Practice Facilitation and Clinical Performance Feedback Using the Electronic Health Record Improved Blood Pressure and Cholesterol Management in Small Primary Care Practices in New York City.

Cardiovascular disease (CVD) disproportionately affects people of color and those with lower household income. Improving blood pressure (BP) and cholesterol management for those with or at risk for CVD can improve health outcomes. The New York City Department of Health implemented clinical performance feedback with practice facilitation (PF) in 134 small primary care practices serving on average over 84% persons of color. Facilitators reviewed BP and cholesterol management data on performance dashboards and guided practices to identify and outreach to patients with suboptimal BP and cholesterol management. Despite disruptions from the COVID-19 pandemic, practices demonstrated significant improvements in BP (68%-75%, P < .001) and cholesterol management (72%-78%, P = .01). Prioritizing high-need neighborhoods for impactful resource investment, such as PF and data sharing, may be a promising approach to reducing CVD and hypertension inequities in areas heavily impacted by structural racism.

Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial.

BACKGROUND: There are well-established guidelines for treating hypertension (HTN), yet only half of patients with HTN meet the defined target of < 140/90. Team-based care (TBC) is an evidence-based strategy for improving blood pressure (BP) management and control. TBC is defined as the provision of health services by at least two health professionals "who work collaboratively with patients and their caregivers to accomplish shared goals to achieve coordinated, high-quality care". However, primary care practices experience challenges to implementing TBC principles and care processes; these are more pronounced in small independent practice settings (SIPs). Practice facilitation (PF) is an implementation strategy that may overcome barriers to adopting evidence-based TBC to improve HTN management in SIPs. METHODS: Using a stepped wedge randomized controlled trial design, we will test the effect of PF on the adoption of TBC to improve HTN management in small practices (< 5 FTE clinicians) in New York City, and the impact on BP control compared with usual care. We will enroll 90 SIPs and randomize them into one of three 12-month intervention waves. Practice facilitators will support SIPs to adopt TBC principles to improve implementation of five HTN management strategies (i.e., panel management, population health, measuring BP, supporting medication adherence, self-management). The primary outcome is the adoption of TBC for HTN management measured at baseline and 12 months. Secondary outcomes include the rate of BP control and sustainability of TBC and BP outcomes at 18 months. Aggregated data on BP measures are collected every 6 months in all clusters so that each cluster provides data points in both the control and intervention conditions. Using a mixed methods approach, we will also explore factors that influence the effectiveness of PF at the organization and team level. DISCUSSION: This study will provide much-needed guidance on how to optimize adoption and sustainability of TBC in independent primary care settings to reduce the burden of disease related to suboptimal BP control and advance understanding of how facilitation works to improve implementation of evidence-based interventions. TRIAL REGISTRATION: ClinicalTrials.gov; NCT05413252 .

How Practice Facilitation Strategies Differ by Practice Context.

BACKGROUND: Practice facilitation is an implementation strategy used to build practice capacity and support practice changes to improve health care outcomes. Yet, few studies have investigated how practice facilitation strategies are tailored to different primary care contexts. OBJECTIVE: To identify contextual factors that drive facilitators' strategies to meet practice improvement goals, and how these strategies are tailored to practice context. DESIGN: Semi-structured, qualitative interviews analyzed using inductive (open coding) and deductive (thematic) approaches. This study was conducted as part of a larger study, HealthyHearts New York City, which evaluated the impact of practice facilitation on adoption of cardiovascular disease prevention and treatment guidelines. PARTICIPANTS: 15 facilitators working in two practice contexts: small independent practices (SIPs) and Federally Qualified Health Centers (FQHCs). MAIN MEASURES: Strategies facilitators use to support and promote practice changes and contextual factors that impact this approach. KEY RESULTS: Contextual factors were described similarly across settings and included the policy environment, patient needs, site characteristics, leadership engagement, and competing priorities. We identified four facilitation strategies used to tailor to contextual factors and support practice change: (a) remain flexible to align with practice and organizational priorities; (b) build relationships; (c) provide value through information technology expertise; and (d) build capacity and create efficiencies. Facilitators in SIPs and FQHCs described using the same strategies, often in combination, but tailored to their specific contexts. CONCLUSIONS: Despite significant infrastructure and resource differences between SIPs and FQHCs, the contextual factors that influenced the facilitator's change process and the strategies used to address those factors were remarkably similar. The findings emphasize that facilitators require multidisciplinary skills to support sustainable practice improvement in the context of varying complex health care delivery settings.

