Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS) in meeting challenges in care management.

BACKGROUND: Parkinson's disease (PD) complexity poses challenges for individuals with Parkinson's, providers, and researchers. A recent multisite randomized trial of a proactive, telephone-based, nurse-led care management intervention - Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS) - demonstrated improved PD care quality. Implementation details and supportive stakeholder feedback were subsequently published. To inform decisions on dissemination, CHAPS Model components require evaluations of their fidelity to the Chronic Care Model and to their implementation. Additionally, assessment is needed on whether CHAPS addresses care challenges cited in recent literature. METHODS: These analyses are based on data from a subset of 140 intervention arm participants and other CHAPS data. To examine CHAPS Model fidelity, we identified CHAPS components corresponding to the Chronic Care Model's six essential elements. To assess implementation fidelity of these components, we examined data corresponding to Hasson's modified implementation fidelity framework. Finally, we identified challenges cited in current Parkinson's care management literature, grouped these into themes using open card sorting techniques, and examined CHAPS data for evidence that CHAPS met these challenges. RESULTS: All Chronic Care Model essential elements were addressed by 17 CHAPS components, thus achieving CHAPS Model fidelity. CHAPS implementation fidelity was demonstrated by adherence to content, frequency, and duration with partial fidelity to telephone encounter frequency. We identified potential fidelity moderators for all six of Hasson's moderator types. Through card sorting, four Parkinson's care management challenge themes emerged: unmet needs and suggestions for providers (by patient and/or care partner), patient characteristics needing consideration, and standardizing models for Parkinson's care management. CHAPS activities and stakeholder perceptions addressed all these themes. CONCLUSIONS: CHAPS, a supportive nurse-led proactive Parkinson's care management program, improved care quality and is designed to be reproducible and supportive to clinicians. Findings indicated CHAPS Model fidelity occurred to the Chronic Care Model and fidelity to implementation of the CHAPS components was demonstrated. Current Parkinson's care management challenges were met through CHAPS activities. Thus, dissemination of CHAPS merits consideration by those responsible for implementing changes in clinical practice and reaching people in need. TRIAL REGISTRATION: ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.

How successful was the use of a community of practice for the implementation of evidence-based practices for heart failure within the United States Department of Veterans Affairs: Insights from a formative evaluation.

BACKGROUND: Communities of Practice (CoPs) are a promising approach to facilitate the implementation of evidence-based practices (EBPs) to improve care for chronic conditions like heart failure (HF). CoPs involve a complex process of acquiring and converting both explicit and tacit knowledge into clinical activities. This study describes the conceptualization, creation, capacity-building and dissemination of a CoP sustained over 9 years, and evaluates its value and impact on EBP. METHODS: In July 2006, a CoP called the Heart Failure Provider Network (HF Network) was established within the United States Department of Veterans Affairs (VA) with the overarching goal of improving the quality of care for HF patients. We assessed (formative) the HF Network in terms of its various activities (inputs) and proximal impacts (mediators) at the individual level, and its distal impacts (outcomes) at the site level including implementation of new/improved EBPs at the systemwide level. RESULTS: The HF Network membership grew steadily over the 9 years. The CoP has involved a total of 1341 multidisciplinary and multilevel members at all 144 VA Health Care Systems (sites). Most members were practising clinicians (n = 891, 66.4%), followed by administrators (n = 342, 25.5%), researchers (n = 70, 5.2%) and others (n = 38, 2.8%). Participation was assessed to be "active" for 70.6% versus "passive" for 29.4% of members. The distribution of active members (clinicians 64.7%, administrators 21.6%) was similar to the distribution of overall membership. CONCLUSIONS: Survey respondents perceived the HF Network as useful in terms of its varied activities and resources relevant for patient care. Strong evidence shows that these members, particularly those who considered themselves influential in improving quality of care, noted multiple benefits of membership, which included confirmation of their own clinical practices, evidence-based changes to their practice and help in understanding facilitators and barriers in setting up or running HF clinics and other programmes. Such CoPs have strong impacts on the quality of care being delivered for both mandated and non-mandated initiatives.

