Human-Centered Design Study to Inform Traceback Cascade Genetic Testing Programs at Three Integrated Health Systems.

INTRODUCTION: A traceback genetic testing program for ovarian cancer has the potential to identify individuals with hereditary breast and ovarian cancer and their relatives. Successful implementation depends on understanding and addressing the experiences, barriers, and preferences of the people served. METHODS: We conducted a remote, human-centered design research study of people with ovarian, fallopian tube, or peritoneal cancer (probands) and people with a family history of ovarian cancer (relatives) at three integrated health systems between May and September 2021. Participants completed activities to elicit their preferences about ovarian cancer genetic testing messaging and to design their ideal experience receiving an invitation to participate in genetic testing. Interview data were analyzed using a rapid thematic analysis approach. RESULTS: We interviewed 70 participants and identified five preferred experiences for a traceback program. Participants strongly prefer discussing genetic testing with their doctor but are comfortable discussing with other clinicians. The most highly preferred experience for both probands and relatives was to discuss with a knowledgeable clinician who could answer questions, followed by directed (sent directly to specific people) or passive (shared in a public area) communication. Repeated contact was acceptable for reminders. CONCLUSION: Participants were open to receiving information about traceback genetic testing and recognized its value. Participants preferred discussing genetic testing with a trusted clinician. Directed communication was preferable to passive communication. Other valued information included how genetic tests help their family and the cost of genetic testing. These findings are informing traceback cascade genetic testing programs at all three sites.

Environmental scan of family chart linking for genetic cascade screening in a U.S. integrated health system.

Background: An alternative to population-based genetic testing, automated cascade genetic testing facilitated by sharing of family health history, has been conceptualized as a more efficient and cost-effective approach to identify hereditary genetic conditions. However, existing software and applications programming interfaces (API) for the practical implementation of this approach in health care settings have not been described. Methods: We reviewed API available for facilitating cascade genetic testing in electronic health records (EHRs). We emphasize any information regarding informed consent as provided for each tool. Using semi-structured key informant interviews, we investigated uptake of and barriers to integrating automated family cascade genetic testing into the EHR. Results: We summarized the functionalities of six tools related to utilizing family health history to facilitate cascade genetic testing. No tools were explicitly capable of facilitating family cascade genetic testing, but few enterprise EHRs supported family health history linkage. We conducted five key informant interviews with four main considerations that emerged including: 1) incentives for interoperability, 2) HIPAA and regulations, 3) mobile-app and alternatives to EHR deployment, 4) fundamental changes to conceptualizing EHRs. Discussion: Despite the capabilities of existing technology, limited bioinformatic support has been developed to automate processes needed for family cascade genetic testing and the main barriers for implementation are nontechnical, including an understanding of regulations, consent, and workflow. As the trade-off between cost and efficiency for population-based and family cascade genetic testing shifts, the additional tools necessary for their implementation should be considered.

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.

Identifying and Prioritizing Workplace Climate Predictors of Burnout Among VHA Primary Care Physicians.

OBJECTIVE: Burnout, or job-related stress, affects more than half of all US physicians, with primary care physicians (PCPs) experiencing some of the highest rates in medicine. Our study analyzes national survey data to identify and prioritize workplace climate predictors of burnout among PCPs within a large integrated health system. DESIGN: Observational study of annual survey data from the Veterans Health Administration (VHA) All Employee Survey (AES) for 2013-2017. AES response rate ranged from 56 to 60% during the study period. Independent and dependent variables were measured from separate random samples. In total, 8,456 individual-level responses among PCPs at 110 VHA practice sites were aggregated at the facility level by reporting year. We used the semi-automated LASSO procedure to identify workplace climate measures that were more influential in predicting burnout and assessed relative importance using the Shapely value decomposition. PARTICIPANTS: VHA employees that self-identify as PCPs. MAIN MEASURES: Dependent variables included two dichotomous measures of burnout: emotional exhaustion and depersonalization. Independent measures included 30 survey measures related to dimensions of workplace climate (e.g., workload, leadership, satisfaction). RESULTS: We identified seven influential workplace climate predictors of emotional exhaustion and nine predictors of depersonalization. With few exceptions, higher agreement/satisfaction scores for predictors were associated with a lower likelihood of burnout. The majority of explained variation in emotional exhaustion was attributable to perceptions of workload (32.6%), organization satisfaction (28.2%), and organization support (19.4%). The majority of explained variation in depersonalization was attributable to workload (25.3%), organization satisfaction (22.9%), and connection to VHA mission (20.7%). CONCLUSION: Identifying the relative importance of workplace climate is important for the allocation of health organization resources to mitigate and prevent burnout within the PCP workplace. In a context of limited resources, efforts to reduce perceived workload and improve organization satisfaction may represent the biggest leverage points for health organizations to address physician burnout.

