Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/17/2019 |
| Start Date: | January 2014 |
| End Date: | January 1, 2020 |
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable
and treatable. Children that are born with hearing loss have to undergo several hearing tests
to diagnose the condition and many families are delayed in receiving this testing or never
obtain the needed testing. This research employs a new method for helping children with
hearing loss receive timely care by using a patient navigator, who is someone who teaches and
provides emotional/social support for the families of these children. The hypothesis of this
study is that a patient navigator will hasten the timing of pediatric audiological testing,
improve compliance with scheduled appointments, and expand parental knowledge of pediatric
hearing loss.
and treatable. Children that are born with hearing loss have to undergo several hearing tests
to diagnose the condition and many families are delayed in receiving this testing or never
obtain the needed testing. This research employs a new method for helping children with
hearing loss receive timely care by using a patient navigator, who is someone who teaches and
provides emotional/social support for the families of these children. The hypothesis of this
study is that a patient navigator will hasten the timing of pediatric audiological testing,
improve compliance with scheduled appointments, and expand parental knowledge of pediatric
hearing loss.
Parents of children who fail infant hearing screening at birth at the University of Kentucky
or other hospitals in the area that are receiving follow up diagnostic testing at UK
Audiology or the Commission for Children with Special Health Care Needs will be enrolled in
the first part of the study and randomized into either a patient navigator group or the
standard practice group. We will compare the failure to follow-up for testing rates between
groups. Of those enrolled subjects, the age of the children when they obtain diagnostic
testing will be assessed and compared between the patient navigator group and the standard
practice group. This arm will further quantify the effect of the navigator on diagnostic
testing timing.
The second arm strives to continue and build upon the first assessment by evaluating hearing
follow up in children up to six months of age who are diagnosed with hearing loss. Parents of
children born at the University of Kentucky and at other hospitals who are following up as
outpatients at UK who are diagnosed with hearing loss will be approached for enrollment.
Parents of children in this arm of the study that did not participate in Aim 1 or did
participate in Aim 1 but that were randomized to the control group are randomized from the
age of enrollment until one year old to a patient navigator group or standard practice group.
Parents of children that participated in Aim 1 that were randomized to patient navigation
that enroll in Aim 2 will not be randomized and will continue to receive patient navigation.
This group of subjects will be assessed to find what follow up is conducted once the child is
diagnosed with hearing loss. As in the first arm, the navigator group will have regular phone
follow ups with the patient navigator and the standard practice group will not have contact.
Both groups will be given or mailed questionnaires, asking them about where they obtained
services for the child with regard to hearing follow up and intervention. This will assess
the effect of a navigator on parental education and support, timing of diagnostic services,
and implementation of interventions with regard to pediatric hearing loss.
or other hospitals in the area that are receiving follow up diagnostic testing at UK
Audiology or the Commission for Children with Special Health Care Needs will be enrolled in
the first part of the study and randomized into either a patient navigator group or the
standard practice group. We will compare the failure to follow-up for testing rates between
groups. Of those enrolled subjects, the age of the children when they obtain diagnostic
testing will be assessed and compared between the patient navigator group and the standard
practice group. This arm will further quantify the effect of the navigator on diagnostic
testing timing.
The second arm strives to continue and build upon the first assessment by evaluating hearing
follow up in children up to six months of age who are diagnosed with hearing loss. Parents of
children born at the University of Kentucky and at other hospitals who are following up as
outpatients at UK who are diagnosed with hearing loss will be approached for enrollment.
Parents of children in this arm of the study that did not participate in Aim 1 or did
participate in Aim 1 but that were randomized to the control group are randomized from the
age of enrollment until one year old to a patient navigator group or standard practice group.
Parents of children that participated in Aim 1 that were randomized to patient navigation
that enroll in Aim 2 will not be randomized and will continue to receive patient navigation.
This group of subjects will be assessed to find what follow up is conducted once the child is
diagnosed with hearing loss. As in the first arm, the navigator group will have regular phone
follow ups with the patient navigator and the standard practice group will not have contact.
Both groups will be given or mailed questionnaires, asking them about where they obtained
services for the child with regard to hearing follow up and intervention. This will assess
the effect of a navigator on parental education and support, timing of diagnostic services,
and implementation of interventions with regard to pediatric hearing loss.
Inclusion Criteria (Arm 1):
1. Parents of children who are born at University of Kentucky Medical Center in the
postpartum ward whose children are born after 34 weeks gestation and fail hearing
screening in one or both ears
2. Parents whose children are receiving follow up testing (due to referral after
mandatory newborn hearing screening) at UK Audiology or the Commission for Children
with Special Health Care Needs
3. Parents who are willing to be contacted by study coordinators and/or navigator to
monitor progress and testing outcomes
4. Parents who are able to speak English or Spanish as the patient navigator will be
speaking one of these languages and this will be the primary means of communication
over the phone.
Exclusion Criteria (Arm 1):
1. Parents of newborns who are hospitalized past 30 days after birth or who are born
prior to 34 weeks gestation (as this may inherently delay diagnostic work-up)
2. Children and parents live outside Kentucky or who will be moving out of Kentucky
within the first year of life (they will not be able to be followed closely at our
institution)
3. Parents of wards of the state and cases of adoption will be excluded
Inclusion Criteria (Arm 2):
1. Children who are 6 months old or less and have been diagnosed with hearing loss in one
or both ears through two separate ABR tests.
2. Parents who are willing to be contacted by study coordinators and/or navigator to
monitor progress and testing outcomes
3. Parents who are able to speak English or Spanish as the patient navigator will be
speaking one of these languages and this will be the primary means of communication
over the phone.
Exclusion Criteria (Arm 2):
1. Parents of newborns who are hospitalized past 30 days after birth or who are born
prior to 34 weeks gestation (as this may inherently delay diagnostic work-up)
2. Children and parents live outside Kentucky or who will be moving out of Kentucky
within the first year of life (they will not be able to be followed closely at our
institution)
3. Parents of wards of the state and cases of adoption will be excluded
We found this trial at
2
sites
Lexington, Kentucky
859) 257-9000
Principal Investigator: Matthew L Bush, M.D.
Phone: 859-218-2171
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Louisville, Kentucky 40222
Phone: 502-429-4430
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