Trial Outcomes & Findings for Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators (NCT NCT01917747)
NCT ID: NCT01917747
Last Updated: 2020-03-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
3 months after birth
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Standard Scheduling and Follow-up
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. 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.
|
Patient Navigator Group
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. 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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
46
|
|
Overall Study
COMPLETED
|
41
|
35
|
|
Overall Study
NOT COMPLETED
|
19
|
11
|
Reasons for withdrawal
| Measure |
Standard Scheduling and Follow-up
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. 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.
|
Patient Navigator Group
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. 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
18
|
9
|
Baseline Characteristics
Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
Baseline characteristics by cohort
| Measure |
Standard Scheduling and Follow-up
n=60 Participants
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.
Standard scheduling and follow-up: 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.
|
Patient Navigator Group
n=46 Participants
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.
Patient Navigator: 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 pediatrics.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
31 Years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
31 Years
STANDARD_DEVIATION 5.3 • n=107 Participants
|
31 Years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/Caucasian
|
37 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latino
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
46 participants
n=107 Participants
|
106 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months after birthThis 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.
Outcome measures
| Measure |
Standard Scheduling and Follow-up
n=41 Participants
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.
Standard scheduling and follow-up: 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.
|
Patient Navigator Group
n=35 Participants
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.
Patient Navigator: 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 pediatrics.
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|---|---|---|
|
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
|
15 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From the date of hearing loss diagnosis up to 6 months after birthPopulation: No data was collected because no patients were recruited into this Aim of the study. None of the study participants (N=106) were found to have hearing loss thus there were not eligible to receive hearing loss treatment and thus not eligible for 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization to first audiological diagnostic test up to 12 months of ageThis 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.
Outcome measures
| Measure |
Standard Scheduling and Follow-up
n=31 Participants
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.
Standard scheduling and follow-up: 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.
|
Patient Navigator Group
n=31 Participants
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.
Patient Navigator: 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 pediatrics.
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|---|---|---|
|
Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1)
|
7.13 weeks
Standard Deviation 6.02
|
6.19 weeks
Standard Deviation 3.49
|
SECONDARY outcome
Timeframe: From the date of hearing loss diagnosis until up to one yearPopulation: No data was collected because no patients were recruited into this Aim of the study. None of the study participants (N=106) were found to have hearing loss thus there were not eligible to receive hearing loss treatment and thus not eligible for 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.
Outcome measures
Outcome data not reported
Adverse Events
Standard Scheduling and Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Navigator Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Matthew L. Bush
UK Dept. of Otolaryngology Head and Neck Surgery
Phone: 859-218-2168
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place