Feasibility and Assessment of a Cascade Traceback Screening Program (FACTS): Protocol for a Multisite Study to Implement and Assess an Ovarian Cancer Traceback Cascade Testing Program.

Ovarian cancer (OVCA) patients may carry genes conferring cancer risk to biological family; however, fewer than one-quarter of patients receive genetic testing. "Traceback" cascade testing -outreach to potential probands and relatives-is a possible solution. This paper outlines a funded study (U01 CA240747-01A1) seeking to determine a Traceback program's feasibility, acceptability, effectiveness, and costs. This is a multisite prospective observational feasibility study across three integrated health systems. Informed by the Conceptual Model for Implementation Research, we will outline, implement, and evaluate the outcomes of an OVCA Traceback program. We will use standard legal research methodology to review genetic privacy statutes; engage key stakeholders in qualitative interviews to design communication strategies; employ descriptive statistics and regression analyses to evaluate the site differences in genetic testing and the OVCA Traceback testing; and assess program outcomes at the proband, family member, provider, system, and population levels. This study aims to determine a Traceback program's feasibility and acceptability in a real-world context. It will account for the myriad factors affecting implementation, including legal issues, organizational- and individual-level barriers and facilitators, communication issues, and program costs. Project results will inform how health care providers and systems can develop effective, practical, and sustainable Traceback programs.

Usefulness of mobile apps for communication of genetic test results to at-risk family members in a U.S. integrated health system: a qualitative approach from user-testing.

OBJECTIVE: To assess the usefulness a mobile based application to send genetic test results to at-risk family members in a U.S. integrated health system. METHODS: We conducted semi-structured in-person interviews with members of Kaiser Permanente Washington who had enrolled in a prospective study and received genetic test results. Participants were given the task to use the app and comment on the experience. The moderator asked participants to share perspectives on the usefulness of a mobile based app and their lived experiences of sharing their test results with family members. RESULTS: Fourteen study participants who had undergone genetic testing were interviewed. Four primary themes emerged as relevant to the use of mobile-based apps as a tool for communicating genetic test results to at-risk family members: (i) Participants felt a sense of obligation to share positive test results with relatives; (ii) Participants felt that the advantages of using email were similar to those of the app; (iii) Participants felt that younger individuals would be more comfortable with an app; and, (iv) Participants felt they could use the app independently and in their own time. CONCLUSION: A mobile based app could be used as a tool to improve cascade screening for pathogenic/likely pathogenic test results. The benefits of such a tool are likely greatest among relatives still at the stage of family planning, as well as among family members with strained relationships. There would be minimal burden on the system to offer a mobile based app as a tool.

How, When, and With Whom Should Cost of Care Conversations Occur? Preferences of Two Distinct Cancer Survivor Groups.

