Integration of Geriatric Care Into Dialysis Clinics
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in geriatric problem management as measured by survey
研究概览
简要总结
The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (RCT) to obtain evidence critical to inform a definitive RCT.
详细描述
The investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the Geriatric screen for OLder Dialysis patients (GOLD) to develop individualized recommendations for geriatric syndrome management based on the patient's priorities. The study population is older adults receiving hemodialysis and dialysis staff. The investigators will have patient participants complete the care model and undergo geriatric evaluation. This phase will be referred to as refinement aim 1. The investigators will then assess agreement of each GOLD instrument with its corresponding geriatric evaluation. The investigators will assess acceptability and feasibility of the care model through surveys and interviews with patients and dialysis staff to complete refinement aim 2. Once the new dialysis care model is redefined, the investigators will conduct the third phase, pilot RCT (geriatric care model vs. usual care) and assess geriatric problem management at 4 months, as well as, patient reported outcomes, physical function, and health care utilization at intervals up to 12 months. The analyses will include 1) measure of agreement using Cohen's kappa, 2) qualitative rapid analyses, 3) descriptive statistics from acceptability and feasibility surveys, 4) descriptive statistics from pilot RCT data, and 5) tests for difference in geriatric problem management between treatment and control groups. The study does not involve activity from participants that would exceed normal or routine care so there are negligible physical, financial, or legal risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •community-dwelling dialysis patients 55 and older
- •may have cognitive impairment
排除标准
- •advanced dementia
- •non-English or Spanish speaking
- •nursing home residents
- •hospice enrollees
研究组 & 干预措施
Usual Care
Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model.
干预措施: Usual Care (Behavioral)
Geriatric Care Model
Participants will complete the GOLD, along with a few additional short surveys and a Short Physical Performance Battery. Information gathered will guide the research geriatric team's recommendation report to the participants' dialysis care team. The dialysis teams will receive training on how to use the recommendation report and local resources to initiate geriatric problem management. Participants will be seen every 4 months for follow-up for roughly 12 months.
干预措施: Geriatric Care Model (Behavioral)
结局指标
主要结局
Change in geriatric problem management as measured by survey
时间窗: Baseline, 4, 8, 12 months
Problems include depression, anxiety, difficulty with memory, difficulty with daily activities, falling or fear of falling, obtaining and following instructions for taking medications, having unwelcome side effects from medications, not having enough support from others, and not having access to or eating enough food. The score for each problem ranges from 0 to 4, where a higher score indicates better management of the problem.
Change in geriatric problem management as measured by survey
时间窗: Baseline, 4 months
Problems include depression, anxiety, difficulty with memory, difficulty with daily activities, falling or fear of falling, obtaining and following instructions for taking medications, having unwelcome side effects from medications, not having enough support from others, and not having access to or eating enough food. The score for each problem ranges from 0 to 4, where a higher score indicates better management of the problem.
Change in geriatric problem management as measured by survey
时间窗: Baseline, 4, 8, 12 months
Problems include depression, anxiety, difficulty with memory, difficulty with daily activities, falling or fear of falling, obtaining and following instructions for taking medications, having unwelcome side effects from medications, not having enough support from others, and not having access to or eating enough food. The score for each problem ranges from 0 to 4, where a higher score indicates better management of the problem.
次要结局
- Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)(up to 12 months)
- Retention as measured by number of participants who complete the study(up to 12 months)
- Fidelity as measured by number of completed study visits(up to 12 months)
- Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial)(up to 12 months)
- Recruitment as measured by number of participants enrolled(up to 12 months)
- Practicality as measured by number of participants who needed study personnel assistance to complete the GOLD electronically(up to 12 months)
- Fidelity as measured by the Care model recommendation checklist(Baseline, 4 months)