Hearing LossEAR-PCNCT03004937
Early Auditory Referral in Primary Care
A study testing Family Medicine Hearing Loss Best Practice Alert in people with Hearing Loss, run by University of Michigan at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Family Medicine Hearing Loss Best Practice Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2014to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Dominos Farms Family Medicine
Ann Arbor, Michigan, 48105
Chelsea Family Medicine
Chelsea, Michigan, 48118
Dexter Health Center
Dexter, Michigan, 48130
Livonia Health Center
Livonia, Michigan, 48152
Beaumont Rochester Hills Family Physicians
Rochester Hills, Michigan, 48307
Beaumont East Area Family Practice
Roseville, Michigan, 48066
Beaumont Shorepointe Family Physicians
Saint Clair Shores, Michigan, 48080
Beaumont Family Practice
Saint Clair Shores, Michigan, 48081
Clearwater Family Medicine
Washington, Michigan, 48095
Ypsilanti Health Center
Ypsilanti, Michigan, 48198
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Family Medicine Hearing Loss Best Practice Alert
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Medicine Hearing Loss Best Practice AlertOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm, Non-Randomized, Stepped Wedge | Experimental | All patients who meet the inclusion criteria will receive the same intervention. Receives: Other: Family Medicine Hearing Loss Best Practice Alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startApr 2014
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Zazove, University of Michigan
- Investigators
- Philip Zazove, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004937
- Sponsor's protocol ID
- HUM00082363
- Acronym
- EAR-PC
- Status last verified
- Apr 2019
- First submitted
- 23 Dec 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: In process of data collection. Data will be analyzed, papers written, and results posted in clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Auditory Referral in Primary Care (EAR-PC)
- ClinicalTrials.gov ID
- NCT03004937
- Acronym / sponsor ID
- EAR-PC / HUM00082363
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm, Non-Randomized, Stepped Wedge | Experimental | Other: Family Medicine Hearing Loss Best Practice AlertAll patients who meet the inclusion criteria will receive the same intervention. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Medicine Hearing Loss Best Practice AlertA 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). | Other | Single-Arm, Non-Randomized, Stepped Wedge |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: Yes. In process of data collection. Data will be analyzed, papers written, and results posted in clinicaltrials.gov.
Related trials for Hearing Loss
Not yet recruiting
Automated Text Message Reminders to Promote Hearing Aid Adoption
Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Zazove, MD principal investigator
University of Michigan
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Medicine Hearing Loss Best Practice Alert in people with Hearing Loss, run by University of Michigan at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.