A Pragmatic Clinical Trial of Hearing Screening in Primary Care Clinics: Effect of Setting and Provider Encouragement.

OBJECTIVES: The prevalence of hearing loss increases with age. Untreated hearing loss is associated with poorer communication abilities and negative health consequences, such as increased risk of dementia, increased odds of falling, and depression. Nonetheless, evidence is insufficient to support the benefits of universal hearing screening in asymptomatic older adults. The primary goal of the present study was to compare three hearing screening protocols that differed in their level of support by the primary care (PC) clinic and provider. The protocols varied in setting (in-clinic versus at-home screening) and in primary care provider (PCP) encouragement for hearing screening (yes versus no). DESIGN: We conducted a multisite, pragmatic clinical trial. A total of 660 adults aged 65 to 75 years; 64.1% female; 35.3% African American/Black completed the trial. Three hearing screening protocols were studied, with 220 patients enrolled in each protocol. All protocols included written educational materials about hearing loss and instructions on how to complete the self-administered telephone-based hearing screening but varied in the level of support provided in the clinic setting and by the provider. The protocols were as follows: (1) no provider encouragement to complete the hearing screening at home, (2) provider encouragement to complete the hearing screening at home, and (3) provider encouragement and clinical support to complete the hearing screening after the provider visit while in the clinic. Our primary outcome was the percentage of patients who completed the hearing screening within 60 days of a routine PC visit. Secondary outcomes following patient access of hearing healthcare were also considered and consisted of the percentage of patients who completed and failed the screening and who (1) scheduled, and (2) completed a diagnostic evaluation. For patients who completed the diagnostic evaluation, we also examined the percentage of those who received a hearing loss intervention plan by a hearing healthcare provider. RESULTS: All patients who had provider encouragement and support to complete the screening in the clinic completed the screening (100%) versus 26.8% with encouragement to complete the screening at home. For patients who were offered hearing screening at home, completion rates were similar regardless of provider encouragement (26.8% with encouragement versus 22.7% without encouragement); adjusted odds ratio of 1.25 (95% confidence interval 0.80-1.94). Regarding the secondary outcomes, roughly half (38.9-57.1% depending on group) of all patients who failed the hearing screening scheduled and completed a formal diagnostic evaluation. The percentage of patients who completed a diagnostic evaluation and received a hearing loss intervention plan was 35.0% to 50.0% depending on the group. Rates of a hearing loss intervention plan by audiologists ranged from 28.6% to 47.5% and were higher compared with those by otolaryngology providers, which ranged from 15.0% to 20.8% among the groups. CONCLUSIONS: The results of the pragmatic clinical trial showed that offering provider encouragement and screening facilities in the PC clinic led to a significantly higher rate of adherence with hearing screening associated with a single encounter. However, provider encouragement did not improve the significantly lower rate of adherence with home-based hearing screening.

A pragmatic clinical trial of hearing screening in primary care clinics: cost-effectiveness of hearing screening.

BACKGROUND: Hearing loss is a high prevalence condition among older adults, is associated with higher-than-average risk for poor health outcomes and quality of life, and is a public health concern to individuals, families, communities, professionals, governments, and policy makers. Although low-cost hearing screening (HS) is widely available, most older adults are not asked about hearing during health care visits. A promising approach to addressing unmet needs in hearing health care is HS in primary care (PC) clinics; most PC providers (PCPs) do not inquire about hearing loss. However, no cost assessment of HS in community PC settings has been conducted in the United States. Thus, this study conducted a cost-effectiveness analysis of HS using results from a pragmatic clinic trial that compared three HS protocols that differed in the level of support and encouragement provided by the PC office and the PCPs to older adults during their routine visits. Two protocols included HS at home (one with PCP encouragement and one without) and one protocol included HS in the PC office. METHODS: Direct costs of the HS included costs of: (1) educational materials about hearing loss, (2) PCP educational and encouragement time, and (3) access to the HS system. Indirect costs for in-office HS included cost of space and minimal staff time. Costs were tracked and modeled for each phase of care during and following the HS, including completion of a diagnostic assessment and follow-up with the recommended treatment plan. RESULTS: The cost-effectiveness analysis showed that the average cost per patient is highest in the patient group who completed the HS during their clinic visit, but the average cost per patient who failed the HS is by far the lowest in that group, due to the higher failure rate, that is, rate of identification of patients with suspected hearing loss. Estimated benefits of HS in terms of improvements in quality of life were also far greater when patients completed the HS during their clinic visit. CONCLUSIONS: Providing HS to older adults during their PC visit is cost-effective and accrues greater estimated benefits in terms of improved quality of life. TRIAL REGISTRATION: clinicaltrials.gov (Registration Identification Number: NCT02928107).

