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BackgroundThere 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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov NCT05018000 . August 23, 2021.

PurposeBecause social conditions such as food insecurity and housing instability shape health outcomes, health systems are increasingly screening for and addressing patients' social risks. This study documented the prevalence of social risks and examined the desire for assistance in addressing those risks in a US-based integrated delivery system.MethodsA survey was administered to Kaiser Permanente members on subsidized exchange health insurance plans (2018-2019). The survey included questions about 4 domains of social risks, desire for help, and attitudes. We conducted a descriptive analysis and estimated multivariate modified Poisson regression models.ResultsOf 438 participants, 212 (48%) reported at least 1 social risk factor. Housing instability was the most common (70%) factor reported. Members with social risks reported more discomfort being screened for social risks (14.2% vs 5.4%; P = .002) than those without risks, although 90% of participants believed that health systems should assist in addressing social risks. Among those with 1-2 social risks, however, only 27% desired assistance. Non-Hispanic Black participants who reported a social risk were more than twice as likely to desire assistance compared with non-Hispanic White participants (adjusted relative risk [RR] 2.2; 95% CI, 1.3-3.8).ConclusionsAthough most survey participants believed health systems have a role in addressing social risks, a minority of those reporting a risk wanted assistance and reported more discomfort being screened for risk factors than those without risks. Health systems should work to increase the comfort of patients in reporting risks, explore how to successfully assist them when desired, and offer resources to address these risks outside the health care sector.VISUAL ABSTRACT.

Embedded pragmatic clinical trials (ePCTs) and quality improvement (QI) activities often occur simultaneously within healthcare systems (HCSs). Embedded PCTs within HCSs are conducted to test interventions and provide evidence that may impact public health, health system operations, and quality of care. They are larger and more broadly generalizable than QI initiatives, and may generate what is considered high-quality evidence for potential use in care and clinical practice guidelines. QI initiatives often co-occur with ePCTs and address the same high-impact health questions, and this co-occurrence may dilute or confound the ability to detect change as a result of the ePCT intervention. During the design, pilot, and conduct phases of the large-scale NIH Collaboratory Demonstration ePCTs, many QI initiatives occurred at the same time within the HCSs. Although the challenges varied across the projects, some common, generalizable strategies and solutions emerged, and we share these as case studies. KEY LESSONS: Study teams often need to monitor, adapt, and respond to QI during design and the course of the trial. Routine collaboration between ePCT researchers and health systems stakeholders throughout the trial can help ensure research and QI are optimally aligned to support high-quality patient-centered care.

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

The Cancer Research Network (CRN) is a consortium of 12 research groups, each affiliated with a nonprofit integrated health care delivery system, that was first funded in 1998. The overall goal of the CRN is to support and facilitate collaborative cancer research within its component delivery systems. This paper describes the CRN's 20-year experience and evolution. The network combined its members' scientific capabilities and data resources to create an infrastructure that has ultimately supported over 275 projects. Insights about the strengths and limitations of electronic health data for research, approaches to optimizing multidisciplinary collaboration, and the role of a health services research infrastructure to complement traditional clinical trials and large observational datasets are described, along with recommendations for other research consortia.

