Identifying factors and causal chains associated with optimal implementation of Lynch syndrome tumor screening: An application of coincidence analysis.

PURPOSE: This study compared Lynch syndrome universal tumor screening (UTS) across multiple health systems (some of which had two or more distinct UTS programs) to understand multi-level factors that may impact the successful implementation of complex programs. METHODS: Data from 66 stakeholder interviews were used to conduct multi-value coincidence analysis (mv-CNA) and identify key factors that consistently make a difference in whether UTS programs were implemented and optimized at the system level. RESULTS: The selected CNA model revealed combinations of conditions that distinguish 4 optimized UTS programs, 10 non-optimized programs, and 4 systems with no program. Fully optimized UTS programs had both a maintenance champion and a positive inner setting. Two independent paths were unique to non-optimized programs: 1) positive attitudes and a mixed inner setting, or 2) limited planning & engaging among stakeholders. Negative views about UTS evidence or lack of knowledge about UTS led to a lack of planning and engaging, which subsequently prevented program implementation. CONCLUSION: The model improved our understanding of program implementation in health care systems and informed the creation of a toolkit to guide UTS implementation, optimization, and changes. Our findings and toolkit may serve as a use case to increase the successful implementation of other complex precision health programs.

Adaptations to a patient navigation program for follow-up colonoscopy in rural primary care practices.

PURPOSE: Patient navigation is a recommended practice to improve cancer screenings among underserved populations including those residing in rural areas with care access barriers. We report on patient navigation programme adaptations to increase follow-up colonoscopy rates after abnormal fecal testing in rural primary care practices. METHODS: Participating clinics delivered a patient navigation programme to eligible patients from 28 affiliated clinics serving rural communities in Oregon clustered within 3 Medicaid health plans. Patient navigation adaptations were tracked using data sources including patient navigation training programme reflections, qualitative interviews, clinic meetings, and periodic reflections with practice facilitators. FINDINGS: Initial, planned (proactive) adaptations were made to address the rural context; later, unplanned (reactive) adaptations were implemented to address the impact of the COVID-19 global pandemic. Initial planned adaptations to the patient navigation programme were made before the main trial to address the needs of the rural context, including provider shortages and geographic dispersion limiting both patient access to care and training opportunities for providers. Later unplanned adaptations were made primarily in response to COVID-19 care suspension and staff redeployments and shortages that occurred during implementation. CONCLUSION: While unplanned adaptations were implemented to address the contextual impact of the COVID-19 pandemic on care access patterns and staffing, the changes to training content and context were beneficial to the rural setting overall and should be sustained. Our findings can guide future efforts to optimise the success of such programmes in other rural settings and highlight the important role of adaptations in implementation projects.

Patient Perspectives on Mental Health and Pain Management Support Needed Versus Received During Opioid Deprescribing.

Prescription opioid tapering has increased significantly over the last decade. Evidence suggests that tapering too quickly or without appropriate support may unintentionally harm patients. The aim of this analysis was to understand patients' experiences with opioid tapering, including support received or not received for pain control or mental health. Patients with evidence of opioid tapering from 6 health care systems participated in semi-structured, in-depth interviews; family members of suicide decedents with evidence of opioid tapering were also interviewed. Interviews were analyzed using thematic analysis. Participants included 176 patients and 16 family members. Results showed that 24% of the participants felt their clinicians checked in with them about their taper experiences while 41% reported their clinicians did not. A majority (68%) of individuals who experienced suicide behavior during tapering reported that clinicians did check in about mood and mental health changes specifically; however, 27% of that group reported no such check-in. More individuals reported negative experiences (than positive) with pain management clinics-where patients are often referred for tapering and pain management support. Patients reporting successful tapering experiences named shared decision-making and ability to adjust taper speed or pause tapering as helpful components of care. Fifty-six percent of patients reported needing more support during tapering, including more empathy and compassion (48%) and an individualized approach to tapering (41%). Patient-centered approaches to tapering include reaching out to monitor how patients are doing, involving patients in decision-making, supporting mental health changes, and allowing for flexibility in the tapering pace. PERSPECTIVE: Patients tapering prescription opioids desire more provider-initiated communication including checking in about pain, setting expectations for withdrawal and mental health-related changes, and providing support for mental health. Patients preferred opportunities to share decisions about taper speed and to have flexibility with pausing the taper as needed.