Influencing Factors Associated with Implementation of INTERACT (Interventions to Reduce Acute Care Transfers) in VA Community Living Centers (CLCs) Using the Consolidated Framework.

Our objective was to identify the influencing factors associated with the implementation of the INTERACT (Interventions to Reduce Acute Care Transfers) Quality Improvement program within a national healthcare system. INTERACT focuses on early identification and management of changes in residents' condition leading to a reduction in potentially preventable hospital transfers. The Consolidated Framework was used to evaluate implementation data from eight VA Community Living Centers. Qualitative implementation data suggest two influencing Consolidated Framework domains had a strong influence: 1) key attributes of the intervention (e.g., adaptability or complexity) and 2) internal organizational factors (e.g., culture or compatibility). Using the Consolidated Framework can assist future adaptations to this and other complex quality improvement initiatives.

Combining Improvement and Implementation Sciences and Practices for the Post COVID-19 Era.

Health services made many changes quickly in response to the SARS-CoV-2 pandemic. Many more are being made. Some changes were already evaluated, and there are rigorous research methods and frameworks for evaluating their local implementation and effectiveness. But how useful are these methods for evaluating changes where evidence of effectiveness is uncertain, or which need adaptation in a rapidly changing situation? Has implementation science provided implementers with tools for effective implementation of changes that need to be made quickly in response to the demands of the pandemic? This perspectives article describes how parts of the research and practitioner communities can use and develop a combination of implementation and improvement to enable faster and more effective change in the future, especially where evidence of local effectiveness is limited. We draw on previous reviews about the advantages and disadvantages of combining these two domains of knowledge and practice. We describe a generic digitally assisted rapid cycle testing (DA-RCT) approach that combines elements of each in order to better describe a change, monitor outcomes, and make adjustments to the change when implemented in a dynamic environment.

Patient and Physician Perspectives of Deprescribing Potentially Inappropriate Medications in Older Adults with a History of Falls: a Qualitative Study.

BACKGROUND: High-risk medications pose serious safety risks to older adults, including increasing the risk of falls. Deprescribing potentially inappropriate medications (PIMs) in older adults who have experienced a fall is a key element of fall reduction strategies. However, continued use of PIMs in older adults is common, and clinicians may face substantial deprescribing barriers. OBJECTIVE: Explore patient and clinician experiences with and perceptions of deprescribing PIMs in patients with a history of falls. DESIGN: We led guided patient feedback sessions to explore deprescribing scenarios with patient stakeholders and conducted semi-structured interviews with primary care physicians (PCPs) to explore knowledge and awareness of fall risk guidelines, deprescribing experiences, and barriers and facilitators to deprescribing. PARTICIPANTS: PCPs from Kaiser Permanente Southern California (KPSC) and patient members of the KPSC Regional Patient Advisory Committee. APPROACH: We used maximum variation sampling to identify PCPs with patients who had a fall, then categorized the resulting PIM dispense distribution for those patients into high and low frequency. We analyzed the data using a hybrid deductive-inductive approach. Coders applied initial deductively derived codes to the data, simultaneously using an open-code inductive approach to capture emergent themes. KEY RESULTS: Physicians perceived deprescribing discussions as potentially contentious, even among patients with falls. Physicians reported varying comfort levels with deprescribing strategies: some felt that the conversations might be better suited to others (e.g., pharmacists), while others had well-planned negotiation strategies. Patients reported lack of clarity as to the reasons and goals of deprescribing and poor understanding of the seriousness of falls. CONCLUSIONS: Our study suggests that key barriers to deprescribing include PCP trepidation about raising a contentious topic and insufficient patient awareness of the potential seriousness of falls. Findings suggest the need for multifaceted, multilevel deprescribing approaches with clinician training strategies, patient educational resources, and a focus on building trusting patient-clinician relationships.

Impact of COVID-19 on Cervical Cancer Screening Rates Among Women Aged 21-65 Years in a Large Integrated Health Care System - Southern California, January 1-September 30, 2019, and January 1-September 30, 2020.