Outcomes of New York City Care Calls: A Prospective Randomized Controlled Effectiveness Trial of Telephone-Delivered Type 2 Diabetes Self-Management Support.

PURPOSE: The purpose of the 12-month randomized controlled trial was to evaluate the effectiveness of a Telephonic Self-Management Support (T-SMS) program among adults with type 2 diabetes (T2D). METHODS: Eight hundred twelve adults with T2D participated in NYC Care Calls (mean age = 59.2, SD = 10.8; female = 57%; mean A1C = 9.3, SD = 1.8; Latino = 86%) and were randomly assigned to T-SMS or enhanced usual care (EUC). A1C (primary outcome), blood pressure, and body mass index (secondary outcomes) were extracted from electronic medical records. Secondary patient-reported outcomes, including depressive symptoms, diabetes distress, medication adherence, and self-management activities, were assessed by telephone in English or Spanish. For T-SMS, the number of assigned phone calls was based on baseline A1C, depressive symptoms, and/or diabetes distress. Analyses were conducted under the intention-to-treat principle. RESULTS: A1C decreased over 12 months in both T-SMS (0.72% percentage points; 95% CI, 0.53-0.91) and EUC (0.66% percentage points; 95% CI, 0.46-0.85; Ps < .001). Diabetes distress and self-management also improved over time in both arms (Ps < .05). Compared to EUC, participants in the T-SMS arm did not differ in outcomes. CONCLUSIONS: The T-SMS and EUC groups were found not to have an appreciable outcome difference. It is unclear whether improvements in A1C across both conditions represent a secular trend or indicate that print-based educational intervention may have a positive impact on self-management and well-being.

Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial.

BACKGROUND: Only half of patients with hypertension have adequately controlled blood pressure. Clinical decision support (CDS) has the potential to overcome barriers to delivering guideline-recommended care and improve hypertension management. However, optimal strategies for scaling CDS have not been well established, particularly in small, independent primary care practices which often lack the resources to effectively change practice routines. Practice facilitation is an implementation strategy that has been shown to support process changes. Our objective is to evaluate whether practice facilitation provided with hypertension-focused CDS can lead to improvements in blood pressure control for patients seen in small primary care practices. METHODS/DESIGN: We will conduct a cluster randomized control trial to compare the effect of hypertension-focused CDS plus practice facilitation on BP control, as compared to CDS alone. The practice facilitation intervention will include an initial training in the CDS and a review of current guidelines along with follow-up for coaching and integration support. We will randomize 46 small primary care practices in New York City who use the same electronic health record vendor to intervention or control. All patients with hypertension seen at these practices will be included in the evaluation. We will also assess implementation of CDS in all practices and practice facilitation in the intervention group. DISCUSSION: The results of this study will inform optimal implementation of CDS into small primary care practices, where much of care delivery occurs in the U.S. Additionally, our assessment of barriers and facilitators to implementation will support future scaling of the intervention. CLINICALTRIALS: gov Identifier: NCT05588466.

Diabetes-Related Quality of Life: Learning From Individuals Making Lifestyle Changes to Improve Type 2 Diabetes Control.

