A CKD Clinical Decision Support System: A Cluster Randomized Clinical Trial in Primary Care Clinics.

Rationale & Objective: The study aimed to develop, implement, and evaluate a clinical decision support (CDS) system for chronic kidney disease (CKD) in a primary care setting, with the goal of improving CKD care in adults. Study Design: This was a cluster randomized trial. Setting & Participants: A total of 32 Midwestern primary care clinics were randomly assigned to either receive usual care or CKD-CDS intervention. Between April 2019 and March 2020, we enrolled 6,420 patients aged 18-75 years with laboratory-defined glomerular filtration rate categories of CKD Stage G3 and G4, and 1 or more of 6 CKD care gaps: absence of a CKD diagnosis, suboptimal blood pressure or glycated hemoglobin levels, indication for angiotensin-converting enzyme inhibitor or angiotensin receptor blocker but not prescribed, a nonsteroidal anti-inflammatory agent on the active medication list, or indication for a nephrology referral. Intervention: The CKD-CDS provided personalized suggestions for CKD care improvement opportunities directed to both patients and clinicians at primary care encounters. Outcomes: We assessed the proportion of patients meeting each of 6 CKD-CDS quality metrics representing care gap resolution after 18 months. Results: The adjusted proportions of patients meeting quality metrics in CKD-CDS versus usual care were as follows: CKD diagnosis documented (26.6% vs 21.8%; risk ratio [RR], 1.17; 95% CI, 0.91-1.51); angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescribed (15.9% vs 16.1%; RR, 0.95; 95% CI, 0.76-1.18); blood pressure control (20.4% vs 20.2%; RR, 0.98; 95% CI, 0.84-1.15); glycated hemoglobin level control (21.4% vs 22.1%; RR, 1.00; 95% CI, 0.80-1.24); nonsteroidal anti-inflammatory agent not on the active medication list (51.5% vs 50.4%; RR, 1.03; 95% CI, 0.90-1.17); and referral or visit to a nephrologist (38.7% vs 36.1%; RR, 1.02; 95% CI, 0.79-1.32). Limitations: We encountered an overall reduction in expected primary care encounters and obstacles to point-of-care CKD-CDS utilization because of the coronavirus disease 2019 pandemic. Conclusions: The CKD-CDS intervention did not lead to a significant improvement in CKD quality metrics. The challenges to CDS use during the coronavirus disease 2019 pandemic likely influenced these results. Funding: National Institute of Diabetes and Digestive and Kidney Diseases (R18DK118463). Trial Registration: clinicaltrials.gov Identifier: NCT03890588.

This study aimed to improve the management of chronic kidney disease (CKD) through a clinical decision support (CDS) system. It involved 32 primary care clinics and 6,420 patients with CKD who had 1 or more of 6 CKD care improvement opportunities. The CDS provided personalized suggestions to both patients and clinicians about CKD care opportunities during primary care visits. After 18 months, the study found no significant differences between patients in clinics with CKD-CDS compared with usual care in diagnosing CKD, prescribing recommended medications, controlling blood pressure or glycated hemoglobin, nonsteroidal anti-inflammatory agent usage, or nephrology referrals. The coronavirus disease 2019 pandemic may have influenced results by introducing unforeseen implementation challenges, reduced visits, and less than expected CDS exposure.

Protocol of a patient randomized clinical trial to improve medication adherence in primary care.

BACKGROUND: Enhanced awareness of poor medication adherence could improve patient care. This article describes the original and adapted protocols of a randomized trial to improve medication adherence for cardiometabolic conditions. METHODS: The original protocol entailed a cluster randomized trial of 28 primary care clinics allocated to either (i) medication adherence enhanced chronic disease care clinical decision support (eCDC-CDS) integrated within the electronic health record (EHR) or (ii) usual care (non-enhanced CDC-CDS). Enhancements comprised (a) electronic interfaces printed for patients and clinicians at primary care encounters that encouraged discussion about specific medication adherence issues that were identified, and (b) pharmacist phone outreach. Study subjects were individuals who at an index visit were aged 18-74 years and not at evidence-based care goals for hypertension (HTN), diabetes mellitus (DM), or lipid management, along with low medication adherence (proportion of days covered [PDC] <80%) for a corresponding medication. The primary study outcomes were improved medication adherence and clinical outcomes (BP and A1C) at 12 months. Protocol adaptation became imperative in response to major implementation challenges: (a) the availability of EHR system-wide PDC calculations that superseded our ability to limit PDC adherence information solely to intervention clinics; (b) the unforeseen closure of pharmacies committed to conducting the pharmacist outreach; and (c) disruptions and clinic closures due to the Covid-19 pandemic. CONCLUSION: This manuscript details the protocol of a study to assess whether enhanced awareness of medication adherence issues in primary care settings could improve patient outcomes. The need for protocol adaptation arose in response to multiple implementation challenges.

