Influence of Cost-Related Considerations on Clinical Trial Participation: Results from the 2020 Health Information National Trends Survey (HINTS).

BACKGROUND: People experiencing financial burden are underrepresented in clinical trials. OBJECTIVE: Describe the prevalence of cost-related considerations influential to trial participation and their associations with person-level characteristics. DESIGN: This cross-sectional study used and assessed how three cost-related considerations would influence the decision to participate in a hypothetical clinical trial. PARTICIPANTS: A total of 3682 US adult respondents to the Health Information National Trends Survey MAIN MEASURES: Survey-weighted multivariable logistic regression estimated associations between respondent characteristics and odds of reporting cost-related considerations as very influential to participation. KEY RESULTS: Among 3682 respondents, median age was 48 (IQR 33-61). Most were non-Hispanic White (60%), living comfortably or getting by on their income (74%), with ≥ 1 medical condition (61%). Over half (55%) of respondents reported at least one cost-related consideration as very influential to trial participation, including if usual care was not covered by insurance (reported by 42%), payment for participation (24%), or support for participation (24%). Respondents who were younger (18-34 vs. ≥ 75, adjusted odds ratio [aOR] 4.3, 95% CI 2.3-8.1), more educated (high school vs.

Evaluation of the Cancer Control P.L.A.N.E.T. Web Portal.

CONTEXT: The Cancer Control P.L.A.N.E.T. (P.L.A.N.E.T.) Web portal was designed to ease access to data and evidence-based resources for cancer control practitioners and researchers focused on developing, implementing, and evaluating cancer control programs. OBJECTIVES: To determine usability, applicability, and opportunities to improve the P.L.A.N.E.T. Web portal after significant changes to the portal over time. DESIGN: The National Cancer Institute surveyed and interviewed cancer control professionals to assess factors influencing utilization of P.L.A.N.E.T. Data were collected from May 2017 to June 2018 via partner agencies, electronic publications, and online links. OUTCOME MEASURES: Descriptive statistics with χ test were used to analyze the quantitative data and examine the relationship among variables. Qualitative interviews further informed the quantitative analysis. RESULTS: Of the 724 participants surveyed, 51% were users of P.L.A.N.E.T., with the majority accessing P.L.A.N.E.T. within the last 6 months. Most users felt that P.L.A.N.E.T. effectively met their needs for accessing specific cancer data, identifying evidenced-based programs, and ascertaining details on various cancer topics. There were statistically significant differences in demographic characteristics between users and nonusers of P.L.A.N.E.T., where users were more likely to have more experience in the cancer field, were older in age, and located in southern states. CONCLUSION: Results indicate that P.L.A.N.E.T. is seen as a viable and credible source for cancer control program planning and delivery. A reassessment of P.L.A.N.E.T.'s goals is warranted, which may support reaching out to new audiences, amplifying or removing underutilized resources, and adding additional resources and topics. Consideration for training and tutorials on P.L.A.N.E.T. would benefit partner agencies and build capacity for evidence-based program development.

Evaluating centralized technical assistance as an implementation strategy to improve cancer prevention and control.

PURPOSE: In 2015-2016, the Comprehensive Cancer Control National Partnership provided technical assistance workshops to support 22 cancer coalitions in increasing human papillomavirus (HPV) vaccination uptake and increasing colorectal cancer (CRC) screening in their local communities. As national efforts continue to invest in providing technical assistance, there is a current gap in understanding its use as a strategy to accelerate implementation of evidence-based interventions (EBIs) for cancer prevention. The objective of this study was to evaluate the impact of technical assistance on the participants' knowledge, attitudes, and skills for implementing EBIs in their local context and enhancing state team collaboration. METHODS: Data were collected August-November 2017 using web-based questionnaires from 44 HPV workshop participants and 66 CRC workshop participants. RESULTS: Both HPV vaccination and CRC screening workshop participants reported changes in knowledge, attitudes, and skills related to implementing EBIs in their local state context. Several participants reported increased abilities in communicating and coordinating with partners in their states and utilizing additional implementation strategies to increase HPV vaccination uptake and CRC screening rates. CONCLUSIONS: Findings from this study suggest that providing technical assistance to members of comprehensive cancer control coalitions is useful in promoting collaborations and building capacity for implementing EBIs for cancer prevention and control.