On March 19, 2020, the governor of California issued a statewide stay-at-home order to contain the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19).* The order reduced accessibility to and patient attendance at outpatient medical visits,† including preventive services such as cervical cancer screening. In-person clinic visits increased when California reopened essential businesses on June 12, 2020.§ Electronic medical records of approximately 1.5 million women served by Kaiser Permanente Southern California (KPSC), a large integrated health care system, were examined to assess cervical cancer screening rates before, during, and after the stay-at-home order. KPSC policy is to screen women aged 21-29 years every 3 years with cervical cytology alone (Papanicolaou [Pap] test); those aged 30-65 years were screened every 5 years with human papillomavirus (HPV) testing and cytology (cotesting) through July 15, 2020, and after July 15, 2020, with HPV testing alone, consistent with the latest recommendations from U.S. Preventive Services Task Force.¶ Compared with the 2019 baseline, cervical cancer screening rates decreased substantially during the stay-at-home order. Among women aged 21-29 years, cervical cytology screening rates per 100 person-months declined 78%. Among women aged 30-65 years, HPV test screening rates per 100 person-months decreased 82%. After the stay-at-home order was lifted, screening rates returned to near baseline, which might have been aided by aspects of KPSC's integrated, organized screening program (e.g., reminder systems and tracking persons lost to follow-up). As the pandemic continues, groups at higher risk for developing cervical cancers and precancers should be evaluated first. Ensuring that women receive preventive services, including cancer screening and appropriate follow-up in a safe and timely manner, remains important.

A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders.

BACKGROUND: Treatment of a child who has an anxiety disorder usually begins with the question of which treatment to start first, medication or psychotherapy. Both have strong empirical support, but few studies have compared their effectiveness head-to-head, and none has investigated what to do if the treatment tried first isn't working well-whether to optimize the treatment already begun or to add the other treatment. METHODS: This is a single-blind Sequential Multiple Assignment Randomized Trial (SMART) of 24 weeks duration with two levels of randomization, one in each of two 12-week stages. In Stage 1, children will be randomized to fluoxetine or Coping Cat Cognitive Behavioral Therapy (CBT). In Stage 2, remitters will continue maintenance-level therapy with the single-modality treatment received in Stage 1. Non-remitters during the first 12 weeks of treatment will be randomized to either [1] optimization of their Stage 1 treatment, or [2] optimization of Stage 1 treatment and addition of the other intervention. After the 24-week trial, we will follow participants during open, naturalistic treatment to assess the durability of study treatment effects. Patients, 8-17 years of age who are diagnosed with an anxiety disorder, will be recruited and treated within 9 large clinical sites throughout greater Los Angeles. They will be predominantly underserved, ethnic minorities. The primary outcome measure will be the self-report score on the 41-item youth SCARED (Screen for Child Anxiety Related Disorders). An intent-to-treat analysis will compare youth randomized to fluoxetine first versus those randomized to CBT first ("Main Effect 1"). Then, among Stage 1 non-remitters, we will compare non-remitters randomized to optimization of their Stage 1 monotherapy versus non-remitters randomized to combination treatment ("Main Effect 2"). The interaction of these main effects will assess whether one of the 4 treatment sequences (CBT➔CBT; CBT➔med; med➔med; med➔CBT) in non-remitters is significantly better or worse than predicted from main effects alone. DISCUSSION: Findings from this SMART study will identify treatment sequences that optimize outcomes in ethnically diverse pediatric patients from underserved low- and middle-income households who have anxiety disorders. TRIAL REGISTRATION: This protocol, version 1.0, was registered in ClinicalTrials.gov on February 17, 2021 with Identifier: NCT04760275 .

Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI).

