Predictors of Specialty Outpatient Palliative Care Utilization Among Persons With Serious Illness.

CONTEXT: Outpatient Palliative Care (OPC) benefits persons living with serious illness, yet barriers exist in utilization. OBJECTIVES: To identify factors associated with OPC clinic utilization. METHODS: Emergency Medicine Palliative Care Access is a multicenter, randomized control trial comparing two models of palliative care for patients recruited from the Emergency Department (ED): nurse-led telephonic case management and OPC (one visit a month for six months). Patients were aged 50+ with advanced cancer or end-stage organ failure and recruited from 19 EDs. Using a mixed effects hurdle model, we analyzed patient, provider, clinic and healthcare system factors associated with OPC utilization. RESULTS: Among the 603 patients randomized to OPC, about half (53.6%) of patients attended at least one clinic visit. Those with less than high school education were less likely to attend an initial visit than those with a college degree or higher (aOR 0.44; CI 0.23, 0.85), as were patients who required considerable assistance (aOR 0.45; CI 0.25, 0.82) or had congestive heart failure only (aOR 0.46; CI 0.26, 0.81). Those with higher symptom burden had a higher attendance at the initial visit (aOR 1.05; CI 1.00, 1.10). Reduced follow up visit rates were demonstrated for those of older age (aRR 0.90; CI 0.82, 0.98), female sex (aRR 0.84; CI 0.71, 0.99), and those that were never married (aRR 0.62; CI 0.52, 0.87). CONCLUSION: Efforts to improve OPC utilization should focus on those with lower education, more functional limitations, older age, female sex, and those with less social support. Trial Registration ClinicalTrials.gov Identifier: NCT03325985.

Serious illness communication skills training for emergency physicians and advanced practice providers: a multi-method assessment of the reach and effectiveness of the intervention.

BACKGROUND: EM Talk is a communication skills training program designed to improve emergency providers' serious illness conversational skills. Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, this study aims to assess the reach of EM Talk and its effectiveness. METHODS: EM Talk consisted of one 4-h training session during which professional actors used role-plays and active learning to train providers to deliver serious/bad news, express empathy, explore patients' goals, and formulate care plans. After the training, emergency providers filled out an optional post-intervention survey, which included course reflections. Using a multi-method analytical approach, we analyzed the reach of the intervention quantitatively and the effectiveness of the intervention qualitatively using conceptual content analysis of open-ended responses. RESULTS: A total of 879 out of 1,029 (85%) EM providers across 33 emergency departments completed the EM Talk training, with the training rate ranging from 63 to 100%. From the 326 reflections, we identified meaning units across the thematic domains of improved knowledge, attitude, and practice. The main subthemes across the three domains were the acquisition of Serious Illness (SI) communication skills, improved attitude toward engaging qualifying patients in SI conversations, and commitment to using these learned skills in clinical practice. CONCLUSION: Our study showed the extensive reach and the effectiveness of the EM Talk training in improving SI conversation. EM Talk, therefore, can potentially improve emergency providers' knowledge, attitude, and practice of SI communication skills. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03424109; Registered on January 30, 2018.

Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

BACKGROUND: Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. METHODS: A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project's duration. RESULTS: The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. CONCLUSIONS: Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Clinical research should involve patient and community stakeholder perspectives to make sure the study addresses questions important to the studied population. One way to do this is by creating a group of stakeholders who can advise on the conduct of a study. We assembled a Study Advisory Committee (SAC) for the Emergency Medicine Palliative Care Access (EMPallA) trial. The purpose of this clinical trial is to compare the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. This paper describes how the SACs involvement translated into direct impacts on the EMPallA trial. The trial research team held regular meetings with the SAC throughout the trial process. Their involvement led to many significant changes in the trial, such as  expanding recruitment inclusion criteria (Spanish-speaking patients), and including survey instruments to measure lonelines and caregiver burden. The SAC also devised strategies to overcome patient and caregiver recruitment and retention challenges, including the creation of patient-friendly materials and training for research coordinators. This study provides a successful example of how actively engaging patient and community stakeholders, through committee engagement, can promote patient priorities in all phases of a trial while facilitating patient recruitment and retention.

What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research.

