Implementation Challenges of a Multi-Center Financial Navigation Intervention: A Qualitative Analysis of Operational Process Data

Abstract

Introduction

The Lessening the Impact of Financial Toxicity (LIFT) intervention—a financial navigation intervention—demonstrated preliminary effectiveness. Scaling LIFT to an eight-site single-arm trial, however, posed implementation challenges that were not present in the single-site pilot study. Here, we analyze factors influencing LIFT implementation.

Methods

We used a deductive-inductive hybrid qualitative approach to analyze transcribed meeting recordings from 55 technical assistance (TA) and 23 peer support (PS) calls with financial navigators (FN). First, we deductively coded all implementation-relevant content into the five domains of the Consolidated Framework for Implementation Research (CFIR). We then inductively generated themes and sub-themes within each of the CFIR domains. Coder reliability was assessed at multiple points during coding via coder consensus.

Results

The qualitative analysis of nearly 78 h of TA and PS calls with FNs resulted in 18 themes and 91 sub-themes across the six CFIR domains. Outer setting themes (7 themes, 37 sub-themes) included institutional workforce problems, limited organizational resources for specific needs, and the unpredictability of external resource application success. Determinants in the inner setting (3 themes, 18 sub-themes) included existing clinical infrastructure and navigators’ competing responsibilities in the clinic. Determinants in the individual domain (2 themes, 11 sub-themes) were the navigator workload and the patient motivation to engage in LIFT. Determinants in the innovation domain (2 themes, 5 sub-themes) were the intervention structure (ie, sequence and timing of LIFT activities). The most common implementation strategies (ie, process; 4 themes, 23 sub-themes) were pacing intervention content to meet patient needs, reframing the study to appeal to patients, and changing intervention delivery (eg, allowing phone visits).

Conclusions

This analysis highlights the challenges of implementing FN across multiple oncology sites, with workforce and administrative barriers being key challenges. Operational process data such as TA and PS calls can provide valuable information to guide implementation.

Plain Language Summary

Cancer-related financial hardship is common, and financial navigation (FN) interventions such as the Lessening the Impact of Financial Toxicity (LIFT) program aim to mitigate financial hardship. While LIFT demonstrated preliminary effectiveness in a single-site pilot, scaling to eight oncology sites introduced new implementation challenges. This study examined factors influencing LIFT implementation across sites using qualitative analysis of 78 hours of transcribed recordings from 55 technical assistance and 23 peer support calls with financial navigators. Guided by the Consolidated Framework for Implementation Research (CFIR), we identified determinants across five domains: Outer setting, inner setting, individuals, process, and innovation. Eighteen themes and 91 sub-themes emerged. Outer setting factors included workforce shortages, limited institutional resources for patient needs (eg, housing), and the unpredictability of external financial aid. Inner setting factors involved existing clinical infrastructure and navigators’ competing clinical responsibilities. Individual-level factors included navigator workload and patient motivation to engage. Innovation-related factors centered on the structure and timing of LIFT activities, while process-related determinants included pacing intervention delivery, reframing LIFT to align with patient needs, and adapting delivery methods (eg, phone visits during COVID-19). Overall, findings highlight the breadth of implementation challenges when implementing financial navigation across multiple sites. Routine analysis of operational data can inform ongoing program tailoring and enhance financial navigation implementation in oncology care.

Keywords

implementation science financial navigation CFIR technical assistance peer support cancer care

Introduction

As a result of high cancer care costs and a growing share of costs being shifted to patients and families, a substantial portion of cancer survivors report financial hardship (50%-70%).^1,2 The consequences of high out-of-pocket costs are often discussed in relation to three domains of financial hardship, each representing a unique impact on the well-being of survivors: material (eg, out-of-pocket costs, inability to pay bills), psychological (eg, stress or worry about being able to pay bills), and behavioral (eg, cost-related delayed or foregone care).¹ Beyond reducing access to care and causing financial stress, financial hardship among cancer survivors has also been associated with worse mental health outcomes, increased symptom burden, and an increased risk of mortality.^3,4,5,6

In a recent scoping review, approaches to addressing financial hardship were categorized into two categories: real-world programs (eg, pharmacy-based medication assistance) and research-based interventions (eg, financial navigation). Across approaches, interventions and programs showed promise in decreasing overall financial hardship, decreasing appointment no-shows, and increasing enrollment in clinical trials.⁷ One such research intervention was the Lessening the Impact of Financial Toxicity (LIFT) study—a single arm financial navigation trial conducted by the authors of this manuscript.⁸ In its pilot, LIFT was implemented at one institution and demonstrated promising preliminary effectiveness, significantly reducing financial hardship from pre-to post-navigation.⁸ The larger LIFT trial was a Type II implementation-effectiveness hybrid design implemented across eight sites in North Carolina.⁹ Due to the increased complexity of implementing across eight clinical sites, a priori implementation strategies were deployed alongside LIFT, including training, mapping workflows, and hosting technical assistance (TA) and peer support (PS) calls with financial navigators. TA and PS calls were meant to be used to address implementation barriers at specific sites and then share strategies for addressing challenges with other site financial navigators.

The purpose of this qualitative analysis was to leverage existing operational process data collected throughout the LIFT Hybrid II Trial (ie, recordings of TA and PS calls with financial navigators) to describe common implementation determinants of the LIFT intervention across eight sites in North Carolina. This study provides important insight into the implementation of financial navigation—crucial for moving towards sustainable and scalable financial navigation in oncology clinics.