INTRODUCTION: Complex health interventions (CHIs) are increasingly studied in comparative effectiveness research (CER), and there is a need for improvements in CHI research practices. The Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee (MC) launched an effort in 2016 to develop formal guidance on this topic. OBJECTIVE: To develop a set of minimal standards for scientifically valid, transparent, and reproducible CER studies of CHIs. The standards are intended to apply to research examining a broad range of healthcare interventions including delivery system, behavior change, and other non-pharmacological interventions. METHODS: We conducted a literature review, reviewed existing methods guidance, and developed standards through an iterative process involving the MC, two panels of external research methods experts, and a 60-day public comment period. The final standards were approved by the PCORI MC and adopted by the PCORI Board of Governors on April 30, 2018. RESULTS: The final standards include the following: (1) fully describe the intervention and comparator and define their core functions, (2) specify the hypothesized causal pathways and their theoretical basis, (3) specify how adaptations to the form of the intervention and comparator will be allowed and recorded, (4) plan and describe a process evaluation, and (5) select patient outcomes informed by the causal pathway. DISCUSSION: The new standards offer three major contributions to research: (1) they provide a simple framework to help investigators address the major methodological features of a CHI study, (2) they emphasize the importance of the causal model and the need to understand how a CHI achieves its effects rather than simply measuring these effects, and (3) they require description of a CHI using the concepts of core functions and forms. While these standards apply formally to PCORI-funded CER studies, they have broad applicability.

Embedded Research in the Learning Healthcare System: Ongoing Challenges and Recommendations for Researchers, Clinicians, and Health System Leaders.

Embedded research is an innovative means to improve performance in the learning healthcare system (LHS). However, few descriptions of successful embedded research programs have been published. In this perspective, we describe the Care Improvement Research Team, a mature partnership between researchers and clinicians at Kaiser Permanente Southern California. The program supports a core team of researchers and staff with dedicated resources to partner with health system leaders and practicing clinicians, using diverse methods to identify and rectify gaps in clinical practice. For example, recent projects helped clinicians to provide better care by reducing prescribing of unnecessary antibiotics for acute sinusitis and by preventing readmissions among the elderly. Embedded in operational workgroups, the team helps formulate research questions and enhances the rigor and relevance of data collection and analysis. A recent business-case analysis cited savings to the organization of over $10 million. We conclude that embedded research programs can play a key role in fulfilling the promise of the LHS. Program success depends on dedicated funding, robust data systems, and strong relationships between researchers and clinical stakeholders. Embedded researchers must be responsive to health system priorities and timelines, while clinicians should embrace researchers as partners in problem solving.

Stakeholder perceptions of components of a Parkinson disease care management intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS).

BACKGROUND: A recent nurse-led proactive care management intervention, Care Coordination for Health Promotion and Activities in Parkinson Disease (CHAPS), improved care quality when compared to usual care in a randomized controlled trial. Therefore, stakeholder (patient participants, nurse care managers, and Parkinson disease (PD) specialists) perceptions of key intervention components merit evaluation to inform decisions about dissemination. METHODS: This multi-site study occurred in five southwest United States Veterans Health Administration medical centers. Stakeholders were surveyed on their perceptions of CHAPS including the CHAPS Assessment, CHAPS nurse care managers, the Siebens Domain Management Model™ (a practical clinical model), and the Siebens Health Care Notebook (Notebook) (self-care tool). Participants' electronic medical records were abstracted for perceptions of the Notebook. Statistical analysis software was used to provide summary statistics; open card sorting methodology was used to identify themes and attributes in qualitative data including usability of some components. RESULTS: Participants, overall, highly rated their medication self-management, acknowledged some challenges with the CHAPS self-care tools, reported knowledge of PD specialist follow-up and PD red flags, and rated CHAPS nurse care managers as helpful. Nurse care manager responses indicated the CHAPS Assessment and Program highly facilitated care of their patients. Most all PD specialists would refer other patients to CHAPS. Nurse care manager and PD specialist responses indicated improved participant management of their PD. Three themes emerged in participant perceptions of the Notebook: Notebook Assets (e.g., benefits and features-liked); Deferring Notebook Review (e.g., no time to review); and Reasons for Not Using (e.g., participant preference). Shared attributes regarding the Siebens Domain Management Model and Notebook usability, reported by nurse care managers, were user-friendly, person/patient-centered, and organized. Some challenges to their use were also reported. CONCLUSIONS: Overall, stakeholder perceptions of the proactive nurse-led CHAPS intervention indicated its value in the care of individuals with PD. Responses about the CHAPS Assessment, Siebens Domain Management Model, and Notebook self-care tool signified their usefulness. Stakeholders' constructive suggestions indicated their engagement in CHAPS. These findings support CHAPS dissemination and contribute to research in care management. TRIAL REGISTRATION: ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.

