Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in financial hardship
Study Overview
Brief Summary
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:
- How did oncology financial navigation implementation strategies affect implementation outcomes?
- What is the impact of financial navigation on patient financial hardship, quality of life, and psychological distress?
- 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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
- •Inclusion criteria:
- •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.
Arms & Interventions
Patients receiving standard-of-care-delivered financial navigation
Intervention: Financial navigation (Behavioral)
Historical control patients who did not receive financial navigation
Outcomes
Primary Outcomes
Change in financial hardship
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported financial distress (COmprehensive Score for financial Toxicity)
Change in financial difficulties
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported financial difficulties (trouble paying for basic needs, utilities, transportation or lodging for treatment, medications, medical supplies, upfront medical payments, insurance or medical bills, child or eldercare, and employment or disability issues)
Change in quality of life
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported quality of life (PROMIS v1.1 Global Health)
Change in psychological distress
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported psychological distress (National Comprehensive Cancer Network Distress Thermometer)
Utilization of implementation strategies
Time Frame: Quarterly tracking of strategies with monthly assessment of implementation outcomes, through study completion, an average of 4 years
Track oncology financial navigation implementation strategies using the Expert Recommendations for Implementing Change (ERIC) implementation strategy taxonomy and their effect on implementation outcomes of Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM)
Patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Time Frame: Annually through study completion, an average of 4 years
Using qualitative interviews, we will assess patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Secondary Outcomes
No secondary outcomes reported
Investigators
Courtney Williams
Assistant Professor
University of Alabama at Birmingham