Comparative implementation-effectiveness of three strategies to perform hearing screening among older adults in primary care clinics: study design and protocol.

BACKGROUND: The burden of hearing loss among older adults could be mitigated with appropriate care. This study compares implementation of three hearing screening strategies in primary care, and examines the reliability and validity of patient self-assessment, primary care providers (PCP) and diagnostic audiologists in the identification of 'red flag' conditions (those conditions that may require medical consultation and/or intervention). METHODS: Six primary care practices will implement one of three screening strategies (2 practices per strategy) with 660 patients (220 per strategy) ages 65-75 years with no history of hearing aid use or diagnosis of hearing loss. Strategies differ on the location and use of PCP encouragement to complete a telephone-based hearing screen (tele-HS). Group 1: instructions for tele-HS to complete at home and educational materials on warning signs and consequences of hearing loss. Group 2: PCP counseling/encouragement on importance of hearing screening, instructions to take the tele-HS from home, educational materials. Group 3: PCP counseling/encouragement, in-office tele-HS, and educational materials. Patients from all groups who fail the tele-HS will be referred for diagnostic audiological testing and medical evaluation, and complete a self-assessment of red flag conditions at this follow-up appointment. Due to the expected low incidence of ear disease in the PCP cohort, we will enroll a complementary population of patients (N = 500) from selected otolaryngology head and neck surgery clinics in a national practice-based research network to increase the likelihood of occurrence of medical conditions that might contraindicate hearing aid fitting. The primary outcome is the proportion of patients who complete the tele-HS within 2 months of the PCP appointment comparing Group 3 (PCP encouragement, in-office tele-HS, education) versus Groups 2 and 1 (education and tele-HS at home, with and without PCP encouragement, respectively). The several secondary outcomes include direct and indirect costs, patient, family and provider attitudes of hearing healthcare, and accuracy of red flag condition evaluations compared with expert medical assessment by an otolaryngology provider. DISCUSSION: Determining the relative effectiveness of three different strategies for hearing screening in primary care and the assessment accuracy of red flag conditions can each lead to practice and policy changes that will reduce individual, family and societal burden from hearing loss among older adults. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02928107; 10/10/2016 protocol version 1.

Steroid Use for Sudden Sensorineural Hearing Loss: A CHEER Network Study.

OBJECTIVE: The objective of this study was to describe patterns of corticosteroid treatment for sudden sensorineural hearing loss and to evaluate effectiveness based on delivery mode (oral vs intratympanic vs both). STUDY DESIGN: Cross-sectional repeated measures. SETTING: Patients were recruited from practices within the Creating Healthcare Excellence through Education and Research (CHEER) Network. CHEER is a National Institutes of Health-funded nationwide network of 30 community and academic otolaryngology practice sites. SUBJECTS AND METHODS: A subset of 117 patients who had been treated with steroids for sudden sensorineural hearing loss were recruited from within a larger initial CHEER Network study on clinical practice guideline compliance. Outcomes included audiometric and speech scores and patient-perceived improvement. Descriptive analyses, Wilcoxon rank-sum tests, and Fisher exact tests were run. RESULTS: Two categories (oral and simultaneous oral + intratympanic) had adequate sample sizes to support statistical comparison of treatment results. Improvements were seen in both audiometry and speech testing scores; 57% of patients self-reported improvement perceived as either minor or major. There were no significant differences in degree of improvement between these treatment groups. CONCLUSIONS: We observed that a majority of steroid-treated patients demonstrated hearing improvement, but this improvement did not meet criteria for statistical significance. As in other studies on this topic, the relatively small sample size may have prevented differentiation of effectiveness among steroid treatments. We propose that the use of alternative approaches, such as pragmatic clinical trials and multidisciplinary electronic health record systems and megadatabases, may hold the most promise for an approach to best practice development.

Patterns of Migraine Disease in Otolaryngology: A CHEER Network Study.

