Diabetes mellitus is a common medical complication of pregnancy, and its treatment is complex. Recent years have seen an increase in the application of mobile health tools and advanced technologies, ...such as remote patient monitoring, with the aim of improving care for diabetes mellitus in pregnancy. Previous studies of these technologies for the treatment of diabetes in pregnancy have been small and have not clearly shown clinical benefit with implementation.
Remote patient monitoring allows clinicians to monitor patients’ health data (such as glucose values) in near real-time, between office visits, to make timely adjustments to care. Our objective was to determine if using remote patient monitoring for the management of diabetes in pregnancy leads to an improvement in maternal and neonatal outcomes.
This was a retrospective cohort study of pregnant patients with diabetes mellitus managed by the maternal-fetal medicine practice at one academic institution between October 2019 and April 2021. This practice transitioned from paper-based blood glucose logs to remote patient monitoring in February 2020. Remote patient monitoring options included (1) device integration with Bluetooth glucometers that automatically uploaded measured glucose values to the patient’s Epic MyChart application or (2) manual entry in which patients manually logged their glucose readings into their MyChart application. Values in the MyChart application directly transferred to the patient’s electronic health record for review and management by clinicians. In total, 533 patients were studied. We compared 173 patients managed with paper logs to 360 patients managed with remote patient monitoring (176 device integration and 184 manual entry). Our primary outcomes were composite maternal morbidity (which included third- and fourth-degree lacerations, chorioamnionitis, postpartum hemorrhage requiring transfusion, postpartum hysterectomy, wound infection or separation, venous thromboembolism, and maternal admission to the intensive care unit) and composite neonatal morbidity (which included umbilical cord pH <7.00, 5 minute Apgar score <7, respiratory morbidity, hyperbilirubinemia, meconium aspiration, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, pneumonia, seizures, hypoxic ischemic encephalopathy, shoulder dystocia, trauma, brain or body cooling, and neonatal intensive care unit admission). Secondary outcomes were measures of glycemic control and the individual components of the primary composite outcomes. We also performed a secondary analysis in which the patients who used the two different remote patient monitoring options (device integration vs manual entry) were compared. Chi-square, Fisher’s exact, 2-sample t, and Mann-Whitney tests were used to compare the groups. A result was considered statistically significant at P<.05.
Maternal baseline characteristics were not significantly different between the remote patient monitoring and paper groups aside from a slightly higher baseline rate of chronic hypertension in the remote patient monitoring group (6.1% vs 1.2%; P=.011). The primary outcomes of composite maternal and composite neonatal morbidity were not significantly different between the groups. However, remote patient monitoring patients submitted more glucose values (177 vs 146; P=.008), were more likely to achieve glycemic control in target range (79.2% vs 52.0%; P<.0001), and achieved the target range sooner (median, 3.3 vs 4.1 weeks; P=.025) than patients managed with paper logs. This was achieved without increasing in-person visits. Remote patient monitoring patients had lower rates of preeclampsia (5.8% vs 15.0%; P=.0006) and their infants had lower rates of neonatal hypoglycemia in the first 24 hours of life (29.8% vs 51.7%; P<.0001).
Remote patient monitoring for the management of diabetes mellitus in pregnancy is superior to a traditional paper-based approach in achieving glycemic control and is associated with improved maternal and neonatal outcomes.
Few data are available on factors associated with low adherence or early clopidogrel discontinuation after percutaneous coronary intervention (PCI). Patients (n = 284) were evaluated before hospital ...discharge after PCI to identify factors associated with low adherence to clopidogrel 30 days later. Adherence to daily medications before PCI was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8) and categorized as low (score <6), medium (score 6 to <8), or high (score 8). Low adherence to clopidogrel was defined as MMAS-8 score <6 (n = 21) or having discontinued clopidogrel (n = 11), which was ascertained during a 30-day interview after PCI. At 30 days after PCI, 11% of patients had low adherence to clopidogrel. Odds ratios (95% confidence intervals CIs) for low adherence to clopidogrel were 3.78 (1.09 to 13.1), 3.06 (1.36 to 6.87), 2.46 (0.97 to 6.27), and 3.36 (0.99 to 11.4) for patients who before PCI reported taking smaller doses of medication because of cost, had difficulty filling prescriptions, had difficulty reaching their primary physician, and were not comfortable asking their doctor for instructions, respectively. Odds ratios (95% CIs) for low clopidogrel adherence after PCI in patients with medium and low versus high adherence to daily medications before PCI were 6.13 (1.34 to 28.2) and 10.9 (2.46 to 48.7), respectively. The c-statistic associated with MMAS-8 scores before PCI for discriminating low clopidogrel adherence at 30 days after PCI was 0.733 (95% CI 0.650 to 0.852). In conclusion, adherence to daily medications before PCI may be a useful indicator for identifying patients who will have low clopidogrel adherence after PCI.
Background
Intensive glycemic control is of unclear benefit and carries increased risk for older adults with diabetes. The American Geriatrics Society’s (AGS)
Choosing Wisely
(CW) guideline promotes ...less aggressive glycemic targets and reduction in pharmacologic therapy for older adults with type II diabetes. Meanwhile, behavioral economic (BE) approaches offer promise in influencing hard-to-change behavior, and previous studies have shown the benefits of using electronic health record (EHR) technology to encourage guideline adherence.
Objective
This study aimed to develop and pilot test an intervention that leverages BE with EHR technology to promote appropriate diabetes management in older adults.
Design
A pilot study within the New York University Langone Health (NYULH) EHR and Epic system to deliver BE-inspired nudges at five NYULH clinics at varying time points from July 12, 2018, through October 31, 2019.
