Development and Implementation of a Combined Nurse Care Manager and Community Health Worker Training Curriculum to Address Hypertension Disparities.

The use of nurse care managers (CMs) and community health workers (CHWs) has demonstrated effectiveness in supporting improved blood pressure management among racially, ethnically, and socioeconomically minoritized populations. We partnered with a community advisory board (CAB) to develop a CM and CHW training curriculum and team-based collaborative care intervention to address uncontrolled hypertension. The objective of this study was to train CMs and CHWs to implement patient-centered techniques and address social determinants of health related to hypertension control. In partnership with a CAB, we developed and implemented a training curriculum for the CM/CHW collaborative care team. The training improved CM and CHW confidence in their ability to address medical and nonmedical issues that contribute to uncontrolled hypertension in their patients; however, preexisting norms and beliefs among CMs and CHWs created challenges with teamwork. The training curriculum was feasible and well-received. Additionally, the CMs' and CHWs' reactions provided insights to improve future collaborative care training and teamwork.

The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health-Funded Workshop.

OBJECTIVES: Severe acute brain injury (SABI) from cardiac arrest and traumatic brain injury happens suddenly and unexpectedly, carrying high potential for lifelong disability with substantial prognostic uncertainty. Comprehensive assessments of family experiences and support needs after SABI are lacking. Our objective is to elicit "on-the-ground" perspectives about the experiences and needs of families of patients with SABI. DESIGN: Two-phase qualitative study of families and multidisciplinary U.S. healthcare professionals (mHCPs) with expertise in SABI: Phase 1 included semistructured interviews to generate formative findings; phase 2 entailed facilitated discussions to confirm and expand initial findings. SETTING: Phase 1: academic medical center; phase 2: virtual workshop. SUBJECTS: Phase 1 included seven family members and 12 mHCPs. Phase 2 included nationally recruited stakeholders (17 family members and 12 mHCPs). INTERVENTION: None. MEASUREMENTS AND RESULTS: We explored: 1) what are families' needs in the first 48 hours? 2) How are these needs addressed? and 3) How can hospitals better meet these needs? Qualitative analysis included inductive and deductive approaches guided by a conceptual ecological model. Four major needs were identified: 1) challenges in coping with uncertainty in early prognostication, 2) inattention to physical needs of family, 3) deficits in compassionate and consistent communication, and 4) need for engagement with families as stakeholders in improving future practices. Participants' recommendations included: 1) ways to communicate more clearly and consistently, 2) better assistance with navigating resources and access to places for families to care for themselves, and 3) opportunities for families to remain connected with their loved ones, social support networks, and the clinical team. CONCLUSIONS: Stakeholders identified novel insights regarding families' experiences during the hospitalization of comatose SABI patients and factors that can contribute to improved decision-making and physical/emotional outcomes. Interventions to address these unmet needs are promising targets to improve outcomes.

Healthcare Leadership Perspectives on Supporting Frontline Workers in Health Center Settings during the Pandemic.

Throughout the COVID-19 pandemic much attention has been given to addressing the needs of hospital-based healthcare professionals delivering critical inpatient care. At the same time, other groups of essential frontline healthcare workers have continued to serve low-income and underserved populations whose healthcare and nonmedical needs did not cease, and in many cases were exacerbated by factors associated with the pandemic shutdown. As these same factors also potentially impacted well-being and effectiveness of frontline healthcare workers, we sought to understand the organizational-level responses to the pandemic, including the support and preparation for frontline workers. As part of a larger study focused on reducing health disparities in hypertension, we conducted semi-structured individual interviews with 14 leaders from healthcare and health services organizations to explore how these organizations responded to accommodate frontline workers' needs. Findings from our sample show that healthcare and health service organizations made a range of major and timely modifications to clinic operations intended to address the needs of both employees and patients and strove to ensure continued patient services as much as possible. Nevertheless, our findings underscore the need for more attention and resources to support healthcare workers in primary care settings especially during emergencies such as COVID-19.

Is this study feasible? Facilitating management of pragmatic trial planning milestones under a phased award funding mechanism.

