Sickle cell disease (SCD) affects millions globally, with pain being the most prevalent symptom. Adolescents and young adults (AYAs) with SCD face high rates of pain crises and healthcare encounters. Digital cognitive behavioral therapy (CBT) shows promise for pain management but faces engagement challenges. The PRESENCE study aims to enhance engagement in and benefit from digital CBT for SCD by adding personalized peer support. This multisite, randomized controlled trial is recruiting 470 AYAs (ages 16–30) with SCD who report chronic pain. Participants are randomized 3:3:2 respectively to one of three groups: (1) CBT with peer support (CBT + Peer), (2) CBT alone (CBT), or (3) usual care (UC). Participants are provided access to the study mobile application, which is used for intervention delivery and data collection. Peer support is provided weekly by trained peer coaches who are individuals with lived experience. Evaluations are completed at baseline, 3, 6, and 12 months post randomization. The primary study aim is to determine whether AYAs receiving any digital CBT have greater reductions in pain intensity and pain interference at 6 months post randomization compared to those receiving UC. The secondary aim is to determine whether CBT + Peer is superior to CBT in reducing pain intensity and interference at 6 months. Secondary outcomes include reductions in mean daily pain intensity, pain days, average weekly opioid dose, emergency department visits, healthcare utilization, internalized stigma, and depression and anxiety symptoms, and improvements in sickle cell self-efficacy. Findings from the PRESENCE trial will inform patients, parents, and providers on how digital CBT and peer support will improve pain management. Ultimately, this study will advance our understanding of how digital interventions can be optimized for populations with complex chronic conditions like SCD, where stigma and healthcare navigation can be barriers to effective care delivery. This approach could offer a scalable, accessible, and culturally responsive strategy to improve pain outcomes, reduce opioid reliance, and enhance overall health and well-being for AYAs with SCD. Clinicaltrials.gov NCT06374238. Registered on April 2025.

KEY POINTS · The influence of social determinants of health (SDOH) on sodium–glucose cotransporter 2 (SGLT2) inhibitor and glucagon-like peptide 1 (GLP-1) receptor agonist prescribing for people with type 2 diabetes and chronic kidney disease (CKD) is not well known. · This study found that younger age and higher A1C were associated with increased likelihood of initiation of SGLT2 inhibitors and GLP-1 receptor agonists. SDOH factors were not associated with initiation of these drugs. A CKD population health management intervention did not affect these associations. · These findings suggest targets for new interventions to increase incident use of SGLT2 inhibitors and GLP-1 receptor agonists among individuals with type 2 diabetes and CKD. Objective. Negative social determinants of health (SDOH) are associated with greater kidney disease incidence and progression, partly because of suboptimal management. We studied the association of demographic, clinical, and individual- and contextual-level SDOH factors with sodium–glucose cotransporter 2 (SGLT2) inhibitor and glucagon-like peptide 1 (GLP-1) receptor agonist initiation in patients with type 2 diabetes and whether these associations were modified by the Kidney Coordinated HeAlth Management Partnership (K-CHAMP) population health management (PHM) program. Research Design and Methods. Using data from the K-CHAMP trial, which cluster-randomized 101 primary care offices to a control arm or the PHM intervention (including nephology electronic consultation, chronic kidney disease education, and pharmacist medication review), we explored associations between SGLT2 inhibitor and GLP-1 receptor agonist initiation with a priori patient factors using adjusted Poisson regression. Enrolled patients with type 2 diabetes who were not prescribed an SGLT2 inhibitor or a GLP-1 receptor agonist at baseline were included. Effect modification by K-CHAMP was assessed using interaction terms. Results. The cohort had 891 patients (402 receiving the PHM intervention and 489 in the control group). Fifty-five percent of participants were female and 89% were White; the cohort had had a mean age of 73 ± 9 years, mean BMI of 33 ± 7 kg/m2, mean A1C of 7.3 ± 1.5%, and mean estimated glomerular filtration rate of 37.4 ± 8.3 mL/min/1.73 m2; and 24% were rural living. Over a median follow-up of 17.7 months (interquartile range [IQR] 12.4–23.8 months), 238 (26.7%) initiated an SGLT2 inhibitor or GLP-1 receptor agonist. In adjusted analysis, age (incidence rate ratio [IRR] 0.92, 95% CI 0.85–0.99) and A1C (IRR 1.15, 95% CI 1.07–1.24) were significantly associated with SGLT2 inhibitor or GLP-1 receptor agonist initiation. The K-CHAMP PHM intervention did not significantly modify association of any factors. Conclusion. Younger age and higher A1C were associated with increased likelihood of initiating an SGLT2 inhibitor or GLP-1 receptor agonist. Other demographic, clinical, and SDOH factors were not significantly associated with medication initiation. The K-CHAMP PHM intervention did not moderate the association of patient-level or SDOH factors with initiation of an SGLT2 inhibitor or GLP-1 receptor agonist.

