Cancer, Financial Burden, Financial Toxicity, Screening Tool
Conditions
Brief summary
Screening and referral program to proactively identify financial hardship in adult patients with cancer and connect those at-risk with education, counseling, and resources. Patients with cancer will be screened as part of routine care and referred to available resources at their institution, following the referral processes developed and mapped in Aim 1.
Detailed description
In Aim 1, we will interview up to 30 clinical leaders and front-line staff across the two healthcare systems and community-based practices to understand workflows and opportunities for I-ACCESS integration. Assessment constructs will focus on understanding structural characteristics (including information technology infrastructure), available resources, culture, compatibility, relational connections, communications, and access to knowledge. These data will inform the creation of tailored process maps to outline processes and procedures to prepare each site for I-ACCESS implementation and elucidate when, how, and by whom I-ACCESS screening should be done. In Aim 2, we will implement I-ACCESS as part of routine clinical practice for eight months at each site. Using a pre-/post-approach, we will examine whether I-ACCESS screening increases the number of financial counseling and oncology social work referrals (primary outcome). We will also examine counseling dispositions, receipt of services among those referred to financial support, and the predictive accuracy of the screening tool (secondary outcomes). In Aim 3, we will analyze approximately 225 patient and 25 clinician surveys, informed by the Practical, Robust, Implementation and Sustainability Model, to gather feedback on I-ACCESS delivery, procedures, and barriers/facilitators to implementation. Based upon survey findings, we will then focus on key implementation determinants and outcomes through in-depth, semi-structured interviews with up to 40 stakeholders. Stakeholders will include patients, caregivers, healthcare providers, financial counselors, clinical support staff, and hospital administration at participating clinical sites.
Interventions
BEHAVIORALFinancial counseling and navigation
Patients who screen positive for financial toxicity on the 2-question screener tool, will be referred to available counseling or navigation resources available at each site.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
No masking
Intervention model description
This is a multi-site, single arm, financial screening and referral intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients: Treatment for cancer at study site, over age 18 years, speak/read English or Spanish; Caregivers: Identified caregiver of a patient with cancer offered financial hardship screening, over age 18 years, speak/read English or Spanish; Staff/Clinicians: Involvement with I-ACCESS pilot implementation; over age 18 years, speak/read English or Spanish
Exclusion criteria
* Unable to read of speak English or Spanish * Under the age of 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening completion | From enrollment to the end of the intervention at 8 months. | Ratio of the number of completed screens to the number of eligible patients |
| Rate of referral assistance | From enrollment to the end of the intervention at 8 months. | Ratio of the number of patients referred to counseling to the number of patients screened positive for financial distress |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of referral | From enrollment to the end of the intervention at 8 months. | Count/percent of reason for referral (out-of-pocket costs, non-medical expense, benefit counseling, medication cost, other) |
| Counseling content | From enrollment to the end of the intervention at 8 months. | Count/percent of counseling disposition (general, insurance, external referral, other) |
| Applications for assistance | From enrollment to the end of the intervention at 8 months. | Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources) |
| Referrals to external resources | From enrollment to the end of the intervention at 8 months. | Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources) |
| Predictive accuracy of tool | From enrollment through the end of data analysis at 12 months | Sensitivity, specificity, positive predictive value, and negative predictive value of tool vs. documented bill-paying challenges |
| Acceptability of Intervention Measure | 4-6 months after implementation of I-ACCESS | Patient and clinician perception of intervention acceptability |
| Intervention Appropriateness Measure | 4-6 months after implementation of I-ACCESS | Patient and clinician perception of intervention appropriateness |
| Feasibility of Intervention Measure | 4-6 months after intervention completion | Patient and clinician perception of intervention feasibility |
Countries
United States
Contacts
CONTACTBrianna Connelly
Outcome results
None listed