PURPOSE: Cost of care (CoC) conversations should occur routinely in oncology practice. However, patient preferences about with whom, when, and how to have these conversations are missing and preferences may vary across patient populations. METHODS: We performed a secondary qualitative analysis of quotes from interviews with 28 cancer survivors from two health care settings (Kaiser Permanente Washington and O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham [UABCCC]). A targeted approach searched for three constructs: (1) Who should have CoC conversations with patients? (2) When should CoC conversations occur? and (3) How should CoC conversations happen? RESULTS: Interviewees were similar in age and education, but UABCCC participants had more racial/ethnic minority representation and financial distress. Within each construct, themes were similar across both groups. As to who should have CoC conversations, we found that (1) providers' main role is medical care, not CoC; and (2) care team staff members are a more appropriate choice to address CoC needs. About the question of when, we found that (3) individuals have strong convictions about when and if they want to discuss CoC; and (4) CoC information and resources need to be available when patients are ready. About the question of how, themes were (5) provide estimates of anticipated out-of-pocket costs and insurance coverage; (6) provide reassurance, sympathy, and concrete solutions; and (7) because of their sensitivity, conduct CoC conversations in a comfortable, private space. CONCLUSION: These findings offer general guidance as to who should conduct CoC conversations and when and how they should occur, with applicability across different patient populations.

Workflow Requirements for Cost-of-Care Conversations in Outpatient Settings Providing Oncology or Primary Care: A Qualitative, Human-Centered Design Study.

Background: Patients prefer to discuss costs in the clinical setting, but physicians and teams may be unprepared to incorporate cost discussions into existing workflows. Objective: To understand and improve clinical workflows related to cost-of-care conversations. Design: Qualitative human-centered design study. Setting: 2 integrated health systems in the U.S. Pacific Northwest: a system-wide oncology service line and a system-wide primary care service line. Participants: Clinicians, clinical team members, operations staff, and patients. Measurements: Ethnographic observations were made at the integrated health systems, assessing barriers to and facilitators of discussing costs with patients. Three unique patient experiences of having financial concerns addressed in the clinic were designed. These experiences were refined after in-person interviews with patients (n = 20). Data were synthesized into a set of clinical workflow requirements. Results: Most patient cost concerns take 1 of 3 pathways: informing clinical care decision making, planning and budgeting concerns, and addressing immediate financial hardship. Workflow requirements include organizational recognition of the need for clinic-based cost-of-care conversations; access to cost and health plan benefit data to support each conversation pathway; clear team member roles and responsibilities for addressing cost-of-care concerns; a patient experience where cost questions are normal and each patient's preferences and privacy are respected; patients know who to go to with cost questions; patients' concerns are documented to minimize repetition to multiple team members; and patients learn their expected out-of-pocket costs before treatment begins. Limitation: Results may have limited generalizability to other health care settings, and the study did not test the effectiveness of the workflows developed. Conclusion: Clinic-based workflows for cost-of-care conversations that optimize patients' care experience require organizational commitment to addressing cost concerns, clear roles and responsibilities, appropriate and complete data access, and a team-based approach. Primary Funding Source: Robert Wood Johnson Foundation.

"It would be so much easier": health system-led genetic risk notification-feasibility and acceptability of cascade screening in an integrated system.

Assess the feasibility and acceptability of health system-led genetic risk notification in a US integrated health system. We conducted semi-structured phone interviews with individuals age 40-64 years who had undergone genetic sequencing, but had not yet received their results, assessing attitudes to direct outreach to relatives. During each interview, we collected contact information for adult relatives identified as members of the same system and attempted to identify each relative in administrative data. We conducted 20 interviews. Most participants expressed support for Kaiser Permanente Washington involvement in familial risk notification. Direct outreach to relatives received the most unqualified support; outreach to the relatives' physician or interaction with the relatives' electronic medical record received more tempered support. Support was motivated by the desire to have risk communicated accurately and quickly. The most common caveat was a desire to alert relatives before the health system contacted them. Of 57 named relatives who were members of the same health system, we retrieved a single match for 40 (70.2%) based on name or birthdate. Health system involvement in familial risk notification received support in a sample of patients in a US integrated health system, and identification of relatives is feasible.

Outreach and Reminders to Improve Human Papillomavirus Vaccination in an Integrated Primary Care System.

