Project Extension for Community Healthcare Outcomes Intervention Evaluations: A Scoping Review of Research Methods.

INTRODUCTION: Since its inception in 2003, the Project Extension for Community Healthcare Outcomes (ECHO) tele-education model has reached and improved outcomes for patients, providers, and health centers through interventions in >180 countries. Utilization of this model has recently increased due to the COVID-19 pandemic and a higher demand for remote education. However, limited research has examined the methodologies used to evaluate Project ECHO interventions. METHODS: We conducted a scoping review to determine the extent and types of research methods used to evaluate outcomes and implementation success of Project ECHO interventions and to identify gaps and opportunities for future investigation. Using Arksey and O'Malley's scoping review framework and the PRISMA-ScR checklist, we reviewed study designs, temporality, analysis methods, data sources, and levels and types of data in 121 articles evaluating Project ECHO interventions. RESULTS: Most interventions addressed substance use disorders (24.8%, n = 30), infectious diseases (24%, n = 29), psychiatric and behavioral health conditions (21.5%, n = 26), and chronic diseases (19%, n = 23). The most frequently reported evaluation methods included cohort studies (86.8%, n = 105), longitudinal designs (74.4%, n = 90), mixed methods analysis (52.1%, n = 63), surveys (61.2%, n = 74), process evaluation measures (98.3%, n = 119), and provider-level outcome measures (84.3%, n = 102). Few evaluations used experimental designs (1.7%, n = 2), randomization (5.8%, n = 7), or comparison groups (14%, n = 17), indicating limited rigor. DISCUSSION: This scoping review demonstrates the need for more rigorous evaluation methods to test the effectiveness of the Project ECHO model at improving outcomes and standardized reporting guidelines to enhance the dissemination of evaluation data from future Project ECHO interventions.

'We're taught green is good': Perspectives on time in range and time in tight range from youth with type 1 diabetes, and parents of youth with type 1 diabetes.

AIMS: Continuous glucose monitoring (CGM) systems are standard of care for youth with type 1 diabetes with the goal of spending >70% time in range (TIR; 70-180 mg/dL, 3.9-10 mmol/L). We aimed to understand paediatric CGM user experiences with TIR metrics considering recent discussion of shifting to time in tight range (TITR; >50% time between 70 and 140 mg/dL, 3.9 and 7.8 mmol/L). METHODS: Semi-structured interviews and focus groups with adolescents with type 1 diabetes and parents of youth with type 1 diabetes focused on experiences with TIR goals and reactions to TITR. Groups and interviews were audio-recorded, transcribed and analysed using content analysis. RESULTS: Thirty participants (N = 19 parents: age 43.6 ± 5.3 years, 79% female, 47% non-Hispanic White, 20 ± 5 months since child's diagnosis; N = 11 adolescents: age 15.3 ± 2 years, 55% female, 55% non-Hispanic White, 16 ± 3 months since diagnosis) attended. Participants had varying levels of understanding of TIR. Some developed personally preferred glucose ranges. Parents often aimed to surpass 70% TIR. Many described feelings of stress and disappointment when they did not meet a TIR goal. Concerns about TITR included increased stress and burden; risk of hypoglycaemia; and family conflict. Some participants said TITR would not change their daily lives; others said it would improve their diabetes management. Families requested care team support and a clear scientific rationale for TITR. CONCLUSIONS: The wealth of CGM data creates frequent opportunities for assessing diabetes management and carries implications for management burden. Input from people with type 1 diabetes and their families will be critical in considering a shift in glycaemic goals and targets.

Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes.

Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programs are being increasingly emphasized. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk for (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in nonspecialized settings. To inform this monitoring, JDRF, in conjunction with international experts and societies, developed consensus guidance. Broad advice from this guidance includes the following: 1) partnerships should be fostered between endocrinologists and primary care providers to care for people who are IAb+; 2) when people who are IAb+ are initially identified, there is a need for confirmation using a second sample; 3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; 4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; 5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and 6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasizes significant unmet needs for further research on early-stage type 1 diabetes to increase the rigor of future recommendations and inform clinical care.

Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes.

Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programmes are being increasingly emphasised. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk of (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in non-specialised settings. To inform this monitoring, JDRF in conjunction with international experts and societies developed consensus guidance. Broad advice from this guidance includes the following: (1) partnerships should be fostered between endocrinologists and primary-care providers to care for people who are IAb+; (2) when people who are IAb+ are initially identified there is a need for confirmation using a second sample; (3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; (4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; (5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and (6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasises significant unmet needs for further research on early-stage type 1 diabetes to increase the rigour of future recommendations and inform clinical care.

Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes.

Few young people with type 1 diabetes (T1D) meet glucose targets. Continuous glucose monitoring improves glycemia, but access is not equitable. We prospectively assessed the impact of a systematic and equitable digital-health-team-based care program implementing tighter glucose targets (HbA1c < 7%), early technology use (continuous glucose monitoring starts <1 month after diagnosis) and remote patient monitoring on glycemia in young people with newly diagnosed T1D enrolled in the Teamwork, Targets, Technology, and Tight Control (4T Study 1). Primary outcome was HbA1c change from 4 to 12 months after diagnosis; the secondary outcome was achieving the HbA1c targets. The 4T Study 1 cohort (36.8% Hispanic and 35.3% publicly insured) had a mean HbA1c of 6.58%, 64% with HbA1c < 7% and mean time in the range (70-180 mg dl-1) of 68% at 1 year after diagnosis. Clinical implementation of the 4T Study 1 met the prespecified primary outcome and improved glycemia without unexpected serious adverse events. The strategies in the 4T Study 1 can be used to implement systematic and equitable care for individuals with T1D and translate to care for other chronic diseases. ClinicalTrials.gov registration: NCT04336969 .

COVID-19 impacts and inequities among underserved communities with diabetes.

Background: People with diabetes have higher COVID-19 morbidity and mortality. These risks are amplified for underserved communities including racial/ethnic minorities and people with lower socioeconomic status. However, limited research has examined COVID-19 outcomes specifically affecting underserved communities with diabetes. Methods: From November 2021 to July 2022, adults with insulin-requiring diabetes at federally qualified health centers in Florida and California (n = 450) completed surveys examining COVID-19 outcomes and demographics. Surveys assessed COVID-19 severity, vaccination uptake, mask-wearing habits, income changes, and healthcare access changes. Surveys also included the full Coronavirus Anxiety Scale (CAS-19). Descriptive statistics were computed for all outcomes. Between-group comparisons for state and race/ethnicity were evaluated via Chi-Squared, Fisher's Exact, Cochran-Mantel-Haenszel, One-Way ANOVA, and t-tests. Logistic regression determined factors associated with COVID-19 vaccination uptake. Data were self-reported and analyzed cross-sectionally. Results: Overall, 29.7 % reported contracting COVID-19; of those, 45.3 % sought care or were hospitalized. Most (81.3 %) received ≥ 1 vaccine. Hispanics had the highest vaccination rate (91.1 %); Non-Hispanic Blacks (NHBs) had the lowest (73.9 %; p =.0281). Hispanics had 4.63x greater vaccination odds than Non-Hispanic Whites ([NHWs]; 95 % CI = [1.81, 11.89]). NHWs least often wore masks (18.8 %; p <.001). Participants reported pandemic-related healthcare changes (62 %) and higher costs of diabetes medications (41 %). Income loss was more frequent in Florida (76 %; p <.001). NHBs most frequently reported "severe" income loss (26.4 %; p =.0124). Loss of health insurance was more common among NHBs (13.3 %; p =.0416) and in Florida (9.7 %; p =.039). COVID-19 anxiety was highest among NHBs and Hispanics (IQR = [0.0, 3.0]; p =.0232) and in Florida (IQR = [0.0, 2.0]; p =.0435). Conclusions: Underserved communities with diabetes had high COVID-19 vaccine uptake but experienced significant COVID-19-related physical, psychosocial, and financial impacts. NHBs and those in Florida had worse outcomes than other racial/ethnic groups and those in California. Further research, interventions, and policy changes are needed to promote health equity for this population.

Multisite Quality Improvement Program Within the Project ECHO Diabetes Remote Network.