Methods

Lessening the Impact of Financial Toxicity (LIFT) Intervention

The Lessening the Impact of Financial Toxicity (LIFT) intervention is a financial navigation intervention for cancer survivors that was tested through a Hybrid Type II implementation-effectiveness, single-arm non-randomized trial (NCT04931251).⁹ The LIFT trial was conducted at eight sites in North Carolina, four of which were in rural locations. The eight sites’ characteristics varied including two NCI-designated comprehensive cancer centers, four community hospital cancer programs, one integrated cancer program, and one teaching hospital cancer program (Table 1). Furthermore, most were voluntary non-profit (7/8, 88%), half had satellite locations (4/8, 50%), and half had over 500 staffed inpatient beds (4/8, 50%).

Table 1.

Site Characteristics of Oncology Practices That Implemented the LIFT Intervention (N = 8)

	N (%)
Cancer program type
NCI-designated comprehensive cancer center	2 (25)
Community hospital cancer program	4 (50)
Integrated cancer program	1 (13)
Teaching hospital cancer program	1 (13)
Hospital ownership structure
Voluntary non-profit	7 (88)
Government	1 (13)
Satellite locations associated with institution
Yes	4 (50)
No	4 (50)
Total staffed inpatient beds
0-100	2 (25)
101-200	1 (13)
201-500	1 (13)
>500	4 (50)
Counties in the catchment area
1	2 (25)
2-10	3 (38)
11-20	2 (25)
>20	1 (13)

NCI, National Cancer Institute

The LIFT intervention consisted of two primary functions: (1) Systematically assessing patient-reported cost-barriers and (2) Addressing patient-reported cost barriers through allocation of resources and application assistance. Patients were eligible for LIFT if they were at least 18 years of age, had received a cancer diagnosis or disease progression within the last five years and/or living with advanced disease, spoke English, and reported financial toxicity. Financial toxicity was measured using the COmprehensive Score for financial Toxicity (COST), which consists of 11 Likert scale questions and yields scores ranging from 0-44, with lower scores indicating worse financial toxicity. Participants with a COST score ≤22 (indicating moderate-to-severe FT) at consent were eligible for LIFT.^10,11 A detailed study protocol has been published elsewhere.⁹

Each LIFT site dedicated at least a 0.5 full-time equivalent (FTE) of 1-2 existing employees to be trained as LIFT FNs. Existing employee roles included nurse navigators, patient navigators, and social workers. FNs received 17 h of training on both identifying and addressing cost barriers as well as study protocols. Training was provided by external organizations (eg, Association of Cancer Care Centers Financial Advocacy Boot Camp) as well as LIFT study team members. As part of LIFT, FNs received access to a comprehensive case management system built in REDCap that was used to conduct a comprehensive in-take, track patients throughout the navigation process, and administer pre- and post-surveys.

Data Collection

Throughout the trial, the LIFT study team consistently met with FNs from each site. Two types of meetings were conducted (a priori implementation strategies) including (1) Technical Assistance (TA) meetings and (2) Peer Support (PS) meetings. TA calls included LIFT study team members and FNs from one site per call. The purpose of the TA calls was to provide site-specific updates and discuss the details of specific implementation challenges and engage in collaborative problem-solving. PS meetings included LIFT study team members and all FNs from sites that were preparing to or already recruiting patients into the trial. The purpose of the PS meetings was to share best practices/lessons learned, discuss common implementation barriers and solutions (often from TA calls) in an open forum, and create community among LIFT FNs. Over the course of the trial, 78 implementation meetings with FNs occurred (TA: N = 55, 70.5%; PS: N = 23, 29.5%) totaling just under 78 hours of meeting content. All TA and PS calls were recorded and transcribed (either live via Zoom transcription or by a third-party transcription service [eTranscription Solutions]). TA and PS calls were not originally recorded with the intent of analyzing the meeting content, therefore financial navigators were not consented. However, the overall implementation evaluation of LIFT was approved by the University of North Carolina Institutional Review Board (#20-1997). In order to protect the privacy and confidentiality of the navigators, quotes were not provided in this manuscript.

Theoretical Grounding and Qualitative Analysis

A deductive-inductive hybrid qualitative analysis was conducted on all 78 transcripts from both TA and PS calls.¹² Content analysis was conducted by the analytical team (ARW, MM, CRM, KP) and was guided by the Consolidated Framework for Implementation Research (CFIR) 2.0.¹³ Two cycles of qualitative coding were used to first deductively sort content into the five domains of CFIR (ie, outer setting, inner setting, individuals, innovation, and process). We then inductively analyzed the content within each domain.

First-cycle coding began with data immersion and CFIR training led by ARW and guided by SBW. Each member of the analytic team read through at least five meeting transcripts and familiarized themselves with CFIR. The analytic team then co-created a visual codebook of how the five domains of CFIR were being conceptualized in the context of LIFT (Figure 1). Each member of the analytic team then coded four transcripts into the five domains of CFIR in Dedoose. During the deductive coding, the analytic team met to discuss how codes were being applied and reviewed every code applied to the initial 20 transcripts (25.6% of transcripts) to maximize inter-coder reliability.^14,15 During the process of reviewing code applications, the codebook was refined and consensus on how codes were being applied was achieved. Analytic decision points were documented throughout consensus meetings. The remaining transcripts were then divided amongst the analytic team and coded into the five CFIR domains.

Figure 1.

