Early Auditory Referral in Primary Care
EAR-PC
1 other identifier
interventional
10,000
1 country
10
Brief Summary
Busy Primary Care providers (PCPs) have complex practices with many competing demands, making it difficult to improve their HL identification rates. Little research has been conducted to identify effective approaches to address the poor PCP knowledge and provide tools for them to better identify/refer patients with HL for appropriate intervention. Current data suggests there is a critical need to redesign how PCPs deliver hearing health care (HHC) by developing focused educational programs and simple clinical management tools to help them integrate HHC into their practices. To address this need, this study will educate providers on hearing loss (HL) screening/treatment as well as create a Best Practice Alert (BPA), or clinical prompt, that is configured for maximal effectiveness in reminding PCPs to ask their patients if they think they have a HL. This combination of education for providers and clinical reminder could help increase HL screening rates but how much is not clear. This 5 year R21/R33 study funded by National Institute of Deafness and Communicative Disorders seeks to provide detailed understanding of both how educating providers on HL and the use of an effective BPA affects HL screening rates and identification for people with mild to moderate hearing loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 23, 2016
CompletedFirst Posted
Study publicly available on registry
December 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedAugust 5, 2019
April 1, 2019
5 years
December 23, 2016
August 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Increase in Screening Referrals for Hearing Testing of Patients at High Risk for Hearing Loss
Baseline data on providers and the clinics will be compared to post-intervention data to determine if hearing loss screening referrals improved; Investigators will also do a step-wedged analysis to look at differences between clinics that have gone live with the BPA and those who have not yet gone live.
Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
Secondary Outcomes (1)
Increase in identification of patients with hearing loss
Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
Study Arms (1)
Single-Arm, Non-Randomized, Stepped Wedge
EXPERIMENTALAll patients who meet the inclusion criteria will receive the same intervention.
Interventions
A Best Practice Alert, or BPA, was created in the electronic medical record system, which fires when patients meet the inclusion criteria. It reminds providers to ask their patients if they think have a hearing loss and allows them to respond as needed (refer to audiology, add hearing loss to the problem summary list, or dismiss for one year).
Eligibility Criteria
You may qualify if:
- years or older, doesn't have a known hearing loss on their problem summary list (found in the electronic health record), doesn't already have an open referral to audiology in their chart, and has an encounter with a provider at a participating Family Medicine clinic.
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Dominos Farms Family Medicine
Ann Arbor, Michigan, 48105, United States
Chelsea Family Medicine
Chelsea, Michigan, 48118, United States
Dexter Health Center
Dexter, Michigan, 48130, United States
Livonia Health Center
Livonia, Michigan, 48152, United States
Beaumont Rochester Hills Family Physicians
Rochester Hills, Michigan, 48307, United States
Beaumont East Area Family Practice
Roseville, Michigan, 48066, United States
Beaumont Shorepointe Family Physicians
Saint Clair Shores, Michigan, 48080, United States
Beaumont Family Practice
Saint Clair Shores, Michigan, 48081, United States
Clearwater Family Medicine
Washington, Michigan, 48095, United States
Ypsilanti Health Center
Ypsilanti, Michigan, 48198, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Zazove, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of the Department of Family Medicine
Study Record Dates
First Submitted
December 23, 2016
First Posted
December 29, 2016
Study Start
April 1, 2014
Primary Completion
March 31, 2019
Study Completion
March 31, 2019
Last Updated
August 5, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
In process of data collection. Data will be analyzed, papers written, and results posted in clinicaltrials.gov.