthing center record. A copy will also be sent to the child’s medical home. It should be noted that all participating audiologists will be state-licensed, and UNHS-trained.

Objective 6.3 Professionals working for state agencies and in local communities will have appropriate access to aggregate UNHS data.

Activity 6.3.1 Project staff will establish an Internet site where professionals working for state, regional, local, and tribal agencies can access UNHS’ aggregate data. Patient-specific information will not be accessible on this web site.

Objective 6.4 The general public will be aware of the program.

Activity 6.4.1 The general public will be provided information about this program and its importance for the infant population in ND. This will be accomplished through various media methods throughout the state.

Goal 7 Universal Newborn Hearing Screening will continue to be implemented statewide after the project ends.

Objective 7.1Consensus statements will be formatted supporting the ongoing provision of UNHS.

Activity 7.1.1 Advisory Panel will convene a task force to develop consensus statements.

Activity 7.1.2 Task force will review data generated over duration of the project.

Activity 7.1.3 Stakeholders, representatives of key disciplines, and consumer groups will participate in developing the consensus statements.

Objective 7.2 Legislation that requires appropriate hearing screening and referral for infants as well as competent follow-up diagnostics will be proposed in the ND legislature.

Activity 7.2.1 A legislation draft proposal will be developed by project staff. The legislation will mandate a statewide newborn hearing-screening program.

Objective 7.3 Consumer groups will have access to national and ND data that support the legislation.

Activity 7.3.1 Consumer groups will be identified for their interests in this program. They will be requested to provide written support for the program.

Objective 7.4 Professional groups will have access to national and ND data that support the legislation.

Activity 7.4.1 Professional groups will be identified for their interests in this program. They will be requested to provide written support for the program.

Objective 7.5 Business groups will have access to national and ND data that support the legislation.

Activity 7.5.1 Business groups will be identified for their interests in this program. They will be requested to provide written support for the program.

Objective 7.6 Representatives of local, regional, state, and tribal agencies will have access to national and ND data that support the legislation.

Activity 7.6.1 Representatives of local, regional, state, and tribal agencies will be identified for their interests in this program. They will be requested to provide written support for the program.

REQUIRED RESOURCES

A detailed description of budget line items has been provided on page vii in the font of the proposal. The budget justification describes the calculations used and why the resource is needed. We have provided spreadsheet printouts in Appendix D that show the allocation of budgeted funds by project activities. This breakdown provides an overview of how resources are allocated to accomplish project activities.

It is the intent of this project to purchase OEA screening equipment to be placed in all birthing hospitals in ND. Training will be provided to audiologists, health care technicians, and nurses in how to use the equipment to conduct infant hearing screening. Audiologists will be further trained on how to interpret the screening results. Project funds will be used to develop and implement a statewide protocol for conducting UNHS, making referrals, reporting the results to a statewide UNHS database, and following-up on referral cases. Training will be provided to clinic and hospital personnel responsible for reporting the data. Finally, resources from the project will be used to increase public awareness about UNHS and advocate for its ongoing support after the project is completed.

NDCPD and MSU assure that grant funds will be used only for the purposes specified in this application. Fiscal control, oversight, and appropriate auditing procedures are in place at NDCPD and MSU to assure that funds are accounted for and spent on appropriate activities. MSU adheres to all appropriate state, federal, and funding agency guidelines with respect to auditing and fiscal oversight.

PROJECT METHODOLOGY

North Dakota has major medical centers located in four geographic quadrants or regions. These centers will provide the "backbone" of the UNHS statewide program in ND. These centers will conduct UNHS screening programs and support smaller medical centers within their region. Over the course of four years, successively smaller hospitals will be provided support through the regional medical center while receiving equipment and training of their own from the statewide UNHS program.

A UNHS Advisory Panel of individuals from various state agencies, health care, and consumer organizations will be assembled (see activity 3.1.1). These stakeholders will include representatives from MCH, Children’s Special Health Services, the North Dakota School for the Deaf, Early Intervention services, Department of Public Instruction, the ND State Tracking System for At-Risk Children, Blue Cross Blue Shield, the North Dakota Family to Family Network, and the North Dakota Family Voices program. Others who have offered to serve on this committee include state neonatologists, ear nose and throat physicians, consumers with children experiencing hearing loss, hospital based audiologists, nurses, speech/language pathologists, leaders of several service organizations, and ND state legislators. Letters of support and commitment are included in Appendix C.

