Continuous Remote Patient Monitoring in Patients With Heart Failure (Cascade Study): Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM). OBJECTIVE: The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution in patients with HF at NorthShore University HealthSystem. METHODS: This study is a feasibility study and uses a wearable biosensor to continuously remotely monitor patients with HF for 30 days after discharge. Eligible patients admitted with an HF exacerbation at NorthShore University HealthSystem are being recruited, and the wearable biosensor is placed before discharge. The biosensor collects physiological ambulatory data, which are analyzed for signs of patient deterioration. Participants are also completing a daily survey through a dedicated study smartphone. If prespecified criteria from the physiological data and survey results are met, a notification is triggered, and a predetermined electronic health record-based pathway of telephonic management is completed. In phase 1, which has already been completed, 5 patients were enrolled and monitored for 30 days after discharge. The results of phase 1 were analyzed, and modifications to the program were made to optimize it. After analysis of the phase 1 results, 15 patients are being enrolled for phase 2, which is a calibration and testing period to enable further adjustments to be made. After phase 2, we will enroll 45 patients for phase 3. The combined results of phases 1, 2, and 3 will be analyzed to determine the feasibility of a CRPM program in patients with HF. Semistructured interviews are being conducted with key stakeholders, including patients, and these results will be analyzed using the affective adaptation of the technology acceptance model. RESULTS: During phase 1, of the 5 patients, 2 (40%) were readmitted during the study period. The study completion rate for phase 1 was 80% (4/5), and the study attrition rate was 20% (1/5). There were 57 protocol deviations out of 150 patient days in phase 1 of the study. The results of phase 1 were analyzed, and the study protocol was adjusted to optimize it for phases 2 and 3. Phase 2 and phase 3 results will be available by the end of 2022. CONCLUSIONS: A CRPM program may offer a low-risk solution to improve care of patients with HF after hospital discharge and may help to decrease readmission of patients with HF to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other groups of patients considered to be at high risk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36741.

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch.

OBJECTIVE: We report on our experience of deploying a continuous remote patient monitoring (CRPM) study soft launch with structured cascading and escalation pathways on heart failure (HF) patients post-discharge. The lessons learned from the soft launch are used to modify and fine-tune the workflow process and study protocol. METHODS: This soft launch was conducted at NorthShore University HealthSystem's Evanston Hospital from December 2020 to March 2021. Patients were provided with non-invasive wearable biosensors that continuously collect ambulatory physiological data, and a study phone that collects patient-reported outcomes. The physiological data are analyzed by machine learning algorithms, potentially identifying physiological perturbation in HF patients. Alerts from this algorithm may be cascaded with other patient status data to inform home health nurses' (HHNs') management via a structured protocol. HHNs review the monitoring platform daily. If the patient's status meets specific criteria, HHNs perform assessments and escalate patient cases to the HF team for further guidance on early intervention. RESULTS: We enrolled five patients into the soft launch. Four participants adhered to study activities. Two out of five patients were readmitted, one due to HF, one due to infection. Observed miscommunication and protocol gaps were noted for protocol amendment. The study team adopted an organizational development method from change management theory to reconfigure the study protocol. CONCLUSION: We sought to automate the monitoring aspects of post-discharge care by aligning a new technology that generates streaming data from a wearable device with a complex, multi-provider workflow into a novel protocol using iterative design, implementation, and evaluation methods to monitor post-discharge HF patients. CRPM with structured escalation and telemonitoring protocol shows potential to maintain patients in their home environment and reduce HF-related readmissions. Our results suggest that further education to engage and empower frontline workers using advanced technology is essential to scale up the approach.

Improved outcomes in cystic fibrosis using modified Re-Education of Airway Clearance Technique (REACT) programme.

