Pragmatic Trial of the Impact of the Electronic Frailty Integrated With Social Needs (eFRIEND) on High Cost, High Burden Healthcare Use of Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,050
- 试验地点
- 1
- 主要终点
- Number of ED Visits or Inpatient Hospitalizations
研究概览
简要总结
Participants in Electronic Frailty Integrated with Social Needs (eFRIEND) will randomize to receive regularly scheduled in-person and telehealth contacts with a community health worker (CHW) or continue to receive standard of care. The purpose of this research is to use CHW to help older adults because there may be some resources that could benefit them that they are not aware of or for which they need help applying.
详细描述
The study team will conduct a pragmatic randomized pilot trial of a CHW-led hybrid in-person/telehealth program pathway (eFRIEND) for frail older adults. Using Zelen's effectiveness design, the study team will identify eligible frail older adults via the Electronic Health Record (EHR). Eligible participants will be randomized to the eFRIEND pathway or usual care. The study team will randomize 2050 older adults (1050 to eFRIEND, 1000 to usual care), with the randomization stratified by primary care clinic. Eligible participants randomized to the eFRIEND pathway will be contacted by phone to discuss study procedures and obtain verbal informed consent. eFRIEND comprises a 6-month intervention. All CHW will be certified and have participated in the North Carolina Community Health Worker Standardized Core Competency Training. CHW are trusted members of the community and are utilized as part of routine care to assist patients. At the first visit, the CHW will assess if the participants have any unmet social and/or functional needs (baseline survey). The frequency and amount of time of each point of contact will be at the discretion of the CHW.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frail based on the electronic Frailty Index (eFI>0.21)
- •Live in Forsyth County, NC
- •Linked to any Accountable Care Organizations (ACO) registry
- •Have a Primary Care Provider (PCP) in Atrium Health Wake Forest Baptist (AHWFB) system, and have seen their PCP or someone else in the clinic of their PCP within the last 12 months
排除标准
- •Diagnosis code for dementia in the past 2 years
- •Does not speak English
研究组 & 干预措施
Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND)
Participants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW.
干预措施: eFRIEND (Behavioral)
Usual Care
Usual care group will be monitored passively for outcomes under a waiver of informed consent
干预措施: Usual Care (Other)
结局指标
主要结局
Number of ED Visits or Inpatient Hospitalizations
时间窗: Month 12
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
Number of ED Visits or Inpatient Hospitalizations
时间窗: Month 6
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
次要结局
- Number of Completed Medicare Annual Wellness Visits (AWVs)(Month 6 and Month 12)
- Usage of Advance Care Planning (ACP)(Month 6 and Month 12)
- Number of Annual Wellness Visits (AWV)s(Month 6 and Month 12)
- Percentage of Participants who Report Social Isolation--Total Number(Month 6 and Month 12)
- Participant Uptake of Home Health Services--Total Number(Month 6 and Month 12)
- Percentage of Participants who Report Lack of Transportation--Proportion(Month 6 and Month 12)
- Percentage of Participants who Report Use of Social Services--Proportion(Month 6 and Month 12)
- Percentage of Participants who Report Use of Home Health Services--Proportion(Month 6 and Month 12)
- Percentage of Participants who Report Housing Instability--Total Number(Month 6 and Month 12)
- Percentage of Participants who Report Lack of Transportation--Total Number(Month 6 and Month 12)
- Percentage of Participants who Report Use of Home Health Services--Total Number(Month 6 and Month 12)
- Percentage of Participants who Report Use of Social Services--Total Number(Month 6 and Month 12)
- Acceptability of Program(Month 6 and Month 12)
- Participant Uptake of Home Health Services--Proportion(Month 6 and Month 12)
- Proportion of eligible patients who interact with CHW(Month 6 and Month 12)
- Percentage of Participants who Report Food Insecurity--Total Number(Month 6 and Month 12)
- Percentage of Participants who Report Food Insecurity--Proportion(Month 6 and Month 12)
- Percentage of Participants who Report Housing Instability--Proportion(Month 6 and Month 12)
- Percentage of Participants who Report Social Isolation--Proportion(Month 6 and Month 12)