PURPOSE: The purpose of this study was to explore how treatment adherence and lifestyle changes required for glycemic control in type 2 diabetes (T2D) are related to quality of life (QoL) among predominantly ethnic minority and socioeconomically disadvantaged adults engaged in making changes to improve T2D self-management. METHODS: Adults with T2D in New York City were recruited for the parent study based on recent A1C (≥7.5%) and randomly assigned to 1 of 2 arms, receiving educational materials and additional self-management support calls, respectively. Substudy participants were recruited from both arms after study completion. Participants (N = 50; 62% Spanish speaking) were interviewed by phone using a semistructured guide and were asked to define QoL and share ways that T2D, treatment, self-management, and study participation influenced their QoL. Interviews were analyzed using thematic analysis. RESULTS: QoL was described as a multidimensional health-related construct with detracting and enhancing factors related to T2D. Detracting factors included financial strain, symptom progression and burden, perceived necessity to change cultural and lifestyle traditions, and dietary and medical limitations. Enhancing factors included social support, diabetes education, health behavior change, sociocultural connection. CONCLUSION: QoL for diverse and socioeconomically disadvantaged adults with T2D is multifaceted and includes aspects of health, independence, social support, culture, and lifestyle, which may not be captured by existing QoL measures. Findings may inform the development of a novel QoL measure for T2D.

Measuring Implementation Strategy Fidelity in HealthyHearts NYC: A Complex Intervention Using Practice Facilitation in Primary Care.

Few studies have assessed the fidelity of practice facilitation (PF) as an implementation strategy, and none have used an a priori definition or conceptual framework of fidelity to guide fidelity assessment. The authors adapted the Conceptual Framework for Implementation Fidelity to guide fidelity assessment in HealthyHearts NYC, an intervention that used PF to improve adoption of cardiovascular disease evidence-based guidelines in primary care practices. Data from a web-based tracking system of 257 practices measured fidelity using 4 categories: frequency, duration, content, and coverage. Almost all (94.2%) practices received at least the required 13 PF visits. Facilitators spent on average 26.3 hours at each site. Most practices (95.7%) completed all Task List items, and 71.2% were educated on all Chronic Care Model strategies. The majority (65.8%) received full coverage. This study provides a model that practice managers and implementers can use to evaluate fidelity of PF, and potentially other implementation strategies.

Using a Customer Relationship Management System to Manage a Quality Improvement Intervention.

HealthyHearts New York City (HHNYC), one of 7 cooperatives funded through the Agency for Healthcare Research and Quality's EvidenceNOW initiative, evaluated the impact of practice facilitation on implementation of the Million Hearts guidelines for cardiovascular disease prevention and treatment. Tracking the intervention required a system to facilitate process data collection that was also user-friendly and flexible. Coupled with protocols and training, a strategically planned and customizable customer relationship management system (CRMS) was implemented to support the quality improvement intervention with 257 small independent practices. Features of the CRMS and implementation protocols were customized to optimize program management, practice facilitation tracking and supervision, and data collection for performance feedback to practices and research. The CRMS was a valuable tool for tracking and managing the intervention systematically. Successful implementation of the HHNYC protocol also required an articulated implementation plan and adoption process.

A practice facilitation-guided intervention in primary care settings to reduce cardiovascular disease risk: a cost analysis.

BACKGROUND: A stepped-wedge, cluster randomized controlled trial assessed the effectiveness of practice facilitation (PF) for adoption of guidelines for prevention and treatment of cardiovascular disease risk factors. This study estimated the associated cost of PF for guideline adoption in small, private primary care practices. METHODS: The cost analysis included categories for start-up costs, intervention costs, and practice staff costs for the implemented PF-guided intervention. We estimated the total 1-year costs to operate the program and calculated the mean and range of the cost-per-practice by quarter of the intervention. We estimated the lower and upper bounds for all salary expenses, rounding to the nearest $100. RESULTS: Total 1-year intervention costs for all 261 practices ranged from $7,900,000 to $10,200,000, with program and practice salaries comprising $6,600,000-$8,400,000 of the total. Start-up costs were a small proportion (3%) of the total 1-year costs. Excluding start-up costs, quarter 1 cost-per-practice was the most expensive at $20,400-$26,700, and quarter 4 was the least expensive at about $10,000. Practice staff time (compared with program staff time) was the majority of the staffing costs at 75-84%. CONCLUSIONS: The PF strategy costs approximately $10,000 per practice per quarter for program and practice costs, once implemented and running at highest efficiency. Whether this program is "worth it" to the decision-maker depends on the relative costs and effectiveness of their other options for improving cardiovascular risk reduction. TRIAL REGISTRATION: This study is retrospectively registered on January 5, 2016, at www.clinicaltrials.gov as NCT02646488 .