BACKGROUND: Improving efficiencies in clinical research is crucial to translation of findings into practice and delivery of effective, patient-centered health care. This paper describes a project that monitored pragmatic clinical trials by working with investigators to track achievement of early phase milestones. The National Institutes of Health (NIH) Pragmatic Trials Collaborative Project supported scientifically diverse, low-cost, randomized, controlled, pragmatic clinical intervention trials. Funds were available through a cooperative agreement award mechanism, with the initial phase supporting trial planning and the subsequent 4-year awards funding trial implementation. A coordinating center provided evaluation and administrative support, which included capturing progress toward achieving milestones. METHODS: Six funded trials participated in monthly calls throughout the first year to identify and demonstrate metrics and deliverables for each milestone in the Notice of Grant Award. Interviews were conducted with investigators, trial team members, and NIH program officers/project scientists to discuss their perceptions of the impact and value of the management strategy. RESULTS: Five of six trials transitioned to the implementation phase with milestones ranging from 6 to 15 and quantifiable metrics ranging from 15 to 33, for a total of 121 deliverables. One third of the metrics (42, 35%) were trial-specific. Trial teams reported that the oversight was onerous but complemented their management strategies; program officers/project scientists found that documentation submitted for review was sufficient to assess trial feasibility; and investigators reported advantages to the phased award mechanism, such as leverage to secure commitments from stakeholders and collaborators, help with task prioritization, and earlier consultation with key members of the trial team. CONCLUSIONS: Implementing systematic approaches to identify milestones and track metrics can strengthen the evidence base regarding time and effort to plan and conduct pragmatic clinical trials. Investigators were unaccustomed to producing evidence of performance, and it was challenging to determine what documentation to provide. Efforts to standardize expectations regarding milestones that mark a significant change or stage in trial development or that represent minimum success criteria may provide guidance for more effective and efficient trial management. A framework with clearly specified metrics is especially critical for transparency, particularly when funding decisions are contingent on both merit and feasibility.

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains.

BACKGROUND: There continues to be debate about what constitutes a pragmatic trial and how it is distinguished from more traditional explanatory trials. The NIH Pragmatic Trials Collaborative Project, which includes five trials and a coordinating unit, has adopted the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) instrument. The purpose of the study was to collect PRECIS-2 ratings at two points in time to assess whether the tool was sensitive to change in trial design, and to explore with investigators the rationale for rating shifts. METHODS: A mixed-methods design included sequential collection and analysis of quantitative data (PRECIS-2 ratings) and qualitative data. Ratings were collected at two annual, in-person project meetings, and subsequent interviews conducted with investigators were recorded, transcribed, and coded using NVivo 11 Pro for Windows. Rating shifts were coded as either (1) actual change (reflects a change in procedure or protocol), (2) primarily a rating shift reflecting rater variability, or (3) themes that reflect important concepts about the tool and/or pragmatic trial design. RESULTS: Based on PRECIS-2 ratings, each trial was highly pragmatic at the planning phase and remained so 1 year later in the early phases of trial implementation. Over half of the 45 paired ratings for the nine PRECIS-2 domains indicated a rating change from Time 1 to Time 2 (N = 24, 53%). Of the 24 rating changes, only three represented a true change in the design of the trial. Analysis of rationales for rating shifts identified critical themes associated with the tool or pragmatic trial design more generally. Each trial contributed one or more relevant comments, with Eligibility, Flexibility of Adherence, and Follow-up each accounting for more than one. CONCLUSIONS: PRECIS-2 has proved useful for "framing the conversation" about trial design among members of the Pragmatic Trials Collaborative Project. Our findings suggest that design elements assessed by the PRECIS-2 tool may represent mostly stable decisions. Overall, there has been a positive response to using PRECIS-2 to guide conversations around trial design, and the project's focus on the use of the tool by this group of early adopters has provided valuable feedback to inform future trainings on the tool.

Bridging the divide: building infrastructure to support community-academic partnerships and improve capacity to conduct patient-centered outcomes research.