Preliminary outcomes of a pilot physical therapy program for HIV-infected patients with chronic pain.

Chronic pain in HIV-infected individuals is common and often undertreated. Physical therapy (PT) is an evidence-based nonpharmacologic treatment for chronic pain. Our objective is to present the results of a pilot PT program in an HIV pain/palliative care clinic, which is embedded within a Ryan White-funded multidisciplinary HIV primary care clinic. Medical records of HIV-infected patients participating in a PT program between November 2012 and July 2013 were retrospectively reviewed. Pain scores on a 0-10 scale and cost data were collected and analyzed. Among 43 patients referred, 27 collectively attended 86 sessions. Median age of enrolled patients was 54 (IQR 49-58). Sixteen (59%) were African-American and 20 (77%) had an undetectable HIV viral load. Mean pain score at initial visit was 6.5 (SD = 1.1). The average session-level decrease was 2.6 (SD = 1.7) and patient-level decrease was 2.5 (SD = 1.2). The largest payors were Medicare managed care (28%), Medicaid (21%), and Ryan White grant-related funds (18%). When the first four months of the program are excluded to account for slow start-up, the program's monthly net revenue during the remaining five months was $163. We present preliminary data from a low-cost pilot PT program integrated into an HIV clinic in a primary care setting associated with clinically significant improvements in pain. Further investigation into the implementation of such programs is essential.

A conceptual framework for understanding chronic pain in patients with HIV.

Chronic pain is common in persons with HIV and is often associated with psychiatric illness and substance abuse. Current literature links psychiatric illness and substance abuse with worse HIV outcomes; however, the relationship of chronic pain, alone and in the context of psychiatric illness and substance abuse, to outcomes in HIV has not been described. To develop this new area of inquiry, we propose an adapted biopsychosocial framework specifically for chronic pain in HIV. This framework will describe these relationships and serve as a conceptual framework for future investigations.

National Cancer Institute funding for rapid cycle interventional research in cancer care delivery.

BACKGROUND: Rapid cycle interventional research can accelerate improvements to cancer care delivery and patient health outcomes by answering multiple questions as part of a single research study. To complement ongoing efforts to increase awareness of and support for rapid cycle interventional research, we conducted a systematic portfolio analysis of research grants funded by the National Cancer Institute on the topic. METHODS: We used standard portfolio analytic methods for identifying, coding, and synthesizing rapid cycle interventional research funded by the National Cancer Institute between 2016 and 2022. A codebook was used to standardize assessment of the grants by common study characteristics, intervention topics, and cancer care delivery context. RESULTS: We identified 26 grants, mostly funded since 2019, as rapid cycle interventional research. Most studies included adult or older adult target populations, used electronic systems for intervention delivery, and focused primarily on testing different components of interventions. Studies also used a range of study designs, intervention content areas, cancer sites, and across the cancer control continuum. CONCLUSIONS: The current portfolio analysis of funded rapid cycle interventional research grants suggests a growing albeit relatively small number of studies in this area. Several efforts are needed to continue to grow this area of research, including training programs, funding opportunities, and strengthening research-practice partnerships. This analysis provides a snapshot of current studies and highlights the opportunity for growing this important area of research to optimize cancer care delivery and improve patient outcomes.

Advancing rapid cycle research in cancer care delivery: a National Cancer Institute workshop report.

Generating actionable research findings quickly and efficiently is critical for improving the delivery of cancer-related care and outcomes. To address this issue, the National Cancer Institute convened subject matter experts, researchers, clinicians, and patients for a 2-day virtual meeting in February 2022. The purpose of this meeting was to identify how rapid cycle interventional research methods can be used to generate findings useful in improving routine clinical practice. The meeting yielded an initial conceptualization of rapid cycle interventional research as being comprised of 6 key elements: use of iterative study designs; reliance on proximal primary outcomes; early and continued engagement with community and clinical partners; use of existing data sources to measure primary outcomes; facilitative features of the study setting and context; and consideration of appropriate rigor relative to intended use of findings. The meeting also identified the types of study designs that can be leveraged to conduct rapid cycle interventional research and provided examples of these; considered this approach from the perspective of key partners; described the clinical and data infrastructure, research resources, and key collaborations needed to support this work; identified research topics best addressed using this approach; and considered needed methodological advances. The National Cancer Institute is committed to exploring opportunities to encourage further development and application of this research approach as a means for better promoting improvements in the delivery of cancer-related care.