Visual codebook for deductive coding of technical assistance and peer support calls from the implementation of an eight site financial navigation intervention—LIFT

An inductive thematic approach was taken during second-cycle coding to account for themes not represented within CFIR domain constructs. The analytic team conducted an inductive content analysis creating themes within each CFIR domain. To begin the process, the analytic team read through all excerpts coded into a CFIR domain and formulated preliminary themes. Up to 20% of excerpts coded into the CFIR domain were coded into the newly generated themes by an analytic team member.^14,15 Application of codes was reviewed by the analytic team, and themes and definitions were refined during study meetings. Once coder consensus was reached on how theme codes were being applied, the remaining excerpts were divided amongst the analytic team to be coded.¹⁵ This process was repeated for each CFIR domain. The findings were then summarized by the study team focusing on both the most frequently coded domains and themes as well as the themes that were deemed important by the study team based on the content of the excerpts. To maximize the applicability of the findings of this study on future implementation of financial navigation, during the analytic process study, specific themes pertaining only to the research study itself (eg, IRB delays) were excluded from the findings reported here.

Once all excerpts were coded, frequencies tables for each theme and sub-theme were generated, and trend lines were fit for frequency of sub-themes by months since site-specific and overall LIFT initiation. Frequency and linear trends were also calculated for the number of TA calls by months since LIFT initiation.

Data were quantified due to the high volume of implementation-related discussions across the implementation of LIFT and the tendency for important or hard to address implementation challenges to be discussed at multiple meetings across time.¹⁶ Quantification of big qualitative data has shown to minimize researcher bias when dealing with a larger number of concepts or themes, however such methods are not often applied in the implementation science setting.¹⁶ Furthermore, the purpose of the TA and PS calls was to assess the current implementation challenges of LIFT rather than probe FNs about their experiences implementing LIFT—resulting in frequencies of each theme and sub-theme that proxies qualitative strength (ie, intensity or importance).

Results

A total of 78 implementation meetings occurred with LIFT FNs. The number of TA and PS meetings attended was dependent on the date of initiation for each site, which occurred from November 2021 to September 2023. There were, on average, two TA calls per month and one PS call every other month.

The qualitative analysis of TA and PS calls with FNs resulted in 19 themes and 91 sub-themes across the five CFIR domains. Definitions for each theme and sub-theme can be found in Table 2. Across all CFIR domains, TA calls covered on average 11.4 (SD: 8.1) implementation determinant sub-themes. The frequency at which implementation determinant sub-themes were discussed in TA calls was relatively stable over time with a small trend downward (y = −0.12x + 12.72; Figure 2A). At the same time, fewer TA calls were scheduled as the number of months post LIFT initiation increased (Figure 3). On average, a similar number of implementation sub-themes were discussed at PS meetings (11.7, SD: 8.4); however, a larger decrease in the number of implementation determinants discussed during PS meetings over time was observed (y = −0.45x + 22.39: Figure 2B). Fewer PS calls took place at the beginning and end of the study.

Table 2.

Consolidated Framework for Implementation Research (CFIR) Domains, Themes, Sub-Themes, and Themes of Implementing LIFT in Eight Oncology Sites