OBJECTIVE:Negative social determinants of health (SDOH) are associated with greater kidney disease incidence and progression, partly because of suboptimal management. We studied the association of demographic, clinical, and individual- and contextual-level SDOH factors with sodium-glucose cotransporter 2 (SGLT2) inhibitor and glucagon-like peptide 1 (GLP-1) receptor agonist initiation in patients with type 2 diabetes and whether these associations were modified by the Kidney Coordinated HeAlth Management Partnership (K-CHAMP) population health management (PHM) program. RESEARCH DESIGN AND METHODS:Using data from the K-CHAMP trial, which cluster-randomized 101 primary care offices to a control arm or the PHM intervention (including nephology electronic consultation, chronic kidney disease education, and pharmacist medication review), we explored associations between SGLT2 inhibitor and GLP-1 receptor agonist initiation with a priori patient factors using adjusted Poisson regression. Enrolled patients with type 2 diabetes who were not prescribed an SGLT2 inhibitor or a GLP-1 receptor agonist at baseline were included. Effect modification by K-CHAMP was assessed using interaction terms. RESULTS:The cohort had 891 patients (402 receiving the PHM intervention and 489 in the control group). Of the participants, 55% were female and 89% were White; the cohort had a mean age of 73 ± 9 years, mean BMI of 33 ± 7 kg/m2, mean A1C of 7.3 ± 1.5%, and mean estimated glomerular filtration rate of 37.4 ± 8.3 mL/min/1.73 m2; and 24% were rural living. Over a median follow-up of 17.7 months (interquartile range [IQR] 12.4-23.8 months), 238 (26.7%) initiated an SGLT2 inhibitor or GLP-1 receptor agonist. In adjusted analysis, age (incidence rate ratio [IRR] 0.92, 95% CI 0.85-0.99) and A1C (IRR 1.15, 95% CI 1.07-1.24) were significantly associated with SGLT2 inhibitor or GLP-1 receptor agonist initiation. The K-CHAMP PHM intervention did not significantly modify association of any factors. CONCLUSION:Younger age and higher A1C were associated with increased likelihood of initiating an SGLT2 inhibitor or GLP-1 receptor agonist. Other demographic, clinical, and SDOH factors were not significantly associated with medication initiation. The K-CHAMP PHM intervention did not moderate the association of patient-level or SDOH factors with initiation of an SGLT2 inhibitor or GLP-1 receptor agonist.

OBJECTIVE:To examine the feasibility, acceptability, and potential health effects of computerized cognitive behavioral therapy-enhanced collaborative care (cCBT-CC) versus usual primary care (UC). BACKGROUND:Internet-based cCBT can effectively treat depression but is not widely used, including in the Veterans Health Administration where it was freely available for veterans. We adapted pre-existing depression collaborative care models using implementation and user-centered design strategies to facilitate cCBT implementation. METHODS:This pilot randomized controlled trial (RCT) included 57 VA primary care patients to cCBT-CC or UC. Participants had Patient Health Questionnaire (PHQ-9) scores of 10+. Those with serious mental illness (e.g., bipolar depression, schizophrenia) and active suicidality were excluded. Intervention patients received tailored Vets Prevail cCBT accompanied by collaborative care manager support, overseen by psychiatry and primary care. UC offered collaborative care services and digital mental health tools at baseline. Feasibility (patient reach, provider adoption, intervention implementation), acceptability (CSQ-8), and potential effectiveness (PHQ-9) data was collected at baseline and 3-months by a blinded study team member. RESULTS:Participants (cCBT-CC n = 29, UC n = 28) were 50 years old (mean); 70 % men; 32 % White, 32 % Hispanic, 25 % Black; 21 % homeless-experienced. Mean baseline PHQ-9 scores were 15.1 (SD = 5.0); 39 % reported suicidal thoughts/behaviors. 72 % of 94 primary care providers, from 6 out of the 8 participating clinics, helped support their patients' participation. cCBT-CC participants received 4 care manager check-ins over 33 days totaling 113 min (64 % clinical; 36 % technical), on average. They completed mean 6.7 out of 11 cCBT lessons. Participants in the cCBT-CC arm experienced a statistically (not clinically) significant decline in the primary outcome of depression (Δ = -2.5; p = 0.02) symptoms from pretreatment to posttreatment. There was a greater, albeit non-significant, decrease in PHQ-9 scores among cCBT-CC participants over 3-months, compared to UC participants (Δ = -2.8; 95 % CI = -5.6, -0.01; p = 0.05). CONCLUSIONS:cCBT-enhanced collaborative care appeared feasible, acceptable, and possibly effective in treating primary care patients with depression.