For research to be useful, trustworthy, and ultimately lead to greater dissemination of findings to patients and communities, it is important to train and mentor academic researchers to meaningfully engage community members in patient-centered outcomes research (PCOR). Thus, it is necessary for research institutions to strengthen their underlying infrastructure to support PCOR. PATIENTS-PATient-centered Involvement in Evaluating effectiveNess of TreatmentS-at the University of Maryland, Baltimore, focuses on improving PCOR methods and addressing health disparities. It relies on evidence-based engagement methods to sustain and leverage innovative partnerships so patients, health care providers, and academic partners are motivated to participate in the conduct and dissemination of PCOR. Program components address training needs, bi-directional engagement, cultural competency, and dissemination and implementation. Activities (guided by community representatives, leadership from university schools, patient advocates, and PCOR experts) include providing resources, conducting PCOR projects, engaging community members, and disseminating PCOR findings. With its emphasis on the broad range of PCOR topics and methods, and through fostering sustainable relationships with community members and researchers, PATIENTS has successfully cultivated bi-directional partnerships and provided operational and scientific support for a new generation of skilled PCOR researchers. Early evidence of effectiveness includes progress in training and mentoring students and investigators, an increase in submission of PCOR proposals, and community-informed strategies for dissemination. Programs such as PATIENTS reinforce the value of bridging the traditional divide between academia and communities to support patient- and community-engaged dissemination and implementation research and foster sustainable PCOR infrastructure.

Local Learning Collaboratives to Improve Quality for Chronic Kidney Disease (CKD): From Four Regional Practice-based Research Networks (PBRNs).

BACKGROUND: Four practice-based research networks (PBRNs) participated in a project to increase the diffusion of evidence-based treatment guidelines for chronic kidney disease (CKD). A multicomponent organizational intervention engaged regionally proximal primary care practices in a series of facilitated meetings, referred to as local learning collaboratives (LLCs). METHODS: The 2-wave strategy began with 8 practices in each PBRN receiving practice facilitation and subsequently joining an LLC. A sequential mixed-methods design addressed the conduct, content, and fidelity of the intervention; clinicians in 2 PBRNs participated in interviews, and PBRN coordinators reflected on implementation challenges. RESULTS: LLCs were formed in 3 PBRNs, with 121 monthly meetings held across 20 LLCs. Slightly more than half of the participants were clinicians. Qualitative data suggest that clinicians increased the priority for CKD care, improved knowledge and skills, were satisfied with the project, and attempted to improve care. Implementation challenges were encountered and concerns about sustainability expressed. CONCLUSION: While PBRNs can successfully leverage resources to diffuse treatment guidelines, and LLCs are well-accepted by clinical staff, the formation of LLCs was not feasible for 1 PBRN, and others struggled to meet regularly and have performance data available despite logistic support.

Leveraging practice-based research networks to accelerate implementation and diffusion of chronic kidney disease guidelines in primary care practices: a prospective cohort study.

BACKGROUND: Four practice-based research networks (PBRNs) participated in a study to determine whether networks could increase dissemination, implementation, and diffusion of evidence-based treatment guidelines for chronic kidney disease by leveraging early adopter practices. METHODS: Motivated practices from four PBRNs received baseline and periodic performance feedback, academic detailing, and weekly practice facilitation for 6 months during wave I of the study. Each wave I practice then recruited two additional practices (wave II), which received performance feedback and academic detailing and participated in monthly local learning collaboratives led by the wave I clinicians. They received only monthly practice facilitation. The primary outcomes were adherence to primary care-relevant process-of-care recommendations from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative Guidelines. Performance was determined retrospectively by medical records abstraction. Practice priority, change capacity, and care process content were measured before and after the interventions. RESULTS: Following the intervention, wave I practices increased the use of ACEIs/ARBs, discontinuation of NSAIDs, testing for anemia, and testing and/or treatment for vitamin D deficiency. Most were able to recruit two additional practices for wave II, and wave II practices also increased their use of ACEIs/ARBs and testing and/or treatment of vitamin D deficiency. CONCLUSIONS: With some assistance, early adopter practices can facilitate the diffusion of evidence-based approaches to other practices. PBRNs are well-positioned to replicate this process for other evidence-based innovations.