Study advisory committees (SACs) provide critical value to clinical trials by providing unique perspectives that pull from personal and professional experiences related to the trial's healthcare topic. The Emergency Medicine Palliative Care Access (EMPallA) study had the privilege of convening a 16-person SAC from the project's inception to completion. The study team wanted to understand the impact this project had on the SAC members. In this narrative, we use reflective dialogue to share SAC members' lived experiences and the impact the EMPallA study has had on members both personally and professionally. We detail the (1) benefits SAC members, specifically patients, and caregivers, have had through working on this project. (2) The importance of recruiting diverse SAC members with different lived experiences and leveraging their feedback in clinical research. (3) Value of community capacity building to ensure the common vision of the clinical trial is promoted.

Psychometric Properties of the Functional Assessment of Cancer Therapy-General for Evaluating Quality of Life in Patients With Life-Limiting Illness in the Emergency Department.

Background: The Functional Assessment of Cancer Therapy-General (FACT-G) is a widely used quality-of-life measure. However, no studies have examined the FACT-G among patients with life-limiting illnesses who present to emergency departments (EDs). Objective: The goal of this study was to examine the psychometric properties of the FACT-G among patients with life-limiting illnesses who present to EDs in the United States. Methods: This cross-sectional study pooled data from 12 EDs between April 2018 and January 2020 (n = 453). Patients enrolled in the study were adults with one or more of the four life-limiting illnesses: advanced cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, or End-Stage Renal Disease. We conducted item, exploratory, and confirmatory analyses (exploratory factor analysis [EFA] and confirmatory factor analysis [CFA]) to determine the psychometric properties of the FACT-G. Results: The FACT-G had good internal consistency (Cronbach's alpha α = 0.88). The simplest EFA model was a six-factor structure. The CFA supported the six-factor structure, evidenced by the adequate fit indices (comparative fit index = 0.93, Tucker-Lewis index = 0.92, root-mean-square error of approximation = 0.05; 90% confidence interval: 0.04 - 0.06). The six-factor structure comprised the physical, emotional, work and daily activities-related functional well-being, and the family and friends-related social well-being domains. Conclusions: The FACT-G is a reliable measure of health-related quality of life among patients with life-limiting illnesses who present to the ED. Clinical Trial Registration: NCT03325985.

Emergency Nurses' Perceived Barriers and Solutions to Engaging Patients With Life-Limiting Illnesses in Serious Illness Conversations: A United States Multicenter Mixed-Method Analysis.

INTRODUCTION: This study aimed to assess emergency nurses' perceived barriers toward engaging patients in serious illness conversations. METHODS: Using a mixed-method (quant + QUAL) convergent design, we pooled data on the emergency nurses who underwent the End-of-Life Nursing Education Consortium training across 33 emergency departments. Data were extracted from the End-of-Life Nursing Education Consortium post-training questionnaire, comprising a 5-item survey and 1 open-ended question. Our quantitative analysis employed a cross-sectional design to assess the proportion of emergency nurses who report that they will encounter barriers in engaging seriously ill patients in serious illness conversations in the emergency department. Our qualitative analysis used conceptual content analysis to generate themes and meaning units of the perceived barriers and possible solutions toward having serious illness conversations in the emergency department. RESULTS: A total of 2176 emergency nurses responded to the survey. Results from the quantitative analysis showed that 1473 (67.7%) emergency nurses reported that they will encounter barriers while engaging in serious illness conversations. Three thematic barriers-human factors, time constraints, and challenges in the emergency department work environment-emerged from the content analysis. Some of the subthemes included the perceived difficulty of serious illness conversations, delay in daily throughput, and lack of privacy in the emergency department. The potential solutions extracted included the need for continued training, the provision of dedicated emergency nurses to handle serious illness conversations, and the creation of dedicated spaces for serious illness conversations. DISCUSSION: Emergency nurses may encounter barriers while engaging in serious illness conversations. Institutional-level policies may be required in creating a palliative care-friendly emergency department work environment.

Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 27 embedded pragmatic clinical trials, and many of the studies collect patient reported outcome measures as primary or secondary outcomes. Study teams have encountered challenges in the collection of these measures, including challenges related to competing health care system priorities, clinician's buy-in for adoption of patient-reported outcome measures, low adoption and reach of technology in low resource settings, and lack of consensus and standardization of patient-reported outcome measure selection and administration in the electronic health record. In this article, we share case examples and lessons learned, and suggest that, when using patient-reported outcome measures for embedded pragmatic clinical trials, investigators must make important decisions about whether to use data collected from the participating health system's electronic health record, integrate externally collected patient-reported outcome data into the electronic health record, or collect these data in separate systems for their studies.

Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory.

Embedded pragmatic clinical trials (ePCTs) play a vital role in addressing current population health problems, and their use of electronic health record (EHR) systems promises efficiencies that will increase the speed and volume of relevant and generalizable research. However, as the number of ePCTs using EHR-derived data grows, so does the risk that research will become more vulnerable to biases due to differences in data capture and access to care for different subsets of the population, thereby propagating inequities in health and the healthcare system. We identify 3 challenges-incomplete and variable capture of data on social determinants of health, lack of representation of vulnerable populations that do not access or receive treatment, and data loss due to variable use of technology-that exacerbate bias when working with EHR data and offer recommendations and examples of ways to actively mitigate bias.

Emergency Providers' Knowledge and Attitudes Toward Hospice and Palliative Care: A Cross-Sectional Analysis Across 35 Emergency Departments in the United States.

Background: Emergency providers' knowledge and attitudes may be a barrier to adopting hospice and palliative care practice. Objective: To assess provider characteristics associated with knowledge and attitudes toward hospice and palliative care (KAHP). Design: Cross-sectional analysis. Setting/Subjects: Emergency physicians, advanced practice providers (APPs), and nurses from 35 U.S. emergency departments (EDs) enrolled in a provider-focused intervention. Measurement: The outcome measures were the total and subscale scores of the KAHP scale. The predictor variables were age, sex, race/ethnicity, and years of practice. We reported the observed association using a linear mixed-effects regression model. Results: The mean KAHP score, rated from 10 to 50, was 36. Increased years of practice were associated with increased mean self-reported knowledge and attitudes scores among APPs and nurses. Conclusion: Understanding the provider characteristics associated with hospice and palliative care adoption in the ED may inform the development of interventions for specific providers. ClinicalTrials.gov (NCT03424109).

Engagement, Advance Care Planning, and Hospice Use in a Telephonic Nurse-Led Palliative Care Program for Persons Living with Advanced Cancer.

Persons living with advanced cancer have intensive symptoms and psychosocial needs that often result in visits to the Emergency Department (ED). We report on program engagement, advance care planning (ACP), and hospice use for a 6-month longitudinal nurse-led, telephonic palliative care intervention for patients with advanced cancer as part of a larger randomized trial. Patients 50 years and older with metastatic solid tumors were recruited from 18 EDs and randomized to receive nursing calls focused on ACP, symptom management, and care coordination or specialty outpatient palliative care (ClinicialTrials.gov: NCT03325985). One hundred and five (50%) graduated from the 6-month program, 54 (26%) died or enrolled in hospice, 40 (19%) were lost to follow-up, and 19 (9%) withdrew prior to program completion. In a Cox proportional hazard regression, withdrawn subjects were more likely to be white and have a low symptom burden compared to those who did not withdraw. Two hundred eighteen persons living with advanced cancer were enrolled in the nursing arm, and 182 of those (83%) completed some ACP. Of the subjects who died, 43/54 (80%) enrolled in hospice. Our program demonstrated high rates of engagement, ACP, and hospice enrollment. Enrolling subjects with a high symptom burden may result in even greater program engagement.

Equity and bias in electronic health records data.

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities. We offer recommendations for how to increase generalizability of ePCT results and begin to mitigate bias to promote health equity.

Knowledge and Attitudes Toward Hospice and Palliative Care: Instrument Validation Among Emergency Providers.