Objective To evaluate the prevalence of migraine disease in an otolaryngologic cohort and migraine-related otologic and sinonasal symptoms in this population. Study Design Cross-sectional study utilizing the CHEER (Creating Healthcare Excellence through Education and Research) network for recruitment. Setting Patients were recruited in a cross-sectional and pragmatic manner in 14 CHEER sites between June 2015 and March 2017 (9 academic, 5 community based). Subjects and Methods Patients were included if they were aged ≥18 years and seen for any concern that was not head and neck cancer. Patients with any history of brain abnormality or headaches that began within 2 weeks of a medical illness, trauma, or head injury were excluded. Patients were screened for migraine with a validated instrument. If they screened positive on the Migraine Assessment Tool (MAT+), the subjects also filled out validated and custom questionnaires for sinonasal, otologic, and migraine-specific symptoms. Results Of 1458 patients screened, 235 (16.1%) screened positive for migraine (MAT+), which is higher than general population (13%, P < .001). The MAT+ group was significantly younger (47.2 vs 55.6 years of age, P < .001) and predominantly women (80.0% vs 55.9%, P < .001). The MAT+ cohort commonly reported ear- and sinus-related symptoms, such as tinnitus (70.5%), ear pressure (61.9%), balance problems (82%), facial pressure (85%), and rhinorrhea (49.9%). There were significantly higher levels of sinus burden with higher levels of dizziness handicap, Jonckheere-Terpstra test = 11,573.00, z = 7.471, P < .001. Conclusion Migraine disease has a higher prevalence in an otolaryngologic cohort than in the general population, presenting with a high rate of sinonasal and otologic symptoms that may be due to or exacerbated by migraines.

Burden of Hearing Loss on Communication Partners and Its Influence on Pursuit of Hearing Evaluation.

OBJECTIVE: Describe how the burden on the communication partner (CP) from the patient's hearing loss, as perceived by both the patient and their CP, influences a patient's pursuit of hearing evaluation. DESIGN: Cross-sectional design. Demographics, perception of patient's hearing loss, and associated burden on the CP were collected from both patient and CP via online questionnaires. Patients and their CPs from Duke University Medical Center Otolaryngology Clinic, 55 to 75 years of age, being seen for any reason, who indicated a CP has expressed concern about their hearing. Final sample was 245 matched pairs. RESULTS: Based on completed questionnaires, on average, patients perceived their own hearing loss as more burdensome to the CP than the CP did. However, CPs of patients who believed themselves to have no hearing handicap scored the patient's hearing loss 54.3% higher than the patient. The patient's perspective about the amount of burden their hearing loss placed on the CP predicted patients seeking a hearing evaluation. CONCLUSIONS: Recognition of early stage hearing loss and associated burden on CPs may be delayed in patients; CPs may help elucidate unrecognized concerns. Educational approaches that raise awareness of burden of hearing loss on CPs along with hearing loss indications could be a feasible, multidimensional strategy to promote help seeking behaviors.

Evaluation of Compliance for Treatment of Sudden Hearing Loss: A CHEER Network Study.

OBJECTIVE: The objective of this study is to describe the presentation and management of sudden sensorineural hearing loss for patients seen in academic and community-based practices within the context of the American Academy of Otolaryngology-Head and Neck Surgery Foundation's "Clinical Practice Guideline: Sudden Hearing Loss." The intention is to use these findings to guide implementation strategies and quality improvement initiatives and as pilot data for the development of clinical research initiatives. STUDY DESIGN: A cross-sectional study of patients with sudden hearing loss. SETTING: Patients were recruited from practices within the Creating Healthcare Excellence through Education and Research (CHEER) network. The CHEER network is an National Institutes of Health-funded network of 30 otolaryngology sites across the country, half of which are community based and half of which are academic practices. SUBJECTS AND METHODS: A total of 173 patients were recruited. Data were gathered via custom questionnaires collected by study site coordinators and entered into a secure online platform. Descriptive analyses and correlation statistics were run with SAS 9.3.1. RESULTS: Of the 13 guideline statements in the American Academy of Otolaryngology-Head and Neck Surgery Foundation's clinical practice guideline on sudden hearing loss, 11 statements were evaluable through this study. Compliance for otolaryngologists was >95% for key action statements (KASs) 1, 3, and 6; 90% to 95% for KASs 5 and 10; and <90% for KASs 7 and 13. Compliance was <45% for nonotolaryngologists for KASs 3 and 5-7. CONCLUSIONS: There is opportunity for nonotolaryngologists to improve for statements 3 and 5-7. Otolaryngologists are compliant with many of the KASs overall, but there is significant room for improvement.

Factors influencing pursuit of hearing evaluation: Enhancing the health belief model with perceived burden from hearing loss on communication partners.