Unpacking organizational readiness for change: an updated systematic review and content analysis of assessments.

BACKGROUND: Organizational readiness assessments have a history of being developed as important support tools for successful implementation. However, it remains unclear how best to operationalize readiness across varied projects or settings. We conducted a synthesis and content analysis of published readiness instruments to compare how investigators have operationalized the concept of organizational readiness for change. METHODS: We identified readiness assessments using a systematic review and update search. We mapped individual assessment items to the Consolidated Framework for Implementation Research (CFIR), which identifies five domains affecting implementation (outer setting, inner setting, intervention characteristics, characteristics of individuals, and implementation process) and multiple constructs within each domain. RESULTS: Of 1370 survey items, 897 (68%) mapped to the CFIR domain of inner setting, most commonly related to constructs of readiness for implementation (n = 220); networks and communication (n = 207); implementation climate (n = 204); structural characteristics (n = 139); and culture (n = 93). Two hundred forty-two items (18%) mapped to characteristics of individuals (mainly other personal attributes [n = 157] and self-efficacy [n = 52]); 80 (6%) mapped to outer setting; 51 (4%) mapped to implementation process; 40 (3%) mapped to intervention characteristics; and 60 (4%) did not map to CFIR constructs. Instruments were typically tailored to specific interventions or contexts. DISCUSSION: Available readiness instruments predominantly focus on contextual factors within the organization and characteristics of individuals, but the specificity of most assessment items suggests a need to tailor items to the specific scenario in which an assessment is fielded. Readiness assessments must bridge the gap between measuring a theoretical construct and factors of importance to a particular implementation.

Quality and extent of implementation of a nurse-led care management intervention: care coordination for health promotion and activities in Parkinson's disease (CHAPS).

BACKGROUND: A recent nurse-led, telephone-administered 18-month intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), was tested in a randomized controlled trial and improved care quality. Therefore, intervention details on nurse care manager activity (types and frequencies) and participant actions are needed to support potential dissemination. Activities include nurse care manager use of a holistic organizing framework, identification of Parkinson's disease (PD)-related problems/topics, communication with PD specialists and care coordination, participant coaching, and participant self-care actions including use of a notebook self-care tool. METHODS: This article reports descriptive data on the CHAPS intervention. The study setting was five sites in the Veterans Affairs Healthcare System. Sociodemographic data were gathered from surveys of study participants (community-dwelling veterans with PD). Nurse care manager intervention activities were abstracted from electronic medical records and logbooks. Statistical analysis software was used to provide summary statistics; closed card sorting was used to group some data. RESULTS: Intervention participants (n = 140) were primarily men, mean age 69.4 years (standard deviation 10.3) and community-dwelling. All received the CHAPS Initial Assessment, which had algorithms designed to identify 31 unique CHAPS standard problems/topics. These were frequently documented (n = 4938), and 98.6% were grouped by assigned domain from the Organizing Framework (Siebens Domain Management Model™). Nurse care managers performed 27 unique activity types to address identified problems, collaborating with participants and PD specialists. The two most frequent unique activities were counseling/emotional support (n = 387) and medication management (n = 349). Both were among 2749 total performed activities in the category Implementing Interventions (coaching). Participants reported unique self-care action types (n = 23) including use of a new notebook self-care tool. CONCLUSIONS: CHAPS nurse care managers implemented multiple activities including participant coaching and care coordination per the CHAPS protocol. Participants reported various self-care actions including use of a personalized notebook. These findings indicate good quality and extent of implementation, contribute to ensuring reproducibility, and support CHAPS dissemination as a real-world approach to improve care quality. TRIAL REGISTRATION: ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.

Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.

OBJECTIVES: Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population. MATERIALS AND METHODS: One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence. RESULTS: There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants. CONCLUSIONS: The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted. TRIAL REGISTRATION: NCT01550822.