The project Advisory Panel, described elsewhere, will form task force workgroups to develop statewide policies and procedures for UNHS administration, referral procedures, database formulation, quality control, and information dissemination activities. Needs assessment regarding capacity of medical centers to conduct UNHS services will also be conducted by these groups. In addition, a task force will adapt UNHS protocols from existing UNHS programs which have previously demonstrated effectiveness. Task force committees will identify and recruit audiologists to coordinate UNHS services in each of ND’s regions. Moreover, the Advisory Panel and task force members will be provided an inservice through the Marion Downs National Center for Infant Hearing (MDNCIH).

The heart of a UNHS program is the screening protocol. The ND UNHS program will adopt features of statewide UNHS programs in Rhode Island, Maryland, and Colorado. The Rhode Island project has validated hearing screening methodology and procedures. The Maryland Newborn Hearing Screening and Colorado state UNHS programs also offer effective screening algorithms for states requiring UNHS at multiple medical centers. The reader is referred to Appendix E for the basic elements of the ND UNHS protocol.

The preliminary protocol developed for the ND UNHS is found in Appendix E. This protocol requires that all newborns be screened using evoked otoacoustic emissions (OAEs) or the auditory brainstem response (ABR). Medical centers providing UNHS programs will choose their method of screening (OAEs or ABR) in accordance to their philosophy and resource capacity. The project will purchase OAE equipment, valued at approximately $5000 per unit, for all participating birthing hospitals. Because it is significantly more expensive than OAE equipment, the project will provide those facilities having a preference for ABR with an equivalent cash value ($5000) towards the purchase of ABR equipment.

After receiving written permission from the parents for participation in ND UNHS, the initial hearing screening will be either OAE or ABR. In addition, each newborn will be evaluated using the high risk factors indicated by the Joint Committee on Infant Hearing (1994). These factors are important as they may have implications for progressive hearing loss or middle ear disorders even though the newborn passes the initial hearing screening.

A strength of the ND UNHS protocol is that it recognizes four possible outcomes for UNHS. First of all, the child might be discharged from the hospital without a hearing screening. In this case an outpatient screening will be conducted within two weeks of discharge. The birthing center will be responsible for ensuring that the screening is completed. A second possibility is that the parent may refuse hearing screening. In this case a letter will be sent to the medical home of the newborn documenting these results and providing information about factors which are related to hearing loss.

The third outcome of UNHS is that a newborn passes the screening. Newborns without risk factors will be given no further considerations for hearing screening or evaluation but parents will be provided with materials on the importance of hearing and factors suggesting hearing loss. The newborns exhibiting any of the JCIH 1994 high risk factors will be referred to a regional audiologist and evaluated or re-evaluated every six months for three years.

The fourth possible outcome of the proposed UNHS program is that the newborn "fails" the initial screening. In this case, at least one hearing rescreening will be conducted before the newborn is discharged. If newborns pass the rescreening, they will follow the "pass" algorithm described in the previous paragraph. When newborns are unable to pass the second hearing screening before hospital discharge, the newborn will be rescreened (using OAEs or ABR) within 2 to 4 weeks. Further, to insure greater compliance, hospital discharge orders will include hearing rescreening at 2 to 4 weeks after birth and an appointment will be made before discharge with the center conducting the rescreening (normally the birthing hospital of the newborn). If the newborn fails to show for this rescreening, the parents of newborns will be phoned by the center for rescheduling. A script will be developed by the project staff for this procedure so that medical center support staff can effectively conduct the follow-up phone calls. When parents refuse further rescreening, a note to that effect will be sent to the medical home. In this circumstance, both the newborn’s primary care physician and parents will receive educational materials regarding the need for hearing screening and signs indicating hearing loss.

After failing a rescreening, newborns will be referred to a regional audiologist within 2 to 4 weeks of the second rescreening. This regional audiologist will be trained to conduct newborn hearing evaluations using ABR and OAE’s and to fit amplification using the Desired Sensation Level (DSL) fitting procedure advocated by Seewald (1994, 1999). These diagnostic and amplification procedures are considered best practice by the JCIH (1994) and by the North Dakota audiology licensure board.

