NCT07107737

Brief Summary

The primary goal of this study is to find out if patients who speak with an EMS physician over the phone are less likely to refuse care compare to patients who do not speak with an EMS physician.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

April 12, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

July 30, 2025

Last Update Submit

June 30, 2026

Conditions

Keywords

EMS transportemergency treatmentEMS protocol

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Transported

    Number of patients who agreed to be transported by EMS

    Day 1

Secondary Outcomes (4)

  • Number of Patients Admitted to Hospital

    Day 1

  • Number of Patients Discharged from Emergency Department

    Day 1

  • Duration of EMS Interaction

    Day 1

  • Number of EMS Same-Day Return

    Hour 24 Post Initial Call

Study Arms (2)

Physician Consultation

EXPERIMENTAL

Mecklenburg EMS agency (MEDIC) crew chiefs (EMTs and/or paramedics) may decide, based on patient circumstances, to consult OMC for patients wishing to refuse care.

Behavioral: Physician Consultation

Standard of Care

ACTIVE COMPARATOR

Refusal-of-care consultation not provided to patient

Behavioral: Standard of Care

Interventions

Every other month will be randomized to either Physician Consultation or Standard of Care. During the months designated for Standard of Care, physician intervention will not be provided. For safety reasons, if physicians or EMS MEDIC clinicians feel that speaking with the patient is important to provide additional clinical benefit, they may do so without hesitation and can override the designated intervention month.

Standard of Care

Every other month will be randomized to either Physician Consultation or Standard of Care. During the months designated for Physician Consultation, direct communication between the patient and a designated physician by phone will be implemented when a patient refuses transport in cases where the EMS clinician feels that physician consultation is warranted for further guidance. The physician will attempt to address patient concerns and provide additional medical advice.

Physician Consultation

Eligibility Criteria

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

You may qualify if:

  • Adult patients ≥18 years old in care of Mecklenburg EMS (MEDIC) on an emergency basis (911 call) who wish to refuse transportation to the hospital in whom MEDIC has, via existing processes and decision-making, engaged online medical control EMS Physicians for further guidance

You may not qualify if:

  • Patients \<18 years old.
  • Patient refuses to speak with online medical control EMS Physicians. MEDIC or patient requests to have primary care physician.
  • Lack of clinical capacity.
  • Incarcerated population.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Stephen Tyler Constantine, MD

    Atrium Health Carolinas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

April 12, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations