Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)

Официальное название

Community Health Support for Emergency Department-Presenting Head and Neck Cancer Patients: A Pilot to Improve Access to Timely Care

Обзор

Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face significant delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple socioeconomic and systems-level barriers to accessing timely cancer care. Delays of more than 30 days have been associated with worse outcomes, including higher recurrence rates and reduced survival. This pilot study will evaluate the feasibility and early impact of a community-based navigation program designed to improve access to timely care for ED-presenting HNC patients. The study embeds trained Community Health Support Specialists (CHSS) from the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program into the ED-to-treatment pathway. After ED discharge, CHSS staff will contact participants by telephone or text message to identify barriers to care-such as transportation, insurance, housing, or communication challenges-and connect them with appropriate community or institutional resources. All participants will receive the CHSS navigation intervention. Outcomes will be compared with a historical cohort of similar ED-presenting HNC patients treated prior to program implementation. The primary outcomes are time from ED discharge to diagnostic biopsy and time from ED discharge to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of participants who complete CHSS navigation, and exploratory analyses of the types of barriers identified and resolved. Findings from this pilot will generate preliminary data to inform larger studies aimed at improving access, reducing disparities, and accelerating treatment for head and neck cancer patients who first present in the emergency setting.

Подробное описание

This is a single-arm, prospective pilot study evaluating the feasibility and process impact of embedding Community Health Support Specialist (CHSS) navigation within the emergency department (ED)-to-treatment pathway for patients with newly suspected or newly diagnosed head and neck cancer (HNC). The study will be conducted at two University of Tennessee Health Science Center (UTHSC)-affiliated hospitals: Methodist University Hospital and Regional One Health.

Eligible participants are adults aged 18 years or older who present to the ED with a new or suspected HNC involving the oral cavity, oropharynx, hypopharynx, larynx, salivary glands, skin, sinonasal region, nasopharynx, thyroid, or an unknown primary. Patients with prior established oncology care for HNC, those enrolled in hospice, incarcerated individuals, or patients who cannot be contacted by telephone will be excluded.

During routine clinical care in the ED, otolaryngology residents identify potentially eligible patients and introduce the study using an IRB-approved consent disclosure statement. ED activities are limited to screening and obtaining permission to contact; no informed consent or HIPAA authorization occurs in the ED.

After ED discharge, a trained study team member conducts the full informed consent process electronically using REDCap eConsent. Participants may review the consent form remotely with study staff and provide electronic signature with date/time acknowledgment. Only participants who complete electronic informed consent and HIPAA authorization are enrolled.

Following enrollment, CHSS specialists initiate outreach within 72 hours of ED discharge and provide structured, non-clinical navigation support through at least two telephone or text-based contacts prior to initiation of definitive cancer treatment. CHSS activities focus on identifying and addressing barriers to care, including transportation challenges, insurance or financial barriers, housing instability, and communication gaps. CHSS staff do not provide medical advice, schedule clinical appointments, or alter treatment plans. All encounters are documented using standardized REDCap case report forms.

The primary outcomes are (1) time from ED discharge to diagnostic biopsy and (2) time from ED discharge to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of enrolled participants who complete CHSS navigation. Exploratory outcomes describe the types of social barriers identified, the proportion of barriers resolved, and patterns of navigation support.

Study data are entered and stored in REDCap, a secure, HIPAA-compliant database hosted by UTHSC. Outcomes for the pilot cohort will be compared with a historical control group of similar ED-presenting HNC patients treated at UTHSC-affiliated hospitals in the 24 months preceding program implementation. Analyses will use descriptive, non-parametric, and regression methods to estimate feasibility metrics and effect sizes to inform future multi-site studies.

This study is funded through the UTHSC Cancer Center's Access to Cancer Care Pilot Project and builds upon the Tennessee Department of Health-supported ENRICH program, which deploys CHSS specialists to reduce disparities in cancer care. Results will inform potential expansion of this navigation model to improve equity, timeliness, and outcomes for head and neck cancer patients presenting through the emergency department.

Вмешательства

• Поведенческое Community Health Support Specialist (CHSS) Navigation
  This intervention consists of structured, non-clinical navigation delivered by trained Community Health Support Specialists (CHSS) as part of the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program. Following emergency department discharge and completion of electronic informed consent, CHSS staff conduct outreach by telephone or text message to identify and address social and logistical barriers to timely head and neck cancer care. Navigation activities may include assista

Первичные конечные точки

• Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days) [Срок оценки: Up to 90 days after ED discharge]
• Time From Emergency Department (ED) Presentation to Treatment Initiation (Days) [Срок оценки: Up to 90 days after ED discharge]

Вторичные конечные точки (1)

• Feasibility of Community Health Support Specialist (CHSS) Navigation [Срок оценки: Up to 90 days after enrollment]

Критерии участия

Критерии включения

• Age 18 years or older
• Presentation to the emergency department (ED) with a new or suspected head and neck cancer (including oral cavity, oropharynx, hypopharynx, larynx, salivary gland, cutaneous, sinonasal, nasopharyngeal, thyroid, or metastatic disease with unknown primary)
• Residence within the regional catchment area of participating UTHSC-affiliated hospitals (Methodist University Hospital or Regional One Health)
• Ability to provide informed consent electronically using REDCap eConsent after ED discharge
• Has a valid telephone number for post-discharge contact

Критерии исключения

• Prior or ongoing established head and neck oncology care at the time of ED presentation
• Currently receiving hospice or palliative-only care
• Incarcerated individuals
• Inability to complete electronic informed consent (e.g., lack of decisional capacity or inability to complete consent even with staff assistance)
• Lacks reliable telephone access or is unable to be reached after three documented contact attempts by study staff
• Non-English or non-Spanish speaking when interpreter services are unavailable
• Expected survival less than four weeks, as determined by the treating clinical team

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Methodist University Hospital — Orlando
• Regional One Health — Memphis

Идентификаторы

NCT: NCT07225725 · 25-10971-XP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