Key PointsA population health management intervention for CKD reduced inpatient hospitalizations by 27% compared with usual care over a 1-year follow-up.Despite lower hospitalizations, total healthcare costs were not significantly different between population health management and usual care.BackgroundCKD represents a substantial economic burden, particularly in the Medicare population in the latter stages of disease progression. There are potential opportunities to provide quality care through population health management (PHM) interventions in the hopes of improving downstream outcomes and costs. In Kidney Coordinated HeAlth Management Partnership, a pragmatic, cluster randomized trial, patients received a PHM, multidisciplinary team approach to improve CKD care or usual care. The primary objective of this study was to conduct a post hoc comparative analysis of the 1-year healthcare utilization between patients who received the PHM intervention compared to usual care with a secondary objective of comparing standardized costs.MethodsA subset of Kidney Coordinated HeAlth Management Partnership patients who had available health insurance claims with enrollment for the full 12 months in the year after trial enrollment were included. Inpatient, outpatient, and pharmacy standardized costs were estimated using diagnosis-related groups, current procedural terminology, and National Drug Codes, respectively. Resource utilization was analyzed using negative binomial models, and costs were analyzed using two-part models. All analyses were adjusted for demographic and clinical characteristics. Subgroups were analyzed by age, sex, CKD stage, and diabetes status.ResultsOf the 1596 trial participants, 614 patients met inclusion criteria (PHM: 300; usual care: 314). Patients in the PHM arm had 27% fewer inpatient hospitalizations than usual care (incident rate ratio=0.73; 95% confidence interval, 0.54 to 0.99), but outpatient visits did not differ significantly. Total standardized costs were similar between the PHM and usual care treatment arms across inpatient, outpatient, and pharmacy categories.ConclusionsThe PHM intervention reduced inpatient hospitalizations but did not significantly affect healthcare costs over 1 year. The reliance on standardized costs and the short follow-up may have obscured potential differences. Longer term data would help provide insight into the economic and resource utilization effect of the PHM intervention.

The transition from adolescence to adulthood in individuals with sickle cell disease (SCD) is a time of high risk for both acute and chronic pain, contributing to poor physical and mental health outcomes. Digital cognitive behavioral therapy (CBT) is a promising non-pharmacological treatment for treating pain and enhancing pain-related coping skills. However, it remains underutilized in SCD care due to clinician and patient unfamiliarity, the need for long-term patient engagement with digital CBT, and lack of knowledge on efficacy as well as how best to integrate this scalable technology into routine clinical care. The NIH-funded PRESENCE Trial aims to determine the effectiveness of a digital CBT program at improving chronic pain outcomes among adolescents and young adults (AYA) with SCD, and whether peer support from health coaches with lived experience with SCD can promote engagement with digital CBT. PRESENCE is recruiting 470 AYAs with SCD reporting chronic pain who present for care at academically affiliated SCD specialty clinics at academic healthcare institutions located across the United States, from SCD community-based organizations, and virtually using online advertising and outreach. Eligibility criteria include: 1) age 16-30years; 2) SCD diagnosis; 3) experience 4 or more days of chronic pain for the past 3months, and/or taking or prescribed pain medication 4 or more days for the past 3 months. Exclusion criteria are: 1) cannot read/speak English; 2) do not have access to a mobile phone/device; 3) prior hematopoietic stem cell transplant; or 4) report active suicidality. Protocol-eligible and consenting patients are randomized 3:3:2 ratio to either: 1) digital CBT with peer support (CBT+peer); 2) digital CBT alone (CBT); or 3) usual care (UC). All participants are provided access to our PRESENCE mobile app which enables them to record brief reports on their pain, mood, and medication use. For those randomized to our CBT+peer and CBT arms, the PRESENCE mobile app also provide access to CaRISMA, a 12-week digital CBT intervention for SCD patients we developed and proved effective in a previous study. Those randomized to CBT+peer also receive peer support from trained peer coaches living with SCD, who help participants develop a personalized plan focused on symptom awareness and management, monitor participant progress with CaRISMA, and promote patient engagement with the program. The primary outcomes of PRESENCE are to determine whether digital CBT is superior to UC at improving pain intensity and interference at 6 months following randomization, and secondary outcomes will evaluate CBT+peer versus CBT. Other outcomes include mean daily pain intensity, pain days, average weekly opioid dose, emergency department visits, healthcare utilization, internalized stigma, self-efficacy, depression, and anxiety symptoms for up to 12-months follow-up. Participants also complete within-app entries on pain, mood, and medication use for at least 3 days during week-long data collection periods after randomization, and at 3, 6, and 12 months. Subgroup analyses will test for differences in effect among age and sex, as well as any baseline variables with large clinically meaningful between-group variability. Enrollment began in March 2025, and we anticipate we will reach our 470 target sample in July 2027. The PRESENCE Trial addresses a critical need for effective, accessible non-opioid pain management interventions for AYAs with SCD. The study evaluates the potential of digital CBT with or without peer support to reduce chronic pain in SCD by utilizing an accessible and available mobile technology to support pain treatment, with the goal of reducing the need for potentially harmful treatments such as chronic opiates. If our hypotheses are supported, we also anticipate PRESENCE will raise awareness and use of digital CBT by patients and providers nationally. Figure 1PRESENCE app launch screen, eDiary, pain level, and video library examplesThe image above represents multiple screenshots of example tasks that a user would see when they gain access to the PRESENCE mobile app.

