Trial Outcomes & Findings for Communities Helping the Hearing of Infants by Reaching Parents (NCT NCT03875339)
NCT ID: NCT03875339
Last Updated: 2025-02-14
Results Overview
This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
COMPLETED
NA
2699 participants
3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
2025-02-14
Participant Flow
The first wave of the stepped-wedge intervention began in January 2020. In the original design, new clinics were supposed to launch every 6 months. Unfortunately, COVID shutdowns halted study activities, and the second wave was not launched until March 2021. The remaining waves occurred on a compressed timeline until the final clinic was launched in March of 2023. Once a clinic entered the intervention arm, they remained in the intervention condition until recruitment ended in September 2023.
While the study design describes "dyads" consisting of infants referred to testing and their parent/guardian, only the infants are considered participants because the outcome of the study describes the number of newborn infants who do not receive diagnostic audiological testing within 3 months of birth. Parents were not considered to be enrolled participants. Participants were counted only once, separate participants are included in each period below.
Unit of analysis: State-run healthcare clinics
Participant milestones
| Measure |
Wave 1: Usual Care Months 1-6, Intervention Month 7 Onward
Wave 1: From month 1-6, one of the participating clinics delivered usual care to all patients referred for a follow-up hearing test. Beginning in Month 7, Patient Navigation became available for all participants referred to this clinic.
The remaining 9 clinics deliver usual care until the intervention condition is activated during their "wave."
|
Wave 2: Usual Care Months 1-20, Intervention Month 21 Onward
Wave 2: From month 1-20 two of the participating clinics delivered usual care to all patients referred for a follow-up hearing test. Beginning in Month 21, Patient Navigation became available for all participants referred to this clinic.
The remaining 7 clinics deliver usual care until the intervention condition is activated during their "wave."
|
Wave 3: Usual Care Months 1-25, Intervention Month 26 Onward
Wave 3: From month 1-25, two of the participating clinics delivered usual care to all patients referred for a follow-up hearing test. Beginning in Month 26, Patient Navigation became available for all participants referred to this clinic.
The remaining 5 clinics deliver usual care until the intervention condition is activated during their "wave."
|
Wave 4: Usual Care Months 1-31, Intervention Month 32 Onward
Wave 4: From month 1-31, two of the participating clinics delivered usual care to all patients referred for a follow-up hearing test. Beginning in Month 32, Patient Navigation became available for all participants referred to this clinic.
The remaining 3 clinics deliver usual care until the intervention condition is activated during their "wave."
|
Wave 5: Usual Care Months 1-32, Intervention Month 33 Onward
Wave 5: From month 1-32 one of the participating clinics delivered usual care to all patients referred for a follow-up hearing test. Beginning in Month 33, Patient Navigation became available for all participants referred to this clinic.
The remaining 2 clinics deliver usual care until the intervention condition is activated during their "wave."
|
Wave 6: Usual Care Months 1-37, Intervention Month 38 Onward
Wave 6: From month 1-37 one of the participating clinics delivered usual care to all patients referred for a follow-up hearing test. Beginning in Month 38, Patient Navigation became available for all participants referred to this clinic.
The remaining 1 clinic delivers usual care until the intervention condition is activated during their "wave."
|
Wave 7: Usual Care Months 1-44, Intervention Month 45
Wave 7: From month 1-44 one of the participating clinics delivered usual care to all patients referred for a follow-up hearing test. Beginning in Month 45, Patient Navigation became available for all participants referred to this clinic.
No clinics remain in the "usual care condition" at Month 45.
|
|---|---|---|---|---|---|---|---|
|
Usual Care
STARTED
|
452 1
|
278 2
|
235 2
|
31 2
|
45 1
|
31 1
|
26 1
|
|
Usual Care
COMPLETED
|
452 1
|
278 2
|
235 2
|
31 2
|
45 1
|
31 1
|
26 1
|
|
Usual Care
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Patient Navigation Available
STARTED
|
36 1
|
795 2
|
283 2
|
342 2
|
97 1
|
21 1
|
27 1
|
|
Patient Navigation Available
COMPLETED
|
36 1
|
795 2
|
283 2
|
342 2
|
97 1
|
21 1
|
27 1
|
|
Patient Navigation Available
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Navigator Arm
n=1601 Participants
Examination of adherence to follow-up with a navigator.
Navigator Guidance: Use of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result.
|
Non-Intervention Arm
n=1098 Participants
Examination of adherence to follow-up without a navigator.
|
Total
n=2699 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1601 Participants
n=1601 Participants
|
1098 Participants
n=1098 Participants
|
2699 Participants
n=2699 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1601 Participants
|
0 Participants
n=1098 Participants
|
0 Participants
n=2699 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1601 Participants
|
0 Participants
n=1098 Participants
|
0 Participants
n=2699 Participants
|
|
Sex: Female, Male
Female
|
712 Participants
n=1601 Participants
|
455 Participants
n=1098 Participants
|
1167 Participants
n=2699 Participants
|
|
Sex: Female, Male
Male
|
889 Participants
n=1601 Participants
|
643 Participants
n=1098 Participants
|
1532 Participants
n=2699 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1601 Participants
n=1601 Participants
|
1098 Participants
n=1098 Participants
|
2699 Participants
n=2699 Participants
|
PRIMARY outcome
Timeframe: 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
Outcome measures
| Measure |
Navigator Arm
n=1601 Participants
Examination of adherence to follow-up with a navigator.
Navigator Guidance: Use of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result.
|
Non-Intervention Arm
n=1098 Participants
Examination of adherence to follow-up without a navigator.
|
|---|---|---|
|
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
|
378 Participants
|
336 Participants
|
Adverse Events
Navigator Arm
Non-Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Matthew L. Bush, Professor and Chair of Otolaryngology- Head and Neck Surgery
University of Kentucky
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place