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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DC017770-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
For Specific Arm 1:
The investigators will (1) use a stepped-wedge trial design to deliver patient navigation (PN) sequentially in 10 state-funded Kentucky Commission for Children with Special Healthcare Needs (CCSHCN) (also referred to as the Office for Children with Special Healthcare needs or OCSHCN) clinics randomized to cross from usual care to PN in steps of 6-month intervals over the project period. Prior to initiation of PN at each clinic, the control condition will be the standard of care. The overall effectiveness of PN will be tested by comparing non-adherence rates during the PN condition to those during the standard of care condition. Simultaneously, the investigators will (2) assess preliminary implementation outcomes (i.e., acceptability, adoption, recruitment/retention, and fidelity) as well as multilevel factors influencing implementation of PN in each clinic.
For Specific Arm 2:
Patient navigators will not be used for all subjects at participating clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigator Arm | Active Comparator | Examination of adherence to follow-up with a navigator. |
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| Non-Intervention Arm | No Intervention | Examination of adherence to follow-up without a navigator. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigator Guidance | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | 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. | 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.) |
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Inclusion Criteria:
Inclusion criteria for parent-infant dyads:
Exclusion Criteria:
1. Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew L Bush, MD, PhD | Associate Professor, Vice Chair of Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| Office for Children with Special Health Care Needs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35440449 | Derived | Bush M, Hatfield M, Schuh M, Balasuriya B, Mahairas A, Jacobs J, Studts C, Westgate P, Schoenberg N, Shinn J, Creel L. Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol. BMJ Open. 2022 Apr 19;12(4):e054548. doi: 10.1136/bmjopen-2021-054548. |
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De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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." |
| FG001 | 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." |
| FG002 | 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." |
| FG003 | 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." |
| FG004 | 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." |
| FG005 | 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." |
| FG006 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Usual Care |
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| Patient Navigation Available |
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Infants referred to state-run clinics for follow-up testing after a failed newborn hearing screening.
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| ID | Title | Description |
|---|---|---|
| BG000 | Navigator Arm | 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. |
| BG001 | Non-Intervention Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) | 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. | Posted | Count of Participants | 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.) |
|
Nine months.
Parents were not considered enrolled, adverse event data reported is for infants only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Navigator Arm | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew L. Bush, Professor and Chair of Otolaryngology- Head and Neck Surgery | University of Kentucky | (859)218-2139 | matthew.bush@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2024 | Sep 27, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 8, 2023 | Jan 30, 2024 | ICF_000.pdf |
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Parallel Assignment via Stepped Wedge Trial Design
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| Louisville |
| Kentucky |
| 40222 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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Examination of adherence to follow-up without a navigator. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Examination of adherence to follow-up without a navigator. |
|
|
| 0 |
| 1,601 |
| 0 |
| 1,601 |
| 0 |
| 1,601 |
| EG001 | Non-Intervention Arm | Examination of adherence to follow-up without a navigator. | 0 | 1,098 | 0 | 1,098 | 0 | 1,098 |
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