Barriers and Facilitators in the Recruitment and Retention of More Than 250 Small Independent Primary Care Practices for EvidenceNOW.

Few studies have examined factors that facilitate recruitment of small independent practices (SIPs) (<5 full-time clinicians) to participate in research and methods for optimizing retention. The authors analyzed qualitative data (eg, recruiter's field notes and diary entries, provider interviews) to identify barriers and facilitators encountered in recruiting and retaining 257 practices in HealthyHearts New York City (NYC). This study was a stepped-wedge randomized controlled trial that took place 2015 through 2018 across 5 boroughs in NYC. Three main factors facilitated rapid recruitment: (1) a prior well-established relationship with the local health department, (2) alignment of project goals with practice priorities, and (3) providing appropriate monetary incentives. Retention was facilitated through similar mechanisms and an ongoing multifaceted communication strategy. This article identifies specific strategies that enhance recruitment of SIPs and fills gaps in knowledge about factors that influence retention in the context of a design that requires waiting to receive the intervention.

Accounting for Blood Pressure Seasonality Alters Evaluation of Practice-Level Blood Pressure Control Intervention.

BACKGROUND: Despite the large body of literature evaluating interventions to improve hypertension management, few studies have addressed seasonal variation in blood pressure (BP) control. This underreported phenomenon has implications for interpreting study findings and informing clinical care. We share a methodology that accounts for BP seasonality, presented through a case study-HealthyHearts NYC, an intervention aimed at increasing adherence to the Million Hearts BP control evidence-based guidelines in primary care practices. METHODS: We used a randomized stepped-wedge design (n = 257 practices). Each intervention included 13 visits from practice facilitators trained in improving practice-level BP control over 12 months. Two models were used to assess the intervention effect-one that did not account for seasonality (model 1) and one that did (model 2). Model 2 was a re-specification of model 1 to include our proposed two fixed-effects terms to address BP seasonality. RESULTS: Model 1 showed a significant negative association between the intervention and BP control (IRR = 0.98, 95% CI = 0.96-0.99, P ≤ 0.05). In contrast, Model 2, which did address seasonality, showed no intervention effect on BP control (IRR = 0.99, 95% CI = 0.97-1.01, P = 0.19). CONCLUSIONS: These findings reveal that analyses that do not account for BP seasonality may not present an accurate picture of intervention effects. In our case study, accounting for BP seasonality turned a negative association into a null association. We recommend that when evaluating BP control, studies compare outcome measures across similar seasons and that the measurement period last long enough to account for seasonal effects. CLINICAL TRIALS REGISTRATION: Trial registration number: NCT02646488.

Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support.

Although problems with type 2 diabetes (T2D) self-management and treatment adherence often co-occur with emotional distress, few translatable intervention approaches are available that can target these related problems in primary care practice settings. The New York City (NYC) Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes. Participants (N = 812) were randomly assigned to a telephonic intervention condition with a stepped protocol of 6-12 phone calls over 1 year, delivered by a health educator, or to a comparison condition of enhanced usual care. The primary outcome is change in A1C over one year, measured at baseline and again approximately 6- and 12-months later. Secondary outcomes measured on the same schedule include blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors. A comprehensive effectiveness evaluation is guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to gather data that can inform dissemination and implementation of the intervention, if successful. This paper describes the study rationale, trial design, and methodology.

Attributes of High-Performing Small Practices in a Guideline Implementation: A Multiple-Case Study.