Introduction: Chronic kidney disease (CKD) represents a substantial economic burden, particularly in the Medicare population in the latter stages of disease progression. There are potential opportunities to provide quality care through population health management (PHM) interventions in the hopes of improving downstream outcomes and costs. In Kidney Coordinated HeAlth Management Partnership (CHAMP), a pragmatic, cluster randomized trial, patients received a PHM, multidisciplinary team approach to improve CKD care or usual care. The primary objective of this study was to conduct a post-hoc comparative analysis of the one-year healthcare utilization between patients who received the PHM intervention compared to usual care with a secondary objective of comparing standardized costs. Methods: A subset of Kidney CHAMP patients who had available health insurance claims with enrollment for the full 12 months in the year following trial enrollment were included. Inpatient, outpatient, and pharmacy standardized costs were estimated using diagnosis-related groups, current procedural terminology, and National Drug Codes, respectively. Resource utilization was analyzed using negative binomial models and costs were analyzed using two-part models. All analyses were adjusted for demographic and clinical characteristics. Subgroups were analyzed by age, sex, CKD stage, and diabetes status. Results: Of the 1,596 trial participants, 614 patients met inclusion criteria (PHM: 300; usual care: 314). Patients in the PHM arm had 27% fewer inpatient hospitalizations than usual care (incident rate ratio=0.73; 95% CI: 0.54-0.99), but outpatient visits did not differ significantly. Total standardized costs were similar between the PHM and usual care treatment arms across inpatient, outpatient, and pharmacy categories. Conclusion: The PHM intervention reduced inpatient hospitalizations but did not significantly impact healthcare costs over one year. The reliance on standardized costs and the short follow-up may have obscured potential differences. Longer term data would help provide insight into the economic and resource utilization impact of the PHM intervention.

Collaborative care is a multicomponent intervention for patients with chronic disease in primary care. Previous meta-analyses have proven the effectiveness of collaborative care for depression; however, individual participant data (IPD) are needed to identify which components of the intervention are the principal drivers of this effect. To assess which components of collaborative care are the biggest drivers of its effectiveness in reducing symptoms of depression in primary care. Data were obtained from MEDLINE, Embase, Cochrane Library, PubMed, and PsycInfo as well as references of relevant systematic reviews. Searches were conducted in December 2023, and eligible data were collected until March 14, 2024. Two reviewers assessed for eligibility. Randomized clinical trials comparing the effect of collaborative care and usual care among adult patients with depression in primary care were included. The study was conducted according to the IPD guidance of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline. IPD were collected for demographic characteristics and depression outcomes measured at baseline and follow-ups from the authors of all eligible trials. Using IPD, linear mixed models with random nested effects were calculated. Continuous measure of depression severity was assessed via validated self-report instruments at 4 to 6 months and was standardized using the instrument’s cutoff value for mild depression. A total of 35 datasets with 38 comparisons were analyzed (N = 20 046 participants [57.3% of all eligible, with minimal differences in baseline characteristics compared with nonretrieved data]; 13 709 [68.4%] female; mean [SD] age, 50.8 [16.5] years). A significant interaction effect with the largest effect size was found between the depression outcome and the collaborative care component therapeutic treatment strategy (−0.07; P < .001). This indicates that this component, including its key elements manual-based psychotherapy and family involvement, was the most effective component of the intervention. Significant interactions were found for all other components, but with smaller effect sizes. Components of collaborative care most associated with improved effectiveness in reducing depressive symptoms were identified. To optimize treatment effectiveness and resource allocation, a therapeutic treatment strategy, such as manual-based psychotherapy or family integration, may be prioritized when implementing a collaborative care intervention.

Background Atrial fibrillation (AF) requires long-term adherence to oral anticoagulation and self-care. Methods We conducted a randomized controlled trial of a smartphone-based relational agent and heart rhythm monitor with the primary outcome of anticoagulation adherence and secondary outcomes of quality of life (QOL) and health care utilization. The trial enrolled individuals with Atrial fibrillation (AF) taking anticoagulation. Intervention participants received a smartphone-based relational agent for disease education, adherence monitoring, and self-care, and a heart rate and rhythm monitor. Attention control participants received a smartphone health education application and the same heart monitor. Participants had baseline and 4-, 8-, and 12-month visits. The primary outcome was 12-month proportion of days covered (PDC) ascertained with pharmacy claims. Results From January, 2020 to April, 2022, the trial enrolled 243 participants (age 70.8 ± 9.8 years; 64.2% female; 30.5% Black race). The adjusted mean PDC at 12 months in the intervention arm was 0.88 (95% Confidence Interval [CI], 0.84-0.93) and in the attention control 0.85 (95% CI, 0.81-0.90) with no difference in odds of PDC ≥ 0.80 in intervention compared to the control (Odds Ratio, 1.26 [95% CI, 0.66-2.38]). Self-reported nonadherence and QOL did not differ by study arm. The event rates for health care utilization were significantly less for intervention than attention control participants as measured by emergency room visits and hospitalizations (P < .001) and number of days hospitalized (P = .004). Conclusion The smartphone-based relational agent intervention did not achieve its primary endpoint of increased anticoagulation adherence but did yield decreased health care utilization. Trial registration ClinicalTrials.gov Identifier: NCT04075994