Usual Care Among Providers Treating Women Veterans: Managing Complexity and Multimorbidity in the Era of Evidence-Based Practice.

To better understand VA providers' approaches to and perspectives on providing care to women Veterans, providers (n = 97) in primary care and mental health settings were interviewed about women's perceived treatment needs, types of care provided, and perceptions of evidence-based treatments (EBTs) for this population. Providers perceived that women Veteran VA users are often diagnostically complex and require a coordinated approach to treatment planning. They struggled with decisions about how to offer services such as EBTs and collaborative care in light of comorbidity and psychosocial stressors, and endorsed the belief that a tailored approach and consideration of these factors is essential in providing care.

The Connectedness of Mental Health Providers Referring Patients to a Treatment Study for Post-Traumatic Stress: A Social Network Study.

We conducted a process evaluation in the context of a Hybrid Type 1 randomized controlled trial testing two treatments for post-traumatic stress, using a web-based social network survey and semi-structured interviews to illustrate the relationship between providers' influence and likelihood of referring patients to the RCT. Providers with high indegree centrality (designated by other providers as someone they seek information from) were significantly more likely to refer patients to the RCT, and serve as an influence to others' referral behavior. Interviews provided additional data to consider for future studies aimed at increasing the uptake of evidence-based practices.

Evaluation of the Implementation Research Institute: Trainees' Publications and Grant Productivity.

With growth in the field of dissemination and implementation (D&I) research, there has been growth in capacity building, with many training opportunities. As such, it is important to continue to evaluate D&I research training programs. This paper reports the results of an evaluation of the Implementation Research Institute (IRI), a R25 funded by the National Institute of Mental Health with additional funding by the Department of Veterans Affairs (VA). The fourth cohort also had a supplement from the National Institute on Drug Abuse. Using bibliometrics data, we report on a quasi-experimental retrospective cohort study assessing whether the rates of scholarly productivity in D&I science of IRI fellows (those who applied and were accepted to the training) were greater than those who applied but were not accepted to IRI. Our findings show that Selected Applicants' odds of publishing in implementation science were higher for earlier alumni, starting at 12% 1 year out and increasing to 94% for those who were 4 years out from starting training. Chances for Non-Selected Applicants remained relatively stable, starting at 47% at 1 year and going to 33% at 4 years since their application, a pattern that was stable even after controlling for demographic characteristics. These results support the hypothesis that IRI is increasing the D&I research productivity of those selected to the program, and that our fellows are advancing the field of D&I compared to those investigators not selected to our institute. Our finding also indicates the importance of a 2-year training.

Follow-up of Abnormal Estimated GFR Results Within a Large Integrated Health Care Delivery System: A Mixed-Methods Study.

BACKGROUND: Timely follow-up of abnormal laboratory results is important for high-quality care. We sought to identify risk factors, facilitators, and barriers to timely follow-up of an abnormal estimated glomerular filtration rate (eGFR) for the diagnosis of chronic kidney disease. STUDY DESIGN: Mixed-methods study: retrospective electronic health record (EHR) analyses, physician interviews. SETTING & PARTICIPANTS: Large integrated health care delivery system. Quantitative analyses included 244,540 patients 21 years or older with incident abnormal eGFRs from January 1, 2010, to December 31, 2015, ordered by 7,164 providers. Qualitative analyses included 15 physician interviews. EXPOSURES: Patient-, physician-, and system-level factors. OUTCOME: Timely follow-up of incident abnormal eGFRs, defined as repeat eGFR obtained within 60 to 150 days, follow-up testing before 60 days that indicated normal kidney function, or diagnosis before 60 days of chronic kidney disease or kidney cancer. ANALYTICAL APPROACH: Multivariable robust Poisson regression models accounting for clustering within provider were used to estimate risk ratios (RRs) and 95% CIs for lack of timely follow-up. Team coding was used to identify themes from physician interviews. RESULTS: 58% of patients lacked timely follow-up of their incident abnormal eGFRs (ie, had a care gap). An abnormal creatinine result flag in the EHR was associated with better follow-up (RR for care gap, 0.65; 95% CI, 0.64-0.66). Patient online portal use and physician panel size were weakly associated with follow-up. Patients seen by providers behind on managing their EHR message box were at higher risk for care gaps. Physician interviews identified system-level (eg, panel size and assistance in managing laboratory results) and provider-level (eg, proficiency using EHR tools) factors that influence laboratory result management. LIMITATIONS: Unable to capture intentional delays in follow-up testing. CONCLUSIONS: Timely follow-up of abnormal results remains challenging in an EHR-based integrated health care delivery system. Strategies improving provider EHR message box management and leveraging health information technology (eg, flagging abnormal eGFR results), making organizational/staffing changes (eg, increasing the role of nurses in managing laboratory results), and boosting patient engagement through better patient portals may improve test follow-up.

