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Application of the FRAME-IS to a multifaceted implementation strategy

Schoenthaler, Antoinette; De La Calle, Franze; De Leon, Elaine; Garcia, Masiel; Colella, Doreen; Nay, Jacalyn; Dapkins, Isaac
BACKGROUND:Research demonstrates the importance of documenting adaptations to implementation strategies that support integration of evidence-based interventions into practice. While studies have utilized the FRAME-IS [Framework for Reporting Adaptations and Modifications for Implementation Strategies] to collect structured adaptation data, they are limited by a focus on discrete implementation strategies (e.g., training), which do not reflect the complexity of multifaceted strategies like practice facilitation. In this paper, we apply the FRAME-IS to our trial evaluating the effectiveness of PF on implementation fidelity of an evidence-based technology-facilitated team care model for improved hypertension control within a federally qualified health center (FQHC). METHODS:Three data sources are used to document adaptations: (1) implementation committee meeting minutes, (2) narrative reports completed by practice facilitators, and (3) structured notes captured on root cause analysis and Plan-Do-Study-Act worksheets. Text was extracted from the data sources according to the FRAME-IS modules and inputted into a master matrix for content analysis by two authors; a third author conducted member checking and code validation. RESULTS:We modified the FRAME-IS to include part 2 of module 2 (what is modified) to add greater detail of the modified strategy, and a numbering system to track adaptations across the modules. This resulted in identification of 27 adaptations, of which 88.9% focused on supporting practices in identifying eligible patients and referring them to the intervention. About half (52.9%) of the adaptations were made to modify the context of the PF strategy to include a group-based format, add community health workers to the strategy, and to shift the implementation target to nurses. The adaptations were often widespread (83.9%), affecting all practices within the FQHC. While most adaptations were reactive (84.6%), they resulted from a systematic process of reviewing data captured by multiple sources. All adaptations included the FQHC in the decision-making process. CONCLUSION/CONCLUSIONS:With modifications, we demonstrate the ability to document our adaptation data across the FRAME-IS modules, attesting to its applicability and value for a range of implementation strategies. Based on our experiences, we recommend refinement of tracking systems to support more nimble and practical documentation of iterative, ongoing, and multifaceted adaptations. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov NCT03713515, Registration date: October 19, 2018.
PMCID:11143702
PMID: 38822342
ISSN: 1472-6963
CID: 5664082

"Hypertension is such a difficult disease to manage": federally qualified health center staff- and leadership-perceived readiness to implement a technology-facilitated team-based hypertension model

Gago, Cristina; De Leon, Elaine; Mandal, Soumik; de la Calle, Franze; Garcia, Masiel; Colella, Doreen; Dapkins, Isaac; Schoenthaler, Antoinette
BACKGROUND:Despite decades of evidence demonstrating the efficacy of hypertension care delivery in reducing morbidity and mortality, a majority of hypertension cases remain uncontrolled. There is an urgent need to elucidate and address multilevel facilitators and barriers clinical staff face in delivering evidence-based hypertension care, patients face in accessing it, and clinical systems face in sustaining it. Through a rigorous pre-implementation evaluation, we aimed to identify facilitators and barriers bearing the potential to affect the planned implementation of a multilevel technology-facilitated hypertension management trial across six primary care sites in a large federally qualified health center (FQHC) in New York City. METHODS:During a dedicated pre-implementation period (3-9 months/site, 2021-2022), a capacity assessment was conducted by trained practice facilitators, including (1) online anonymous surveys (n = 124; 70.5% of eligible), (2) hypertension training analytics (n = 69; 94.5% of assigned), and (3) audio-recorded semi-structured interviews (n = 67; 48.6% of eligible) with FQHC leadership and staff. Surveys measured staff sociodemographic characteristics, adaptive reserve, evidence-based practice attitudes, and implementation leadership scores via validated scales. Training analytics, derived from end-of-course quizzes, included mean score and number attempts needed to pass. Interviews assessed staff-reported facilitators and barriers to current hypertension care delivery and uptake; following audio transcription, trained qualitative researchers employed a deductive coding approach, informed by the Consolidated Framework for Implementation Research (CFIR). RESULTS:Most survey respondents reported moderate adaptive reserve (mean = 0.7, range = 0-1), evidence-based practice attitudes (mean = 2.7, range = 0-4), and implementation leadership (mean = 2.5, range = 0-4). Most staff passed training courses on first attempt and demonstrated high scores (means > 80%). Findings from interviews identified potential facilitators and barriers to implementation; specifically, staff reported that complex barriers to hypertension care, control, and clinical communication exist; there is a recognized need to improve hypertension care; in-clinic challenges with digital tool access imposes workflow delays; and despite high patient loads, staff are motivated to provide high-quality cares. CONCLUSIONS:This study serves as one of the first to apply the CFIR to a rigorous pre-implementation evaluation within the understudied context of a FQHC and can serve as a model for similar trials seeking to identify and address contextual factors known to impact implementation success. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT03713515 , date of registration: October 19, 2018.
PMCID:11067286
PMID: 38698497
ISSN: 2662-2211
CID: 5734262