Outer setting	Definitions
Health systems
Remote intervention delivery	Shifting from in-person to telephonic remote delivery of intervention
More/less patients coming into clinic	How patient volume fluctuations (driven by policy changes, public health crises, etc.) affected recruitment and delivery
Labor and workforce problems	Describes how lack of workforce, either paid or volunteer, influenced intervention delivery
Stimulus checks and economic protections	Describes how government relief measures or other policies affected patients’ financial need, and therefore, the eligible patient population
Impact of restructuring and infrastructure changes	Shifts in institutional ownership or management and their effects on intervention delivery (eg, branding, alterations of provider networks)
COVID-19 impacts	How COVID-19 influenced intervention delivery. How COVID-19 protocols (eg, scheduling, staffing, patient access) directly influenced intervention delivery
Administrative and system issues	Administrative or technical glitches that disrupt financial navigation
Institutional preparedness and healthcare system buy-in
Lack of institutionally assigned value to social work	The institution’s prioritization, both explicit and implicit, of social work roles
Workflows and EHR access	How differences in EHR permissions and access to financial information imapcted financial navigation delivery
Institutional buy-in	Executive or departmental support (eg, dedicated staff time) for embedding intervention
Financial aid and health insurance application systems
Lack of common financial assistance application	Absence of a unified portal or form that covers multiple aid programs; how each program required different applications
Length and complexity of applications	The number and complexity of questions and required materials for applications
Interdependent applications	Situations where approval from one or more programs influences eligibility in another
Workforce issues
Not enough social workers	Insufficient clinical social workers in regions with high demand or patient need
Not enough oncologists	Shortage of cancer specialists relative to patient need
Not enough lay navigation support	Availability of other staff to provide patient navigation beyond the intervention
Institutional resources	Budget, infrastructure, or other institutional constraints that limit intervention delivery (eg, insufficient office space for SWs, no private rooms for check-ins)
Communication between systems/clinics and patients
Lack of communication to patient about financial issues	Whether and how patients are alerted to bills, coverage gaps, or outstanding balances
Restructuring of services without clear communication	Lack of communication around changes in services provided (eg, offerings, hours, locations)
Misalignment between patient need and enrollment	Patients enrolled in programs that don’t match their actual needs
No notification of receipt of aid for navigators	Lack of systems notifying financial navigators that assistance applications were approved and funds distributed
Limited financial aid and complex systems
Increase in financial needs and availability of existing resources	Growing patient financial needs outpace availability of existing financial aid
Increased prices resulting in increased cost sharing	Increases in prices of goods and services lead to increased financial burdens for patients
Lack of or limited organizational resources for some needs	Limitations around the needs that are covered by existing organizations (eg, housing, transportation)
Limitations of charity care programs	Factors such as funding shortages, eligibility requirements, or administrative hurdles that limit charity care programs
Poorly distributed available system resources or financial aid	Assistance and support is skewed toward uninsured and lowest-income patients, leaving underinsured and middle-income groups with insufficient aid
Poorly distributed available organization resources or financial aid	Certain cancer diagnoses and social needs receive more aid but may have lengthier applications while other diagnoses and needs receive minimal support
Policies for what is reimbursable	Policies for which services and tests insurances will cover drive financial need
Accessing and navigating financial aid and health insurance
Varying financial aid and insurance eligibility	Patients qualify for different amounts and types of aid based on cancer type, stage, and treatment, leading to unequal access to financial assistance
Unpredictability of external resources	Navigators and patients cannot reliably predict whether applications will be funded or rejected
Wait times for benefit determination varies substantially	Time from submission to decision for assistance (eg, Medicare/Medicaid, external organization) varies
Varying difficulty in applying for or receiving aid	The complexity of forms and documentation requirements and likelihood of receiving aid varies widely
Politicization of the ACA	How political rhetoric and media framing influenced patients’ understanding and uptake of ACA benefits
Medicaid expansion	State-level decisions (in North Carolina) to expand Medicaid eligibility led to increased access to financial assistance
PCPs charging to fill out paperwork	Some providers charged fees for completing forms which created an unexpected cost barrier
Inner setting
Fit and prioritization of financial navigation
Clinic restructuring in the context of larger restructuring	Shifts in clinic-level organization and management in the context of institutional level changes in ownership or management
Lack of awareness among providers in clinic and pharmacy	Clinicians, clinic staff, or pharmacy employees are unaware of the existence, scope, or referral processes of financial navigation services through LIFT
High clinic turnover	Frequent cycles of turnovers, hirings, and onboardings among clinic personnel disrupted intervention delivery
Clashing with existing financial/charity care workflows	Times where LIFT financial navigation overlapped or conflicted with established financial assistance or charity care workflows, leading to confusion, friction, and duplicate work
Lack of clarity about how to fit into existing workflow for best timing and presentation	Flexibility for optimal timing and presentation of LIFT financial navigation required FNs to independently experiment to determine best practices for their site
Understaffed clinics	Insufficient clinicians and support staff limited the number of patient referrals and FN capacity, and therefore intervention delivery
Targeted financial navigation in clinics where resource availability is better	Navigators concentrated recruitment and outreach efforts on clinics where patients may have more access to financial assistance (eg, by diagnosis, by treatment modality)
Clinic impressions and perception of intervention	Clinic personnel’s attitudes about LIFT financial navigation (eg, value, relevance, effectiveness) shaped buy-in and day-to-day engagement with the intervention
Good fit with existing structure	Occasions where financial navigation aligned with the existing clinic organization leading to improved implementation
Clinic systems that impact the implementation of LIFT
Clinic workflow	Scheduling patterns, visit types, and how SWs usually interact with patients drive intervention delivery
