Implementing HearVA (I-HearVA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,050
- 试验地点
- 12
- 主要终点
- ED 3-day Readmissions
研究概览
简要总结
HearVA involves six VA facility emergency departments (ED) over a 3-year intervention period. The first part of this study will test whether providing personal amplifiers to Veteran ED patients who self-report hearing difficulty is acceptable to these patients, can improve their hearing, enhance understanding of discharge instructions, and can reduce the risk of coming back to the ED in a short period of time (3 days and 30 days). The second part of the study will then identify whether ED staff can implement this program and achieve similar results. The second part will give ED staff increasing levels of responsibility for screening Veterans for hearing difficulty and providing personal amplifiers when such difficulty is detected.
详细描述
HearVA is a randomized controlled trial to explore the utility and outcomes of providing point-of-care access to hearing-impaired Veterans, comparing an offer of personal amplifiers versus control in an environment where the clinical stakes are high. It addresses a knowledge gap about the utility of providing such hearing assistance during clinical encounters. The study measures whether providing personal amplifiers is acceptable to older patients, can improve hearing, enhance understanding of discharge instructions, and improve care transitions at discharge. If such a strategy is beneficial, this simple low-tech approach has great potential for implementation and wide dissemination. HearVA-ED has two phases - the first, which has been completed, established the feasibility and acceptability of research and procedures in the ED environment through a pilot efficacy study and the second phase will be to complete a larger more definitive efficacy study and a detailed implementation study resulting in a strategic approach that can be widely disseminated across all VA emergency departments throughout the United States. This second phase will use a mixed-methods, hybrid effectiveness-implementation design to implement and evaluate the hearing assistance intervention in six VA Emergency Department Sites (in different facilities across the country). Implementation will occur in four stages with variation in the starting sequence at each site: The first group of two VA emergency departments will initiate implementation with an efficacy trial; second group of two sites will initiate implementation with delivery and support of personal amplifiers after screening and randomization by a research assistant (Stage 1); the third group of two sites will initiate implementation with the entire implementation (Stage 2) and the presence of a research assistant to conduct discharge interviews; and all sites will progress from this sequence to Stage 3 - Sustainability - which is the full implementation without research assistant presence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Emergency severity index criterion of 3 (medium), 4, or 5 (low acuity)
- •Hearing Handicap Inventory-Screen greater than or equal to 10 or positive answer to a single-item screening question
- •Capacity to consent to participate in research
排除标准
- •Inability to consent to participate in research
- •Emergency severity index criterion of 1-2 (high acuity)
- •Hearing Handicap Inventory-Screen less than 10 and negative answer to single item screening question
- •Inability to speak English
- •Using cochlear implants
结局指标
主要结局
ED 3-day Readmissions
时间窗: 3-5 days after initial ED stay
The Investigators will determine whether patients have had an ED revisit within three days through CPRS review as well as a brief follow-up phone call 3-5 days after ED discharge
次要结局
- ED 30-day Readmissions(30-35 days after initial ED stay)
- Patient-Rated Quality of Post-Discharge Care(At time of discharge from ED, average 1 day)
- Self-Reported Understanding of Discharge Instructions(3-5 days after initial ED stay)
- Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay(Duration of ED stay, average of 1 day)