Background: Emergency providers can engage in goals of care discussions and hospice and palliative care referrals. Little is known about their knowledge and attitudes, which may influence these care practices. Objective: This study aims to re-validate the knowledge and attitude towards hospice and palliative care (KAHP) scale and assess the scale's latent constructs among emergency providers. Methods: The scale consists of ten items measured on a five-point Likert scale. Five of the ten items were reverse scored. Content validation was performed by ten experts in Hospice and Palliative Medicine and Emergency Medicine. Baseline surveys of emergency physicians, advance practice providers, and nurses conducted in the context of a pragmatic, randomized control trial were used for the item analysis and the exploratory and confirmatory factor analyses. Results: The KAHP scale is a ten-item scale scored from 10 to 50. Based on the synthesis of content validation results and the item analysis, all ten items were retained. The item and scale Content Validity Index were each .91. The reliability of the scale was .64 and the exploratory factor analysis identified three underlying constructs defined as self-rated knowledge, support for hospice and palliative care practice, and views on provider-patient communication. The presence of good model fit indices supported the structural integrity of the constructs. Conclusion: We present a validated instrument that is suitable for assessing knowledge and attitude variations toward interventions designed to improve hospice and palliative care practice among emergency providers.

Palliative care models for patients living with advanced cancer: a narrative review for the emergency department clinician.

Eighty-one percent of persons living with cancer have an emergency department (ED) visit within the last 6 months of life. Many cancer patients in the ED are at an advanced stage with high symptom burden and complex needs, and over half is admitted to an inpatient setting. Innovative models of care have been developed to provide high quality, ambulatory, and home-based care to persons living with serious, life-limiting illness, such as advanced cancer. New care models can be divided into a number of categories based on either prognosis (e.g., greater than or less than 6 months), or level of care (e.g., lower versus higher intensity needs, such as intravenous pain/nausea medication or frequent monitoring), and goals of care (e.g., cancer-directed treatment versus symptom-focused care only). We performed a narrative review to (1) compare models of care for seriously ill cancer patients in the ED and (2) examine factors that may hasten or impede wider dissemination of these models.

Emergency provider perspectives on facilitators and barriers to home and community services for older adults with serious life limiting illness: A qualitative study.

BACKGROUND: Older adults account for a large proportion of emergency department visits, but those with serious life-limiting illness may benefit most from referral to home and community services instead of hospitalization. We aim to document emergency provider perspectives on facilitators and barriers to accessing home and community services for older adults with serious life-limiting illness. METHODS: We conducted interviewer-administered semi-structured interviews with emergency providers from health systems across the United States to obtain provider perspectives on facilitators and barriers to accessing home and community services. We completed qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize provider responses. RESULTS: We interviewed 8 emergency nurses and 10 emergency physicians across 11 health systems. Emergency providers were familiar with local home and community services. Facilitators to accessing these services include care management and social workers. Barriers include services that are not accessible full-time to receive referrals, insurance/payment, and the busy nature of the emergency department. The most helpful reported services were hospice, physical therapy, occupational therapy, and visiting nursing services. Home-based palliative care and full-time emergency department-based care management and social work were the services most desired by providers. Providers expressed support for improving access to home and community services in the hopes of decreasing unnecessary emergency visits and inpatient admissions, and to provide patients with greater options for supportive care. CONCLUSION: Obtaining the perspective of emergency providers highlights important considerations to accessing HCS for older-adults with serious life-limiting illness from the emergency department. This study provides foundational information for futures studies and initiatives for improving access to home and community services directly from the emergency department.

Emergency and post-emergency care of older adults with Alzheimer's disease/Alzheimer's disease related dementias.

BACKGROUND: The emergency department (ED) is a critical juncture in the care of persons living with dementia (PLwD), as they have a high rate of hospital admission, ED revisits, and subsequent inpatient stays. We examine ED disposition of PLwD compared with older adults with non-dementia chronic disease as well as healthcare utilization and survival. METHODS: Medicare claims data were used to identify community-dwelling older adults 66+ years old from 34 hospitals with either Alzheimer's disease/Alzheimer's disease related dementias (AD/ADRD) or a non-AD/ADRD chronic condition between January 1, 2014, and December 31, 2018. We compared ED disposition at the index visit, as well as healthcare utilization and mortality in the 12 months following an index ED visit, and adjusted for age, gender, and risk of mortality. RESULTS: There were 29,626 patients in the AD/ADRD sample, and 317,046 in the comparison sample. The AD/ADRD sample was older (82.4 years old [SD: 8.2] vs. 76.0 years old [SD: 7.7]) and had more female patients (59.9% vs. 54.7%). The AD/ADRD sample was more likely to experience ED disposition to acute care (OR 1.039, p < 0.001, 95% CI 1.029-1.050), to have an ED revisit (OR 1.077, p < 0.001, 95% CI 1.066-1.087), and an inpatient stay in the subsequent 12 months (OR 1.085, p < 0.001, 95% CI 1.075-1.095). ED disposition to hospice was low in both samples (0.2%). AD/ADRD patients had a higher risk of mortality (OR 1.099, p < 0.001, 95% CI 1.091-1.107) and high short-term mortality (31.9% within 12 months) than those without AD/ADRD (15.3% within 12 months). CONCLUSIONS: PLwD who visit the ED have high short-term mortality. Despite this, disposition to acute care, ED revisits, and inpatient stays, rather than hospice, remain the predominant mode of care delivery. Transition directly from the ED to hospice for PLwD is rare.

