Trial record 18 of 107 for:    infant care | Open Studies | NIH

Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Kentucky
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Matthew Bush, MD, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01917747
First received: August 2, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Congenital Hearing Loss
Behavioral: Patient Navigator
Behavioral: Standard scheduling and follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Number of participants who do not receive diagnostic audiological testing (Aim 1) [ Time Frame: 3 months after birth ] [ Designated as safety issue: No ]
    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: Date of hearing loss diagnosis up to one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of weeks between date of hearing loss diagnosis and intervention (Aim 2) [ Time Frame: Date of hearing loss diagnosis up to one year ] [ Designated as safety issue: No ]
    This outcome is the timing of hearing loss diagnosis from the date of randomization until the date of first documented diagnostic audiological testing, assessed up to 12 months.


Estimated Enrollment: 346
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: 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 or rescheduling of the hearing test, as is standard practice.
Experimental: 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.
Behavioral: 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 pediatric hearing loss is imparted.

Detailed Description:

Parents of children who fail infant hearing screening at birth at the University of Kentucky 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 are also randomized from the age of enrollment until one year old to a patient navigator group or standard practice group. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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 as the patient navigator will be English-speaking and 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 as the patient navigator will be English-speaking and 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917747

Contacts
Contact: Matthew L Bush, M.D. 859-218-2171 matthew.bush@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Matthew L Bush, M.D.    859-218-2171    matthew.bush@uky.edu   
Principal Investigator: Matthew L Bush, M.D.         
Sponsors and Collaborators
Matthew Bush, MD
Investigators
Principal Investigator: Matthew L Bush, MD University of Kentucky
  More Information

No publications provided

Responsible Party: Matthew Bush, MD, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01917747     History of Changes
Other Study ID Numbers: MLB-001-KL2TR000116, 1U24DC012079-01, KL2TR000116
Study First Received: August 2, 2013
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Kentucky:
Infant hearing screening
Patient Navigator

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014