Early Auditory Referral in Primary Care (EAR-PC)

Early Auditory Referral in Primary Care (EAR-PC)

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Other: Family Medicine Hearing Loss Best Practice Alert

Detailed Description

The Best Practice Alert (BPA) was developed via an iterative process during a two year pilot phase at one site at each health system. First, a "standard" BPA was developed to be launched at each site during the pilot phase. Similarly, a pilot 10-minute education system was developed to be presented just before the above BPA was launched. Pre and post surveys of clinicians were conducted to evaluate the effectiveness of the education program. After clinicians had experience with the BPA, Cognitive Task Analyses (CTAs) with clinicians were conducted to identify ways to make the BPA more effective, and then the BPA was iteratively improved. Similarly, the CTAs helped the investigators understand why clinicians do or do not use BPAs in general. Using this process, a highly rated, easy to use BPA was created and will be utilized in the actual study. The investigators also revamped the education program to a 10 minute video that focused on clinicians mental models of HL, to be used in the actual study. The bigger study, i.e., the R33 phase, will launch at several Family Medicine practices within each of the two different health systems. One of these systems is a traditional academic institution with only academic faculty (physicians and audiologists), midlevels and residents, and the other is a newer academic system, based within a private health system, that includes non-academic physicians and private audiologists. Patients who trigger the BPA will be 55 years or older, do not have an open referral in their chart to audiology, and do not have a known hearing loss already on their problem summary list (PSL). These patients are asked to complete a Hearing Handicap Inventory (HHI) at check-in, a common hearing loss screening tool (score of 10+ indicates probable hearing loss); the results of this will not be shared with clinicians. If the physician chooses to address the prompt during the patient encounter, the BPA design allows them to, 1) Indicate that the patient declines hearing screening (BPA is dismissed for 1 year), 2) Indicate that the patient already has a known hearing loss (HL) and add HL to the PSL (The BPA will be permanently dismissed), 3) Indicate that the patient does not have any HL at this time (The BPA is dismissed for one year), or 4) refer the patient to audiology for hearing screening. The data generated by the BPA is extracted from the electronic health record (EHR) and analyzed to determine if HL screening rates improve when compared to baseline data, whether or not providers are interacting with the BPA, and whether HL is being added to the PSL. The HHI results are used as the "gold standard," i.e., when compared to the data generated by the BPA, indicate whether or not patients with probable HL are getting appropriate care. When an enrolled patient shows up in Audiology the audiologist is asked to complete a three question survey to verify that 1) the referral was appropriate, 2) what is the severity of hearing loss if any, and 3) were hearing aids recommended. This step is to study whether the BPA is generating appropriate referrals. 20% of patients that score 10 or above on their HHI and/or were referred to audiology are contacted by phone and researchers ask them questions about any conversation they may recall related to HL at their appointment as well as their experience in audiology. Iterative improvements will be made to the BPA based on Cognitive Task Analysis (CTA) interviews with randomly selected providers (mostly family physicians). Finally, the implementation of the BPA into clinical practice is observed using the principles of Normalization Process Theory (NPT) to study whether there are other potential issues that may impact whether patients at risk for HL are being screened and referred. The revamped educational video will be shown a week prior to the BPA going live at each site, and repeating the pre and post evaluations. The investigators will be studying whether the education video increases identification and referral of patients at high risk for HL.

• Study Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Dominos Farms Family Medicine
    • Chelsea, Michigan, United States, 48118
      • Chelsea Family Medicine
    • Dexter, Michigan, United States, 48130
      • Dexter Health Center
    • Livonia, Michigan, United States, 48152
      • Livonia Health Center
    • Rochester Hills, Michigan, United States, 48307
      • Beaumont Rochester Hills Family Physicians
    • Roseville, Michigan, United States, 48066
      • Beaumont East Area Family Practice
    • Saint Clair Shores, Michigan, United States, 48080
      • Beaumont Shorepointe Family Physicians
    • Saint Clair Shores, Michigan, United States, 48081
      • Beaumont Family Practice
    • Washington, Michigan, United States, 48095
      • Clearwater Family Medicine
    • Ypsilanti, Michigan, United States, 48198
      • Ypsilanti Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-55 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.

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Single-Arm, Non-Randomized, Stepped Wedge; All patients who meet the inclusion criteria will receive the same intervention.

Other: Family Medicine Hearing Loss Best Practice Alert; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in identification of patients with hearing loss	Baseline data on providers will be compared to post-intervention data to determine if the percentage of patients with hearing loss on the problem lists is approaching accepted population rates for this age group	Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Philip Zazove, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (ESTIMATE): December 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: HUM00082363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In process of data collection. Data will be analyzed, papers written, and results posted in clinicaltrials.gov.