Impact of Opioid Dose Reductions on Patient-Reported Mental Health and Suicide-Related Behavior and Relationship to Patient Choice in Tapering Decisions.

Mental health and suicide-related harms resulting from prescription opioid tapering are poorly documented and understood. Six health systems contributed opioid prescribing data from January 2016 to April 2020. Patients 18 to 70 years old with evidence of opioid tapering participated in semi-structured interviews. Individuals who experienced suicide attempts were oversampled. Family members of suicide decedents who had experienced opioid tapering were also interviewed. Interviews were analyzed using thematic analysis. The study participants included 176 patients and 16 family members. Patients were 68% female, 80% White, and 15% Hispanic, mean age 58. All family members were female spouses of White, non-Hispanic male decedents. Among the subgroup (n = 60) who experienced a documented suicide attempt, reported experiencing suicidal ideation during tapering, or were family members of suicide decedents, 40% reported that opioid tapering exacerbated previously recognized mental health issues, and 25% reported that tapering triggered new-onset mental health concerns. Among participants with suicide behavior, 47% directly attributed it to opioid tapering. Common precipitants included increased pain, reduced life engagement, sleep problems, withdrawal, relationship dissolution, and negative consequences of opioid substitution with other substances for pain relief. Most respondents reporting suicide behavior felt that the decision to taper was made by the health care system or a clinician (67%) whereas patients not reporting suicide behavior were more likely to report it was their own decision (42%). This study describes patient-reported mental health deterioration or suicide behavior while tapering prescription opioids. Clinicians should screen for, monitor, and treat suicide behavior while assisting patients in tapering opioids. PERSPECTIVE: This work describes changes in patient-reported mental health and suicide behavior while tapering prescription opioids. Recommendations for improving care include mental health and suicide risk screening during and following opioid tapering.

"I was screaming hallelujah": Patient and provider perceptions of blood-based testing for colorectal cancer screening.

BACKGROUND: Blood-based tests for colorectal cancer (CRC) screening can offer many advantages over stool-based tests such as FIT. Yet, we know little about patients' and providers' perceptions of this type of test. We report findings from a qualitative study comparing patient and provider perceptions of blood-based testing for CRC screening. METHODS: Patient participants were aged 45-75 years and members of a large, integrated health system. Participants were mailed, but did not complete, a FIT through an organized FIT-screening program and were scheduled for a health-care encounter at any of nine clinical sites. Participants were consented to complete a blood draw. We used purposive sampling to select and recruit patients (who did and did not complete the blood test) and providers/specialists who would be involved in offering the blood test to patients or explaining results. We administered telephone interviews using a semi-structured interview guide and recorded and transcribed all interviews, then coded and analyzed content. RESULTS: We interviewed 15 patients (11 completed and 4 did not complete the blood test) and 5 providers (3 primary care providers, one gastroenterologist (GI), and one GI medical assistant). Patients were enthusiastic about completing a blood test, citing the simplicity, ease, convenience, and high perceived accuracy of the test. Providers were also receptive to a blood-based option, if adequate test performance could be achieved and if they have information that informs patients about the pros and cons of blood-based screening versus other screening tests. CONCLUSIONS: Patients and providers were willing and enthusiastic about blood-based CRC screening tests. Future research focusing on performance and communication is needed.

"Go ahead and screen" - advice to healthcare systems for routine lynch syndrome screening from interviews with newly diagnosed colorectal cancer patients.