A Dynamic Clinical Decision Support Tool to Improve Primary Care Outcomes in a High-Volume, Low-Resource Setting

Dapkins, Isaac; Prescott, Rasheda; Ladino, Nathalia; Anderman, Judd; McCaleb, Chase; Colella, Doreen; Gore, Radhika; Fontil, Valy; Szerencsy, Adam; Blecker, Saul
The Family Health Centers at New York University Langone (FHC), a federally qualified health center network in New York City, created a novel clinical decision support (CDS) tool that alerts primary health care providers to patients"™ gaps in care and triggers a dynamic, individualized order set on the basis of unique patient factors, enabling providers to readily act on each patient"™s specific gaps in care. FHC implemented this tool in 2017, starting with 15 protocols for quality measures; as of February 2024, there are 30 such protocols. During a patient visit with a provider, when there is a gap in care, a best-practice alert (BPA) fires, which includes an order set unique to the patient and visit. The provider can bypass the alert (not open it) or acknowledge the alert (open it). The provider may review the content of the order set and accept it as is or with modifications, or they can decline its recommendations if they believe it is not appropriate or plan to address the gap in care another way during the visit. To accept the dynamic order set is the intended workflow. The authors present data from September 2019 to January 2023 totaling 171,319 patient visits with at least one open gap in care among providers in pediatrics, family medicine, and internal medicine. The rate at which providers acknowledged the BPA in the first 6 months was 45% and steadily increased. In the last 6 months of the period, providers acknowledged the BPA 78% (19,281 of 24,575) of the time. Similarly, in the first 6 months, in all encounters in which a BPA was fired, 28.8% (8,585 of 29,829) had an order placed via the dynamic order set (accepted); that rate increased to 49.7% (12,210 of 24,575) during the last 6 months. This order set completion rate is notable given that most CDS use rates are low. Gap closure was higher when providers acknowledged the alert. In an analysis of all encounters with at least one open gap, spanning 2019"“2023, 46% (48,431 of 105,371) of the time, at least one gap was closed when the alert was acknowledged compared with 33% (21,993 of 65,948) when the alert was bypassed (and the recommendations of the dynamic order set were never followed). The authors show that CDS tools can be successfully implemented in a high-volume, low-resource setting if designed with efficiency in mind, ensuring provider utilization and clinical impact through closing care gaps. CDS tools that are dynamically patient specific can help improve quality of care if they are part of a broader culture of quality improvement.
SCOPUS:85190307342
ISSN: 2642-0007
CID: 5670482

Key Principles Underlying a Research-Practice Alignment in a Federally Qualified Health Center