OBJECTIVE: There is limited application of health behavior-based theoretical models in hearing healthcare, yet other fields utilizing these models have shown their value in affecting behavior change. The health belief model (HBM) has demonstrated appropriateness for hearing research. This study assessed factors that influence an individual with suspected hearing loss to pursue clinical evaluation, with a focus on perceived burden of hearing loss on communication partners, using the HBM as a framework. DESIGN: Cross-sectional design collecting demographics along with three validated hearing-loss related questionnaires. STUDY SAMPLE: Patients from Duke University Medical Center Otolaryngology Clinic aged 55-75 years who indicated a communication partner had expressed concern about their hearing. A final sample of 413 completed questionnaire sets was achieved. RESULTS: The HBM model construct 'cues to action' was a significant (p <0.001) predictor of pursuing hearing evaluation. Perceived burden of hearing loss on communication partners was a significant (p <0.001) predictor of pursuing hearing evaluation and improves the model fit when added to the HBM: 72.0% correct prediction when burden is added versus 66.6% when not (p <0.0001). CONCLUSIONS: Hearing healthcare initiatives that incorporate these factors may improve hearing help-seeking behavior. More research using sound theoretical models in hearing healthcare is warranted.

Caregiver Quality of Life Is Related to Severity of Otitis Media in Children.

OBJECTIVE: Otitis media (OM) in children is the most frequent reason for physician visits in developed countries and burdens caregivers, society, and the child. Our objective was to describe the impact of OM severity on parent/caregiver quality of life (QoL). STUDY DESIGN: Multi-institutional prospective cross-sectional study. SETTING: Otolaryngology, family, and pediatric practices. SUBJECTS AND METHODS: Children 6 to 24 months old with and without a primary diagnosis of recurrent OM and their caregivers. Physicians provided patient history, and parents/caregivers completed a Family Information Form, the PedsQL Family Impact survey, the Patient Reported Outcomes Measurement Information System (PROMIS) survey, and the OM 6-item severity survey (OM-6). RESULTS: A total of 2413 subjects were enrolled and data from 1208 patients and physician were analyzed. The average child age was 16 months, and 54% were male. The mean OM-6 score was 3.2. The mean PedsQL Family Impact score for parents was 66.9 from otolaryngology sites and 78.8 from pediatrics/family practice sites (P < .001). Higher (worse) OM-6 scores correlated significantly with worse PedsQL Family Impact scores (Pearson r = -0.512, P < .01). Similarly, increasing OM-6 scores strongly correlated with increased parental anxiety, depression, and fatigue, as well as decreased satisfaction (all P < .01). CONCLUSIONS: Worse PedsQL Family Impact and PROMIS scores were highly correlated with elevated OM-6 scores, suggesting that severity of childhood OM significantly affects parent/caregiver QoL. Understanding the impact of a child's illness on parent/caregiver QoL can help physicians counsel patients and families and provide better family-centered, compassionate care.

Impact of Otitis Media Severity on Children's Quality of Life.

OBJECTIVE: Children with otitis media (OM) suffer sleep disturbances, loss of appetite, earache, and behavioral problems. Our objective was to quantitate the average burden of OM and to compare the associated impact of tympanostomy tubes on infant health related quality of life (HR-QoL). STUDY DESIGN: Multi-institutional prospective cross-sectional study. SETTING: Otolaryngology, family practice, and pediatric clinics. SUBJECTS AND METHODS: Children ages 6 to 24 months of age with or without recurrent OM. Patient history, the PedsQL Infant QoL survey, and the 6-item child with OM survey (Otitis Media 6 [OM-6]) were collected from providers and parents. RESULTS: Data from 1208 patients were analyzed. Mean age was 14.7 months, and 54% were male. The mean OM-6 score of children with recurrent OM was 3.3, whereas similarly aged well-children had a mean OM-6 score of 2.5. The mean PedsQL Infant scores of recurrent OM patients were significantly worse than those of children from well-child visits. Worse OM-6 scores were correlated with poorer PedsQL Infant scores, Pearson r = -0.581 (1-12 months) and -0.558 (13-24 months), P < .001. Otolaryngology patients who were recommended to undergo ear tube placement had significantly poorer OM-6 scores and worse PedsQL Infant scores, whereas patients with prior tube placement had significantly better OM-6 and PedsQL Infant scores. CONCLUSION: Children with recurrent OM had significantly worse HR-QoL than similarly aged healthy children. Increased burden of OM strongly affected HR-QoL, and recommendation for tube placement was associated with increased disease burden and poorer HR-QoL. The presence of tympanostomy tubes was associated with better OM-6 and PedsQL Infant scores.