Participants
Clinicians across five practices in the NYULH system whose patients were older adults (age 76 and older) with type II diabetes.
Interventions
A BE-EHR module comprising six nudges was developed through a series of design workshops, interviews, user-testing sessions, and clinic visits. BE principles utilized in the nudges include framing, social norming, accountable justification, defaults, affirmation, and gamification.
Main Measures
Patient-level CW compliance.
Key Results
CW compliance increased 5.1% from a 16-week interval at baseline to a 16-week interval post intervention. From February 14 to June 5, 2018 (prior to the first nudge launch in Vanguard clinics), CW compliance for 1278 patients was mean (95% CI)—16.1% (14.1%, 18.1%). From July 3 to October 22, 2019 (after BE-EHR module launch at all five clinics), CW compliance for 680 patients was 21.2% (18.1%, 24.3%).
Conclusions
The BE-EHR module shows promise for promoting the AGS CW guideline and improving diabetes management in older adults. A randomized controlled trial will commence to test the effectiveness of the intervention across 66 NYULH clinics.
NIH Trial Registry Number
NCT03409523
Highlights ► This study successfully combined “think-aloud” protocol analysis with “near-live” clinical simulations in a usability evaluation of a new primary care CDS tool. ► These two forms of ...usability evaluation provided complementary observations on problems with the new tool and were used to refine both its usability and workflow integration. ► Their synergistic use provided a robust assessment of how CDS tools would interact in live clinical environments and allowed for enhanced early redesign to augment clinician utilization. ► These findings suggest the importance of using complementary testing methods before releasing CDS for live use.
Recent linkages between electronic health records (EHRs) and pharmacy data hold opportunity for up-to-date assessment of medication adherence at the point of care.
To validate linked EHR-pharmacy ...data, which can be used for point-of-care interventions for concordance with insurance claims data for patients in a large health care delivery system.
We performed a retrospective cohort study of adult patients with an active antihypertensive medication order and seen as outpatients between August 25, 2019, and August 31, 2019. Pharmacy fill information was obtained from the EHR via linkages with Surescripts pharmacy and pharmacy benefit manager data, as well as from insurance claims available at our institution. We matched antihypertensive medication fills observed in the linked EHR-pharmacy database with available fills in the insurance claims database and calculated the percentage of medication fills that were available in each database. We estimated medication adherence using proportion of days covered in the linked EHR-pharmacy database and in the insurance claims database.
Of 26,679 patients with hypertension, 23,348 (87.5%) had at least 1 antihypertensive medication fill recorded in the linked EHR-pharmacy database. Of 1,501 patients matched with the insurance database and with a documented medication fill, a fill was present for 1,484 (98.9%) and 1,259 (83.9%) patients in the linked EHR-pharmacy and insurance databases, respectively. Of 12,109 medication fills recorded in the insurance data, we found an overlap of 11,060 (91.3%) fills with the linked EHR-pharmacy database. The linked EHR-pharmacy database also contained 18,232 of 19,281 (94.6%) medication fills present in either database. Measured medication adherence was higher for patients when based on linked EHR-pharmacy data compared with insurance claims data (42% vs 30%,
< 0.001).
Linked EHR-pharmacy data captured medication fills for the vast majority of patients and resulted in higher estimates of adherence than insurance claims. Our results suggest that pharmacy fill data available in the EHR have sufficient reliability to be used for point-of-care assessment of medication adherence.
This study was supported by grant R01HL155149 from the National Heart, Lung, and Blood Institute. Allen Thorpe provided funding for the NYU Langone Health Learning Health System Program, which helped fund this project. The authors have nothing to disclose.
The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared ...decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use.
This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM).
By the project's end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care.
ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.
BackgroundEffective implementation of technologies into clinical workflow is hampered by lack of integration into daily activities. Normalisation process theory (NPT) can be used to describe the ...kinds of ‘work’ necessary to implement and embed complex new practices. We determined the suitability of NPT to assess the facilitators, barriers and ‘work’ of implementation of two clinical decision support (CDS) tools across diverse care settings.MethodsWe conducted baseline and 6-month follow-up quantitative surveys of clinic leadership at two academic institutions’ primary care clinics randomised to the intervention arm of a larger study. The survey was adapted from the NPT toolkit, analysing four implementation domains: sense-making, participation, action, monitoring. Domains were summarised among completed responses (n=60) and examined by role, institution, and time.ResultsThe median score for each NPT domain was the same across roles and institutions at baseline, and decreased at 6 months. At 6 months, clinic managers’ participation domain (p=0.003), and all domains for medical directors (p<0.003) declined. At 6 months, the action domain decreased among Utah respondents (p=0.03), and all domains decreased among Wisconsin respondents (p≤0.008).ConclusionsThis study employed NPT to longitudinally assess the implementation barriers of new CDS. The consistency of results across participant roles suggests similarities in the work each role took on during implementation. The decline in engagement over time suggests the need for more frequent contact to maintain momentum. Using NPT to evaluate this implementation provides insight into domains which can be addressed with participants to improve success of new electronic health record technologies.Trial registration numberNCT02534987.
Clinical prediction rules (CPRs) represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic ...health record (EHR) has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR) trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting.
A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS) tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149) were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated) groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters) and chest x-rays (pneumonia iCPR only) between intervention and control providers.
Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative process will lead to higher rates of utilization and EBM guided use of antibiotics and chest x-ray's in primary care.
ClinicalTrials.gov Identifier NCT01386047.
Highlights • First study to combine think-aloud usability testing with “near-live” clinical simulation. • This study successfully improved the functionality and usability of the prototype system. • ...Successful usability evaluation of a new primary care pre-diabetes shared goal setting tool.
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