跳至主要内容
临床试验/NCT06604663
NCT06604663Enrolling By Invitation不适用

Data Science for Decision Support in the HIV Care Cascade

Brown University1 个研究点 分布在 1 个国家目标入组 80,000 人开始时间: 2024年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
80,000
试验地点
1
主要终点
The proportion of scheduled patient visits kept by the patient (1-day)

研究概览

简要总结

The goal of this study is to determine whether clinical prediction algorithms derived using statistical machine learning methods can be used to improve patient outcomes in large HIV care programs in sub-Saharan Africa and elsewhere.

There are two main questions to be answered. First, can the prediction algorithms accurately identify those who are at risk for (a) missing scheduled clinic visits and/or (b) treatment failure, evidenced by elevated HIV viral load? And second, can the risk predictions be used in a structured way to (a) improve retention in care and/or (b) reduce the number of patients having elevated viral load? Researchers will develop machine learning prediction algorithms, incorporate the risk prediction information into the electronic health record, provide guidance to clinical health workers on use of the point-of-care interface tools that display risk prediction information, and incorporate feedback from clinic staff to modify and co-develop the protocol for using risk predictions for improving patient outcomes.

They will then compare the proportion of patients having missed visits and longer-term loss to follow up, and the proportion with elevated viral load, between clinics that use the information from the risk prediction algorithms and those that do not.

详细描述

Clinical decision support systems (CDSS) tailored to the requirements of low- and middle-income countries (LMIC) have been shown to improve compliance with guidelines and quality of care by a range of healthcare staff. To be most effective CDSS should be developed and tested with large clinical data sets from the local region. Use of machine learning algorithms allows the development of prediction models for clinical complications and outcomes, which can guide health care staff in early identification of problems and appropriate interventions. This requires well established electronic health record (EHR) systems acting as both data sources and as platforms for delivering feedback through CDSS (Learning Health System approach). The EHR at the Academic Model Providing Access to Healthcare (AMPATH), a large HIV care program in western Kenya funded in large part by President's Emergency Plan for AIDS Relief (PEPFAR), has used a version of the OpenMRS EHR for nearly two decades and provides a unique environment for this research.

The objective of this proposal is to develop and implement data-driven tools to aid health-related decision-making at patient, clinic and county levels, and evaluate the efficacy of using these methods. The hypothesis is that health facilities utilizing these data driven CDSS will show improvements in the processes and outcomes of care compared to health facilities not utilizing data driven CDSS within their EHRs.

The two primary endpoints for the study are retention in care and viral load suppression.

The motivation is driven by 95-95-95 HIV cascade of care benchmarks established by UNAIDS for eradicating HIV worldwide. In brief, the framework calls for diagnosis of 95% of individuals who have HIV, initiating antiretroviral (ART) treatment for 95% of those who have been diagnosed, and achieving suppression of viral load (VL) for 95% of those who are on treatment. Our project addresses the second and third phases.

Regarding the second 95, retention is a necessary condition for maintaining persons living with HIV (PLWH) on antiretroviral therapy (ART) because global care guidelines now specify that all PLWH initiate ART once engaged in care. Regarding the third 95, in Kenya and many other LMIC, viral load testing for most adult clients is done six months after treatment initiation and annually thereafter. Even after a measured VL indicating suppression, viral failure due to nonadherence or drug resistance can occur well before the next follow up one year later. Hence our models will generate predicted viral load values in the interim and use them to flag individuals who should have a VL measurement prior to the scheduled follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study will include adult patients (age 18 and over) receiving HIV care through the AMPATH program in Eldoret, Kenya. There is not a patient-level enrollment process. The primary endpoints will be summarized at the clinic level (e.g., proportion of patients who keep an appointment within 7 days of the scheduled appointment).

排除标准

  • 未提供

研究组 & 干预措施

Usual Care

No Intervention

Usual Care at AMPATH involves telephoning clients or care supporters the day prior to their appointment (at some clinics) and/or telephoning or making a home visits after appointments are missed. This will be in place at usual care clinics until the date at which the clinic is randomized to receive the CDSS support.

Clinical decision support, CDSS

Experimental

When a clinic is assigned to receive the CDSS support intervention two components will be enacted to enable proactive outreach that prevents a missed visit. These patients are considered to be in the active, experimental arm. Please seem the section above on Detailed Description for background and details on how this intervention is implemented.

干预措施: Activation of the CDSS system (Behavioral)

结局指标

主要结局

The proportion of scheduled patient visits kept by the patient (1-day)

时间窗: The study has 6 waves (or wedges in the stepped-wedge design). The proportion will be measured weekly for the 4 weeks preceding the first wave of CDSS implementation, and then weekly until 8 weeks after the date of the final wave of CDSS implementation.

The proportion of scheduled patient visits where the patient returns on or before the scheduled visit date. Measured weekly at the clinic level.

The proportion of scheduled patient visits kept by the patient (7-day)

时间窗: The study has 6 waves (or wedges in the stepped-wedge design). The proportion will be measured weekly for the 4 weeks preceding the first wave of CDSS implementation, and then weekly until 8 weeks after the date of the final wave of CDSS implementation.

The proportion of scheduled patient visits where the patient returns on or before the 7th day following the scheduled visit date. Measured weekly at the clinic level.

The proportion of patients with suppressed VL among those with measured VL

时间窗: The study has 6 waves (or wedges in the stepped-wedge design). The proportion will be measured for the month preceding the first wave of CDSS implementation, and then monthly until 2 months after the date of the final wave of CDSS implementation.

The proportion of patients with suppressed VL among those with measured VL. This outcome reflects the fraction suppressed only among those who show up for their VL measurement and is the metric designed for tracking progress toward 95-95-95 goals. This endpoint will be measured monthly at the clinic level. The denominator will be number of patient-level VL measures, and the numerator will be number of occasions where the measured VL is undetectable.

The proportion of patients with suppressed VL among those with scheduled VL measurement, whether or not that measure was taken.

时间窗: The study has 6 waves (or wedges in the stepped-wedge design). The proportion will be measured for the month preceding the first wave of CDSS implementation, and then monthly until 2 months after the date of the final wave of CDSS implementation.

The proportion of patients with suppressed VL among those with scheduled VL measurement, whether or not that measure was taken. This outcome is designed to reflect the fraction of the overall patient population having suppressed VL and is potentially more relevant as a population-level parameter. This endpoint will be measured monthly at the clinic level. The denominator will be number of VL measurements scheduled, and the numerator will be number of occasions where the VL is measured and is undetectable.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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