BACKGROUND:Rural individuals with atrial fibrillation (AF) experience challenges to anticoagulation adherence and self-management of the condition. We tested an intervention to improve anticoagulation adherence, quality of life, and health care utilization in rural individuals with AF. METHODS:We randomized rural patients with AF receiving anticoagulation to receive a smartphone-based relational agent (for disease education and adherence guidance) and a heart rate and rhythm monitor for 4 months or a smartphone-based health education app. Adherence was determined with 12-month proportion of days covered (PDC), and secondary outcomes of quality of life and health care utilization from interviews and health records. RESULTS:The trial randomized 270 individuals 1:1 (median [IQR] age 73.1 [67.5-78.6]; 163 [60.4 %] female sex). Over the 4-month intervention, intervention participants used the relational agent a median of 101 (IQR: 72, 110) days. In an intention-to-treat analysis there was no significant difference in 12-month PDC between the intervention and control groups (median [IQR]: intervention 0.97 [0.89-1.00] versus control 0.97 [0.92-1.00]) or in PDC ≥0.80. Intervention participants were more likely to self-report anticoagulation adherence than control at 4 and 8 months (95.7 % vs 88.4 % and 93.0 % vs 78.8 %, respectively) but not at 12 months. There were no significant differences by assigned intervention for the other secondary outcomes. CONCLUSIONS:Randomization to the relational agent intervention was not associated with improved PDC at 12-months but with greater interim self-reported adherence compared to a control. This study demonstrates the successful use of a smartphone-based agent to address adherence among rural individuals with AF.

Importance Collaborative care is a multicomponent intervention for patients with chronic disease in primary care. Previous meta-analyses have proven the effectiveness of collaborative care for depression; however, individual participant data (IPD) are needed to identify which components of the intervention are the principal drivers of this effect. Objective To assess which components of collaborative care are the biggest drivers of its effectiveness in reducing symptoms of depression in primary care. Data Sources Data were obtained from MEDLINE, Embase, Cochrane Library, PubMed, and PsycInfo as well as references of relevant systematic reviews. Searches were conducted in December 2023, and eligible data were collected until March 14, 2024. Study Selection Two reviewers assessed for eligibility. Randomized clinical trials comparing the effect of collaborative care and usual care among adult patients with depression in primary care were included. Data Extraction and Synthesis The study was conducted according to the IPD guidance of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline. IPD were collected for demographic characteristics and depression outcomes measured at baseline and follow-ups from the authors of all eligible trials. Using IPD, linear mixed models with random nested effects were calculated. Main Outcomes and Measures Continuous measure of depression severity was assessed via validated self-report instruments at 4 to 6 months and was standardized using the instrument's cutoff value for mild depression. Results A total of 35 datasets with 38 comparisons were analyzed (N = 20 046 participants [57.3% of all eligible, with minimal differences in baseline characteristics compared with nonretrieved data]; 13 709 [68.4%] female; mean [SD] age, 50.8 [16.5] years). A significant interaction effect with the largest effect size was found between the depression outcome and the collaborative care component therapeutic treatment strategy (-0.07; P < .001). This indicates that this component, including its key elements manual-based psychotherapy and family involvement, was the most effective component of the intervention. Significant interactions were found for all other components, but with smaller effect sizes. Conclusions and Relevance Components of collaborative care most associated with improved effectiveness in reducing depressive symptoms were identified. To optimize treatment effectiveness and resource allocation, a therapeutic treatment strategy, such as manual-based psychotherapy or family integration, may be prioritized when implementing a collaborative care intervention.