This study evaluated the impact of health system-based outreach and reminders on human papillomavirus (HPV) vaccine series initiation and completion. Parents of 10 to 12 year olds (n = 1805) were randomized to receive either (1) an outreach letter and brochure recommending HPV vaccination followed by automated HPV vaccine reminders or (2) usual care. We interviewed a subset of 50 parents to assess program acceptability. Outcomes were HPV vaccine initiation during the study period and on-time series completion. Rates of HPV vaccine initiation during the study period (July 2015 to August 2016) were similar between the intervention and control groups, but initiation within 120 days of randomization was higher in the intervention group (23.6% and 18.8%, P = .04) as was completion during the study period (10.3% vs 6.8%, P = .04). Reminders for doses 2 and 3 did not affect completion. The program was acceptable to parents. This study provides evidence that health system-based outreach and reminders can improve HPV vaccination.

Communication with Physicians about Health Care Costs: Survey of an Insured Population.

CONTEXT: Health care costs have increasingly shifted to patients, and financial distress caused by medical care has increased. Patients may wish to discuss costs with their clinicians. OBJECTIVE: Describe patient preferences for communication about cost in the clinical setting. DESIGN: Cross-sectional, self-administered survey of a stratified random sample of the population insured in an integrated health care system in Washington State. Our sampling frame was the entire membership aged 21 years or older. Sampling was stratified by sex and group practice enrollment. MAIN OUTCOME MEASURES: Preference for discussing health care costs with one's physician. We conducted regression analyses to determine predictors of communication preference; potential predictors included demographic characteristics, financial burden, delay in seeking care because of cost, and socioeconomic variables. Survey responses were weighted to adjust for nonresponse and sampling. RESULTS: Of 7200 invitations sent, 2200 survey responses were returned. Ninety-two percent wished to know their out-of-pocket costs before beginning treatment. Most respondents preferred their physician talk with them about out-of-pocket costs (81.4%) and expressed comfort with discussing costs with their physician (75.6%). Overall, 43.7% reported any delay in seeking care in the previous 12 months. One in 5 respondents (21.6%) reported family medical debt. Delay in seeking care was positively and independently associated with preferring to discuss costs with one's physician; current medical financial burden was not. CONCLUSION: Patient preferences for communication about costs with physicians are high, and medical debt and delay in care-seeking are prevalent. Delay in care-seeking independently predicts cost communication preferences.

Employee knowledge of value-based insurance design benefits.

BACKGROUND: Value-based insurance designs (VBD) incorporate evidence-based medicine into health benefit design. Consumer knowledge of new VBD benefits is important to assessing their impact on health care use. PURPOSE: To assess knowledge of features of a VBD. METHODS: The eligible study population was employees receiving healthcare benefits in an integrated care system in the U.S. Pacific Northwest. In 2010, participants completed a web-based survey 2 months after rollout of the plan, including three true/false questions about benefit design features including copays for preventive care visits and chronic disease medications and premium costs. Analysis was completed in 2012. Knowledgeable was defined as correct response to all three questions; self-reported knowledge was also assessed. RESULTS: A total of 3,463 people completed the survey (response rate=71.7%). The majority of respondents were female (80.1%) Caucasians (79.6%) aged 35-64 years (79.0%), reflecting the overall employee population. A total of 45.7% had at least a 4-year college education, and 69.1% were married. About three quarters of respondents correctly answered each individual question; half (52.1%) of respondents answered all three questions correctly. On multivariate analysis, knowledge was independently associated with female gender (OR=1.80, 95% CI=1.40, 2.31); Caucasian race (OR=1.72, 95% CI=1.28, 2.32); increasing household income (OR for ≥$100,000=1.86, 95% CI=1.29, 2.68); nonunion job status (OR compared to union status=1.63, 95% CI=1.17, 2.26); and high satisfaction with the health plan (OR compared to low satisfaction=1.26; 95% CI=1.00, 1.57). CONCLUSIONS: Incomplete knowledge of benefits is prevalent in an employee population soon after VBD rollout.

Evaluating Washington State's immunization information system as a research tool.