Correction to: Core Functions and Forms of Complex Health Interventions: a Patient-Centered Medical Home Illustration.

This paper was originally published without changes made in the correction process. It has been republished with correction.

Core Functions and Forms of Complex Health Interventions: a Patient-Centered Medical Home Illustration.

Despite policy and practice support to develop and test interventions designed to increase access to quality care among high-need patients, many of these interventions fail to meet expectations once deployed in real-life clinical settings. One example is the Patient-Centered Medical Home (PCMH) model, designed to deliver coordinated care. A meta-analysis of PCMH initiatives found mixed evidence of impacts on service access, quality, and costs. Conceptualizing PCMH as a complex health intervention can generate insights into the mechanisms by which this model achieves its effects. It can also address heterogeneity by distinguishing PCMH core functions (the intervention's basic purposes) from forms (the strategies used to meet each function). We conducted a scoping review to identify core functions and forms documented in published PCMH models from 2007 to 2017. We analyzed and summarized the data to develop a PCMH Function and Form Matrix. The matrix contributes to the development of an explicit theory-based depiction of how an intervention achieves its effects, and can guide decision-support tools in the field. This innovative approach can support transformations of clinical settings and implementation efforts by building on a clear understanding of the intervention's standard core functions and the forms adapted to local contexts' characteristics.

A randomized controlled trial of Explore Transplant at Home to improve transplant knowledge and decision-making for CKD 3-5 patients at Kaiser Permanente Southern California.

BACKGROUND: Five-year survival on dialysis is only 40%, compared to 74% with a deceased donor kidney transplant (DDKT) and 87% with a living donor kidney transplant (LDKT). An American Society of Transplantation (AST) Consensus Conference recommended that patients with chronic kidney disease (CKD) Stages 3-5 have the opportunity to learn about and decide which treatment option is right for them, particularly about LDKT. However, early education about LDKT and DDKT outside of transplant centers is inconsistent and often poor, with patients in CKD 3 and 4 and ethnic/racial minorities even less likely to receive it. A new randomized control trial (RCT), in partnership with Kaiser Permanente Southern California (KPSC), will assess knowledge gaps and the effectiveness of a supplementary video-guided, print and technology-based education intervention for English- and Spanish-speaking patients in CKD Stages 3, 4, and 5 to increase LDKT knowledge and decision-making. To date, no published LDKT educational interventions have studied such a large and diverse CKD population. METHODS: In this RCT, 1200 English and Spanish-speaking CKD Stage 3-5 patients will be randomly assigned to one of two education conditions: ET@Home or KPSC standard of care education. Randomization will be stratified by CKD stage and primary language spoken. Those in the ET@Home condition will receive brochures, postcards, DVDs, and text messages delivering educational content in modules over a six-month period. Baseline data collection will measure demographics, transplant derailers, and the amount of previous CKD and transplant education they have received. Changes in CKD and transplant knowledge, ability to make an informed decision about transplant, and self-efficacy to pursue LDKT will be captured with surveys administered at baseline and at six months. DISCUSSION: At the conclusion of the study, investigators will understand key knowledge gaps for patients along the CKD continuum and between patients who speak different languages and have assessed the effectiveness of both English- and Spanish-language supplementary education in increasing KPSC patients' knowledge about the opportunities for and risks and benefits of LDKT. We hope this program will reduce disparities in access to transplant. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03389932; date registered: 12/26/2017.