BACKGROUND:Few studies have examined the impact of neighborhood-level factors on outcomes for patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVES:The purpose of this study was to understand the impact of neighborhood factors on readmission and mortality risk hospitalized patients with HFrEF. METHODS:We analyzed data from the Hopeful Heart Trial that evaluated the impact of blended collaborative care for treating HFrEF and depression among patients discharged from 8 Pittsburgh-area hospitals from March 2014 to October 2017. Using patients' home address at discharge to determine neighborhood Walk Score (WS; 0-100 scale) and Area Deprivation Index (ADI; 0-100), we examined the incidence of 12-month all-cause and cardiovascular-related hospital readmissions and vital status up to 5 years postdischarge through June 2022 using multivariable-adjusted Cox proportional hazards models. RESULTS:Hopeful Heart enrolled 756 people with HFrEF (baseline mean age 64.0, 44% female, 73% White race, 28% ± 9.1% mean left ventricular ejection fraction, mean 9-Item Patient Health Questionnaire score 12 ± 5.7, median WS 69 (IQR: 49-88), and median ADI 12 (IQR: 10-15) and followed them for a median of 57.7 months (IQR: 25.0-68.4). Individuals from the least walkable neighborhoods experienced greater 12-month all-cause mortality (HR: 1.70 [95% CI: 1.11-2.61]; P = 0.016), while those from the most deprived neighborhoods had higher 12-month cardiovascular-related hospital readmission (HR: 1.39 [95% CI: 1.09-1.78]; P = 0.008). Neither WS nor ADI predicted 12-month all-cause readmission and cardiovascular-related mortality or 5-year all-cause mortality. CONCLUSIONS:Among recently hospitalized HFrEF patients, neighborhood factors affect 12-month rehospitalization and mortality risk but not 5-year mortality. (Blended Collaborative Care for Heart Failure and Co-Morbid Depression; NCT02044211).

Background Gaps in guideline-concordant care for CKD lead to poor outcomes. The Kidney Coordinated HeAlth Management Partnership (K-CHAMP) cluster randomized trial tested the effect of a population health management intervention versus usual care on CKD progression and evidence-based care delivery in the primary care setting. Methods K-CHAMP included adults aged 18-85 years with eGFR<60 ml/min per 1.73 m(2) and moderate-high risk of CKD progression who were not seeing a nephrologist. The multifaceted intervention included nephrology e-consult, pharmacist-led medication management, and patient education. In this post hoc analysis, we evaluate the effectiveness of K-CHAMP on guideline-concordant care processes (BP and glycemic control, annual albuminuria testing) and medication exposure days (angiotensin-converting enzyme inhibitor [ACEi]/angiotensin receptor blocker [ARB], moderate-high intensity statin, sodium-glucose cotransporter-2 inhibitor [SGLT2i], glucagon-like peptide-1 receptor agonists [GLP-1RA]). Given multiplicity of outcomes, Benjamini-Hochberg method was used to control false discovery rate. Results All 1596 (754 intervention, 842 usual care) enrolled patients (mean age 74 +/- 9 years, eGFR 37 +/- 8 ml/min per 1.73 m2, 928 [58%] female, 127 [8%] Black) were analyzed. After a median 17-month follow-up, intervention arm patients had significantly higher exposure days per year to SGLT2i (56 versus 32 days; relative benefit 1.72; 95% confidence interval [CI], 1.14 to 2.30) and GLP-1RA (78 versus 29 days; relative benefit 2.65; 95% CI, 1.59 to 3.71) compared with usual care in adjusted analysis. At study initiation in 2019, similar proportion of patients were prescribed SGLT2i and/or GLP-1RA in intervention and control arm (8% versus 6%, respectively; rate ratio 1.23; 95% CI, 0 to 2.99), but by 2022, prescription of these medications was significantly higher in intervention arm (44% versus 27%, respectively; rate ratio 1.63; 95% CI, 1.32 to 1.94). There was no significant difference in any process measures or exposure days to ACEi/ARB in patients with albuminuria or moderate-high intensity statin. Conclusions K-CHAMP was effective in accelerating implementation of SGLT2i and GLP-1RA but did not increase ACEi/ARB in patients with albuminuria or moderate-high intensity statin use or improve BP control, glycemic control, or albuminuria testing in individuals with CKD in the primary care setting.

Background: Patient-reported symptoms are associated with inflammation biomarkers in many chronic diseases. We examined associations of inflammation biomarkers with pain, fatigue, and depression in patients with end-stage kidney disease (ESKD) and the effects of a Technology Assisted stepped Collaborative Care (TĀCcare) intervention on these biomarkers. Methods: In the TĀCcare multi-site randomized control trial, data on patient-reported symptoms were collected at baseline, 3, and 6 months. Anti-inflammatory [interleukin 1 receptor agonist (IL-1RA), IL-10], pro-inflammatory [tumor necrosis factor alpha (TNF-α), high sensitivity C-reactive protein (hs-CRP), IL-6] and regulatory [IL-2] biomarkers were assayed. Linear mixed-effects modeling was used to examine within- and between-group differences after adjusting for age, sex, race, and comorbidities. Results: Among the 160 patients (mean age 58±14 years, 55% men, 52% white), there were no significant associations between inflammation biomarkers and pain, fatigue or depression at baseline. Both intervention and control group demonstrated reductions in IL-10 and IL-1RA over 6 months (β range=-1.22 to -0.40, p range=<0.001 to 0.02) At 3 months, the treatment group exhibited decreases in TNF-α (β=-0.22, p<0.001) and IL-2 (β=-0.71, p<0.001), whereas the control group showed increases in IL-6/IL-10 ratio (β=0.33, p=0.03). At 6 months, both groups exhibited decreases in IL-2 (β range=-0.66 to -0.57,p<0.001); the control group showed significant increases in the ratio of IL-6/IL-10 (β=0.75,p<0.001) and decrease in TNF-α (β=-0.16, p=0.02). Compared to controls, the treatment group demonstrated significantly decreased IL-2 at 3 months (β=-0.53, p<0.001). Significant interaction effects of treatment were observed on the association between changes in pro-inflammatory biomarkers (TNF-α and hs-CRP) levels and changes in symptom scores from baseline to 6 months. Conclusions: The TĀCcare intervention had a short-term impact on reducing inflammatory burden in patients with ESKD. More studies are needed to confirm our findings and to determine if these biomarkers mediate the link between symptoms and disease progression.