Financial navigation referral process	Ways by which financial navigators identified eligible patients
Existing clinic services and resources that facilitate financial navigation	Pre-existing programs or resources that influenced delivery of financial navigation
Financial navigation as a clinical role
Overlapping roles in clinic	When FN responsibilities overlap with other members’ roles, leading to unclear ownership of financial navigation tasks
Competing responsibilities	Occasions when SWs split time between their core duties and delivery of FN, leading to reduced capacity and focus on financial assistance
Need for specific qualifications and training	Refers to the specialized skills and experience (across a healthcare institution, the US healthcare system, and community resources) required for effective, efficient FN
Structure and staffing of social work and navigation	Structure (eg, dedicated navigation team, diagnosis-specific) and staffing of SW team impacts capacity to deliver LIFT FN
How social work/navigation fit into clinical teams and revenue generation	Perceptions of how SW contributes to value-based care metrics and how that connects to clinic-level budgeting decisions
Individual
Financial navigators
Financial navigator capability	Navigators’ training and experience in FN shapes intervention delivery
Financial navigator workforce	The availability of navigators and stability of their positions influences intervention delivery
Financial navigator workload	Caseload volume and other job duties shape navigators’ capacity to deliver FN
LIFT patients
Distrust of government and external support	Patient skepticism or refusal of public programs driven by political beliefs, media narratives, or prior experiences
Feeling physically ill	Acute symptoms and treatment side effects driving patients’ reduced capacity to initiate or follow through with FN
Financial needs	How perceived financial needs by the participant shaped interest in FN
Motivation to engage with LIFT	Participants’ readiness and willingness to participate in a FN intervention
Felling overwhelmed or overloaded	Emotional or cognitive strain from managing medical, financial, and other personal and professional challenges influences engagement with the intervention
Research literacy	Ability to comfortably understand and engage with language of research affected interest in receiving the intervention, as it was part of a research project
Satisfaction with LIFT	Patient evaluations of the intervention influenced participation and uptake
Social barriers	Patient-level social factors that, in the context of existing structural barriers, limit access to financial assistance or the provision of FN (eg, language, internet, homeless)
Innovation
LIFT and Patient Advocate Foundation (PAF)
PAF referral	Workflow by which patients are referred to the PAF for specialized support
PAF role	Scope of PAF’s contributions in collaboration with LIFT (eg, negotiating medical bills, handling complex appeals)
LIFT structure
Intervention structure	The framework of LIFT activities (ie, intake assessment, follow-up visits, closeout assessment)
Recouping funds	FNs tracking their progress and funds secured to justify providing LIFT
Time-limited interventions	LIFT’s structure as a defined-duration financial navigation intervention
Process
Attempting to adjust to policy and organizations
Developed relationships with external organization staff to move applications forward	Navigators developed relationships with individuals at organizations that provided financial assistance to facilitate timely application review
Order of operation of navigation driven by wait time	Navigators’ prioritization of applications based on processing delays, length of application, or available funds to maximize access to financial assistance
Policy driven resource prioritization	Navigators’ allocation of time and effort based on policy windows, such as benefit resets and expansions in eligibility
Reframing study components when communicating with patients	Tailoring communication about the provision of LIFT FN to patients to improve understanding and potential buy-in
Tracking financial assistance received	Systematic documentation of approved aid amounts, application statuses, and timelines to assess intervention impact and evaluate personal approach
Building financial navigator capacity
Building capacity through technical assistance	Troubleshooting in peer support and technical assistance calls to support FNs in delivering the intervention
Resource and best practices sharing between navigators	Navigators shared resources and strategies to facilitate intervention delivery
Technology training	Providing hands-on training with the data management platform to boost navigators’ confidence and efficiency in intervention delivery
Tools to build financial navigator motivation (eg, prizes)	Implementing site-based team challenges to sustain navigator engagement and acknowledge achievements
Use of tracking and data management systems for LIFT	Using a data management system to track patient outreach and financial assistance received in real time
Outside referrals	Leveraging partnerships with external organizations to facilitate FN and provision of assistance
Fitting LIFT into clinics
Alignment of adaptions to clinic workflow	Fitting intervention delivery (eg, touchpoints between FNs and participants, avoiding recruitment during consult visits) into appointment schedules and existing care pathways
Developed relationships with internal staff to move applications forward	Engaging clinicians, billing departments, pharmacy, and other internal folks to streamline applications, approvals, and handoffs
Engaging with internal financial assistance providers	Coordinating with charity care teams and other internal financial assistance providers to share information about eligibility, co-manage cases, and reduce duplicate work
Raising awareness of LIFT services with clinic staff	Promoting awareness of LIFT within clinics and institutions through direct engagement with personnel, education sessions, and distribution of promotional materials
Ways to use existing infrastructure to engage with patients	Using existing electronic health record systems and LIFT metrics (eg, pre- vs post-intervention COST scores) to engage with patients
Tailoring and adapting delivery
Aligning visit to clinic schedule	FNs aligning their follow-up with when the patient was in-person at the clinic
Change in delivery mode	Flexibility around delivery based on patient needs and preferences (eg, phone, in-person)
Pacing intervention components and follow-up	Adjusting the frequency (eg, artificially splitting or lumping) of components to match patient readiness, appointments, or application deadlines
Printing intervention components	Distributing printed copies of study and intervention digital materials to better cater to patient needs and preferences
Providing education and emotional support	Integrating counseling techniques, motivational interviewing, and a human touch to address emotional barriers and promote trust
Varied time of initial contact	Experimenting with the timing of pre-visit outreach and initial assessment to determine the most effective engagement window
Updating communication to external changes	Regularly revising study and intervention materials to reflect institutional and clinic-level changes

