AzTrials
AzTrials

Population Health ManagementNCT04547374

Evaluation of Geisinger at Home (GaH) Patient Management

An observational study of Population Health Management, run by Geisinger Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Population Health Management
What is being tested?
GaH Intervention
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Apr 2021to 12 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients not eligible for enrollment into GaH

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Geisinger

    Danville, Pennsylvania, 17822

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
GaH Intervention
Keywords
Machine Learning, Supervised Machine Learning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GaH InterventionOther

    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.

Study groups in NCT04547374
Study groupRoleWhat they receive
Cohort 1 - GaH InterventionCohort 1 - GaH intervention group
Receives: Other: GaH Intervention
Cohort 2 - Standard-of-care control groupCohort 2 - Standard-of-care control group *Importantly, these individuals are eligible for referral to GaH at the discretion of their physicians.*

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start1 Apr 2021
  3. Primary completion12 Jul 2021
  4. Study completion12 Jul 2021

Why it stopped: Principle investigator changed academic affiliation- No longer at Geisinger- Study terminated prematurely- No Participants Enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04547374
Sponsor's protocol ID
2020-0769
Status last verified
Oct 2023
First submitted
4 Sep 2020
Last updated
19 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Population Health Management, run by Geisinger Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Visits and Admissions (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in