BACKGROUND: Lynch syndrome (LS) is the most common cause of inherited colorectal cancer (CRC). Universal tumor screening (UTS) of newly diagnosed CRC cases is recommended to aid in diagnosis of LS and reduce cancer-related morbidity and mortality. However, not all health systems have adopted UTS processes and implementation may be inconsistent due to system and patient-level complexities. METHODS: To identify barriers, facilitators, and suggestions for improvements of the UTS process from the patient perspective, we conducted in-depth, semi-structured interviews with patients recently diagnosed with CRC, but not screened for or aware of LS. Patients were recruited from eight regionally diverse US health systems. Interviews were conducted by telephone, 60-minutes, audio-recorded, and transcribed. An inductive, constant comparative analysis approach was employed.  RESULTS: We completed 75 interviews across the eight systems. Most participants were white (79%), about half (52%) were men, and the mean age was 60 years. Most self-reported either no (60%) or minimal (40%) prior awareness of LS. Overall, 96% of patients stated UTS should be a routine standard of care for CRC tumors, consistently citing four primary motivations for wanting to know their LS status and engage in the process for LS identification: "knowledge is power"; "family knowledge"; "prevention and detection"; and "treatment and surveillance." Common concerns pertaining to the process of screening for and identifying LS included: creating anticipatory worry for patients, the potential cost and the accuracy of the genetic test, and possibly having one's health insurance coverage impacted by the LS diagnosis. Patients suggested health systems communicate LS results in-person or by phone from a trained expert in LS; offer proactive verbal and written education about LS, the screening steps, and any follow-up surveillance recommendations; and support patients in communicating their LS screening to any of their blood relatives. CONCLUSION: Our qualitative findings demonstrate patients with CRC have a strong desire for healthcare systems to regularly implement and offer UTS. Patients offer key insights for health systems to guide future implementation and optimization of UTS and other LS screening programs and maximize diagnosis of individuals with LS and improve cancer-related surveillance and outcomes. TRIAL REGISTRATION: Not available: not a clinical trial.

Combining Asian and European genome-wide association studies of colorectal cancer improves risk prediction across racial and ethnic populations.

Polygenic risk scores (PRS) have great potential to guide precision colorectal cancer (CRC) prevention by identifying those at higher risk to undertake targeted screening. However, current PRS using European ancestry data have sub-optimal performance in non-European ancestry populations, limiting their utility among these populations. Towards addressing this deficiency, we expand PRS development for CRC by incorporating Asian ancestry data (21,731 cases; 47,444 controls) into European ancestry training datasets (78,473 cases; 107,143 controls). The AUC estimates (95% CI) of PRS are 0.63(0.62-0.64), 0.59(0.57-0.61), 0.62(0.60-0.63), and 0.65(0.63-0.66) in independent datasets including 1681-3651 cases and 8696-115,105 controls of Asian, Black/African American, Latinx/Hispanic, and non-Hispanic White, respectively. They are significantly better than the European-centric PRS in all four major US racial and ethnic groups (p-values < 0.05). Further inclusion of non-European ancestry populations, especially Black/African American and Latinx/Hispanic, is needed to improve the risk prediction and enhance equity in applying PRS in clinical practice.

Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial.

BACKGROUND: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to optimize these programs for effectiveness and cost. METHODS: PROMPT was a pragmatic, stepped-wedge, cluster-randomized effectiveness trial of mailed FIT outreach. Participants in the standard condition were mailed a FIT and received live telephone reminders to return it. Participants in the enhanced condition also received a tailored advance notification (text message or live phone call) and two automated phone call reminders. The primary outcome was 6-month FIT completion; secondary outcomes were any colorectal cancer screening completion at 6 months, implementation, and program costs. RESULTS: The study included 27,585 participants (80% ages 50-64, 82% Hispanic/Latino; 68% preferred Spanish). A higher proportion of enhanced participants completed FIT at 6 months than standard participants, both in intention-to-treat [+2.8%, 95% confidence interval (CI; 0.4-5.2)] and per-protocol [limited to individuals who were reached; +16.9%, 95% CI (12.3-20.3)] analyses. Text messages and automated calls were successfully delivered to 91% to 100% of participants. The per-patient cost for standard mailed FIT was $10.84. The enhanced program's text message plus automated call reminder cost an additional $0.66; live phone calls plus an automated call reminder cost an additional $10.82 per patient. CONCLUSIONS: Adding advance notifications and automated calls to a standard mailed FIT program boosted 6-month FIT completion rates at a small additional per-patient cost. IMPACT: Enhancements to mailed FIT outreach can improve colorectal cancer screening participation. Future research might test the addition of educational video messaging for screening-naïve adults.