Implementing asthma guidelines using practice facilitation and local learning collaboratives: a randomized controlled trial.

PURPOSE: Guideline implementation in primary care has proven difficult. Although external assistance through performance feedback, academic detailing, practice facilitation (PF), and learning collaboratives seems to help, the best combination of interventions has not been determined. METHODS: In a cluster randomized trial, we compared the independent and combined effectiveness of PF and local learning collaboratives (LLCs), combined with performance feedback and academic detailing, with performance feedback and academic detailing alone on implementation of the National Heart, Lung and Blood Institute's Asthma Guidelines. The study was conducted in 3 primary care practice-based research networks. Medical records of patients with asthma seen during pre- and postintervention periods were abstracted to determine adherence to 6 guideline recommendations. McNemar's test and multivariate modeling were used to evaluate the impact of the interventions. RESULTS: Across 43 practices, 1,016 patients met inclusion criteria. Overall, adherence to all 6 recommendations increased (P ≤.002). Examination of improvement by study arm in unadjusted analyses showed that practices in the control arm significantly improved adherence to 2 of 6 recommendations, whereas practices in the PF arm improved in 3, practices in the LLCs improved in 4, and practices in the PF + LLC arm improved in 5 of 6 recommendations. In multivariate modeling, PF practices significantly improved assessment of asthma severity (odds ratio [OR] = 2.5, 95% CI, 1.7-3.8) and assessment of asthma level of control (OR = 2.3, 95% CI, 1.5-3.5) compared with control practices. Practices assigned to LLCs did not improve significantly more than control practices for any recommendation. CONCLUSIONS: Addition of PF to performance feedback and academic detailing was helpful to practices attempting to improve adherence to asthma guidelines.

A mixed-methods study of research dissemination across practice-based research networks.

Practice-based research networks may be expanding beyond research into rapid learning systems. This mixed-methods study uses Agency for Healthcare Research and Quality registry data to identify networks currently engaged in dissemination of research findings and to select a sample to participate in qualitative semistructured interviews. An adapted Diffusion of Innovations framework was used to organize concepts by characteristics of networks, dissemination activities, and mechanisms for rapid learning. Six regional networks provided detailed information about dissemination strategies, organizational context, role of practice-based research network, member involvement, and practice incentives. Strategies compatible with current practices and learning innovations that generate observable improvements may increase effectiveness of rapid learning approaches.

Supporting better science in primary care: a description of practice-based research networks (PBRNs) in 2011.

BACKGROUND: Bound by a shared commitment to improving medical care through systematic inquiry, practice-based research networks (PBRNs) provide a basic laboratory for primary care research and dissemination. METHODS: Data from US primary care PBRNs were collected as part of the 2011 Agency for Healthcare Research and Quality PBRN registration process. Data addressed PBRN characteristics, research activities, and perceived strengths and weaknesses. RESULTS: One hundred forty-three primary care PBRNs were registered with the resource center in 2011, including 131 that were identified as either eligible for Agency for Healthcare Research and Quality recognition (n = 121) or as developing (n = 10). These PBRNs included 12,981 practices with more than 63,000 individual members providing care to approximately 47.5 million people. PBRNs had an average of 482 individual members (median, 170) from 101 practices (median, 32). CONCLUSIONS: PBRNs are growing in experience and research capacity. With member practices serving approximately 15% of the US population, PBRNs are adopting more advanced study designs, disseminating and implementing practice change, and participating in clinical trials. PBRNs provide valuable capacity for investigating questions of importance to clinical practice, disseminating results, and implementing evidence-based strategies. PBRNs are well positioned to support the emerging public health role of primary care providers and provide an essential component of a learning health care system.

Coordinating centers and multi-practice-based research network (PBRN) research.

Practice-based research networks (PBRNs) have emerged as laboratories in which to address important primary care challenges. In 2011, the Agency for Healthcare Research and Quality's PBRN database included more than 130 networks, most regional and some national, with member practices in every state. Regional networks may have certain advantages over national networks with respect to practice recruitment and project quality control because of closer relationships and shorter distances. However, national networks often can achieve larger numbers of practices with greater diversity, resulting in broader generalizability of results. Increasingly, regional networks are collaborating on multinetwork projects, but this creates significant study coordination challenges. A potential solution is to incorporate PBRN coordinating centers similar to those used in many National Institutes of Health and industry-sponsored multi-center clinical trials. In this article, we discuss the potential functions of a coordinating center in multi-region PBRN studies based on our experience with 2 recent studies.

