Innovation of Hearing Rehabilitation and Effects of Reform (InHEAR)
The Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Demographic changes forecast increasing numbers of +65-year-olds and consequently increased demand for hearing rehabilitation. To remedy this situation, the Danish Ministry of Health has proposed a new national initiative to implement innovative digital approaches to improve hearing rehabilitation, including a new, digital remote assessment routine.
The aim of this study is to investigate:
Primarily:
- Patient safety of remote vs. conventional assessment
Patient-reported satisfaction and treatment effect of remote vs. conventional assessment
Secondarily:
- Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine
- Translation and validation of the Danish adapted version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire.
The main study is a randomized clinical trial with three arms and 1:1:1 assignment comprising 751 potential first-time adult hearing aid users.
Since March 2021, 751 patients have been randomized and assigned to 20 different clinics. The remote assessment routine works well for both patients, assessors, and clinics. Inclusion is expected to end in December 2021 and overall study completion is anticipated in april 2022.
Deficient diagnosis of complicating conditions in first time hearing aid users is the main concern in remote assessment. If the study shows the practice to be safe, it could form the foundation of a future nationwide implementation of remote care in Danish hearing rehabilitation.
調査の概要
詳細な説明
InHEAR is a prospective randomized controlled trial aimed to investigate a new, Danish digital remote assessment routine applied in 751 hearing-impaired adults. The existing, traditional Danish referral model requires a physical consultation with an ear-nose- and throat (ENT) specialist prior to treatment initiation. The digital referral reform replaces the traditional physical ENT specialist assessment with a standardized examination package performed by educated and experienced audiology assistants, allowing physicians to assess and refer hearing-impaired adults to the relevant treatment regime remotely and asynchronously without meeting the patients physically.
After inclusion, the participants will be randomized equally into three groups:
Test group 1 (TG1) will be testing the digital assessment routine in private hearing clinics.
Test group 2 (TG2) will be testing the digital assessment routine in public hearing clinics.
Control group 3 (CG3) will be assessed in accordance with current Danish practice.
The examination package performed on test group participants comprises of:
- A standardized, focused medical hearing history record (questionnaire)
- A standard audiometry test, including air conduction, bone conduction, speech discrimination test and acoustic reflex test
- Tympanometry
- Still images of the eardrums performed by video-otoscopy
Four ENT-specialists, two audiologists and to private ENT specialist, will independently and remotely assess the standardized test group examination packages and refer the test group participants to relevant treatment. Participants in the control group are assessed by a private ENT specialist at a physical consultation and referred to relevant treatment in accordance with current Danish practice. Participants with simple hearing loss will be offered hearing rehabilitation with hearing aids. Participants with complicated hearing loss or complicated ear related diseases will be offered a physical ENT specialist assessment at the Department of Audiology at Aalborg University Hospital prior to treatment initiation.
Patient-reported data concerning treatment satisfaction-, quality- and effect will be registered throughout the study period.
Two-three months after treatment initiation, all participants are evaluated by an ENT specialist in Audiology or Otology at a "golden standard" physical consultation at the Department of Audiology at Aalborg University Hospital. Assessment and referral accuracy, patient-reported treatment quality and satisfaction between the test groups and the control group participants will be compared.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Aalborg、デンマーク、9000
- Department of Otorhinolaryngology and Audiology, Aalborg University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Subjective hearing difficulty
- Must be able to understand and read Danish
Exclusion Criteria:
- Recent ENT specialist assessment
- Prior HA usage
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Test Group 1 (TG1)
TG1 participants are testing the new digital assessment routine in a private setting. Audiology assistants in private hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The private hearing clinics also conduct hearing aid treatment for TG1 participants with simple hearing loss. TG21 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. |
Remote digital assessment of test group participants
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実験的：Test Group 2 (TG2)
TG2 participants are testing the new digital assessment routine in a public setting. Audiology assistants in public hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The public hearing clinics also conduct hearing aid treatment for TG2 participants with simple hearing loss. TG2 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. |
Remote digital assessment of test group participants
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アクティブコンパレータ：Control Group 3 (CG3)
CG3 participants will be assessed conventionally by a private practicing ENT specialist in the Region of Northern Jutland in Denmark at physical consultation in accordance with current Danish practice. CG3 participants with simple hearing loss can choose whether hearing aid treatment should be conducted in either a private or a public hearing clinic. CG3 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. |
Conventional physical assessment of control group participants
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diagnosis of complicating hearing and/or ear-related conditions in hearing impaired adults
時間枠：Baseline
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ENT specialist assessments were performed remotely in test group participants and physically in control group participants at baseline. Based on this assessment, participants were divided into three categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. Hearing aid treatment was administered when indicated. The primary focus was to correctly identify participants with severe/complicated hearing loss and/or complicating ear-related conditions in both test and control groups. |
Baseline
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Remote ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
時間枠：Month 3
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A physical, "golden standard" ENT assessment was performed in all test group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the remote ENT assessment at baseline and diagnostic differences were registered. Outcome measures: Sensitivity and specificity of the remote ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults. |
Month 3
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Conventional, physical ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
時間枠：Month 3
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A physical, "golden standard" ENT assessment was performed control group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the physical ENT assessment at baseline and diagnostic differences were registered. Outcome measures: Sensitivity and specificity of the conventional physical ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults. |
Month 3
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Remote vs. physical ENT assessment on correct diagnosis of severe/complicated hearing loss and/or complicating ear-related conditions.
時間枠：Month 3
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Comparison of sensitivity and specificity of remote vs. physical ENT assessment on correct identification of severe/complicated hearing loss and/or complication ear-related conditions in hearing impaired adults (p-values for comparison).
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Month 3
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient-reported treatment effect
時間枠：Month 3
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The Speech, Spatial- and Qualities of Hearing Scale questionnaire af hearing aid treatment (SSQ12B) provides a score correlated to the subjective hearing difficulty severity after hearing aid treatment is initiated. Possible scores ranged from -5 (a worsening of conditions after HAs) to 5 (an improvement of conditions after HAs). |
Month 3
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Effect of hearing aid treatment
時間枠：Month 3
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The International Outcome Inventory for Hearing Aids (IOI-HA) covers a minimal set of seven core outcome items.
The items are practically oriented and comprise a mini-profile more than a scale.
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Month 3
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Patient-reported satisfaction
時間枠：Month 1
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A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered. The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction) |
Month 1
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Patient-reported satisfaction
時間枠：Month 2
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A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered. The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction) |
Month 2
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Patient-reported satisfaction
時間枠：Month 3
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A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered. The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction) |
Month 3
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HA usage time
時間枠：Month 3
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Overall and average daily usage time (hours) was registered digitally from the hearing aids 3 months after treatment initiation.
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Month 3
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協力者と研究者
捜査官
- スタディディレクター：Morten Hoegsbro, MD, PhD, MSc、Department of Otorhinolaryngology and Audiology, Aalborg University Hospital, Denmark
研究記録日
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一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
詳しくは
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