Implementing an enhanced mailed FIT program to improve CRC screening at a federally qualified health center: experiences of patients and staff.

Colorectal cancer (CRC) is a leading cause of cancer death in the USA. Screening programs in federally qualified health centers (FQHCs) are essential to reducing CRC-related mortality and morbidity among underserved populations. Centralized, population-based mailed fecal immunochemical test (FIT) programs can improve CRC screening rates, but barriers to implementation remain. We qualitatively explored barriers and facilitators to implementation of a mailed FIT program at a large, urban FQHC that employed advance notification "primers" (live calls and texts) and automated reminders. We interviewed 25 patients and 45 FQHC staff by telephone about their experience with the program. Interviews were transcribed, coded, and content analyzed using NVivo.12. Patients and staff found advance notifications conveyed through live phone calls or text messages to be acceptable and motivational for FIT completion. Live phone primers were helpful in addressing patients' questions and misconceptions about screening, particularly for patients new to screening. Advance notifications sent by text were considered timely and useful in preparing patients for receipt of the FIT. Barriers to implementation included lack of receipt of primers, reminders, or the mailed FIT itself due to inaccurate patient contact information within the FQHC medical record; lack of systems for documenting mailed FIT outreach to coordinate with clinical care; and lack of local caller identification for primers and reminders. Our findings demonstrate that an enhanced mailed FIT program using primers and reminders was acceptable. Our findings can help other FQHCs implement and optimize their mailed FIT programs.

A picture is worth a thousand words: advancing the use of visualization tools in implementation science through process mapping and matrix heat mapping.

BACKGROUND: Identifying key determinants is crucial for improving program implementation and achieving long-term sustainment within healthcare organizations. Organizational-level complexity and heterogeneity across multiple stakeholders can complicate our understanding of program implementation. We describe two data visualization methods used to operationalize implementation success and to consolidate and select implementation factors for further analysis. METHODS: We used a combination of process mapping and matrix heat mapping to systematically synthesize and visualize qualitative data from 66 stakeholder interviews across nine healthcare organizations, to characterize universal tumor screening programs of all newly diagnosed colorectal and endometrial cancers and understand the influence of contextual factors on implementation. We constructed visual representations of protocols to compare processes and score process optimization components. We also used color-coded matrices to systematically code, summarize, and consolidate contextual data using factors from the Consolidated Framework for Implementation Research (CFIR). Combined scores were visualized in a final data matrix heat map. RESULTS: Nineteen process maps were created to visually represent each protocol. Process maps identified the following gaps and inefficiencies: inconsistent execution of the protocol, no routine reflex testing, inconsistent referrals after a positive screen, no evidence of data tracking, and a lack of quality assurance measures. These barriers in patient care helped us define five process optimization components and used these to quantify program optimization on a scale from 0 (no program) to 5 (optimized), representing the degree to which a program is implemented and optimally maintained. Combined scores within the final data matrix heat map revealed patterns of contextual factors across optimized programs, non-optimized programs, and organizations with no program. CONCLUSIONS: Process mapping provided an efficient method to visually compare processes including patient flow, provider interactions, and process gaps and inefficiencies across sites, thereby measuring implementation success via optimization scores. Matrix heat mapping proved useful for data visualization and consolidation, resulting in a summary matrix for cross-site comparisons and selection of relevant CFIR factors. Combining these tools enabled a systematic and transparent approach to understanding complex organizational heterogeneity prior to formal coincidence analysis, introducing a stepwise approach to data consolidation and factor selection.

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

Combining Asian-European Genome-Wide Association Studies of Colorectal Cancer Improves Risk Prediction Across Race and Ethnicity.