Using this algorithm, hearing loss will be diagnosed and qualified within two months of a birth. When hearing loss is diagnosed at audiological evaluation, the managing audiologist will make ear molds for amplification needs and schedule an evaluation for a fitting of amplification within two weeks. Also at the time of the diagnosis of hearing loss, the audiologist will immediately notify the North Dakota School for the Deaf (NDSD) and the appropriate regional human service center for prompt early intervention service provision and coordination. In addition, the newborn medical home and family support services will be notified. With the ND UNHS protocol, a newborn with hearing loss should be diagnosed with the loss and fit with amplification by 2 ½ months of age. The ND UNHS protocol will meet or exceed the Healthy People 2010 goals regarding infant hearing screening.

This protocol will provide effective hearing screening before hospital discharge, good communication with the medical home of the newborn, and should reduce the documented poor follow-up for rescreening and hearing evaluations which occur in ND.The implementation of finalized UNHS protocols will occur at medical centers in each of four quadrants in the state. Please refer to activity 1.1.1. After medical centers are identified in each quadrant in the state, audiology and other hearing screening personnel will receive a two day workshop by faculty from MDNCIH. A third day of this workshop will be provided for audiologists who will provide evaluation and amplification services to newborns identified with hearing loss. This workshop will emphasize specific diagnostic and amplification strategies associated with habilitation of newborns with hearing loss. Dr. Richard Seewald, an internationally renowned expert in the field of pediatric amplification, will present this workshop. The reader is referred to activity 4.1.1.

A database will track the services provided to infants. This database will also be used to insure appropriate screening follow-up, diagnostic services, early intervention services, and family support services. The reader is referred to objective 2.1 for further explanation of these services.

A key to UNHS programming is a high degree of participation for newborn hearing rescreenings, audiology evaluations, and continuity of services with early interventionists. Therefore a task force will develop guidelines to insure that infants with hearing loss receive service coordination with appropriate early intervention agencies, the primary care physician of the newborn’s medical home, and the Family to Family network (a support network for families with children who have disabilities). The reader is referred to activities 3.1.1 and 3.1.2.

Once the UNHS program is underway a scheduled program of periodic evaluation will occur. These evaluations will insure that follow-up to rescreening, audiology evaluation and early intervention services are occurring in a timely fashion. Follow-up to further services is a critical issue as demonstrated by the CSHS survey (1999) and analysis of this issue is mandatory. Program evaluation will also assess program costs, effectiveness and will provide information to national health databases. The reader is referred to activity 7.1.2.

EVALUATION PLAN?????

The proposed project is designed to develop, and implement UNHS in ND. The evaluation strategies described in this section of the proposal are organized by project goal.

Goal 1.0 - Equipment.

Question 1.1. Has the project had a significant impact on the availability of equipment for OAE infant screening in ND?

Data 1.1. The number and location of OAE infant screening devices in ND.

Strategy 1.1. Once, during each quarter of project operation, staff will contact personnel at birthing hospitals and ask if they have access to OAE infant screening devices that have not been supplied by the project. When non-project OAE devices are found project staff will ask why the device was acquired.

Evaluation 1.1. Project staff will evaluate any change in the availability of hardware, the percentage of change that can be directly attributed to project activities, and the reason why non-project OAE devices were purchased.

Goal 2.0 Data Management.

Question 2.1. What percentage of the infant OAE screening data collected in ND is accurately recorded on a statewide data system?

Data 2.1. The number of cases entered in the state wide data system, the number of children born in ND, and randomly selected birthing center OAE screening records.

Strategy 2.1. Each month project staff will monitor the statewide data collection system, comparing the number of cases entered with the state’s number of live births. Twice each year project staff will visit all active birthing hospitals randomly selecting at least 25 birthing files and recording any OAE data in the file.

Evaluation 2.1. Project staff will compare file data with statewide system data to establish use and accuracy estimates.?

Goal 3.0 - ND UNHS Protocols

Question 3.1. Is a high quality ND UNHS protocol in place and available for review by the end of the project’s first six months of operation?

Data 3.1. Nominal data and expert review comments.

Strategy 3.1. Project staff will submit a draft ND UNHS protocol to at least three out-of-state experts and three in-state audiologists for review.

Evaluation 3.1. A summary of and response to reviewer comments as well as a revised protocol will be written by project staff and approved by the advisory committee.

Goal 4.0 – Training.

Question 4.1. Do enough North Dakotans have the technical and professional skills to operate ND UNHS?