BACKGROUND: The telementoring Project ECHO (Extension for Community Healthcare Outcomes) model has been shown to improve disease management in diabetes in many underserved communities. The authors aim to evaluate if ECHO could also be an effective tool for quality improvement (QI) of diabetes care in these communities. METHODS: Thirteen clinics in underserved communities in California and Florida participating in Project ECHO Diabetes were recruited for a 12-month QI program. The program provided weekly tele-education sessions, including a didactic presentation and case-based discussion. In addition, clinics chose their own set of quality measures to improve and met remotely to discuss their efforts, successes, and setbacks every quarter with mentorship from QI experts. RESULTS: Of the 31 QI initiatives attempted by different clinics, all had either made improvements (25 initiatives, 80.6%) or were in the process of making improvements (6 initiatives, 19.4%) in structural, process, and outcome measures. Examples of these measures include whether clinics have protocols to identify high-risk patients (structure), numbers of continuous glucose monitor prescriptions submitted by the clinics (process), and percentage of patients with diabetes whose most recent HbA1c are > 9% (outcome). For one measure, 40.0% of the clinics had achieved a higher percentage of cumulative HbA1c measurement in the third quarter of the year, compared to the fourth quarter in the previous year. The cost of QI implementation varied widely due to different number of personnel involved across sites. CONCLUSION: A QI program delivered via Project ECHO Diabetes can facilitate quality improvements in underserved communities.

Current Practices in Operationalizing and Addressing Racial Equity in the Provision of Type 1 Diabetes Care: Insights from the Type 1 Diabetes Exchange Quality Improvement Collaborative Health Equity Advancement Lab.

OBJECTIVE: Medical racism contributes to adverse health outcomes. Type 1 Diabetes Exchange Quality Improvement Collaborative (T1DX-QI) is a large population-based cohort engaged in data sharing and quality improvement to drive system changes in T1D care. The annual T1DX-QI survey included questions to evaluate racial equity in diabetes care and practices to promote equity. METHODS: The annual T1DX-QI survey was administered to participating clinics in fall 2022 and had a 93% response rate. There were 50 responses (pediatric: 66% and adult: 34%). Questions, in part, evaluated clinical resources and racial equity. Response data were aggregated, summarized, and stratified by pediatric/adult institutions. RESULTS: Only 21% pediatric and 35% adult institutions felt that all their team members can articulate how medical racism contributes to adverse diabetes outcomes. Pediatric institutions reported more strategies to address medical racism than adult (3.6 vs 3.1). Organizational strategies to decrease racial discrimination included employee trainings, equity offices/committees, patient resources, and hiring practices. Patient resources included interpreter services, transportation, insurance navigation, and housing and food assistance. Hiring practices included changing prior protocols, hiring from the community, and diversifying workforces. Most institutions have offered antiracism training in the last year (pediatric: 85% and adult: 72%) and annually (pediatric: 64% and adult: 56%). Pediatric teams felt that their antiracism training was effective more often (pediatric: 60% and adult: 45%) and more commonly, they were provided resources (pediatric: 67% and adult: 47%) to help address inequities. CONCLUSION: Despite increased antiracism training, insufficient institutional support and perceived subeffective training still represent obstacles, especially in adult institutions. Sharing effective strategies to address medical racism will help institutions take steps to mitigate inequities.

"It changed everything we do": A mixed methods study of youth and parent experiences with a pilot exercise education intervention following new diagnosis of type 1 diabetes.

AIMS: This pilot study delivered a comprehensive exercise education intervention to youth with new-onset type 1 diabetes (T1D) and their parents to increase knowledge and confidence with physical activity (PA) shortly after diagnosis. METHODS: Youth initiated continuous glucose monitoring (CGM) and PA trackers within 1 month of diagnosis. Youth and their parents received the 4-session intervention over 12 months. Participants completed self-report questionnaires at baseline, 6- and 12-months. Surveys were analyzed using linear mixed effects models. Semi-structured interviews and focus groups explored experiences with the exercise education intervention. Groups and interviews were audio-recorded, transcribed, and analyzed using content analysis. RESULTS: A total of 16 parents (aged 46 ± 7 years; 88 % female; 67 % non-Hispanic White) and 17 youth (aged 14 ± 2 years; 41 % female; 65 % non-Hispanic White) participated. Worry about hypoglycemia did not worsen throughout the study duration. Parents and youth reported increased knowledge and confidence in managing T1D safely and preventing hypoglycemia during PA following receiving the tailored exercise education intervention. CONCLUSION: This study assessed a novel structured exercise education program for youth and their parents shortly following T1D diagnosis. These results support the broad translation and acceptability of a structured exercise education program in new-onset T1D.