Polygenic risk scores (PRS) have great potential to guide precision colorectal cancer (CRC) prevention by identifying those at higher risk to undertake targeted screening. However, current PRS using European ancestry data have sub-optimal performance in non-European ancestry populations, limiting their utility among these populations. Towards addressing this deficiency, we expanded PRS development for CRC by incorporating Asian ancestry data (21,731 cases; 47,444 controls) into European ancestry training datasets (78,473 cases; 107,143 controls). The AUC estimates (95% CI) of PRS were 0.63(0.62-0.64), 0.59(0.57-0.61), 0.62(0.60-0.63), and 0.65(0.63-0.66) in independent datasets including 1,681-3,651 cases and 8,696-115,105 controls of Asian, Black/African American, Latinx/Hispanic, and non-Hispanic White, respectively. They were significantly better than the European-centric PRS in all four major US racial and ethnic groups (p-values<0.05). Further inclusion of non-European ancestry populations, especially Black/African American and Latinx/Hispanic, is needed to improve the risk prediction and enhance equity in applying PRS in clinical practice.

Validation of a Genetic-Enhanced Risk Prediction Model for Colorectal Cancer in a Large Community-Based Cohort.

BACKGROUND: Polygenic risk scores (PRS) which summarize individuals' genetic risk profile may enhance targeted colorectal cancer screening. A critical step towards clinical implementation is rigorous external validations in large community-based cohorts. This study externally validated a PRS-enhanced colorectal cancer risk model comprising 140 known colorectal cancer loci to provide a comprehensive assessment on prediction performance. METHODS: The model was developed using 20,338 individuals and externally validated in a community-based cohort (n = 85,221). We validated predicted 5-year absolute colorectal cancer risk, including calibration using expected-to-observed case ratios (E/O) and calibration plots, and discriminatory accuracy using time-dependent AUC. The PRS-related improvement in AUC, sensitivity and specificity were assessed in individuals of age 45 to 74 years (screening-eligible age group) and 40 to 49 years with no endoscopy history (younger-age group). RESULTS: In European-ancestral individuals, the predicted 5-year risk calibrated well [E/O = 1.01; 95% confidence interval (CI), 0.91-1.13] and had high discriminatory accuracy (AUC = 0.73; 95% CI, 0.71-0.76). Adding the PRS to a model with age, sex, family and endoscopy history improved the 5-year AUC by 0.06 (P < 0.001) and 0.14 (P = 0.05) in the screening-eligible age and younger-age groups, respectively. Using a risk-threshold of 5-year SEER colorectal cancer incidence rate at age 50 years, adding the PRS had a similar sensitivity but improved the specificity by 11% (P < 0.001) in the screening-eligible age group. In the younger-age group it improved the sensitivity by 27% (P = 0.04) with similar specificity. CONCLUSIONS: The proposed PRS-enhanced model provides a well-calibrated 5-year colorectal cancer risk prediction and improves discriminatory accuracy in the external cohort. IMPACT: The proposed model has potential utility in risk-stratified colorectal cancer prevention.

"I really had somebody in my corner." Patient experiences with a pharmacist-led opioid tapering program.

BACKGROUND: Opioid tapering has been identified as an effective strategy to prevent the dangers associated with long-term opioid therapy for patients with chronic pain. However, many patients are resistant to tapering, and conversations about tapering can be challenging for health care providers. Pharmacists can play a role in supporting both providers and patients with the process of opioid tapering. OBJECTIVE: Qualitatively describe patient experiences with a unique phone-based and pharmacy-led opioid tapering program implemented within an integrated health care system. METHODS: In-depth telephone interviews with patients who completed the program were recorded, transcribed, and analyzed. Themes were identified through a constant comparative approach. RESULTS: We completed 25 interviews; 80% of patients were women (20), with a mean age of 58 years, and 72% (18) had been using opioids for pain management for 10 or more years. Most (60%) described a positive and satisfying experience with the tapering program. Strengths of the program reported by patients included a patient-centered and compassionate taper approach, flexible taper pace, easy access to knowledgeable pharmacist advocates, and resultant improvements in quality of life (e.g., increased energy). Challenges reported included: unhelpful or difficult-to-access nonpharmacological pain management options, negative quality of life impacts (e.g., inability to exercise), and lack of choice in the taper process. At the end of tapering, most patients (72%) described their pain as reduced or manageable rather than worse and expressed willingness to use the program in the future if a need should arise. CONCLUSIONS: Patients in a pharmacist-led opioid tapering program appreciated the program's individualized approach to care and access to pharmacist' expertise. Most interviewed patients successfully reduced their opioid use and recommended that the program should continue as an offered service. To improve the program, patients suggested increased personalization of the taper process and additional support for withdrawal symptoms and nonpharmacological pain management.