Data 4.1. Attendance data describing the number and geographical distribution of people attending ND UNHS training and criterion referenced performance data describing ND UNHS skill proficiency.

Strategy 4.1. Project staff will collect attendance data at all ND UNHS training sessions. They will also collect performance data at training sessions. Project staff will then visit all birthing hospitals to evaluate trainee’s on-the-job skills.

Evaluation 4.1. Project staff will develop a report describing attendance and trainee performance on both in-class and on-the-job skill tests.

Goal 5.0 – Technical support.

Question 5.1. Are on-line and telephone-based technical support systems used and effective?

Data 5.1. The number of "hits" on the project’s technical assistance web sites, the number of calls to the project’s support telephone services, and qualitative interviews with service users.

Strategy 5.1. Project staff will place "counters" and user-identification passwords on all of the project’s technical assistance sites. Data describing system use will be collected and summarized each quarter. Paper and pencil telephone-assistance records will also be collected that describes callers and their need for technical assistance. Twice each year project staff will contact 20 randomly selected support-system users (10 Internet and 10 telephone) to inquire about their experience with the support system.

Evaluation 5.1. Project staff will develop a document that reports quarterly support system use figures. Each year project staff will summarize system-user comments and describes the project’s response to user comments.

Goal 6.0 – Awareness.

Question 6.1.Were ND parents of infants aware of ND UNHS before their child was born and did they approve of the program?

Data 6.1. Questionnaire data and data describing the number of children born, and screened at participating birthing hospitals.

Strategy 6.1. Questionnaire data will be collected when parents are informed of the results of the "initial" screening. Staff at participating birthing hospitals will record the number of parents who refuse to let their child participate in ND UNHS.

Evaluation 6.1. Project staff will calculate the percentage of parents who were informed prior to their child’s birth. The percentage of cases where parents refused ND UNHS participation will also be calculated.

Question 6.2. Who used the data-access web site?

Data 6.2 The number of "hits" on the project’s data access web site.

Strategy 6.2. In the project’s fourth year project staff will use "counters" and a password-based user identification system on the data access web site.

Evaluation 6.2. Project staff will count and categorize data access users.

Goal 7 – Implementation

Question 7.1. How many children were screened during the project?

Data 7.1. Numbers of infants from the ND Department of Health and UNHS’ statewide record keeping system.

Strategy 7.1. Project staff will collect data from the ND Department of Health and the UNHS system.

Evaluation 7.1. A "Percentage of Children Screened" will be calculated.

Question 7.2. How many children were accurately identified with hearing loss through this program?

Data 7.2 .Case data from the UNHS system including data collected during the initial screening test, the follow-up screening test, and the audiological assessment.

Strategy 7.2. Once each year project staff will access the statewide UNHS data system and collect data. When necessary birthing center and referral center records will be reviewed.

Evaluation 7.2. Project staff will calculate a correlation describing the predictive validity of the initial screening on both the results of the follow-up screening and the audiological assessment. They will also establish a false positive and false negative rate for both components of ND UNHS.

Erenberg, A., Lemons, J.,Sia, C., Trunkel, D., & Ziring, P., (1999). Newborn and infant hearing loss: detection and intervention. American Academy of Pediatrics. Task Force on Newborn and Infant Hearing, 1998_ 1999. Pediatrics, 103(2):527_30

Healthy People 2010 Objectives: Draft Copy, (1999). Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services, Washington, DC .

Joint Committee on Infant Hearing (1994). 1994 Position Statement. ASHA, 36(12):38_41.

NIH, (1993). Early identification of hearing impairment in infants and young children. NIH Consensus Statement: 11, (1): 1-25.

Seewald, R., (1994). Fitting children with the DSL method. The Hearing Journal, 47 (9).

Seewald R., (1999). Hearing aids for children. ASHA. 41(3):43_4.

White, K., Maxon, A., Behrens, T., Blackwell, P., & Vohr, B., (1992). Neonatal Hearing Screening using otoacoustic emissions: The Rhode Island hearing assessment project. In Bess, F., & Hall, J. (Eds). Screening Children For Auditory Function (pp. 207-228). Nashville, TN: Bill Wilkerson Center Press.

Yoshinaga-Itano, C., Sedey, A., Coulter, D., & Mehl, A., (1998). Language of early- and later-identified children with hearing loss. Pediatrics, 102: 1161-1171.