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 .

Access to Home and Community Health Services for Older Adults With Serious, Life-Limiting Illness: A Study Protocol.

OBJECTIVES: The objective of this study is to identify contextual access factors to home and community health services for end-of-life support for older adults with serious life-limiting illness, as well as determine if access to home and community services is associated with health-care utilization. DESIGN: This study includes an environmental scan, grey literature review, qualitative interviews, and health-care utilization analysis. This study is a subproject of the Grudzen et al. Primary Palliative Care for Emergency Medicine (PRIM-ER) study. SETTINGS/LOCATION: Analysis will include data collection from 17 health systems implementing the PRIM-ER intervention. PARTICIPANTS: For the qualitative interviews, one emergency medicine (EM) physician and one EM nurse will be interviewed from each of the 17 participating health systems. For the health-care utilization analysis, we will use the Senior Care Services Scale (SCSS), American Hospital Association Annual Survey of Hospitals (AHA-ASH), and Medicare claims for all emergency department (ED) visits for serious illness who present at each participating health system. OUTCOME MEASURES: The contextual analysis will obtain data on home and community services, such as hospice, home health services, assisted living, integrative medicine services, etc., available around each health system's highest volume ED, federal and state regulations influencing access to services, as well as EM provider perspectives on access to services. The health-care utilization analysis will determine if SCSS scores, which measure service availability, are associated with health-care usage. High or low SCSS scores are determined by comparing health system service availability on the AHA-ASH to the national median SCSS value.

Effectiveness and Reach of the Primary Palliative Care for Emergency Medicine (PRIM-ER) Pilot Study: a Qualitative Analysis.

BACKGROUND: Palliative care interventions in the ED capture high-risk patients at a time of crisis and can dramatically improve patient-centered outcomes. OBJECTIVE: To understand the facilitators that contributed to the success of the Primary Palliative Care for Emergency Medicine (PRIM-ER) quality improvement pilot intervention. DESIGN: Effectiveness was evaluated through semi-structured interviews. Reach outcomes were measured by percent of all full-time emergency providers (physicians, physician assistants, nurses) who completed the intervention education components and baseline survey assessing attitudes and knowledge on end-of-life care. PARTICIPANTS: Emergency medicine providers affiliated with two medical centers (N = 197). Interviews conducted with six key informants at both institutions. APPROACH: Interviews were recorded, transcribed, and analyzed using deductive and inductive approaches. Descriptive statistics include reach outcomes and baseline survey results. KEY RESULTS: Both sites successfully implemented all components of the intervention and achieved a high level (> 75%) of intervention reach. Two themes emerged as facilitators to successful effectiveness facilitators of PRIM-ER: (1) institutional leadership support and (2) leveraging established quality improvement (QI) processes. Institutional support included leveraging leadership with authority to (a) mandate trainings; (b) substitute PRIM-ER education for normally scheduled education; and (c) provide protected time to implement intervention components. Effectiveness was also enhanced by capitalizing on existing QI processes which included (a) leveraging interdisciplinary partnerships and communication plans and (b) monitoring performance improvement data. CONCLUSIONS: Capitalizing on strong institutional leadership support and established QI processes enhanced the reach and effectiveness of the PRIM-ER pilot. These findings will guide the PRIM-ER researchers in scaling up the intervention in the remaining 33 sites, as well as enhance the planning of other complex quality improvement interventions in clinical settings. REGISTRATION DETAILS: ClinicalTrials.gov Identifier: NCT03424109; Grant Number: AT009844-01.

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.

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.