NCT07042477

Brief Summary

This project will evaluate a virtual, on-demand telemedicine program for High emergency department (ED) utilizers with comorbid physical health conditions and behavioral health correlates. Researchers will randomize patients to have either full access to the full intervention (treatment group) or to receive only standard care (control group). Analyses will be intent-to-treat. The primary outcome is the number of ED visits 120 days after the first Best Practice Alert (BPA) firing. The research team plans to enroll 3200 patients in this study. However, randomization may end due to system constraints on December 31, 2025 before reaching that target. This sample provides 80% power to detect a 35% relative reduction in ED utilization using a two-tailed test with an alpha of .15, assuming 40% compliance with the program.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 18, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 18, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

June 18, 2025

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Emergency Department Visits

    Number of emergency department visits

    within 120 days of the initial BPA firing

Other Outcomes (1)

  • Health-related quality of life (HRQoL)

    Within 120 days of randomization

Study Arms (2)

Integrated Telemedicine Program

EXPERIMENTAL

Patients will be invited to participate in the integrated telemedicine program through text, email, and/or phone calls.

Behavioral: Integrated Telemedicine Program

Control

NO INTERVENTION

Patients will receive only standard care and will receive no invitation to participate in the integrated telemedicine program.

Interventions

The integrated telemedicine program is short-term bridge support provided by a virtually accessible team, including a behavioral health provider (Health Psychologist or Licensed Clinical Social Worker \[LCSW\]) and Community Health Worker (CHW). Once stabilized, members transition from bridge support to ongoing care with a Geisinger Health System Primary Care Provider and Behavioral Health Provider.

Integrated Telemedicine Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years old
  • + Geisinger ED visits in the last 6 months
  • Geisinger Health Plan (GHP) insurance member
  • Has a Geisinger PCP
  • Patient is being seen at one of the following facilities: Geisinger Lewistown Hospital, Geisinger Medical Center, Geisinger Bloomsburg Hospital, Geisinger Jersey Shore Hospital, Geisinger Community Medical Hospital, Geisinger Wyoming Valley, Geisinger Medical Center Muncy, Geisinger Shamokin Ach Hospital, Geisinger South Wilkes Barre

You may not qualify if:

  • Patient being seen in departments determined ineligible by the study team
  • Patient is diagnosed with alcohol and substance-related disorders
  • Patient is going to receive inpatient care
  • Patient is coded in the ED as Level 1 (i.e., seeking life-saving measures)
  • Patient has an Intellectual Disability or Traumatic Brain Injury
  • Patient is actively seeing a BH provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 29, 2025

Study Start

June 18, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations