- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07042477
- Original Trial
Integrated Telemedicine Program Evaluation (ITP)
An Integrated, Virtual and On-Demand Solution to Avoid ED Utilization
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Patient presents to the ED and meets the following criteria:
Inclusion Criteria:
- 18+ years old
- 4+ 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Telemedicine Program
Patients will be invited to participate in the integrated telemedicine program through text, email, and/or phone calls.
|
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.
|
|
No Intervention: Control
Patients will receive only standard care and will receive no invitation to participate in the integrated telemedicine program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency Department Visits
Time Frame: within 120 days of the initial BPA firing
|
Number of emergency department visits
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within 120 days of the initial BPA firing
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life (HRQoL)
Time Frame: Within 120 days of randomization
|
HRQoL will be measured via the RAND Short Form 36 (36-item questionnaire) administered each BH visit.
A high score indicates a better health state or functioning.
The lowest and highest possible scores are 0 and 100 respectively.
|
Within 120 days of randomization
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0554
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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