Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation

Обзор

The purpose of this study is to understand the implementation and impact of a pragmatically-delivered oncology financial navigation program. The main questions it aims to answer are: 1. How did oncology financial navigation implementation strategies affect implementation outcomes? 2. What is the impact of financial navigation on patient financial hardship, quality of life, and psychological distress? 3. How were implementation strategies utilized to overcome barriers to oncology financial navigation? Researchers will examine secondary, standard-of-care collected, patient-reported data, electronic medical record data, and qualitative interview data to answer these questions.

Подробное описание

Guided by the RE-AIM Extension for Equitable Sustainability framework, the investigators will use a series of implementation and effectiveness aims to evaluate equitable implementation of oncology financial navigation into routine cancer care delivery. The investigators hypothesize the proposed assessment will identify potential areas to improve implementation of oncology financial navigation, which will result in better financial and clinical outcomes for patients with cancer. The investigators propose a pragmatic, hybrid effectiveness-implementation study to assess outcomes of oncology financial navigation delivered as routine cancer care and collect information on strategies to address implementation barriers. Outcomes will be assessed overall and for inequities by race, residence, and insurance status using the following specific aims:

Aim 1. Track oncology financial navigation implementation strategies and their effect on implementation outcomes

Aim 2. Evaluate oncology financial navigation effectiveness

Aim 3. Assess how implementation strategies were utilized to overcome barriers to oncology financial navigation

Вмешательства

• Поведенческое Financial navigation
  Oncology financial navigation is an evidence-based intervention which helps patients prepare for out-of-pocket treatment costs, optimize health insurance, and access financial resources to reduce cancer-related financial hardship.

Первичные конечные точки

• Change in financial hardship [Срок оценки: 6 months post-initiation of systemic therapy]
• Change in financial difficulties [Срок оценки: 6 months post-initiation of systemic therapy]
• Change in quality of life [Срок оценки: 6 months post-initiation of systemic therapy]
• Change in psychological distress [Срок оценки: 6 months post-initiation of systemic therapy]
• Utilization of implementation strategies [Срок оценки: Quarterly tracking of strategies with monthly assessment of implementation outcomes, through study completion, an average of 4 years]
• Patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies [Срок оценки: Annually through study completion, an average of 4 years]

Критерии участия

Aim 1:

Inclusion criteria: As oncology financial navigation will be implemented as standard of care, implementation outcomes will be evaluated for:

• All patients with cancer seen at the University of Alabama at Birmingham (UAB) Medical Oncology clinic
• UAB oncology financial navigators

Exclusion criteria: None.

Aim 2:

Inclusion criteria: This will be a secondary data analysis of patient-reported data routinely collected since 2020, which will include:

• Patients with cancer seen at the UAB Medical Oncology clinic
• Patients with non-missing patient-reported outcome data

Exclusion criteria: None.

Aim 3:

Критерии включения

• Patients who have received oncology financial navigation
• Providers (oncology financial navigators, social workers, nurse managers, oncologists) involved with the oncology financial navigation program
• Health system team members (billing specialists, cancer service line leadership) involved with the oncology financial navigation program

Exclusion criteria: None.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT07281287 · IRB-300012763 · 1K01CA296932

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