NCT04547374

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2021

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 4, 2020

Last Update Submit

October 17, 2023

Conditions

Keywords

Machine LearningSupervised Machine Learning

Outcome Measures

Primary Outcomes (1)

  • Hospital Visits and Admissions

    The primary outcomes of number of IP admission and number of ED visits through 6 months post-enrollment will be compared between groups.

    6 months

Study Arms (2)

Cohort 1 - GaH Intervention

Cohort 1 - GaH intervention group

Other: GaH Intervention

Cohort 2 - Standard-of-care control group

Cohort 2 - Standard-of-care control group \*Importantly, these individuals are eligible for referral to GaH at the discretion of their physicians.\*

Interventions

Patients in this cohort will be referred for management/intervention with GaH. However, the purpose of this program 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.

Cohort 1 - GaH Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult Geisinger patients (≥18 years of age) eligible for enrollment into Geisinger at Home (TM) (GaH).

You may qualify if:

  • All adult Geisinger patients (≥18 years of age) eligible for enrollment into GaH.

You may not qualify if:

  • Patients not eligible for enrollment into GaH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Study Officials

  • Brandon K Fornwalt, MD,Phd

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR
  • H. Lester Kirchner, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 14, 2020

Study Start

April 1, 2021

Primary Completion

July 12, 2021

Study Completion

July 12, 2021

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations