Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04547374 |
| Other study ID # |
2020-0769 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
July 12, 2021 |
Study information
| Verified date |
October 2023 |
| Source |
Geisinger Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Healthcare cost has increased drastically in the last decade, and over 50% of the cost can be
attributed to a small portion (5-10%) of the population. Certain clinical programs, such as
home-based care, aim to reduce this utilization but need methods to identify the most
appropriate patients to enroll. The Investigators believe that data-driven approaches can
optimize this new healthcare delivery system to target patients who may likely benefit from
the program. The primary aim of this project is to determine the effectiveness of the
Geisinger at Home ™ (GaH) program on survival, emergency department (ED) visits and
hospitalizations in multiple patient populations defined by clinical characteristics.
Description:
BACKGROUND AND RATIONALE:
Geisinger at Home™ brings personalized healthcare to eligible Geisinger Gold Medicare
Advantage members where they live. Geisinger's at-home care program aims to keep patients
healthier, safer, and better connected to their healthcare team. Working closely with
patients' primary care physicians, Geisinger's team of doctors, registered nurses,
dietitians, case managers, pharmacists and other medical support staff can visit patients as
needed. The goal of the program is to meet the health needs of patients with chronic health
conditions through regular home visits, potentially reducing acute exacerbations of these
conditions requiring trips to the emergency room or hospital.
Geisinger at Home's spectrum of care includes:
Checkups Routine testing Wound care Respiratory care Nutritional needs Urgent care Specialty
care
Currently, there are about 7,000 Geisinger Gold members enrolled in the Geisinger at Home
program and over 11,000 are eligible based on current screening approach.
A fundamental operational challenge of this program is determining how to optimally
deploy/distribute its scarce resources-the members of the care team-among those 7,000
enrolled members to the optimize their impact. The current screening process uses limited
data (billing codes) and simple heuristics for assessing patient risk, and does not leverage
the rich, highly granular clinical data available, such as imaging, laboratory values, and
vital signs, which can greatly enhance the ability to accurately predict outcomes and
identify patients most appropriate for the program. The Investigators believe that using
these more granular data can optimize this new healthcare delivery system to target patients
who have the highest risk of future healthcare utilization or adverse events such as death.
As a proof-of-concept, the Investigators generated a machine learning model to predict risk
of future utilization in the next 12 months. This model utilized 191 input variables
including clinical data, imaging measures, comorbidities, medications, past utilization
metrics, as well as social metrics. The results showed that the machine learning model had
the ability to predict utilization endpoints compared to current screening approaches
utilizing billing code data. The Investigators now seek to prospectively evaluate the effect
that GaH interventions have on patient outcomes (e.g., hospitalizations and ED visits,
mortality), when informed by these accurate predictive modeling results and other
stratification approaches.
PROCEDURES:
Research Design This is a prospective pragmatic randomized controlled study to evaluate the
effects of GaH intervention on eligible patients as compared against current best practices
for care management. Patients will be identified and screened based on available data from
the EHR, randomly assigned GaH intervention or standard of care (SoC) and followed for 6
months. The primary endpoints of the study are number of hospitalizations and ED visits.
Secondary endpoint will be 6-month survival after enrollment.
Detailed Procedures: Once the cohorts are identified, cohort 2 (controls) will continue to
receive standard clinical care and management. There will be no intent for members of the
project team to intervene or interact with these individuals. Cohort 1 will be onboarded for
GaH intervention through the clinically directed process by the GaH team. Of note, the
purpose of this project is not to define, control, or evaluate the specific details of the
GaH process or procedure, but to evaluate its effectiveness as an alternative clinical care
path in this setting. As such, the specific details and actions of the GaH care team in each
patient interaction are left to their medical discretion.