Diabetic Ketoacidosis at Diagnosis in Youth with Type 1 Diabetes Is Associated with a Higher Hemoglobin A1c Even with Intensive Insulin Management.

Introduction: Diabetic ketoacidosis (DKA) at diagnosis is associated with short- and long-term complications. We assessed the relationship between DKA status and hemoglobin A1c (A1c) levels in the first year following type 1 diabetes (T1D) diagnosis. Research Design and Methods: The Pilot Teamwork, Targets, Technology, and Tight Control (4T) study offered continuous glucose monitoring to youth with T1D within 1 month of diagnosis. A1c levels were compared between historical (n = 271) and Pilot 4T (n = 135) cohorts stratified by DKA status at diagnosis (DKA: historical = 94, 4T = 67 versus without DKA: historical = 177, 4T = 68). A1c was evaluated using locally estimated scatter plot smoothing. Change in A1c from 4 to 12 months postdiagnosis was evaluated using a linear mixed model. Results: Median age was 9.7 (interquartile range [IQR]: 6.6, 12.7) versus 9.7 (IQR: 6.8, 12.7) years, 49% versus 47% female, 44% versus 39% non-Hispanic White in historical versus Pilot 4T. In historical and 4T cohorts, DKA at diagnosis demonstrated higher A1c at 6 (0.5% [95% confidence interval (CI): 0.21-0.79; P < 0.01] and 0.38% [95% CI: 0.02-0.74; P = 0.04], respectively), and 12 months (0.62% [95% CI: -0.06 to 1.29; P = 0.07] and 0.39% [95% CI: -0.32 to 1.10; P = 0.29], respectively). The highest % time in range (TIR; 70-180 mg/dL) was seen between weeks 15-20 (69%) versus 25-30 (75%) postdiagnosis for youth with versus without DKA in Pilot 4T, respectively. Conclusions: Pilot 4T improved A1c outcomes versus the historical cohort, but those with DKA at diagnosis had persistently elevated A1c throughout the study and intensive diabetes management did not mitigate this difference. DKA prevention at diagnosis may translate into better glycemic outcomes in the first-year postdiagnosis. Clinical Trial Registration: clinicaltrials.gov: NCT04336969.

Following in Banting's footsteps or straying from the path? Observations from contemporary diabetes innovation.

While advancements in the treatment of diabetes continue to rapidly evolve, many of the newer technologies have financial barriers to care, opposing the egalitarian ethos of Banting who sold his patent on insulin for a nominal cost to allow it to be made widely available. Inequity in access to new therapies drives disparity in diabetes burden with potential for these gaps to widen in the future. The 2023 International Conference on Advanced Technologies and Treatments of Diabetes (ATTD) presented ground-breaking and current research in diabetes technology. Oral presentations of the ATTD conference 2023 were analyzed to describe what percentage of speakers discussed equity in their talks. Overall, less than a quarter of presenters discussed equity, though there was regional variation. To ensure that diabetes technologies reduce disparity and improve outcomes, we encourage future speakers at diabetes (technology) conferences to consider equity of diabetes care and incorporate this into their presentations.

Safe use of the ketogenic diet in an infant with microcephaly, epilepsy, and diabetes syndrome: a case report.

BACKGROUND: Microcephaly, epilepsy, and diabetes syndrome (MEDS) is a rare syndromic form of monogenic diabetes caused by bi-allelic loss of function mutations in IER3IP1. In vitro studies have shown that loss of IER31P leads to apoptosis in both neurons and pancreatic ß-cells. Simultaneous management of seizures and diabetes is challenging in patients with MEDS. We present the challenges and successes in the use of ketogenic diet in an infant with insulinopenic diabetes. CASE PRESENTATION: Our term female proband presented at 2 months of age with new onset multifocal seizures followed by the onset of infantile spasms (IS) at 4 months of age. An epilepsy gene panel identified bi-allelic variants, c.239T > G (p.Leu80*) and c.2T > A (initiator codon), in IER3IP1 that were subsequently shown to be inherited in trans. Following initiation of steroid therapy for IS, the patient developed clinically apparent insulin requiring diabetes. Her epilepsy was ultimately refractory to multiple antiseizure medications, thus the ketogenic diet (KD) was initiated. We were able to successfully titrate to a therapeutic KD ratio of 3:1 and maintain a ketotic state without diabetic ketoacidosis (DKA). With intercurrent illnesses, however, the patient had rapid decompensation and mild DKA due to delays in treatment, and for this reason, KD was discontinued after 5 months. CONCLUSIONS: We report two novel IER31P1 mutations in a patient with MEDS and the successful management of the cooccurring conditions of IS and insulinopenic diabetes with the KD. Our experience underscores the importance of careful monitoring during KD as our patient had DKA more easily when on the KD.