ImportanceLarge gaps in clinical care in patients with chronic kidney disease (CKD) lead to poor outcomes.ObjectiveTo compare the effectiveness of an electronic health record–based population health management intervention vs usual care for reducing CKD progression and improving evidence-based care in high-risk CKD.Design, Setting, and ParticipantsThe Kidney Coordinated Health Management Partnership (Kidney CHAMP) was a pragmatic cluster randomized clinical trial conducted between May 2019 and July 2022 in 101 primary care practices in Western Pennsylvania. It included patients aged 18 to 85 years with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m2 with high risk of CKD progression and no outpatient nephrology encounter within the previous 12 months.InterventionsMultifaceted intervention for CKD comanagement with primary care clinicians included a nephrology electronic consultation, pharmacist-led medication management, and CKD education for patients. The usual care group received CKD care from primary care clinicians as usual.Main Outcomes and MeasuresThe primary outcome was time to 40% or greater reduction in eGFR or end-stage kidney disease.ResultsAmong 1596 patients (754 intervention [47.2%]; 842 control [52.8%]) with a mean (SD) age of 74 (9) years, 928 (58%) were female, 127 (8%) were Black, 9 (0.6%) were Hispanic, and the mean (SD) estimated glomerular filtration rate was 36.8 (7.9) mL/min/1.73m2. Over a median follow-up of 17.0 months, there was no significant difference in rate of primary outcome between the 2 arms (adjusted hazard ratio, 0.96; 95% CI, 0.67-1.38; P = .82). Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker exposure was more frequent in intervention arm compared with the control group (rate ratio, 1.21; 95% CI, 1.02-1.43). There was no difference in the secondary outcomes of hypertension control and exposure to unsafe medications or adverse events between the arms. Several COVID-19–related issues contributed to null findings in the study.Conclusion and RelevanceIn this study, among patients with moderate-risk to high-risk CKD, a multifaceted electronic health record–based population health management intervention resulted in more exposure days to angiotensin-converting enzyme inhibitors/angiotensin receptor blockers but did not reduce risk of CKD progression or hypertension control vs usual care.Trial RegistrationClinicalTrials.gov Identifier: NCT03832595

Background: Gaps in guideline-concordant care for chronic kidney disease (CKD) lead to poor outcomes. The Kidney Coordinated HeAlth Management Partnership (K-CHAMP) cluster randomized trial tested the effect of a population health management intervention versus usual care on CKD progression and evidence-based care delivery in the primary care setting. Methods: K-CHAMP included adults aged 18-85 years with eGFR <60 mL/min/1.73m2 and moderate-high risk of CKD progression who were not seeing a nephrologist. The multi-faceted intervention included nephrology e-consult, pharmacist-led medication management, and patient education. In this post-hoc analysis, we evaluate the effectiveness of K-CHAMP on guideline-concordant care processes (blood pressure and glycemic control, annual albuminuria testing), and medication exposure days (ACEi/ARB, moderate-high intensity statin, SGLT-2i, GLP-1RA). Given multiplicity of outcomes, Benjamini-Hochberg method was used to control false discovery rate (FDR). Results: All 1,596 (754 intervention, 842 usual care) enrolled patients (mean age 74±9 years, eGFR 37±8 mL/min/1.73m2, 928 (58%) female, 127 (8%) Black) were analyzed. After a median 17-month follow-up, intervention arm patients had significantly higher exposure days per year to SGLT-2i (56 vs 32 days, relative benefit 1.72, 95% CI 1.14-2.30) and GLP-1RA (78 vs 29 days, relative benefit 2.65, 95% CI 1.59-3.71) compared to usual care in adjusted analysis. At study initiation in 2019, similar proportion of patients were prescribed SGLT-2i and/or GLP-1RA in intervention and control arm (8% vs 6% respectively, rate ratio 1.23, 95% CI 0-2.99), but by 2022, prescription of these medications was significantly higher in intervention arm (44% vs 27% respectively, rate ratio 1.63, 95% CI 1.32-1.94). There was no significant difference in any process measures or exposure days to ACEi/ARB in patients with albuminuria or moderate-high intensity statin. Conclusions: K-CHAMP was effective in accelerating implementation of SGLT-2i and GLP-1RA but did not increase ACEi/ARB in patients with albuminuria or moderate-high intensity statin use, or improve blood pressure control, glycemic control, or albuminuria testing in individuals with CKD in the primary care setting.