Should Health Systems Share Genetic Findings With At-Risk Relatives When the Proband Is Deceased? Interviews With Individuals Diagnosed With Lynch Syndrome.

Purpose: Genetic information has health implications for patients and their biological relatives. Death of a patient before sharing a genetic diagnosis with at-risk relatives is a missed opportunity to provide important information that could guide interventions to minimize cancer-related morbidity and mortality in relatives. Methods: We performed semi-structured interviews with individuals diagnosed with Lynch syndrome at 1 of 4 health systems to explore their perspectives on whether health systems should share genetic risk information with relatives following a patient's death. An inductive, open-coding approach was used to analyze audio-recorded content, with software-generated code reports undergoing iterative comparative analysis by a qualitative research team to identify broad themes and representative participant quotes. Results: Among 23 participating interviewees, 19 supported health systems informing relatives about their Lynch syndrome risk while the remaining 4 were conflicted about patient privacy. Most (n=22) wanted their Lynch syndrome diagnosis shared with relatives if they were unable to share and to be informed of their own risk if a diagnosed relative was unable to share. The most common issues noted regarding information-sharing with relatives included patient privacy and privacy laws (n=8), potential anxiety (n=5), and lack of contact information for relatives (n=3). Interviewee perspectives on how health systems could communicate genetic findings generated a consensus: When - a few months after but within a year of the patient's death; How - explanatory letter and follow-up phone call; and Who - a knowledgeable professional. Conclusions: Interviews demonstrated strong and consistent perspectives from individuals diagnosed with Lynch syndrome that health systems have a role and responsibility to inform relatives of genetic findings following a patient's death.

Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients.

Social needs contribute to persistent diabetes disparities; thus, it is imperative to address social needs to optimize diabetes management. The purpose of this study was to determine determine the feasibility and acceptability of health system-based social care versus social care + behavioral intervention to address social needs and improve diabetes self-management among patients with type 2 diabetes. Black/African American, Hispanic/Latino, and low-income White patients with recent hemoglobin A1C (A1C) ≥ 8%, and ≥1 social need were recruited from an integrated health system. Patients were randomized to one-of-two 6-month interventions: (a) navigation to resources (NAV) facilitated by a Patient Navigator; or (b) NAV + evidence-based nine-session diabetes self-management support (DSMS) program facilitated by a community health worker (CHW). A1C was extracted from the electronic health record. We successfully recruited 110 eligible patients (54 NAV; 56 NAV + DSMS). During the trial, 78% NAV and 80% NAV + DSMS participants successfully connected to a navigator; 84% NAV + DSMS connected to a CHW. At 6-month follow-up, 33% of NAV and 34% of NAV + DSMS participants had an A1C < 8%. Mean reduction in A1C was clinically significant in NAV (-0.65%) and NAV + DSMS (-0.72%). By follow-up, 89% of NAV and 87% of NAV + DSMS were successfully connected to resources to address at least one need. Findings suggest that it is feasible to implement a health system-based social care intervention, separately or in combination, with a behavioral intervention to improve diabetes management among a high-risk, socially complex patient population. A larger, pragmatic trial is needed to test the comparative effectiveness of each approach on diabetes-related outcomes.

Patient expectations of and experiences with a suicide risk identification algorithm in clinical practice.