Themes and sub-theme percentages were calculated with respect to the total number of codes in that CFIR domain. CFIR domain percentages were calculated with respect to the total number of codes.

Figure 2.

Linear trends of implementation determinant sub-themes from technical assistance (TA) and peer support (PS) calls for the implementation of LIFT

Figure 3.

Frequency of technical assistance calls by months since LIFT initiation and freq

Outer Setting

Within the outer setting CFIR domain, 7 themes and 37 sub-themes were generated from the analysis (Table 3). Across the five CFIR domains, outer setting codes made up 11.4% of codes. The most frequently discussed outer setting themes included accessing and navigating financial aid and health insurance (28.8% of outer setting codes), health systems (28.2%), and limited financial aid and complex systems (21.2%).

Table 3.

Consolidated Framework for Implementation Research Domains, Themes, Sub-Themes, and Frequencies of Implementing Financial Navigation in Eight Oncology Sites

Outer setting	156	11.4%*
Health systems	44	28.2%
Remote intervention delivery	3	1.9%
More/less patients coming into clinic	4	2.6%
Labor and workforce problems	21	13.5%
Stimulus checks and economic protections	1	0.6%
Impact of restructuring and infrastructure changes	8	5.1%
COVID-19 impacts	6	3.8%
Administrative and system issues	1	0.6%
Institutional preparedness and healthcare system buy-in	5	3.2%
Lack of institutionally assigned value to social work	1	0.6%
Workflows and EHR access	1	0.6%
Institutional buy-in	3	1.9%
Financial aid and health insurance application systems	12	7.7%
Lack of common financial assistance application	3	1.9%
Length and complexity of applications	7	4.5%
Interdependent applications	2	1.3%
Workforce issues	11	7.1%
Not enough social workers	4	2.6%
Not enough oncologists	3	1.9%
Not enough lay navigation support	1	0.6%
Institutional resources	3	1.9%
Communication between systems/clinics and patients	6	3.8%
Lack of communication to patient about financial issues	3	1.9%
Restructuring of services without clear communication	1	0.6%
Misalignment between patient need and enrollment	1	0.6%
No notification of receipt of aid for navigators	1	0.6%
Limited financial aid and complex systems	33	21.2%
Increase in financial needs and availability of existing resources	8	5.1%
Increased prices resulting in increased cost sharing	2	1.3%
Lack of or limited organizational resources for some needs	11	7.1%
Limitations of charity care programs	3	1.9%
Poorly distributed available system resources or financial aid	5	3.2%
Poorly distributed available organization resources or financial aid	3	1.9%
Policies for what is reimbursable	1	0.6%
Accessing and navigating financial aid and health insurance	45	28.8%
Varying financial aid and insurance eligibility	7	4.5%
Unpredictability of external resources	12	7.7%
Wait times for benefit determination varies substantially	15	9.6%
Varying difficulty in applying for or receiving aid	1	0.6%
Politicization of the ACA	2	1.3%
Medicaid expansion	7	4.5%
PCPs charging to fill out paperwork	1	0.6%
Inner setting	222	16.2%*
Fit and prioritization of financial navigation	63	28.4%
Clinic restructuring in the context of larger restructuring	2	0.9%
Lack of awareness among providers in clinic and pharmacy	11	5.0%
High clinic turnover	6	2.7%
Clashing with existing financial/charity care workflows	3	1.4%
Lack of clarity about how to fit into existing workflow for best timing and presentation	3	1.4%
Understaffed clinics	13	5.9%
Targeted financial navigation in clinics where resource availability is better	2	0.9%
Clinic impressions and perception of intervention	8	3.6%
Good fit with existing structure	15	6.8%
Clinic systems that impact the implementation of LIFT	65	29.3%
Clinic workflow	19	8.6%
Financial navigation referral process	11	5.0%
Existing clinic services and resources that facilitate financial navigation	35	15.8%
Financial navigation as a clinical role	94	42.3%
Overlapping roles in clinic	9	4.1%
Competing responsibilities	35	15.8%
Need for specific qualifications and training	4	1.8%
Structure and staffing of social work and navigation	31	14.0%
How social work/navigation fit into clinical teams and revenue generation	15	6.8%
Individual	356	26.0%*
Financial navigators	125	35.1%
Financial navigator capability	34	9.6%
Financial navigator workforce	31	8.7%
Financial navigator workload	60	16.9%
LIFT patients	231	64.9%
Distrust of government and external support	16	4.5%
Feeling physically ill	8	2.2%
Financial needs	58	16.3%
Motivation to engage with LIFT	55	15.4%
Felling overwhelmed or overloaded	49	13.8%
Research literacy	21	5.9%
Satisfaction with LIFT	9	2.5%
Social barriers	15	4.2%
Innovation	72	5.3%*
LIFT and PAF	29	40.3%
PAF referral	13	18.1%
PAF role	16	22.2%
LIFT structure	43	59.7%
Intervention structure	24	33.3%
Recouping funds	15	20.8%
Time-limited interventions	4	5.6%
Process	561	41.0%*
Attempting to adjust to policy and organizations	80	14.3%
Developed relationships with external organization staff to move applications forward	16	2.9%
Order of operation of navigation driven by wait time	5	0.9%
Policy driven resource prioritization	10	1.8%
Reframing study components when communicating with patients	37	6.6%
Tracking financial assistance received	12	2.1%
Building financial navigator capacity	141	25.1%
Building capacity through technical assistance	15	2.7%
Resource and best practices sharing between navigators	28	5.0%
Technology training	21	3.7%
Tools to build financial navigator motivation (eg, prizes)	16	2.9%
Use of tracking and data management systems for LIFT	43	7.7%
Outside referrals	18	3.2%
Fitting LIFT into clinics	108	19.3%
Alignment of adaptions to clinic workflow	39	7.0%
Developed relationships with internal staff to move applications forward	12	2.1%
Engaging with internal financial assistance providers	17	3.0%
Raising awareness of LIFT services with clinic staff	14	2.5%
Ways to use existing infrastructure to engage with patients	26	4.6%
Tailoring and adapting delivery	232	41.4%
Aligning visit to clinic schedule	27	4.8%
Change in delivery mode	58	10.3%
Pacing intervention components and follow-up	68	12.1%
Printing intervention components	19	3.4%
Providing education and emotional support	38	6.8%
Varied time of initial contact	21	3.7%
Updating communication to external changes	1	0.2%

Themes and sub-theme percentages were calculated with respect to the total number of codes in that CFIR domain. CFIR domain percentages were calculated with respect to the total number of codes.

Within the theme of accessing and navigating financial aid and health insurance, FNs frequently discussed the challenges associated with the variability of wait times for benefit determination. Such variability in wait times made it difficult to implement LIFT as FNs were unable to give patients a timeframe of when to expect aid. Within the health systems theme, FNs most frequently discussed labor shortages within their systems, including high rates of turnover, and COVID-19-related hiring freezes and restrictions on volunteer interactions with patients. The workforce issues in this category were viewed by FNs as a health system issue that hindered implementation—including health systems not prioritizing the role of social work or restricting hiring. Within the limited financial aid and complex systems themes, FNs frequently discussed a dearth of resources for specific needs (eg, housing) that limited their ability to help some patients. Across the outer setting domain, themes and sub-themes most were described by FNs as barriers to implementation, with the exception of Medicaid expansion in North Carolina and the presence of institutional resources, which were both viewed as facilitators of implementation.