BACKGROUND AND OBJECTIVES: Cystic fibrosis (CF) is known to reduce lung function as measured by per cent predicted for the forced expiratory volume in the first second (ppFEV1) over time. Our paediatric CF programme demonstrated significant gaps in benchmarked ppFEV1 predicted compared with the national median. Our objective was to assess whether the implementation of a modified Re-Education of Airway Clearance Techniques (REACT) programme could lead to an improvement in lung function as measured by ppFEV1. METHODS: This 2-year prospective quality improvement study at Lurie Children's CF Center for children aged >6 years used improvement methodology to implement a modified REACT programme. Outcome measures were assessed for our entire programme via the CF Foundation Patient Registry (CFFPR) and statistical process control. Comparisons were also made before and after REACT for outcome measures. RESULTS: By the end of implementation, monthly participation rate achieved 100%. Using CFFPR data and SPC, median ppFEV1 increased by 3.9%, whereas only body mass index (BMI) as a secondary outcome increased. Comparison of pre and post REACT showed improvements in average ppFEV1 (95% vs 96%, p<0.0001), FEF25%-75% (82% vs 83%, p=0.0590), rate of ppFEV1 decline (+2% vs -4%, p=0.0262) and BMI percentile (57% vs 60%, p<0.0001). CONCLUSIONS: Implementation of a modified REACT at Lurie Children's paediatric CF programme led to an increase in ppFEV1, FEF25%-75% and BMI percentile.

Feed-forward active contour analysis for improved brachial artery reactivity testing.

The object of this study was to utilize a novel feed-forward active contour (FFAC) algorithm to find a reproducible technique for analysis of brachial artery reactivity. Flow-mediated dilation (FMD) is an important marker of vascular endothelial function but has not been adopted for widespread clinical use given its technical limitations, including inter-observer variability and differences in technique across clinical sites. We developed a novel FFAC algorithm with the goal of validating a more reliable standard. Forty-six healthy volunteers underwent FMD measurement according to the standard technique. Ultrasound videos lasting 5-10 seconds each were obtained pre-cuff inflation and at minutes 1 through 5 post-cuff deflation in longitudinal and transverse views. Automated segmentation using the FFAC algorithm with initial boundary definition from three different observers was used to analyze the images to measure diameter/cross-sectional area over the cardiac cycle. The %FMD was calculated for average, minimum, and maximum diameters/areas. Using the FFAC algorithm, the population-specific coefficient of variation (CV) at end-diastole was 3.24% for transverse compared to 9.96% for longitudinal measurements; the subject-specific CV was 15.03% compared to 57.41%, respectively. For longitudinal measurements made via the conventional method, the population-specific CV was 4.77% and subject-specific CV was 117.79%. The intraclass correlation coefficient (ICC) for transverse measurements was 0.97 (95% CI: 0.95-0.98) compared to 0.90 (95% CI: 0.84-0.94) for longitudinal measurements with FFAC and 0.72 (95% CI: 0.51-0.84) for conventional measurements. In conclusion, transverse views using the novel FFAC method provide less inter-observer variability than traditional longitudinal views. Improved reproducibility may allow adoption of FMD testing in a clinical setting. The FFAC algorithm is a robust technique that should be evaluated further for its ability to replace the more limited conventional technique for measurement of FMD.

The impact of educational workshops on individuals at risk for glaucoma in the Philadelphia Glaucoma Detection and Treatment Project.

OBJECTIVES: The purpose of this study was to investigate the impact of educational workshops, led by community health educators, on the level of knowledge, perceived risk of glaucoma, and rate of attendance in a subsequent glaucoma detection examination. METHODS: Participants attended an educational workshop about glaucoma and completed an 8-question pre- and post-test to assess knowledge. A paired samples t-test assessed mean differences in composite pre- and post-test scores, correct responses for each question, and perceived risk of glaucoma after the workshop. RESULTS: Seven hundred and seven (707) pre- and post-test surveys were completed. There was a significant increase in the level of knowledge about glaucoma as reflected in the pre- and post-test composite scores (M=3.86, SD=1.95 vs. M=4.97, SD=1.82, P<0.001). In the 5 largest community sites, 44% (n=221/480) of the participants who attended an educational workshop scheduled a glaucoma detection examination appointment and 76% (n=160/211) of these participants completed this eye examination in the community setting. CONCLUSIONS: Educational workshops increased knowledge and awareness about glaucoma and were helpful in recruiting patients for community-based glaucoma detection examinations. PRACTICE IMPLICATIONS: We recommend including educational workshops when conducting community-based outreach programs.

Treatment outcomes of micropulse transscleral cyclophotocoagulation in advanced glaucoma.