Designing effective HIV/AIDS social and behavioral interventions for the population of those age 50 and older.

Social and behavioral HIV/AIDS prevention interventions designed to test their effects on older cohorts are sorely lacking in the scientific literature even though middle-aged and older people represent a significant minority of both existing and new AIDS cases. This article raises key issues relevant in developing and evaluating HIV/AIDS social and behavioral interventions for older cohorts. These interventions must build on our current understanding of behavior change and HIV prevention successes with younger populations while considering important intervention principles gathered from work with older populations in other health arenas. In addition, the authors expand on recent national panels and published reviews relevant to the topic and provide a set of intervention recommendations for use in tandem with these intervention principles. The article also calls for additional research into the sociocultural contexts that influence risk-taking among older cohorts and for the development of interventions at multiple levels. Pragmatic considerations such as identifying and dismantling ageism in interventions, delineating intervention outcomes, and planning for intervention transferability, dissemination, and sustainability also are raised.

A profile of U.S.-based trials of behavioral and social interventions for HIV risk reduction.

We describe 99 (experimental and certain quasi-experimental) U.S.-based trials, reported or published since 1988, of behavioral and social interventions that measured prespecified behavioral and biologic outcomes and aimed to reduce risk for HIV infection. Studies identified through June 1998 by the HIV/AIDS Prevention Research Synthesis project were grouped into 4 risk behavior areas: drug-related (k [number of studies] = 48), heterosexual youth (k = 24), heterosexual adult (k = 17), and same-sex (k = 10). We compared the studies in the 4 areas by variables key to the development, evaluation, and transfer of interventions. Participants comprised injection drug users (43% of studies), drug users out of treatment (29%), African Americans (18%), clinic patients (18%), youth in schools (10%), and drug users in treatment (10%). Most studies were randomized (85%), provided another intervention to the control or comparison groups (71%), and evaluated behavioral interventions (92%). On average, interventions were conducted in 5 sessions (total, 8 hours) during 3 months. The theoretical basis of the intervention was not noted in 57% of the reports. At least one variable from each of the 3 outcome classifications was measured in 8% of the studies: behavioral, biologic, and psychosocial. Distinct profiles exist for the 4 risk areas. Addressing gaps in research and reporting would be helpful for analytical and program activities. This sizable portfolio of evaluated interventions contributes to effectiveness reviews and to considerations of transfer to program practice.

Recruitment of older participants in frailty/injury prevention studies.

Despite the lifelong health benefits of physical activity, frailer older adults have typically been excluded from studies promoting more active lifestyles. This study documents the recruitment process and costs from a multisite study to identify effective strategies for recruiting older adults in frailty/injury prevention research. Randomized controlled clinical trials were conducted at 7 sites; an 8th site was a compliance study. Interventions reflected center- and home-based health promotion programs. Site objectives, eligibility criteria, and contact and screening methods were obtained from manuals of operation. Recruitment results (number screened, eligibility rates, randomized to screened ratios) were ascertained from recruitment data. Sites furnished estimated recruitment costs (nonlabor expenses, investigator and staff time, fringe benefits) up to signing the consent form. The sites targeted diverse populations and sample sizes. The majority revised recruitment methods to meet their recruitment goals. Most sites estimated costs of recruitment at over $300 per participant randomized. Recruitment costs were affected by staff time spent alleviating concerns about participants' health, essential interactions with family members, and arranging for transportation. Neither frailty nor intervention intensity was found to be a major predictor of recruitment outcomes. Recruitment expense was associated with selection criteria and frailty status of the target population. Older people can be successfully recruited into beneficial health promotion programs, but it is often challenging. In planning health promotion studies, investigators need to be aware of the numbers of older people they may need to screen and different strategies for increasing recruitment success.