Inner Setting

Three themes and 18 sub-themes were created for implementation determinants in the inner setting (Table 3). FNs most frequently discussed determinants revolving around financial navigation as a clinical role (42.5% of inner setting codes). Within the clinical role theme, FNs commonly discussed the implementation of LIFT being challenging in the context of competing responsibilities—FNs in LIFT were only 0.5 FTE on the study but often continued to be responsible for their prior full-time responsibilities. Furthermore, FNs discussed how social work team structures both facilitated implementation (eg, systems to work with patients on social needs) and were a barrier to implementation (eg, understaffing). FNs discussed the two other themes at roughly the same frequency, including the fit and prioritization of financial navigation in the clinic (28.4%) and clinical systems that impact the implementation of LIFT (29.3%). When discussing the fit and prioritization of financial navigation, FNs commonly discussed financial navigation as a good fit with the clinical structures and how they interact with patients; however, FNs did share that they felt that there was a lack of awareness among providers and other staff in their clinics about LIFT and the services they could provide. In the context of clinical systems that impacted LIFT, FNs frequently shared existing clinical systems that facilitated the implementation of LIFT including support groups, lists of uninsured patients to approach, newsletters, and distress screening. Less commonly discussed, but important to the implementation of LIFT, FNs also discussed instances where LIFT did not align well with existing financial assistance and charity care programs within their system as well as challenges surrounding fitting LIFT into the clinic flow (eg, when to approach patients and where).

Individual

Two themes and 11 sub-themes were created within the individual CFIR domain (Table 3), one theme for each of the primary roles involved in the implementation of LIFT—the FNs and the patients. Of all codes, 26.0% were coded into the individual CFIR domain, with most (64.9% of individual codes) focused on the patients receiving LIFT. Within the theme focused on patients, FNs most discussed the need for LIFT by discussing the financial needs of patients and their motivation to engage with LIFT. FNs also frequently discussed patients feeling overwhelmed or overloaded with information near diagnosis and expressed concern that approaching them to discuss LIFT added to that feeling of overwhelm. The FN intervention required information sharing about patients’ personal finances, and FNs reported that some patients felt uncomfortable sharing financial information, citing distrust of the government or not wanting “a handout.” Within the theme focused on the FNs themselves, FNs often discussed having a tremendous workload with LIFT and their other job responsibilities. However, FNs typically discussed their workload in the context of their capability and motivation to engage with patients about their financial needs.

Innovation

Within the innovation CFIR domain two themes and five sub-themes were created (Table 3). Discussion of LIFT itself was the least frequently discussed CFIR domain (5.3% of all codes) and encompassed two themes. The first theme focused on how to refer patients to the Patient Advocate Foundation (PAF) if LIFT FNs could not address the needs of the patient. The second theme focused on the structure of LIFT itself, most commonly FNs discussed the structured nature of LIFT facilitating the implementation and providing suggestions to improve the implementation of LIFT (eg, proposing the study as session-based or time-limited to patients).

Process

The process CFIR domain was the most frequently discussed domain (41.0% of all codes), consisting of 4 themes, 23 sub-themes. The process domain focused broadly on what the FNs and LIFT study team were actively doing to address the implementation challenges that they faced throughout the study period. The most frequently discussed process CFIR domain themes were tailoring and adapting delivery of LIFT (41.4% of process codes) and building FN capacity (25.1%).

When discussing tailoring and adapting the delivery of LIFT, FNs often discussed changes in delivery mode to facilitate meeting patients “where they were” emotionally or physically. Specifically, this entailed changes in delivery mode from in-person to phone-based or via videoconferencing—either in response to patient need (eg, patient felt ill or overwhelmed) or in response to health system mandates amid the COVID-19 Public Health Emergency. FNs also frequently discussed changes to how the intervention was paced, mostly focused on asking patients to complete only the portions of the study (eg, consent, screening, financial intake, pre-questionnaires) they were feeling up to in the moment. While less frequently, FNs also discussed aligning LIFT follow-ups with clinical schedules and providing general education and support to patients (though complementary, these were not explicitly part of the intervention).

When discussing building FN capacity, FNs frequently discussed their use of the tracking and data management systems. These discussions often centered on their experiences using the system and providing tips and tricks to other FNs. Some FNs also discussed the need for technology training to increase their comfort with using the REDCap tracking system. Less frequent process CFIR domain themes included integrating and adapting LIFT into clinics and attempting to adjust to policy and organizations. When discussing fitting LIFT into their clinics, FNs often discussed aligning their adaptations (eg, mode of delivery, pacing of intervention) to LIFT to the clinic workflow. These adaptations worked in harmony with the adaptations that were carried out to meet the needs of the patients. Importantly, FNs also shared that implementation barriers were reduced when engaging with other internal financial assistance providers such as charity care and copay assistance in the pharmacy. In the context of attempting to adjust LIFT to policy and organizations, FNs often discussed reframing the study components (eg, consent language) when communicating with patients to ensure that it was clear LIFT would be able to assist them and would not share identifiable information with the external individuals or organizations. FNs also discussed challenges trying to adapt the intervention in the context of long benefit determination wait times (eg, Medicaid) and building relationships with external financial aid organizations to streamline aid/benefit determination.

Discussion

Findings from this qualitative analysis highlight the variety of implementation determinants associated with conducting a large financial navigation trial (ie, LIFT) across eight sites. While we were unable to fully disentangle determinants driven by study procedures vs financial navigation itself (for example, the administrative burden imposed on site staff associated with IRB approval), study-specific determinants were excluded from this manuscript—thus, this manuscript highlights only those determinants relevant to the real-world implementation of financial navigation in diverse oncology settings. Applying CFIR, our findings showed that the outer setting contained the highest variety of determinants, while determinants within the individual and process domains were the most frequently discussed during TA and PS calls. Common themes in the individual and process domains included themes focused on the patient, the financial navigator, tailoring delivery of LIFT, and building financial navigator capacity. Recognizing and addressing the challenges and successes identified by financial navigators in real-time throughout implementation vs retrospectively is a crucial step toward the scalability and sustainability of future financial navigation efforts.