Pragmatic clinic randomized trial to improve chronic kidney disease care: Design and adaptation due to COVID disruptions.

BACKGROUND: We describe a clinic-randomized trial to improve chronic kidney disease (CKD) care through a CKD-clinical decision support (CKD-CDS) intervention in primary care clinics and the challenges we encountered due to COVID-19 care disruption. METHODS/DESIGN: Primary care clinics (N = 32) were randomized to usual care (UC) or to CKD-CDS. Between April 17, 2019 and March 14, 2020, more than 7000 patients had accrued for analysis by meeting study-eligibility criteria at an index office visit: age 18-75, laboratory criteria for stage 3 or 4 CKD (eGFR 15-59 mL/min/1.73 m2), and one or more opportunities algorithmically identified to improve CKD care such as blood pressure (BP) or glucose control, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use, discontinuance of a nonsteroidal anti-inflammatory drug (NSAID), or nephrology referral. At CKD-CDS clinics, CDS provided individualized treatment suggestions that were printed for patients and clinicians at the start of office encounters and were viewable within the electronic health record. By initial design, the impact of the CKD-CDS intervention on care gaps was to be assessed 12 months after the index date, but COVID-19 caused major disruptions to care delivery during the intervention period. In response to disruptions, the intervention was temporarily suspended while we expanded CDS use for telehealth encounters and programmed new criteria for displaying the CKD-CDS to intervention patients due to clinic closures and scheduling changes. DISCUSSION: We describe a NIH-funded pragmatic trial of web-based EHR-integrated CKD-CDS and modifications necessary mid-study to complete the study as intended in the face of COVID-19 pandemic challenges.

Serostatus disclosure among a cohort of HIV-infected pregnant women enrolled in HIV care in Moshi, Tanzania: A mixed-methods study.

HIV-infected pregnant women face complex decisions about whether and how to disclose their serostatus. Previous studies have shown that HIV disclosure is associated with better care engagement, emotional adjustment to the disease, and reduced risk of HIV transmission, but women face both real and perceived barriers to disclosure. We examined patterns and predictors of HIV disclosure in a cohort of 200 women diagnosed or confirmed to have HIV during antenatal care in the Kilimanjaro region of Tanzania and followed participants to three months postpartum. Twenty women also completed qualitative in-depth interviews during pregnancy and three months postpartum. During the pregnancy period (at least 30 days post-diagnosis), 79.5% of women had disclosed to at least one other person, with disclosures generally restricted to the father of the child and/or a small number of close family members. By three months postpartum, 11.9% of women had still not disclosed to anyone. Women who presented to antenatal care with an established HIV diagnoses and married women were more likely to report disclosures. Social support was positively associated with disclosure. In qualitative interviews, women pointed to community gossip and stigma as barriers to disclosure. Those who had not disclosed to the father of the child noted fears of abandonment during the vulnerable pregnancy period. Despite expressed fears, participants reported overall positive experiences of disclosure that led to increased support. Taken together, these results point to the need for comprehensive, flexible, and culturally informed interventions that assist pregnant and postpartum women in deciding when and how to disclose. Such interventions should acknowledge and explore common barriers to disclosure, including fears of public stigma and personal consequences. Given the strong associations between disclosure, social support, and community stigma, interventions for disclosure should be nested in broader efforts of public education and HIV stigma reduction.

Retention in HIV Care During Pregnancy and the Postpartum Period in the Option B+ Era: Systematic Review and Meta-Analysis of Studies in Africa.

BACKGROUND: Under Option B+ guidelines for prevention of mother-to-child transmission of HIV, pregnant and breastfeeding women initiate antiretroviral therapy for lifelong use. The objectives of this study were: (1) to synthesize data on retention in care over time in option B+ programs in Africa, and (2) to identify factors associated with retention in care. METHODS: PubMed, EMBASE, and African Index Medicus were systematically searched from January 2012 to June 2017. Pooled estimates of the proportion of women retained were generated and factors associated with retention were analyzed thematically. RESULTS: Thirty-five articles were included in the final review; 22 reported retention rates (n = 60,890) and 25 reported factors associated with retention. Pooled estimates of retention were 72.9% (95% confidence interval: 66.4% to 78.9%) at 6 months for studies reporting <12 months of follow-up and 76.4% (95% confidence interval: 69.0% to 83.1%) at 12 months for studies reporting ≥12 months of follow-up. Data on undocumented clinic transfers were largely absent. Risk factors for poor retention included younger age, initiating antiretroviral therapy on the same day as diagnosis, initiating during pregnancy versus breastfeeding, and initiating late in the pregnancy. Retention was compromised by stigma, fear of disclosure, and lack of social support. CONCLUSIONS: Retention rates in prevention of mother-to-child transmission under option B+ were below those of the general adult population, necessitating interventions targeting the complex circumstances of women initiating care under option B+. Improved and standardized procedures to track and report retention are needed to accurately represent care engagement and capture undocumented transfers within the health system.