Evaluating an Algorithm-Based Implementation Strategy to Improve HIV Care Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: predictive emergency room alerts (pERA), Standard of care.
- Who it may be relevant to
- Registry conditions: HIV (Human Immunodeficiency Virus). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Harnessing Data Science to Improve HIV Care Continuum Outcomes: A Hybrid Type 2 Trial Evaluating a Machine-Learning Algorithm-Based Implementation Strategy
Overview
This study tests a strategy for helping Care Management Agencies prioritize patients with HIV (PWH) for outreach and support. Under the new strategy, care managers are given a list of highest-priority patients who have been identified by a computer algorithm as being at high risk of going to the emergency room in the next two weeks. This strategy is compared to traditional (standard of care) care management, in which care managers reach out to patients based on a set schedule and their clinical judgement (but not based on a computerized report). We are looking at whether the use of the computer report helps care managers reach the right patients at the right time, preventing them from having to go to the emergency room.
Detailed description
Comprehensive Care Management and Care Coordination (CCM/CC) is a medical case management intervention with demonstrated effectiveness in reducing ED visits and hospitalization for PWH, and improving both health outcomes (viral load, CD4 count) and retention in care. However, despite CCM/CC's effectiveness, there are persistent challenges to its implementation. This project is based on the scientific premise that the effectiveness of the CCM/CC intervention can be greatly improved by utilizing a data-driven implementation strategy that optimizes timely provision of CCM/CC services to the patients who need it most. Our community-based collaborator, Comprehensive Care Management Partners (CCMP) Health Home, has developed and validated a machine-learning algorithm that can reliably predict which of its PWH patients are most likely to visit the ED in the next two weeks. In this project, we will apply this algorithm as a targeted implementation strategy for CCM/CC, focusing service provision on the PWH who need it most, when they need it most. Our core hypothesis (supported by preliminary studies data) is that this "just-in-time" strategy for implementing a care management intervention will overcome both provider-level barriers to the provision of CCM/CC services and patient-level barriers to the receipt of HIV treatment and care. We will conduct a Hybrid 2 implementation-effectiveness trial, guided by the RE-AIM implementation science framework and the behavioral economics theory of Scarcity to collect rigorous data on the impact of this algorithm-driven implementation strategy on the reach, effectiveness, adoption, implementation and maintenance of the CCM/CC intervention
Interventions
- Other predictive emergency room alerts (pERA)
pERA is a machine-learning algorithm-driven implementation strategy that identifies patients at higher risk of emergency room visits and alerts the care manager to follow-up with them. - Other Standard of care
Care managers interact with patients according to their standard of care protocols
Primary outcome measures
- ER visits [Time frame: Each 18 month cluster period (36 months total)]
- Hospitalizations [Time frame: Each 18 month Cluster Period (36 months total)]
- Viral Suppression [Time frame: Each 18 month cluster period (36 months total)]
- CD4 Count [Time frame: Each 18 month Cluster Period (36 months total)]
Eligibility criteria
Inclusion criteria
- Participants must be members of one of the Care Management Agencies that comprise the Community Care Management Partners (CCMP) Health Home
- Participants must be living with HIV
Exclusion criteria
- None, other than those listed above.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Community Care Management Partners Health Home — New York
Identifiers
NCT: NCT07279376 · R01MH136903