OBJECTIVE: Immunization information systems (IISs) are powerful public health tools for vaccination activities. To date, however, their use for public health research has been limited, in part as a result of insufficient understanding on accuracy and quality of IIS data. We evaluated the completeness and accuracy of Washington State IIS (WAIIS) data, with particular attention to data elements of research interest. METHODS: We analyzed all WAIIS records on all children born between 2006 and 2010 with at least 1 vaccination recorded in WAIIS between 2006 and 2010. We assessed all variables for completeness and tested selected variables for internal validity. To assess external validity, we matched WAIIS data to records from Group Health, a large integrated health care organization in Washington State. On these children, we compared vaccination data in WAIIS with vaccination data from Group Health's immunization registry. RESULTS: The WAIIS data included 486,265 children and 8,670,234 unique vaccinations. Variables required by WAIIS (such as date of vaccination) were highly complete, but optional variables were often missing. For example, most records were missing data on route (80.7%) and anatomic site (81.7%) of vaccination. WAIIS data, when complete, were highly accurate relative to the Group Health immunization registry, with 96% to 99% agreement between fields such as vaccination code and anatomic site. CONCLUSIONS: Required data elements in WAIIS are highly complete and have both internal and external validity, suggesting that these variables are useful for research. Research requiring nonrequired variables should use additional validity checks before proceeding.

Comparative effectiveness of exercise, acupuncture, and spinal manipulation for low back pain.

STUDY DESIGN: Systematic review. OBJECTIVE: We sought to answer the following clinical questions: (1) Is structured exercise more effective in the treatment of chronic low back pain (LBP) than spinal manipulative therapy (SMT)? (2) Is structured exercise more effective in the treatment of chronic LBP than acupuncture? (3) Is SMT more effective in the treatment of chronic LBP than acupuncture? (4) Do certain subgroups respond more favorably to specific treatments? (5) Are any of these treatments more cost-effective than the others? SUMMARY OF BACKGROUND DATA: Exercise, SMT, and acupuncture are widely used interventions in the treatment of chronic LBP. There is evidence that all of these approaches may offer some benefit for patients with chronic LBP when compared with usual care or no treatment. The relative benefits or cost-effectiveness of any one of these treatments when compared with the others are less well-defined, and it is difficult to identify specific subgroups of those with chronic LBP who may preferentially respond to a particular treatment modality. METHODS: A systematic review of the literature was performed to identify randomized controlled trials comparing a structured exercise program, SMT, or acupuncture with one another in patients with chronic LBP. RESULTS: Two studies were identified comparing the use of structured exercise with SMT that met our inclusion criteria. Although these studies utilized different approaches for the exercise and SMT treatment groups, patients in both groups improved in terms of pain and function in both studies. Using random-effects modeling, there was no difference between the exercise and SMT groups when the data from these studies were pooled. We identified no studies meeting our inclusion criteria that compared acupuncture with either structured exercise or SMT or that addressed the relative cost-effectiveness of these approaches in the treatment of patients with chronic LBP. CONCLUSION: The studies identified indicate that structured exercise and SMT appear to offer equivalent benefits in terms of pain and functional improvement for those with chronic LBP with clinical benefits evident within 8 weeks of care. However, the level of evidence is low. There is insufficient evidence to comment on the relative benefit of acupuncture compared with either structured exercise or SMT or to address the differential effects of structured exercise, SMT, or acupuncture for specific subgroups of individuals with chronic LBP. There is also insufficient evidence regarding the relative cost-effectiveness of structured exercise, SMT, or acupuncture in the treatment of chronic LBP. CLINICAL RECOMMENDATIONS: Structured exercise and SMT appear to offer equivalent benefits in the management of pain and function for patients with nonspecific chronic LBP. If no clinical benefit is appreciated after using one of these approaches for 8 weeks, then the treatment plan should be reevaluated and consideration should be given to modifying the treatment approach or using alternate forms of care. Strength of recommendation: Weak.There is insufficient evidence regarding the relative benefits of the acupuncture compared with either structured exercise or SMT in the treatment of chronic LBP.There is insufficient evidence to address differential effects of structured exercise, SMT, or acupuncture for specific subgroups of individuals with chronic LBP. There is insufficient evidence regarding the relative cost-effectiveness of structured exercise, SMT, or acupuncture in the treatment of chronic LBP.