Epividian, Inc. and AIDS Healthcare Foundation: Positive Pathways - HIV Retention in Care RIC-20190212 (Pro00037143)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Epividian
- 入组人数
- 10,521
- 试验地点
- 1
- 主要终点
- Rate of Kept Appointments
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of a clinical decision support system (CDSS) combined with enhanced patient contact to retain HIV+ patients in care with AIDS Healthcare Foundation. Specifically, the study aims to evaluate the effectiveness of having the patient's primary caregiver (or dedicated case manager) telephone the patient when the patient is identified as a significant risk to loss of follow-up (at-risk patients) based upon pre-defined criteria. The secondary objective Gain a better understanding about the implementation of the study's procedures in clinical practice by evaluating survey responses delivered to participating healthcare providers and AHF staff members engaging with the study's intervention.
详细描述
Retention in care and re-engagement in care is a primary concern in HIV treatment today and a major obstacle in the US to reach the UNAIDS 90-90-90 goal [1]. The U.S. CDC supports the use of HIV surveillance data to identify not-in-care (NIC) patients and re-link them to care (Data-to-Care). The optimal strategy for identifying patients for Data-to-Care is unknown. It has been postulated that by increasing follow up of high-risk patients not meeting the retention in care measures, the number of people living with HIV being retained in care may be increased by 10%.
Multiple HIV clinics within the AHF organization in the US are eligible for study participation. "Primary" HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective EHRs and identified through CHORUS, a CDSS developed by Epividian. The CDSS will track patient case status as active or inactive (loss to follow-up, transferred medical care, or deceased). Providers will be informed of the study and sites will be contracted to participate in this collaborative research study.
The CDSS will generate alerts to the providers warning of suboptimal patient attendance among the population. The alerts will be generated using the following four criteria of at-risk of loss to follow-up:
- At Risk #1: No visit in the previous 4 months and no scheduled appointment in the subsequent 2 months.
- High Risk #2: Single appointment in the previous year, a missed appointment in the previous month and no scheduled appointment in the next 2 months.
- High Risk #3: Those with 2 missed sequential appointments, and no scheduled appointment in the subsequent 7 days.
- High Risk #4: Those with an attended appointment >3 months ago and their most recent viral load >1000 copies/ml.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years old or older
- •Seen at least once in a US-based AHF clinic in the last 2 years with care documented in the EHR
排除标准
- •Patients known to have left the practice
- •Patients who choose not to be contacted about their care via telephone
结局指标
主要结局
Rate of Kept Appointments
时间窗: 16 months, 01-Nov-2019 to 30-Apr-2021
Pre and post-baseline rate of patients who attended their scheduled office visits.
次要结局
- Viral suppression(16 months, 01-Nov-2019 to 30-Apr-2021)
- Ranked Scoring of Implementation effectiveness(16 months, 01-Nov-2019 to 30-Apr-2021)