In developing public resources for the Networks Enhancing Addiction Recovery – Forum Activity Roadmap (NEAR-FAR), we completed a systematic observational study of English-language online forums related to recovery from alcohol or other drug addiction in late 2021. Among 207 identified forums, the majority were classified as “general addiction” or alcohol-focused, though classifications related to other substances were common on websites hosting multiple forums. Commonly used social media platforms such as Reddit, Facebook, or Quora offered easily accessible venues for individuals seeking online support related to a variety of substances. Forums were related to established recovery programs such as 12-step and SMART Recovery as well as other nonprofit and for-profit recovery programs, and to community forums without formal recovery programming. Among 148 forums with any observed user activity, the median time between unique user engagements was 27 days (inter-quartile range: 2–74). Among 98 forums with past-month posting activity, we found a median of <10 posts per week (inter-quartile range: 1–78). This study compares three metrics of observed forum activity (posts per week, responses per post, time between unique user engagements) and operationalizes forum characteristics that may potentiate opportunities for enhanced engagement and social support in addiction recovery.

BackgroundHypertension is a leading cause of cardiovascular and kidney disease in the United States, yet blood pressure (BP) control at a population level is poor and worsening. Systematic home BP monitoring (HBPM) programs can lower BP, but programs supporting HBPM are not routinely used. The MyBP program deploys automated bidirectional text messaging for HBPM and disease self-management support. ObjectiveWe aim to produce a qualitative analysis of input from providers and staff regarding implementation of an innovative HBPM program in primary care practices. MethodsSemistructured interviews (average length 31 minutes) were conducted with physicians (n=11), nurses, and medical assistants (n=6) from primary care settings. The interview assessed multiple constructs in the Consolidated Framework for Implementation Research domains of intervention characteristics, outer setting, inner setting, and characteristics of individuals. Interviews were transcribed verbatim and analyzed using inductive coding to organize meaningful excerpts and identify salient themes, followed by mapping to the updated Consolidated Framework for Implementation Research constructs. ResultsHealth care providers reported that MyBP has good ease of use and was likely to engage patients in managing their high BP. They also felt that it would directly support systematic BP monitoring and habit formation in the convenience of the patient’s home. This could increase health literacy and generate concrete feedback to raise the day-to-day salience of BP control. Providers expressed concern that the cost of BP devices remains an encumbrance. Some patients were felt to have overriding social or emotional barriers, or lack the needed technical skills to interact with the program, use good measurement technique, and input readings accurately. With respect to effects on their medical practice, providers felt MyBP would improve the accuracy and frequency of HBPM data, and thereby improve diagnosis and treatment management. The program may positively affect the patient-provider relationship by increasing rapport and bidirectional accountability. Providers appreciated receiving aggregated HBPM data to increase their own efficiency but also expressed concern about timely routing of incoming HBPM reports, lack of true integration with the electronic health record, and the need for a dedicated and trained staff member. ConclusionsIn this qualitative analysis, health care providers perceived strong relative advantages of using MyBP to support patients. The identified barriers suggest the need for corrective implementation strategies to support providers in adopting the program into routine primary care practice, such as integration into the workflow and provider education. Trial RegistrationClinicalTrials.gov NCT03650166; https://tinyurl.com/bduwn6r4

This paper proposes an approach to assess digital health readiness in clinical settings to understand how prepared, experienced, and equipped individual people are to participate in digital health activities. Existing digital health literacy and telehealth prediction tools exist but do not assess technological aptitude for particular tasks or incorporate available electronic health record data to improve efficiency and efficacy. As such, we propose a multidomain digital health readiness assessment that incorporates a person’s stated goals and motivations for use of digital health, a focused digital health literacy assessment, passively collected data from the electronic health record, and a focused aptitude assessment for critical skills needed to achieve a person’s goals. This combination of elements should allow for easy integration into clinical workflows and make the assessment as actionable as possible for health care providers and in-clinic digital health navigators. Digital health readiness profiles could be used to match individuals with support interventions to promote the use of digital tools like telehealth, mobile apps, and remote monitoring, especially for those who are motivated but do not have adequate experience. Moreover, while effective and holistic digital health readiness assessments could contribute to increased use and greater equity in digital health engagement, they must also be designed with inclusivity in mind to avoid worsening known disparities in digital health care.