The Promising Success of Project Extension for Community Healthcare Outcomes (ECHO) Diabetes: Case Series.

BACKGROUND: In the United States, there are over 37 million people with diabetes but only 8000 endocrinologists. Therefore, many people with diabetes receive care exclusively from primary care providers (PCPs). To democratize knowledge regarding insulin-requiring diabetes through tele-education, Stanford University and the University of Florida developed Project Extension for Community Healthcare Outcomes (ECHO) Diabetes. OBJECTIVE: ECHO Diabetes uses a Hub and Spoke model connecting specialists (the "Hub") with PCPs (the "Spokes"). One-hour, weekly sessions include Hub diabetes didactic presentations and Spoke deidentified case presentations. Lessons learned during these sessions target provider knowledge and confidence surrounding diabetes management and patient care. METHODS: Spokes were asked to provide short descriptions of people with diabetes whose diabetes management improved directly or indirectly from their providers' participation or their involvement with a Diabetes Support Coach (DSC). We provide a case series to describe individuals and outcomes. Because this study was not a randomized controlled trial and was a prospective observation of patients with the intervention delivered to providers, the trial is not registered in a public trials registry. RESULTS: A case series of 11 people with diabetes was compiled from 10 PCPs and 1 DSC from California and Florida between 2021 and 2022. The principal impact of ECHO Diabetes is the education amplified from PCPs and DSCs to people with diabetes. In all cases, people with diabetes reported increased engagement and improved diabetes management. Several cases reflected increased access to diabetes technology, improvement in glycemic outcomes, and positive trends in mental health measures. CONCLUSIONS: This case series elucidates the potential value of the ECHO Diabetes program to people with diabetes who receive their diabetes care from PCPs. Those matched with a DSC saw clinically significant improvements in hemoglobin A1c and mental health outcomes.

Recruiting historically under-represented individuals into Project ECHO Diabetes: using barrier analysis to understand disparities in clinical research in the USA.

OBJECTIVES: Individuals under-recruited in diabetes research studies include those not seen at endocrinology centres and those from rural, low socioeconomic and/or under-represented racial/ethnic groups. The purpose of this descriptive analysis is to detail recruitment and retention efforts of Project ECHO Diabetes clinical sites affiliated with Stanford University and University of Florida. DESIGN: Prospective collection of participant engagement and qualitative analysis of barriers and facilitators of research engagement within Project ECHO Diabetes, a virtual tele-education programme for healthcare providers in the management of individuals with insulin-requiring diabetes. SETTING: Data were collected at the patient level, provider level and clinic level between 1 May 2021 and 31 July 2022. PARTICIPANTS: Participants and study personnel were recruited from 33 Project ECHO Diabetes sites in California and Florida. OUTCOMES: We report study completion rates for participants recruited into 33 Project ECHO Diabetes sites. Using barrier analysis, a methodology designed for the real-time assessment of interventions and system processes to identify barriers and facilitators, study personnel identified significant barriers to recruitment and retention and mapped them to actionable solutions. RESULTS: In total, 872 participants (California n=495, Florida n=377) were recruited with differing recruitment rates by site (California=52.7%, Florida=21.5%). Barrier analysis identified lack of trust, unreliable contact information, communication issues and institutional review board (IRB) requirements as key recruitment barriers. Culturally congruent staff, community health centre (CHC) support, adequate funding and consent process flexibility were solutions to address recruitment challenges. Barriers to retention were inconsistent postal access, haemoglobin A1c kit collection challenges, COVID-19 pandemic and broadband/connectivity issues. Additional funding supporting research staff and analogue communication methods were identified as solutions address barriers to retention. CONCLUSIONS: Funded partnerships with CHCs, trusted by their local communities, were key in our recruitment and retention strategies. IRB consent process flexibility reduced barriers to recruitment. Recruiting historically under-represented populations is feasible with funding aimed to address structural barriers to research participation.