The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method.

BACKGROUND: Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time. METHODS: The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User's Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study. RESULTS: Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies. CONCLUSIONS: The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative.

BACKGROUND: Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative. METHODS: We developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation. RESULTS: ACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs. CONCLUSIONS: Our detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice.

Coping with HIV stigma: do proactive coping and spiritual peace buffer the effect of stigma on depression?

Although HIV stigma is a significant predictor of depression, little is known about which factors might most effectively buffer, or attenuate, this effect. We examined whether two coping-related factors-proactive coping and spiritual peace-modified the effect of HIV stigma on likelihood of depression among a sample of 465 people living with HIV/AIDS (PLWHA). In a cross-sectional analysis, we conducted hierarchical logistic regressions to examine the effect of HIV stigma, proactive coping, spiritual peace, and their interactions on likelihood of significant depressive symptoms. Spiritual peace moderated the effect of HIV stigma on depression at high-but not low-levels of HIV stigma. No such effect was observed for proactive coping. Findings suggest that spiritual peace may help counteract the negative effect of HIV stigma on depression. Intervention components that enhance spiritual peace, therefore, may potentially be effective strategies for helping PLWHA cope with HIV stigma.

HIV-infected women's relationships with their health care providers in the rural deep south: an exploratory study.

Through this qualitative study we explored the patient/provider relationships of rural HIV-infected women. Thirty-nine women from rural Alabama were recruited to participate in one of four focus groups. The focus groups were audiorecorded, and the participants were asked to complete surveys measuring patient/provider trust. The verbatim-transcribed audio recordings were analyzed using content analysis. The participants' descriptions of their relationships with health care providers were represented by three major thematic categories: caring, informative, and competent. These findings provide a foundation for further research on the role of patient/provider relationships in the health outcomes of HIV disease in rural, resource-poor settings.

Health care system and policy factors influencing engagement in HIV medical care: piecing together the fragments of a fractured health care delivery system.

Grounded in a socio-ecological framework, we describe salient health care system and policy factors that influence engagement in human immunodeficiency virus (HIV) clinical care. The discussion emphasizes successful programs and models of service delivery and highlights the limitations of current, fragmented health care system components in supporting effective, efficient, and sustained patient engagement across a continuum of care. A fundamental need exists for improved synergies between funding and service agencies that provide HIV testing, prevention, treatment, and supportive services. We propose a feedback loop whereby actionable, patient-level surveillance of HIV testing and engagement in care activities inform educational outreach and resource allocation to support integrated "testing and linkage to care plus" service delivery. Ongoing surveillance of programmatic performance in achieving defined benchmarks for linkage of patients who have newly diagnosed HIV infection and retention of those patients in care is imperative to iteratively inform further educational efforts, resource allocation, and refinement of service delivery.

Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool.

BACKGROUND: First articulated by Schwartz and Lellouch (1967), randomized controlled trials (RCTs) can be conceptualized along a continuum from more explanatory to more pragmatic. The purpose and intent of the former is to test interventions under ideal contexts, and the purpose and intent of the latter is to test interventions in real-world contexts. The PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) is a validated tool that helps researchers make decisions about the elements of the trial to match the overall purpose and intent of the trial along the continuum. The PRECIS-2 tool has guided the design of hundreds of RCTs. However, a few aspects of the tool would benefit from greater clarity, including its application to provider-focused implementation trials rather than patient-focused intervention trials. MAIN TEXT: We describe the newly developed PRECIS-2-Provider Strategies (PRECIS-2-PS) tool, an extension of the PRECIS-2 tool, which has been adapted for trials testing provider-focused strategies. We elaborate on nine domains that can make a provider-focused trial more explanatory or more pragmatic, including eligibility, recruitment, setting, implementation resources, flexibility of provider strategies, flexibility of intervention, data collection, primary outcome, and primary analysis. We detail the complementary roles that researchers and stakeholders play in the trial design phase, with implications for generalizability of trial results to the contexts in which they are intended to be applied. CONCLUSIONS: The PRECIS-2-PS tool is designed to help research and practice teams plan for provider-focused trials that reflect the overall intent and purpose of the trial. The tool has potential to help advance the science of provider-focused strategies across a range of trials, with the ultimate goal of facilitating the adoption, integration, and sustainability of provider-focused strategies outside the context of trials.

Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States.

Importance: Representative enrollment in clinical trials is critical to ensure equitable and effective translation of research to practice, yet disparities in clinical trial enrollment persist. Objective: To examine person-level factors associated with invitation to and participation in clinical trials. Design, Setting, and Participants: This cross-sectional study analyzed responses from 3689 US adults who participated in the nationally representative Health Information National Trends Survey, collected February through June 2020 via mailed questionnaires. Exposures: Demographic, clinical, and health behavior-related characteristics. Main Outcomes and Measures: History of invitation to and participation in a clinical trial, primary information sources, trust in information sources, and motives for participation in clinical trials were described. Respondent characteristics are presented as absolute numbers and weighted percentages. Associations between respondent demographic, clinical, and health behavior-related characteristics and clinical trial invitation and participation were estimated using survey-weighted logistic regression models. Results: The median (IQR) age of the 3689 respondents was 48 (33-61) years, and most were non-Hispanic White individuals (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]). Overall, 439 respondents (9%) had been invited to participate in any clinical trial. Respondents with increased odds of invitation were non-Hispanic Black compared with non-Hispanic White (adjusted odds ratio [aOR], 1.85; 95% CI, 1.13-3.02), had greater than a high school education compared with less than high school education (eg, ≥college degree: aOR, 4.84; 95% CI, 1.89-12.39), were single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and had at least 1 medical condition compared to none (eg, 1 medical condition: aOR, 2.25; 95% CI, 1.32-3.82). Respondents residing in rural vs urban areas had 77% decreased odds of invitation to a clinical trial (aOR 0.33; 95% CI 0.17-0.65). Of invited respondents, 199 (47%) participated. Compared with non-Hispanic White respondents, non-Hispanic Black respondents had 72% decreased odds of clinical trial participation (aOR, 0.28; 95% CI, 0.09-0.87). Respondents most frequently reported "health care providers" as the first and most trusted source of clinical trial information (first source: 2297 [59%]; most trusted source: 2597 [70%]). The most frequently reported motives for clinical trials participation were "wanting to get better" (2294 [66%]) and the standard of care not being covered by insurance (1448 [41%]). Conclusions and Relevance: The findings of this study suggest that invitation to and participation in clinical trials may differ by person-level demographic and clinical characteristics. Strategies toward increasing trial invitation and participation rates across diverse patient populations warrant further research to ensure equitable translation of clinical benefits from research to practice.

DeImplementing Ineffective and Low-Value Clinical Practices: Research and Practice Opportunities in Community Oncology Settings.

Patients, practitioners, and policy makers are increasingly concerned about the delivery of ineffective or low-value clinical practices in cancer care settings. Research is needed on how to effectively deimplement these types of practices from cancer care. In this commentary, we spotlight the National Cancer Institute Community Oncology Research Program (NCORP), a national network of community oncology practices, and elaborate on how it is an ideal infrastructure for conducting rigorous, real-world research on deimplementation. We describe key multilevel issues that affect deimplementation and also serve as a guidepost for developing strategies to drive deimplementation. We describe optimal study designs for testing deimplementation strategies and elaborate on how and why the NCORP network is uniquely positioned to conduct rigorous and impactful deimplementation trials. The number and diversity of affiliated community oncology care sites, coupled with the overall objective of improving cancer care delivery, make the NCORP an opportune infrastructure for advancing deimplementation research while simultaneously improving the care of millions of cancer patients nationwide.

A scoping review of de-implementation frameworks and models.