BackgroundLong-term adherence to colorectal cancer (CRC) screening is particularly important for fecal testing. Some U.S. studies report that only 25% of individuals repeat fecal testing annually. The purpose of this qualitative study was to identify barriers and facilitators reported by patients with suboptimal screening adherence to refine interventions for starting ongoing adherence to CRC screening. We also explored whether participants, particularly never screeners, would be willing to do a CRC screening blood test.MethodsForty-one patients who previously enrolled in the Systems of Support to Increase CRC Screening (SOS) trial were interviewed 4-5 years later. Participants were purposively selected to include men and women with diverse race/ethnicities who had either been inconsistent screeners or had never screened during the first three years of SOS despite receiving at least two rounds of mailed fecal tests. Two interviewers conducted 30-min telephone interviews using a semi-structured interview guide. An iterative thematic analysis approach was used.ResultsThemes related to screening barriers were more pervasive among never screeners including: (1) Avoidance (inattention, procrastination) (2) Concerns about handling stool; (3) Health concerns; (4) Fear of a cancer diagnosis or positive test results. Themes related to screening facilitators were more often mentioned by participants who screened at least once including: (1) Use of a simpler 1-sample fecal test; (2) Convenience of mailings and doing the test at home; (3) Salience of prevention, especially as one got older; and (4) Influence of recommendations from providers, family and friends. Participants had diverse preferences for the number (3 on average) and types (phone, mail, text) of screening reminders. Some participants did not prefer e-mail links to the patient shared electronic health record because of difficulties remembering their password. It was acceptable for a nurse or medical assistant not from their clinic to call them as long as that person was knowledgeable about their records and could communicate with their physician. Participants, especially never screeners, were generally very enthusiastic about the potential option of a CRC screening blood test.ConclusionFuture CRC screening programs should be designed to minimize these barriers and maximize facilitators to improve long-term screening adherence.Trial registrationPrimary Funding Agency: The National Cancer Institute of the National Institutes of Health (R01CA121125). Registered at clinicaltrials.gov NCT00697047 .

ObjectiveThe patient-centered medical home (PCMH) includes comprehensive chronic illness and preventive services, including identifying patients who are overdue for colorectal cancer screening (CRCS). The association between PCMH implementation and CRCS during the Systems of Support to Increase Colorectal Cancer Screening Trial (SOS) is described.MethodsThe SOS enrolled 4664 patients from 21 clinics from August 2008 to November 2009. Patients were randomized to usual care, mailed fecal kits, kits plus brief assistance, or kits plus assistance and navigation. A PCMH model that included a workflow for facilitating CRCS was implemented at all study clinics in late 2009. Patients enrolled early had little exposure to the PCMH, whereas patients enrolled later were exposed during most of their first year in the trial. Logistic regression models were used to assess the association between PCMH exposure and CRCS.ResultsUsual care patients with ≥8 months in the PCMH had higher CRCS rates than those with ≤4 months in the PCMH (adjusted difference, 10.1%; 95% confidence interval, 5.7-14.6). SOS interventions led to significant increases in CRCS, but the magnitude of effect was attenuated by exposure to the PCMH (P for interaction = .01).ConclusionExposure to a PCMH was associated with higher CRCS rates. Automated mailed and centrally delivered stepped interventions increased CRCS rates, even in the presence of a PCMH.

PURPOSE We conducted a randomized controlled trial to compare the effectiveness of adding various forms of enhanced external support to practice facilitation on primary care practices' clinical quality measure (CQM) performance. METHODS Primary care practices across Washington, Oregon, and Idaho were eligible if they had fewer than 10 full-time clinicians. Practices were randomized to practice facilitation only, practice facilitation and shared learning, practice facilitation and educational outreach visits, or practice facilitation and both shared learning and educational outreach visits. All practices received up to 15 months of support. The primary outcome was the CQM for blood pressure control. Secondary outcomes were CQMs for appropriate aspirin therapy and smoking screening and cessation. Analyses followed an intention-to-treat approach. RESULTS Of 259 practices recruited, 209 agreed to be randomized. Only 42% of those offered educational outreach visits and 27% offered shared learning participated in these enhanced supports. CQM performance improved within each study arm for all 3 cardiovascular disease CQMs. After adjusting for differences between study arms, CQM improvements in the 3 enhanced practice support arms of the study did not differ significantly from those seen in practices that received practice facilitation alone (omnibus P = .40 for blood pressure CQM). Practices randomized to receive both educational outreach visits and shared learning, however, were more likely to achieve a blood pressure performance goal in 70% of patients compared with those randomized to practice facilitation alone (relative risk = 2.09; 95% CI, 1.16-3.76). CONCLUSIONS Although we found no significant differences in CQM performance across study arms, the ability of a practice to reach a target level of performance may be enhanced by adding both educational outreach visits and shared learning to practice facilitation. Key words: primary health care; cardiovascular disease; quality improvement; chronic illness; prevention; health promotion; quantitative methods; health services; organizational change; practice-based research, INTRODUCTION Past efforts to transform primary care have included practice redesign based on medical home principles and adoption of electronic health records. (1-4) More recently, primary care practices face increasing [...]