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

OBJECTIVE: To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. STUDY DESIGN: Database analysis. SETTING: Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. METHODS: Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. RESULTS: A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. CONCLUSIONS: Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

Consumer assessment of healthcare providers and systems surgical care survey: benefits and challenges.

OBJECTIVE: To describe the feasibility and initial results of the implementation of a continuous quality improvement project using the newly available Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS), in a small cohort of otolaryngology-head and neck surgery practices. STUDY DESIGN: Prospective observational study using a newly validated health care consumer survey. SETTING: Two community-based and 2 university-based otolaryngology-head and neck surgery outpatient clinic practices. METHODS: Fourteen board-certified otolaryngology, head and neck surgeons from 4 practice sites voluntarily participated in this project. All adult patients scheduled for surgery during a 12-month period were asked to complete the S-CAHPS survey through an electronic data capture (EDC) system 7 to 28 days after surgery. The surgeons were not directly involved in administration or collection of survey data. RESULTS: Three sites successfully implemented the S-CAHPS project. A 39.9% response rate was achieved for the cohort of surgical patients entered into the EDC system. While most patients rated their surgeons very high (mean of 9.5 or greater out of 10), subanalysis revealed there is variability among sites and surgeons in communication practices. From these data, a potential surgeon Quality Improvement report was developed that highlights priority areas to improve surgeon-patient rapport. CONCLUSIONS: The S-CAHPS survey can be successfully implemented in most otolaryngology practices, and our initial work holds promise for how the survey can be best deployed and analyzed for the betterment of both the surgeon and the patient.

Implementation and testing of research infrastructure for practice-based research in hearing and communication disorders.

OBJECTIVE: To describe site capability and experience of the CHEER network (Creating Healthcare Excellence through Education and Research) to rapidly collect descriptive data on patients with tinnitus and dizziness visiting participating CHEER sites. STUDY DESIGN: Prospective observational data collection study over 6 months. SETTING: Twenty one community otology and otolaryngology practices in the United States. SUBJECTS AND METHODS: As proof of concept, a data collection study was developed for patients with tinnitus and dizziness (presenting with or without associated migraine) through a collaborative effort of the CHEER principal investigator (PI) and co-PIs. The 9-page questionnaire included validated instruments and additional patient- and physician-reported information. Information was captured electronically via REDCap by each site's CHEER research coordinator. Site initiation, data entry rates, and research coordinator feedback were also collected. RESULTS: Of the 21 CHEER sites, 15 participated in the study. Nine sites entered a patient within the first 31 days of study initiation, and all 15 sites were entering patients and corresponding clinical data within 72 days. During the 6-month study, 1044 patients were entered into the REDCap database. Research coordinator engagement was a major driver for success, whereas time and resources were deterrents. Incentives included altruism, professional development, and future financial opportunities. CONCLUSION: The CHEER research network has significant capability and infrastructure to collect prospective data in a practice-based environment. Research coordinator engagement undergirds network success; however, future efforts will cultivate stronger collaboration of the coordinator and site PI. Central coordination of practice-based research through a hub and spoke concept can be successful.

Assessment of acute otitis externa and otitis media with effusion performance measures in otolaryngology practices.

OBJECTIVE: To evaluate the acute otitis externa and otitis media with effusion performance measure sets in a clinical setting and provide preliminary data on measure compliance. STUDY DESIGN AND SETTING: Quality improvement study. SUBJECTS AND METHODS: Convenience sampling (N = 84) was performed at five sites of ENT and Allergy Associates, LLC. RESULTS: Physicians reported prescribing topical antibiotic preparations and assessing for auricular or periauricular pain in 98% of acute otitis externa cases (N = 55). In addition, 87% did not prescribe systemic antimicrobials. Pneumatic otoscopy was used by 76% of physicians as a method for otitis media with effusion diagnosis and 10% administered a hearing test within 6 months before tympanostomy tube placement (N = 29). Furthermore, as recommended, 86% did not prescribe decongestants or antihistamines whereas 93% and 90% did not prescribe antimicrobials or systemic steroids, respectively. CONCLUSION: Although compliance in this study was generally high across both measure sets, actual use of the face sheet forms for appropriate patients was lower than the 80% reporting mandate by the Centers for Medicare and Medicaid Services that allows physicians to receive the monetary bonus. Incentive-based reporting should be continuously investigated to assess challenges for evaluating current measures.