Physician Consultation for Patient Refusal

Overseen By Stephen Tyler Constantine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if speaking with an EMS (emergency medical services) physician over the phone can reduce the number of patients who refuse care after a 911 call. The study includes two groups: one where patients receive a call from a physician and another where they do not. It targets adult patients in Mecklenburg EMS care who wish to refuse hospital transport after an emergency call. The researchers hope to find better ways to ensure patients receive necessary care. As an unphased trial, it offers patients the opportunity to contribute to improving emergency care protocols.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe?

Research has shown that talking to a doctor can boost patients' confidence in their healthcare decisions. This study examines whether phone consultations with EMS doctors can reduce the number of patients who opt out of receiving care.

There are no safety concerns because this trial does not test a new drug or treatment. It focuses solely on communication between patients and doctors, similar to receiving advice over the phone from a healthcare professional. Speaking with a doctor over the phone is common and carries no known risks.

The main goal is to determine how a conversation can help patients make informed choices. Since no physical treatment is involved, there is no need to worry about side effects or adverse events. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Physician Consultation treatment because it introduces a direct communication line between EMS crew chiefs and medical consultants when patients want to refuse care. Unlike the standard approach, which involves no consultation, this method allows for an expert opinion to be considered on-site, potentially leading to more informed decisions. This trial aims to find out whether real-time physician input can improve patient outcomes and safety by ensuring that patients who might need care are encouraged to receive it.

What evidence suggests that physician consultation is effective for reducing patient refusal of care?

Research has shown that talking to a doctor can reduce the likelihood of patients refusing medical care. In this trial, some participants will receive a physician consultation, where Mecklenburg EMS agency (MEDIC) crew chiefs may consult with a doctor for patients wishing to refuse care. Studies have found that when patients speak with doctors, they often feel more informed and confident about their health choices, leading to less regret about their treatment decisions. Additionally, talking to a doctor can build trust, which is crucial for patients unsure about accepting medical care. By addressing concerns and providing clear information, doctors can help patients make decisions they feel more comfortable with. ^{1 4 6 7 8}

Who Is on the Research Team?

Stephen Tyler Constantine, MD

Principal Investigator

Atrium Health Carolinas Medical Center

Are You a Good Fit for This Trial?

This trial is for patients who have called emergency medical services (EMS) and are considering refusing transport or care. There's no specific list of inclusion or exclusion criteria provided, so it appears open to any patient in this situation.

Inclusion Criteria

I am over 18, treated by MEDIC after a 911 call, and chose not to go to the hospital after consulting with EMS physicians.

Exclusion Criteria

I or my MEDIC have requested a primary care physician.

Incarcerated population

I refuse to speak with online EMS doctors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Intervention

Participants receive either physician consultation or standard care during EMS interaction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as EMS return and hospital admission

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Physician Consultation

Trial Overview The study is testing whether a phone consultation with an EMS physician can reduce the number of patients who refuse care compared to those receiving standard EMS care without a physician consult.

How Is the Trial Designed?

Group I: Physician Consultation Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

Refusal-of-care consultation not provided to patient

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10297854/

The Right to Refuse: Understanding Healthcare Providers ... This study aimed to delve into the attitudes of these providers toward treatment refusal, unearthing the strategies they employ in navigating such challenging ...

2. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-016-0558-0

More primary care patients regret health decisions if they ... Most primary care patients experience relatively low levels of decision regret after their consultations with family physicians, although higher ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064407005434

Refusal of Care: The Physician-Patient Relationship and ... This article offers a practical approach to patients who refuse treatment, including assessment of decisionmaking capacity but emphasizing the role of trust, ...

4. mhealth.amegroups.org mhealth.amegroups.org/article/view/127554/html

a systematic review of reasons for patient refusal - mHealth The most common reasons for declination included concerns about model effectiveness, safety at home, preference for in-hospital care, physician advice, family ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4351276/

Why do People Avoid Medical Care? A Qualitative Study ... Approximately one-third of participants (n=456, 33.3%) provided responses that demonstrated unfavorable evaluations of the process or outcomes of seeking ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560886/

Refusal of Care - StatPearls - NCBI Bookshelf - NIH A patient's right to the refusal of care is founded upon one of the basic ethical principles of medicine, autonomy.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064417304535

Ethics/concepts Refusal of Emergency Medical Treatment This article addresses important considerations for patients who refuse treatment, including case studies and discussion of definitions.

8. annemergmed.com annemergmed.com/article/S0196-0644(17)30453-5/fulltext

Refusal of Emergency Medical Treatment: Case Studies ... This article addresses important considerations for patients who refuse treatment, including case studies and discussion of definitions, epidemiology, ...