Innovation of Hearing Rehabilitation and Effects of Reform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 751
- 试验地点
- 1
- 主要终点
- Conventional, physical ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
研究概览
简要总结
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: 3. Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine 4. 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjective hearing difficulty
- •Must be able to understand and read Danish
排除标准
- •Recent ENT specialist assessment
- •Prior HA usage
研究组 & 干预措施
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.
干预措施: Remote digital assessment (Diagnostic Test)
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.
干预措施: Remote digital assessment (Diagnostic Test)
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.
干预措施: Conventional physical assessment (Diagnostic Test)
结局指标
主要结局
Conventional, physical ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
时间窗: Month 3
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.
Diagnosis of complicating hearing and/or ear-related conditions in hearing impaired adults
时间窗: Baseline
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.
Remote ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
时间窗: Month 3
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.
Remote vs. physical ENT assessment on correct diagnosis of severe/complicated hearing loss and/or complicating ear-related conditions.
时间窗: Month 3
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).
次要结局
- Patient-reported treatment effect(Month 3)
- Effect of hearing aid treatment(Month 3)
- Patient-reported satisfaction(Month 3)
- HA usage time(Month 3)
- Patient-reported satisfaction(Month 1)
- Patient-reported satisfaction(Month 2)
研究者
Lene Dahl Siggaard
Principal Investigator
Aalborg University Hospital