Schoenthaler, Antoinette; Colella, Doreen; De La Calle, Franze; Bueno, Gisella; Nay, Jacalyn; Garcia, Masiel; Shahin, George; Gago, Cristina; Dapkins, Isaac
CONTEXT/UNASSIGNED:Minoritized populations such as racial and ethnic minorities and individuals of less privileged socioeconomic status experience a disproportionate burden of poor hypertension (HTN) control in the United States. Multilevel systems interventions have been shown to improve patient-level outcomes in minoritized populations; however, there remains a large translational gap in implementing these approaches into federally qualified health centers (FQHC), which serve those at highest risk of HTN-related morbidity and mortality. The paucity of purposeful collaborations between academic researchers and practice staff throughout the research process remains a significant roadblock to the timely translation of evidence to practice. DESIGN/UNASSIGNED:This commentary describes the key principles and best practices that underlie the development and sustainment of an equitable research-practice alignment, which is supporting the implementation of multilevel systems intervention for improved HTN care in a large FQHC in Brooklyn, New York. The key principles, which are derived from the central tenants of relationship development and maintenance in community-engaged participatory research, patient-centered outcomes research, and organizational alignment theory include (1) cocreation of a shared mental model, (2) bridging multilevel communication, (3) ensuring mutual accountability, and (4) creating a culture of continuous improvement. CONCLUSIONS/UNASSIGNED:Together, the principles guide how the research and practice teams work together to achieve a shared goal of improving the health and well-being of minoritized patients through the provision of high quality, community-oriented HTN care. Best practices to sustain our alignment require an ongoing and deliberate investment in honest and transparent communication by all members.
PMCID:11099517
PMID: 38846732
ISSN: 1945-0826
CID: 5665832

Patient and Clinician Satisfaction with the Early Implementation of Telemental Health Services in an Urban Behavioral Health Clinic During the COVID-19 Pandemic

Reliford, Aaron; Zhang, Emily; Lanina, Olga; Williams, Sharifa Z; Sanichar, Navin; Khan, Shabana; Dapkins, Isaac; Frankle, W Gordon
PMID: 36912813
ISSN: 1556-3669
CID: 5449312

Simultaneous Quantitative SARS-CoV-2 Antigen and Host Antibody Detection and Pre-Screening Strategy at the Point of Care

Srinivasan Rajsri, Kritika; McRae, Michael P; Christodoulides, Nicolaos J; Dapkins, Isaac; Simmons, Glennon W; Matz, Hanover; Dooley, Helen; Fenyö, David; McDevitt, John T
As COVID-19 pandemic public health measures are easing globally, the emergence of new SARS-CoV-2 strains continue to present high risk for vulnerable populations. The antibody-mediated protection acquired from vaccination and/or infection is seen to wane over time and the immunocompromised populations can no longer expect benefit from monoclonal antibody prophylaxis. Hence, there is a need to monitor new variants and its effect on vaccine performance. In this context, surveillance of new SARS-CoV-2 infections and serology testing are gaining consensus for use as screening methods, especially for at-risk groups. Here, we described an improved COVID-19 screening strategy, comprising predictive algorithms and concurrent, rapid, accurate, and quantitative SARS-CoV-2 antigen and host antibody testing strategy, at point of care (POC). We conducted a retrospective analysis of 2553 pre- and asymptomatic patients who were tested for SARS-CoV-2 by RT-PCR. The pre-screening model had an AUC (CI) of 0.76 (0.73-0.78). Despite being the default method for screening, body temperature had lower AUC (0.52 [0.49-0.55]) compared to case incidence rate (0.65 [0.62-0.68]). POC assays for SARS-CoV-2 nucleocapsid protein (NP) and spike (S) receptor binding domain (RBD) IgG antibody showed promising preliminary results, demonstrating a convenient, rapid (<20 min), quantitative, and sensitive (ng/mL) antigen/antibody assay. This integrated pre-screening model and simultaneous antigen/antibody approach may significantly improve accuracy of COVID-19 infection and host immunity screening, helping address unmet needs for monitoring vaccine effectiveness and severe disease surveillance.
PMCID:10295356
PMID: 37370601
ISSN: 2306-5354
CID: 5540242

A feasibility and acceptability study of screening the parents/guardians of pediatric dental patients for the social determinants of health