Glaucoma is the leading cause of irreversible blindness worldwide. The goal of this study was to describe our experience with the novel micropulse transscleral cyclophotocoagulation (MP-TSCPC; IRIDEX IQ810 Laser Systems, CA) in patients with advanced glaucoma. Patients with advanced glaucoma who underwent MP-TSCPC were included in our study. Laser settings were 2000 mW of 810 nm infrared diode laser set on micropulse delivery mode. The laser was delivered over 360° for 100-240 s. The duty cycle was 31.3 %, which translated to 0.5 ms of "on time" and 1.1 ms of "off time." Surgical success was defined as an intraocular pressure (IOP) of 6-21 mmHg or a reduction of IOP by 20 % at the last follow-up visit. Failure was defined as an inability to meet the criteria for success or a need for incisional glaucoma surgery. Nineteen patients underwent MP-TSCPC with mean follow-up of 60.3 days. Mean IOP dropped from 37.9 mmHg preoperatively to 22.7 mmHg at last follow-up, representing a 40.1 % decrease. The success rate for initial treatment was 73.7 % (n = 14). Three patients underwent a second treatment, increasing the overall success rate to 89.5 % (n = 17). Four patients gained one line of vision, and four patients lost one line of vision. The novel MP-TSCPC laser had a high rate of surgical success after a short follow-up period in patients with advanced glaucoma. Further long-term evaluation and comparison to the traditional transscleral cyclophotocoagulation are warranted.

Capacity planning for maternal-fetal medicine using discrete event simulation.

BACKGROUND: Maternal-fetal medicine is a rapidly growing field requiring collaboration from many subspecialties. We provide an evidence-based estimate of capacity needs for our clinic, as well as demonstrate how simulation can aid in capacity planning in similar environments. METHODS: A Discrete Event Simulation of the Center for Fetal Diagnosis and Treatment and Special Delivery Unit at The Children's Hospital of Philadelphia was designed and validated. This model was then used to determine the time until demand overwhelms inpatient bed availability under increasing capacity. FINDINGS: No significant deviation was found between historical inpatient censuses and simulated censuses for the validation phase (p = 0.889). Prospectively increasing capacity was found to delay time to balk (the inability of the center to provide bed space for a patient in need of admission). With current capacity, the model predicts mean time to balk of 276 days. Adding three beds delays mean time to first balk to 762 days; an additional six beds to 1,335 days. CONCLUSION: Providing sufficient access is a patient safety issue, and good planning is crucial for targeting infrastructure investments appropriately. Computer-simulated analysis can provide an evidence base for both medical and administrative decision making in a complex clinical environment.

Brachial artery vasomotion and transducer pressure effect on measurements by active contour segmentation on ultrasound.

PURPOSE: To use feed-forward active contours (snakes) to track and measure brachial artery vasomotion on ultrasound images recorded in both transverse and longitudinal views; and to compare the algorithm's performance in each view. METHODS: Longitudinal and transverse view ultrasound image sequences of 45 brachial arteries were segmented by feed-forward active contour (FFAC). The segmented regions were used to measure vasomotion artery diameter, cross-sectional area, and distention both as peak-to-peak diameter and as area. ECG waveforms were also simultaneously extracted frame-by-frame by thresholding a running finite-difference image between consecutive images. The arterial and ECG waveforms were compared as they traced each phase of the cardiac cycle. RESULTS: FFAC successfully segmented arteries in longitudinal and transverse views in all 45 cases. The automated analysis took significantly less time than manual tracing, but produced superior, well-behaved arterial waveforms. Automated arterial measurements also had lower interobserver variability as measured by correlation, difference in mean values, and coefficient of variation. Although FFAC successfully segmented both the longitudinal and transverse images, transverse measurements were less variable. The cross-sectional area computed from the longitudinal images was 27% lower than the area measured from transverse images, possibly due to the compression of the artery along the image depth by transducer pressure. CONCLUSIONS: FFAC is a robust and sensitive vasomotion segmentation algorithm in both transverse and longitudinal views. Transverse imaging may offer advantages over longitudinal imaging: transverse measurements are more consistent, possibly because the method is less sensitive to variations in transducer pressure during imaging.