The breadth of the determinants discussed during TA and PS calls throughout the implementation of LIFT is generally more expansive than what has been reported in the financial navigation implementation literature previously.¹⁷ This finding in context suggests that TA and PS meetings serve an important role in identifying and addressing implementation challenges in real-time and serve as an innovative data source. While this study did not seek to directly assess the effectiveness of TA and PS calls, a recent scoping review revealed that most studies that measured the impact of TA on implementation reported a positive association between assistance provided and implementation success.¹⁸ While unintentional, LIFT site initiation was staggered over time, however, the linear trends findings of consistent decrease in CFIR determinants discussed over time suggests that PS calls may serve as an effective mechanism to share successful implementation strategies developed on TA calls with new sites. Overall, the findings of this study suggest that using operational process data could be an effective way to contribute to the understanding of implementation when paired with quantifiable implementation outcomes and retrospective qualitative data collected with the purpose of understanding implementation. Quantifying operations data has the potential to highlight commonly discussed implementation challenges even when those challenges are not necessarily the challenges that stick out as important to implementers.^16,19

Workforce-related issues were identified across multiple CFIR domains, creating a consistent thread throughout the TA and PS calls. Reported concerns included understaffing, competing responsibilities, and hiring restrictions. These issues are not unique to the LIFT implementation, however, are reflective of broader concerns related to behavioral workforce shortages.²⁰ Calls to address these concerns have centered on an alignment of training, regulation, and payment policies, but progress in this regard is often incremental and heavily influenced by funding allocations and political consideration.²¹ Although there have been promising developments in policy (eg, allowing Medicare reimbursement of navigation in patients with serious illness), targeted navigation programs like LIFT would be ineligible for these payment policies and thus must rely on alternative sources of support.²² This finding suggests a need for cost-effectiveness analyses and other business case analysis for financial navigation.

Within the individual, outer setting, and inner setting domains, findings from this analysis reinforce recent work to illustrate the profound complexity of the financial aspects of healthcare system and the resulting administrative burden. In this analysis, FNs reported unpredictable benefits, lengthy and detailed applications for assistance, and limited available resources, mirroring the harmful impact of fragmented health systems on patients.²³ Recent literature has demonstrated that patient administrative burdens (eg, finding in-network providers, prior authorization, and paying bills) are associated with delayed or foregone care and non-adherence with prescription medications.^24,25 These findings suggest that a major function of financial navigation is not only reducing cost-related barriers to care but also minimizing the financial-related administrative burden shouldered by patients. Future inquiry should assess the impact of financial navigation on patient and caregiver administrative burden.

Finally, the findings of this analysis suggest several potential recommendations for implementing financial navigation into the oncology setting. First, throughout the initiation of the LIFT trial we assessed the clinical context, workflows, and organizational readiness.^26,27 This pre-implementation work facilitated a site-specific implementation that was continuously tailored throughout the trial. Continuous context-specific adaptation and tailoring is crucial for the development and implementation of responsive and scalable financial navigation programs. Finally, consistent engagement with financial navigators to reassess and address implementation barriers is a crucial component of multi-site oncology financial navigation.

Limitations

This study should be interpreted in the context of certain limitations. First, TA and PS calls focused on the implementation challenges brought up by the FNs and study team throughout the implementation of LIFT but were not structured to elicit discussion on any specific topic or CFIR domain. Furthermore, the nature of TA and PS calls, focusing on addressing implementation challenges, likely led to more discussion of process in comparison to other CFIR domains. The ability to attend TA and PS calls relied on not being too overloaded and therefore this analysis likely underestimates some workforce and role clarity challenges. While discussing implementation, FNs often talked about LIFT as both the financial navigation intervention and study-related tasks that influenced implementation—which were unable to be completely separated for analysis.

Conclusions

Overall, the findings from this analysis highlights the complexity of implementing FN into oncology care—particularly across multiple sites. During TA and PS calls, there was a large breadth of implementation topics discussed within each CFIR domain. However, overall, the frequency of implementation discussions during calls decreased over time. Our findings highlight major workforce and administrative barriers faced by FNs while implementing LIFT. Finally, operational process data may serve as an innovative and important source of implementation data when paired with quantifiable implementation outcomes and retrospective qualitative interviews/focus groups focused on implementation.

Footnotes

ORCID iDs

Austin R. Waters

Arrianna Marie Planey

Ethical Considerations

Analysis of operations data reported in this study were approved by the University of North Carolina Institutional Review Board (#20-1997).

Consent to Participate

Financial navigators did not consent to participate as meeting recordings were not originally intended for research purposes.

Author Contributions

Conceptualization: ARW, SBW; Methodology: ARW, SAB, SBW; Validation: ARW, MLM, CRW, SBW; Formal analysis: ARW, MLM, CRW, KP; Data curation: MLM; Writing – original draft: ARW, MLM, CRW, BT; Writing – review & editing: ARW, MLM, CRW, BT, KP, AMP, MG, NP, SAB, DLR, SBW; Visualization: ARW; Supervision: SAB, DLR, SBW; Project administration; MLM, MG, NP; Funding acquisition: DLR, SBW.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by the National Institutes of Health, National Cancer Institute under the award numbers R01CA240092 (PIs: Wheeler, Rosenstein), T32CA092203, and T32CA116339.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

The data analyzed in this study may be available from the corresponding author upon reasonable request.*

Disclaimer

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

Trial Information

ClincialTrials.gov NCT04931251 06/11/2021 .

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