Kaur, Raghbir; Lieberman, Martin; Mason, Margaret K; Dapkins, Isaac P; Gallager, Rebecca; Hopkins, Kathleen; Wu, Yinxiang; Troxel, Andrea B; Rashwan, Ayah; Hope, Chelsea; Kane, Daniel J; Northridge, Mary E
BACKGROUND:The social determinants of health (SDOH) are the conditions in which people are born, grow, work, live, and age. Lack of SDOH training of dental providers on SDOH may result in suboptimal care provided to pediatric dental patients and their families. The purpose of this pilot study is to report the feasibility and acceptability of SDOH screening and referral by pediatric dentistry residents and faculty in the dental clinics of Family Health Centers at NYU Langone (FHC), a Federally Qualified Health Center (FQHC) network in Brooklyn, NY, USA. METHODS:Guided by the Implementation Outcomes Framework, 15 pediatric dentists and 40 pediatric dental patient-parent/guardian dyads who visited FHC in 2020-2021 for recall or treatment appointments participated in this study. The a priori feasibility and acceptability criteria for these outcomes were that after completing the Parent Adversity Scale (a validated SDOH screening tool), ≥ 80% of the participating parents/guardians would feel comfortable completing SDOH screening and referral at the dental clinic (acceptable), and ≥ 80% of the participating parents/guardians who endorsed SDOH needs would be successfully referred to an assigned counselor at the Family Support Center (feasible). RESULTS:The most prevalent SDOH needs endorsed were worried within the past year that food would run out before had money to buy more (45.0%) and would like classes to learn English, read better, or obtain a high school degree (45.0%). Post-intervention, 83.9% of the participating parents/guardians who expressed an SDOH need were successfully referred to an assigned counselor at the Family Support Center for follow-up, and 95.0% of the participating parents/guardians felt comfortable completing the questionnaire at the dental clinic, surpassing the a priori feasibility and acceptability criteria, respectively. Furthermore, while most (80.0%) of the participating dental providers reported being trained in SDOH, only one-third (33.3%) usually or always assess SDOH for their pediatric dental patients, and most (53.8%) felt minimally comfortable discussing challenges faced by pediatric dental patient families and referring patients to resources in the community. CONCLUSIONS:This study provides novel evidence of the feasibility and acceptability of SDOH screening and referral by dentists in the pediatric dental clinics of an FQHC network.
PMCID:9996555
PMID: 36895054
ISSN: 2055-5784
CID: 5495522

Effectiveness of Goal-Directed and Outcome-Based Financial Incentives for Weight Loss in Primary Care Patients With Obesity Living in Socioeconomically Disadvantaged Neighborhoods: A Randomized Clinical Trial (vol 183, pg 61, 2023) [Correction]

Ladapo, Joseph A.; Orstad, Stephanie L.; Wali, Soma; Wylie-Rosett, Judith; Tseng, Chi-Hong; Chung, Un Young Rebecca; Cuevas, Miguel A.; Hernandez, Christina; Parraga, Susan; Ponce, Robert; Sweat, Victoria; Wittleder, Sandra; Wallach, Andrew B.; Shu, Suzanne B.; Goldstein, Noah J.; Dapkins, Isaac; Jay, Melanie
ISI:000938839800002
ISSN: 2168-6106
CID: 5477662

The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study

Nagler, Arielle R; Horwitz, Leora I; Jones, Simon; Petrilli, Christopher M; Iturrate, Eduardo; Lighter, Jennifer L; Phillips, Michael; Bosworth, Brian P; Polsky, Bruce; Volpicelli, Frank M; Dapkins, Isaac; Viswanathan, Anand; François, Fritz; Kalkut, Gary
DISCLAIMER/CONCLUSIONS:In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE/OBJECTIVE:Despite progress in the treatment of coronavirus disease 2019 (COVID-19), including the development of monoclonal antibodies (mAbs), more clinical data to support the use of mAbs in outpatients with COVID-19 is needed. This study is designed to determine the impact of bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab on clinical outcomes within 30 days of COVID-19 diagnosis. METHODS:A retrospective cohort study was conducted at a single academic medical center with 3 campuses in Manhattan, Brooklyn, and Long Island, NY. Patients 12 years of age or older who tested positive for COVID-19 or were treated with a COVID-19-specific therapy, including COVID-19 mAb therapies, at the study site between November 24, 2020, and May 15, 2021, were included. The primary outcomes included rates of emergency department (ED) visit, inpatient admission, intensive care unit (ICU) admission, or death within 30 days from the date of COVID-19 diagnosis. RESULTS:A total of 1,344 mAb-treated patients were propensity matched to 1,344 patients with COVID-19 patients who were not treated with mAb therapy. Within 30 days of diagnosis, among the patients who received mAb therapy, 101 (7.5%) presented to the ED and 79 (5.9%) were admitted. Among the patients who did not receive mAb therapy, 165 (12.3%) presented to the ED and 156 (11.6%) were admitted (relative risk [RR], 0.61 [95% CI, 0.50-0.75] and 0.51 [95% CI, 0.40-0.64], respectively). Four mAb patients (0.3%) and 2.64 control patients (0.2%) were admitted to the ICU (RR, 01.51; 95% CI, 0.45-5.09). Six mAb-treated patients (0.4%) and 3.37 controls (0.3%) died and/or were admitted to hospice (RR, 1.61; 95% CI, 0.54-4.83). mAb therapy in ambulatory patients with COVID-19 decreases the risk of ED presentation and hospital admission within 30 days of diagnosis.
PMCID:9619808
PMID: 36242772
ISSN: 1535-2900
CID: 5361302

