Implementation and patient outcome measures | Data source/measurement description | Pre-FN intervention | Post-FN intervention |
---|---|---|---|
Implementation determinants | |||
Financial navigator characteristics | Financial navigator questionnaire (study-specific instrument) regarding knowledge, self-efficacy and confidence related to FT and FN | X | X |
Intervention complexity | Financial navigator and practice stakeholder structured interviews | X | |
Outer setting patient needs and resources | Financial navigator and practice stakeholder structured interviews | X | |
Inner setting implementation climate, learning climate, resources and access to information | Financial navigator and practice stakeholder structured interviews | X | |
Process of reflecting and evaluating | Financial navigator and practice stakeholder structured interviews | X | |
Implementation outcomes | |||
Fidelity to financial navigation protocol | Assessed via 10% random sample of all FN intake forms and appointment notes recorded by financial navigators in a patient tracking database built in RedCap to assess: whether the full comprehensive intake form was completed, whether participants received at least two visits with the financial navigator, whether the financial navigator re-contacted participants within 2–3 weeks after each financial clinic visit, and level of completeness of tracking data (e.g., were financial assistance applications submitted, was the resolution status recorded?) | X | |
Uptake of financial navigation intervention | Assessed using patient tracking database in RedCap as the ratio of the number of patients served by FN to the number of patients screened positive for financial distress and referred to FN; and the percentage of patients who are successfully navigated to specific financial assistance resources (including, but not limited to, Social Security Disability Insurance (SSDI); Medicaid; private insurance subsidies; charity care) | X | |
Acceptability of financial navigation to practices | Financial navigator and practice stakeholder structured interviews | X | |
Perceived sustainability of financial navigation | Financial navigator and practice stakeholder structured interviews | X | |
Cost of financial navigation | Assessed using patient tracking database in RedCap and navigator time-audits as the sum of all wages associated with intervention-related navigator activity for the duration of the study period, specifically: time spent training, time spent with patients delivering financial navigation services, time spent conducting administrative functions (e.g., patient scheduling and tracking, researching financial assistance resources, and submitting and resolving financial assistance applications), and time spent engaged in technical support and tailored coaching | X | |
Patient outcomes | |||
Socio-demographic variables | Patient survey of age, race, ethnicity, marital status, education, income, employment status, health insurance, household size, and dependents | X | |
Cancer-related financial toxicity | COmprehensive Score for financial Toxicity (COST) instrument | X | X |
Emotional distress and anxiety | PROMIS Emotional Distress-Anxiety Short Form 6a: 6-item measure of anxiety over the past 7 days | X | X |
Depression | PROMIS Depression Short Form 8a: 8-item measure of depression over the past 7 days | X | X |
Health-related quality of life | PROMIS Global Health Questionnaire: 10-item measure of symptoms, functioning, and healthcare-related quality of life (HRQoL) | X | X |
Illness impact | Psychosocial Illness Impact Short Form-Pos 4a: 4-item measure of positive emotional and social outcomes of illness | X | X |
Care-altering behaviors (foregoing, delaying care) | Patient questionnaire (study-specific instrument) | X | X |
Patient perspectives on FN acceptability, responsiveness and alignment with needs, patient-centeredness, and timeliness | Patient questionnaire (study-specific instrument) | X |