BACKGROUND: Suicide risk prediction models derived from electronic health records (EHR) and insurance claims are a novel innovation in suicide prevention but patient perspectives on their use have been understudied. METHODS: In this qualitative study, between March and November 2020, 62 patients were interviewed from three health systems: one anticipating implementation of an EHR-derived suicide risk prediction model and two others piloting different implementation approaches. Site-tailored interview guides focused on patients' perceptions of this technology, concerns, and preferences for and experiences with suicide risk prediction model implementation in clinical practice. A constant comparative analytic approach was used to derive themes. RESULTS: Interview participants were generally supportive of suicide risk prediction models derived from EHR data. Concerns included apprehension about inducing anxiety and suicidal thoughts, or triggering coercive treatment, particularly among those who reported prior negative experiences seeking mental health care. Participants who were engaged in mental health care or case management expected to be asked about their suicide risk and largely appreciated suicide risk conversations, particularly by clinicians comfortable discussing suicidality. CONCLUSION: Most patients approved of suicide risk models that use EHR data to identify patients at-risk for suicide. As health systems proceed to implement such models, patient-centered care would involve dialogue initiated by clinicians experienced with assessing suicide risk during virtual or in person care encounters. Health systems should proactively monitor for negative consequences that result from risk model implementation to protect patient trust.

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship.

BACKGROUND: There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention. METHODS: The Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received. DISCUSSION: The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial's strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective. TRIAL REGISTRATION: ClinicalTrials.gov NCT05018000 . August 23, 2021.

Clinic Factors Associated With Mailed Fecal Immunochemical Test (FIT) Completion: The Difference-Making Role of Support Staff.

PURPOSE: Mailed fecal immunochemical test (FIT) programs can facilitate colorectal cancer (CRC) screening. We sought to identify modifiable, clinic-level factors that distinguish primary care clinics with higher vs lower FIT completion rates in response to a centralized mailed FIT program. METHODS: We used baseline observational data from 15 clinics within a single urban federally qualified health center participating in a pragmatic trial to optimize a mailed FIT program. Clinic-level data included interviews with leadership using a guide informed by the Consolidated Framework for Implementation Research (CFIR) and FIT completion rates. We used template analysis to identify explanatory factors and configurational comparative methods to identify specific combinations of clinic-level conditions that uniquely distinguished clinics with higher and lower FIT completion rates. RESULTS: We interviewed 39 clinic leaders and identified 58 potential explanatory factors representing clinic workflows and the CFIR inner setting domain. Clinic-level FIT completion rates ranged from 30% to 56%. The configurational model for clinics with higher rates (≥37%) featured any 1 of the following 3 factors related to support staff: (1) adding back- or front-office staff in past 12 months, (2) having staff help patients resolve barriers to CRC screening, and (3) having staff hand out FITs/educate patients. The model for clinics with lower rates involved the combined absence of these same 3 factors. CONCLUSIONS: Three factors related to support staff differentiated clinics with higher and lower FIT completion rates. Adding nonphysician support staff and having those staff provide enabling services might help clinics optimize mailed FIT screening programs.

Barriers to family history knowledge and family communication among LGBTQ+ individuals in the context of hereditary cancer risk assessment.

Openness about identity as lesbian, gay, bisexual, transgender, queer, and other sexual orientations and gender identities (LGBTQ+) may cause strain on relationships between family members, which could lead to limited knowledge of cancer family history and reduced communication with family members. As a result, members of the LGBTQ+ community may have more difficulty accessing genetic counseling services for inherited cancer risk. We applied a mixed-methods approach to explore potential barriers to knowledge of cancer family history and family communication among participants of the Cancer Health Assessments Reaching Many (CHARM) study who self-identified as LGBTQ+. We assessed perceptions of family functioning and communication of genetic test results to family members using survey tools and supplemented these data with 20 in-depth interviews to further assess participant perspectives and experiences. LGBTQ+ participants were more likely to report unhealthy family functioning on the survey tool, and some interviewees endorsed that openness about their LGBTQ+ identity led to strained family relationships and reduced communication about their family history of cancer. Overall, this study identified barriers that may be faced by members of the LGBTQ+ community which could limit their ability to access genetic counseling services for inherited cancer risk.