Tele health for prep initiation: A pilot program to expand access to hiv prevention services [Meeting Abstract]

Schubert, F; Bhat, S; Keneipp, K; Dapkins, I
STATEMENT OF PROBLEMOR QUESTION (ONE SENTENCE): To determine the feasibility and acceptability of using a virtual-only model for initiating and maintaining patients on PrEP (pre-exposure prophylaxis) for HIV prevention. LEARNING OBJECTIVES 1: Participants will be able to identify 3 key considerations in developing a clinical workflow for virtual PrEP initiation. LEARNING OBJECTIVES 2: Participants will be able to discuss 3-5 challenges associated with virtual PrEP initiation, and identify strategies to address these challenges. DESCRIPTION OF PROGRAM/INTERVENTION, INCLUDING ORGANIZATIONAL CONTEXT (E.G. INPATIENT VS. OUTPATIENT, PRACTICE OR COMMUNITY CHARACTERISTICS): The Family Health Centers at NYU Langone (FHC) is a federally qualified health center network with 8 clinical sites in Brooklyn, NY, primarily serving a low-income, immigrant community. Since 2016, FHC has operated a focused outreach program to promote PrEP to high-risk individuals, using targeted strategies to engage those not currently in PrEP care. Our intervention sought to expand on our successful outreach model by using tele health to remove geographic barriers to participation. We developed clinical and patient navigation workflows to enable patients to initiate and continue PrEP through virtual visits. For necessary labs, patients were supported in identifying a lab collection site convenient to their home. Patient navigation staff played a key role in risk reduction education, benefits navigation, and facilitating compliance with labs and virtual care. MEASURES OF SUCCESS (DISCUSS QUALITATIVE AND/OR QUANTITATIVEMETRICSWHICHWILL BEUSEDTOEVALUATE PROGRAM/INTERVENTION): The key measure of success is PrEP uptake and continuation among the virtual visits cohort. Additional evaluation measures include the referral source of patients for virtual PrEP initiation, patient demographics, and HIV risk-these measures will enable us to assess whether we are reaching a more diverse or higher risk population through this program. FINDINGS TO DATE (IT IS NOT SUFFICIENT TO STATE FINDINGS WILL BE DISCUSSED): The pilot project launched in October 2020. In the three months since project launch, 8 patients were served through this program. Six of the patients (75%) had been initially engaged with the FHC through the HIV prevention program, while two were existing FHC patients-one of whom had previously been in standard PrEP care, but struggled to make the in-person visits. Six patients were cisgender men who have sex with men, while two were transgender women. Virtual PrEP provided an opportunity to link patients to other needed healthcare services, including vaccination and STI treatment. KEY LESSONS FOR DISSEMINATION (WHAT CAN OTHERS TAKE AWAY FOR IMPLEMENTATION TO THEIR PRACTICE OR COMMUNITY): The tele health PrEP pilot program enabled us to reach a diverse group of high-risk patients, a majority of whom had not previously been engaged in care within our health system, and we anticipate continued growth this program as we expand our outreach to additional geographic areas. Navigation staff were key in overcoming some of the barriers associated with the virtual model by building relationships with the patients and serving as a reliable source of support for patients encountering logistical barriers. PrEP initiation by tele health must account for additional logistical considerations-most notably, ensuring patient compliance with labs-but it is a feasible approach for engaging high-risk patients in HIV prevention services
EMBASE:635797094
ISSN: 1525-1497
CID: 4984852