Congenital Hearing LossNCT01917747
Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
A study testing Patient Navigator and Standard scheduling and follow-up in people with Congenital Hearing Loss, run by Matthew Bush, MD at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Congenital Hearing Loss
- What is being tested?
- Patient Navigator and Standard scheduling and follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2014to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
- Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
- 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.
- 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.
- Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
- 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.
Who cannot join
- 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)
- 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)
- Parents of wards of the state and cases of adoption will be excluded
- 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)
- 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)
- Parents of wards of the state and cases of adoption will be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40536
Commission for Children with Special Health Care Needs
Louisville, Kentucky, 40222
About this study
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.
Read the detailed description
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 Arm 1 or did participate in Arm 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 Arm 1 that were randomized to patient navigation that enroll in Arm 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.
- Conditions
- Congenital Hearing Loss
- Being tested
- Patient Navigator, Standard scheduling and follow-up
- Keywords
- Infant hearing screening, Patient Navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigatorBehavioural
The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted.
Standard scheduling and follow-upBehavioural
The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test, as is standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Standard scheduling and follow-up | Active comparator | The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice. Receives: Behavioral: Standard scheduling and follow-up |
| Patient Navigator Group | Experimental | The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. Receives: Behavioral: Patient Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
This outcome is the number of participants who do not follow-up for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
Measured: 3 months after birth
Number of Participants Who do Not Receive Hearing Intervention by Six Months of Age (Aim 2)
This outcome is the number of participants who do not follow-up for therapeutic audiological intervention after a diagnosis of infant hearing loss is made from the date of randomization to 6 months after birth.
Measured: From the date of hearing loss diagnosis up to 6 months after birth
Secondary outcomes (2)
Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1)
This outcome is the timing of diagnostic audiological testing after failed newborn hearing screening from the date of randomization until the date of first documented diagnostic audiological testing, assessed up to 12 months after birth.
Measured: From date of randomization to first audiological diagnostic test up to 12 months of age
Number of Weeks Between Date of Hearing Loss Diagnosis and Intervention (Aim 2)
This outcome is the timing of hearing loss intervention from the date of hearing loss diagnosis until the date of documented hearing loss intervention, assessed up to 12 months.
Measured: From the date of hearing loss diagnosis until up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start1 Jan 2014
- Primary completion30 Sep 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Bush, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Matthew Bush, MD, University of Kentucky
- Investigators
- Matthew L Bush, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917747
- Sponsor's protocol ID
- MLB-001-KL2TR000116
- Other IDs
- KL2TR000116, K23DC014074
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2013
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
- ClinicalTrials.gov ID
- NCT01917747
- Acronym / sponsor ID
- MLB-001-KL2TR000116
- Conditions
- Congenital Hearing Loss
- Keywords
- Infant hearing screening, Patient Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Matthew Bush, MDUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Posted 24 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 Arm 1 or did participate in Arm 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 Arm 1 that were randomized to patient navigation that enroll in Arm 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard scheduling and follow-up | Active comparator | Behavioral: Standard scheduling and follow-upThe subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice. |
| Patient Navigator Group | Experimental | Behavioral: Patient NavigatorThe patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
- Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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)
- 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)
- Parents of wards of the state and cases of adoption will be excluded
- 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)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigatorThe patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted. | Behavioural | Patient Navigator Group |
| Standard scheduling and follow-upThe subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test, as is standard practice. | Behavioural | Standard scheduling and follow-up |
Primary outcome
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
Time frame: 3 months after birth
This outcome is the number of participants who do not follow-up for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
Number of Participants Who do Not Receive Hearing Intervention by Six Months of Age (Aim 2)
Time frame: From the date of hearing loss diagnosis up to 6 months after birth
This outcome is the number of participants who do not follow-up for therapeutic audiological intervention after a diagnosis of infant hearing loss is made from the date of randomization to 6 months after birth.
2 secondary outcomes
Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1)
Time frame: From date of randomization to first audiological diagnostic test up to 12 months of age
Number of Weeks Between Date of Hearing Loss Diagnosis and Intervention (Aim 2)
Time frame: From the date of hearing loss diagnosis until up to one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew L Bush, MD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator and Standard scheduling and follow-up in people with Congenital Hearing Loss, run by Matthew Bush, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) (time frame: 3 months after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.