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Early Auditory Referral in Primary Care (EAR-PC)

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ClinicalTrials.gov Identifier: NCT03004937
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Zazove, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Other: Family Medicine Hearing Loss Best Practice Alert Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Early Auditory Referral in Primary Care (EAR-PC)
Actual Study Start Date : April 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Increase in Screening Referrals for Hearing Testing of Patients at High Risk for Hearing Loss [ Time Frame: Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology. ]
    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.


Secondary Outcome Measures :
  1. Increase in identification of patients with hearing loss [ Time Frame: Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology. ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004937


Contacts
Contact: Philip Zazove, MD 734-615-2688 pzaz@med.umich.edu

Locations
United States, Michigan
Dominos Farms Family Medicine Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Lauren S Schleicher, MA    517-648-5897    lschlei@med.umich.edu   
Chelsea Family Medicine Recruiting
Chelsea, Michigan, United States, 48118
Contact: Lauren S Schleicher, MA    517-648-5897    lschlei@med.umich.edu   
Dexter Health Center Recruiting
Dexter, Michigan, United States, 48130
Contact: Lauren S Schleicher, MA    517-648-5897    lschlei@med.umich.edu   
Livonia Health Center Recruiting
Livonia, Michigan, United States, 48152
Contact: Lauren S Schleicher, MA    517-648-5897    lschlei@med.umich.edu   
Beaumont Rochester Hills Family Physicians Recruiting
Rochester Hills, Michigan, United States, 48307
Contact: Kathleen Bradley    248-551-6407    Kathleen.Bradley@Beaumont.org   
Beaumont East Area Family Practice Recruiting
Roseville, Michigan, United States, 48066
Contact: Kathleen Bradley    248-551-6407    Kathleen.Bradley@Beaumont.org   
Beaumont Shorepointe Family Physicians Recruiting
Saint Clair Shores, Michigan, United States, 48080
Contact: Kathleen Bradley    248-551-6407    Kathleen.Bradley@Beaumont.org   
Beaumont Family Practice Recruiting
Saint Clair Shores, Michigan, United States, 48081
Contact: Kathleen Bradley    248-551-6407    Kathleen.Bradley@Beaumont.org   
Clearwater Family Medicine Recruiting
Washington, Michigan, United States, 48095
Contact: Kathleen Bradley,    248-551-6407    Kathleen.Bradley@Beaumont.org   
Ypsilanti Health Center Recruiting
Ypsilanti, Michigan, United States, 48198
Contact: Lauren S Schleicher, MA    517-648-5897    lschlei@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Philip Zazove, MD University of Michigan

Responsible Party: Philip Zazove, Chair of the Department of Family Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03004937     History of Changes
Other Study ID Numbers: HUM00082363
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In process of data collection. Data will be analyzed, papers written, and results posted in clinicaltrials.gov.

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