OBJECTIVE: HealthyHearts NYC was a stepped wedge randomized control trial that tested the effectiveness of practice facilitation on the adoption of cardiovascular disease guidelines in small primary care practices. The objective of this study was to identify was to identify attributes of small practices that signaled they would perform well in a practice facilitation intervention implementation. METHODS: A mixed methods multiple-case study design was used. Six small practices were selected representing 3 variations in meeting the practice-level benchmark of >70% of hypertensive patients having controlled blood pressure. Inductive and deductive approaches were used to identify themes and assign case ratings. Cross-case rating comparison was used to identify attributes of high performing practices. RESULTS: Our first key finding is that the high-performing and improved practices in our study looked and acted similarly during the intervention implementation. The second key finding is that 3 attributes emerged in our analysis of determinants of high performance in small practices: (1) advanced use of the EHR; (2) dedicated resources and commitment to quality improvement; and (3) actively engaged lead clinician and office manager. CONCLUSIONS: These attributes may be important determinants of high performance, indicating not only a small practice's capability to engage in an intervention but possibly also its readiness to change. We recommend developing tools to assess readiness to change, specifically for small primary care practices, which may help external agents, like practice facilitators, better translate intervention implementations to context.

Cardiovascular Disease Guideline Adherence: An RCT Using Practice Facilitation.

INTRODUCTION: Practice facilitation is a promising practice transformation strategy, but further examination of its effectiveness in improving adoption of guidelines for multiple cardiovascular disease risk factors is needed. The objective of the study is to determine whether practice facilitation is effective in increasing the proportion of patients meeting the Million Hearts ABCS outcomes: (A) aspirin when indicated, (B) blood pressure control, (C) cholesterol management, and (S) smoking screening and cessation intervention. STUDY DESIGN: The study used a stepped-wedge cluster RCT design with 4 intervention waves. Data were extracted for 13 quarters between January 1, 2015 and March 31, 2018, which encompassed the control, intervention, and follow-up periods for all waves, and analyzed in 2019. SETTING/PARTICIPANTS: A total of 257 small independent primary care practices in New York City were randomized into 1 of 4 waves. INTERVENTION: The intervention consisted of practice facilitators conducting at least 13 practice visits over 1 year, focused on capacity building and implementing system and workflow changes to meet cardiovascular disease care guidelines. MAIN OUTCOME MEASURES: The main outcomes were the Million Hearts' ABCS measures. Two additional measures were created: (1) proportion of tobacco users who received a cessation intervention (smokers counseled) and (2) a composite measure that assessed the proportion of patients meeting treatment targets for A, B, and C (ABC composite). RESULTS: The S measure improved when comparing follow-up with the control period (incidence rate ratio=1.152, 95% CI=1.072, 1.238, p<0.001) and when comparing follow-up with intervention (incidence rate ratio=1.060, 95% CI=1.013, 1.109, p=0.007). Smokers counseled improved when comparing the intervention period with control (incidence rate ratio=1.121, 95% CI=1.037, 1.211, p=0.002). CONCLUSIONS: Increasing the impact of practice facilitation programs that target multiple risk factors may require a longer, more intense intervention and greater attention to external policy and practice context. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02646488.

Primary Care Practices' Abilities And Challenges In Using Electronic Health Record Data For Quality Improvement.

Federal value-based payment programs require primary care practices to conduct quality improvement activities, informed by the electronic reports on clinical quality measures that their electronic health records (EHRs) generate. To determine whether EHRs produce reports adequate to the task, we examined survey responses from 1,492 practices across twelve states, supplemented with qualitative data. Meaningful-use participation, which requires the use of a federally certified EHR, was associated with the ability to generate reports-but the reports did not necessarily support quality improvement initiatives. Practices reported numerous challenges in generating adequate reports, such as difficulty manipulating and aligning measurement time frames with quality improvement needs, lack of functionality for generating reports on electronic clinical quality measures at different levels, discordance between clinical guidelines and measures available in reports, questionable data quality, and vendors that were unreceptive to changing EHR configuration beyond federal requirements. The current state of EHR measurement functionality may be insufficient to support federal initiatives that tie payment to clinical quality measures.