Refusal of TransportNCT07107737
Physician Engagement in EMS Transport Refusal Rates
A study testing Physician Consultation in people with Refusal of Transport, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refusal of Transport
- What is being tested?
- Physician Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Stephen Tyler Constantine, MD, 704-355-3181, stephen.constantine@advocatehealth.org
About this study
Official title: The Role of Direct Physician Engagement in EMS Transport Refusal Rates: A Prospective Study
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.
Read the detailed description
This study aims to assess the impact of direct physician communication on patients' decisions to refuse EMS transport. The research approach is designed to measure the influence of physician interaction on patient transport decisions in a prospective model. By conducting this research, the study team hopes to provide evidence-based recommendations for EMS protocols regarding patient engagement and refusal management.
- Conditions
- Refusal of Transport
- Being tested
- Physician Consultation, Standard of Care
- Keywords
- EMS transport, emergency treatment, EMS protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician ConsultationBehavioural
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.
Standard of CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physician Consultation |
| Standard of Care | Active comparator | Refusal-of-care consultation not provided to patient Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Transported
Number of patients who agreed to be transported by EMS
Measured: Day 1
Secondary outcomes (4)
Number of Patients Admitted to Hospital
Number of patients admitted to hospital after being transported by EMS
Measured: Day 1
Number of Patients Discharged from Emergency Department
Number of patients discharged from Emergency Department after being transported by EMS
Measured: Day 1
Duration of EMS Interaction
Length of time from EMS arrival to the end of the patient interaction in minutes and seconds
Measured: Day 1
Number of EMS Same-Day Return
Number of times EMS is called again to attend to a patient who earlier refused transport
Measured: Hour 24 Post Initial Call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start12 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refusal of TransportStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Tyler Constantine, MD, Principal investigator, Atrium Health Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107737
- Sponsor's protocol ID
- IRB00134848
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Direct Physician Engagement in EMS Transport Refusal Rates: A Prospective Study
- ClinicalTrials.gov ID
- NCT07107737
- Acronym / sponsor ID
- IRB00134848
- Conditions
- Refusal of Transport
- Keywords
- EMS transport, emergency treatment, EMS protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to assess the impact of direct physician communication on patients' decisions to refuse EMS transport. The research approach is designed to measure the influence of physician interaction on patient transport decisions in a prospective model. By conducting this research, the study team hopes to provide evidence-based recommendations for EMS protocols regarding patient engagement and refusal management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician Consultation | Experimental | Behavioral: Physician ConsultationMecklenburg EMS agency (MEDIC) crew chiefs (EMTs and/or paramedics) may decide, based on patient circumstances, to consult OMC for patients wishing to refuse care. |
| Standard of Care | Active comparator | Behavioral: Standard of CareRefusal-of-care consultation not provided to patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician ConsultationEvery 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. | Behavioural | Physician Consultation |
| Standard of CareEvery 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. | Behavioural | Standard of Care |
Primary outcome
Number of Patients Transported
Time frame: Day 1
Number of patients who agreed to be transported by EMS
4 secondary outcomes
Number of Patients Admitted to Hospital
Time frame: Day 1
Number of Patients Discharged from Emergency Department
Time frame: Day 1
Duration of EMS Interaction
Time frame: Day 1
Number of EMS Same-Day Return
Time frame: Hour 24 Post Initial Call
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Tyler Constantine, MD principal investigator
Atrium Health Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Consultation in people with Refusal of Transport, run by Wake Forest University Health Sciences 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 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Tyler Constantine (704-355-3181, stephen.constantine@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Transported (time frame: Day 1). 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 3 Nov 2026.