BACKGROUND: Reduction or elimination of inappropriate, ineffective, or potentially harmful healthcare services and public health programs can help to ensure limited resources are used effectively. Frameworks and models (FM) are valuable tools in conceptualizing and guiding the study of de-implementation. This scoping review sought to identify and characterize FM that can be used to study de-implementation as a phenomenon and identify gaps in the literature to inform future model development and application for research. METHODS: We searched nine databases and eleven journals from a broad array of disciplines (e.g., healthcare, public health, public policy) for de-implementation studies published between 1990 and June 2020. Two raters independently screened titles and abstracts, and then a pair of raters screened all full text records. We extracted information related to setting, discipline, study design, methodology, and FM characteristics from included studies. RESULTS: The final search yielded 1860 records, from which we screened 126 full text records. We extracted data from 27 articles containing 27 unique FM. Most FM (n = 21) were applicable to two or more levels of the Socio-Ecological Framework, and most commonly assessed constructs were at the organization level (n = 18). Most FM (n = 18) depicted a linear relationship between constructs, few depicted a more complex structure, such as a nested or cyclical relationship. Thirteen studies applied FM in empirical investigations of de-implementation, while 14 articles were commentary or review papers that included FM. CONCLUSION: De-implementation is a process studied in a broad array of disciplines, yet implementation science has thus far been limited in the integration of learnings from other fields. This review offers an overview of visual representations of FM that implementation researchers and practitioners can use to inform their work. Additional work is needed to test and refine existing FM and to determine the extent to which FM developed in one setting or for a particular topic can be applied to other contexts. Given the extensive availability of FM in implementation science, we suggest researchers build from existing FM rather than recreating novel FM. REGISTRATION: Not registered.

Information-motivation-behavioral skills barriers associated with intentional versus unintentional ARV non-adherence behavior among HIV+ patients in clinical care.

Since the arrival of antiretroviral (ARV) therapy, HIV has become better characterized as a chronic disease rather than a terminal illness, depending in part on one's ability to maintain relatively high levels of adherence. Despite research concerning barriers and facilitators of ARV adherence behavior, relatively little is known about specific challenges faced by HIV-positive persons who report "taking a break" from their ARV medications. The present study employed the Information-Motivation-Behavioral Skills Model of ARV adherence as a framework for understanding adherence-related barriers that may differentiate between non-adherent patients who report "taking a break" versus those who do not report "taking a break" from their ARV medications. A sample of 327 HIV-positive patients who reported less than 100% adherence at study baseline provided data for this research. Participants who reported "taking a break" from their HIV medications without first talking to their healthcare provider were classified as intentionally non-adherent, while those who did not report "taking a break" without first talking with their healthcare provider were classified as unintentionally non-adherent. Analyses examined differences between intentionally versus unintentionally non-adherent patients with respect to demographic characteristics and responses to the adherence-related information, motivation, and behavioral skills questionnaire items. Few differences were observed among the groups on demographics, adherence-related information, or adherence-related motivation; however, significant differences were observed on about half of the adherence-related behavioral skills items. Implications for future research, as well as the design of specific intervention components to reduce intentionally non-adherent behavior, are discussed.

Unpacking the complexities of de-implementing inappropriate health interventions.

De-implementing inappropriate health interventions is essential for minimizing patient harm, maximizing efficient use of resources, and improving population health. Research on de-implementation has expanded in recent years as it cuts across types of interventions, patient populations, health conditions, and delivery settings. This commentary explores unique aspects of de-implementing inappropriate interventions that differentiate it from implementing evidence-based interventions, including multi-level factors, types of action, strategies for de-implementation, outcomes, and unintended negative consequences. We highlight opportunities to continue to advance research on the de-implementation of inappropriate interventions in health care and public health.

An agenda for advancing the science of implementation of evidence-based HIV prevention interventions.

In the past 25 years, a tremendous amount of time and resources have been committed to developing evidence-based HIV prevention interventions. More recently, there have been noteworthy efforts to develop an infrastructure and related policies to promote the dissemination (i.e., "the targeted distribution of information and intervention materials to a specific public health or clinical practice audience") of evidence-based interventions. Despite these advances, however, we have had comparatively little success in the effective implementation (i.e., "the use of strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings") of such interventions in everyday practice or community settings. The objective of the current paper is to highlight select and initial areas of research that are critically needed to advance the state-of-the-science of implementation of HIV prevention interventions in our broader efforts to curb the epidemic worldwide.