Effectiveness Of Home Monitoring Research Articles

ALL-071: A Phase 4 Study to Evaluate Outpatient Blinatumomab in Patients with Minimal/Measurable Residual Disease (MRD) Positivity (+) of B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)

Context/Objective: Blinatumomab, a CD3/CD19-directed BiTE® (bispecific T-cell engager) molecule, is an effective treatment for patients with MRD+ BCP-ALL.1 Blinatumomab is infused continuously (cIV) 28 days/cycle. Severe adverse events (AEs), e.g., cytokine release syndrome (CRS) and neurologic toxicity (NT), may occur; thus, hospitalization is recommended for cycle 1: days 1–3 (C1:D1–3) and C2:D1–2. However, the incidence of severe AEs is low (CRS: 2%, NT: 13%).1 We believe that with digital monitoring, blinatumomab can be safely administered as an outpatient. Design: Adult patients (n=45) with BCP-ALL in complete remission and MRD+ (≥0.1% blasts) are being enrolled at ≤25 sites, with endpoint: grade ≥3 AE (Amgen NCT04506086). Patient suitability and outpatient monitoring are established. Patients receive 2–4 blinatumomab cycles. Cycles are initiated in the outpatient setting, and digital monitoring devices are activated/attached. Once home, patients set up the home hub and real-time data transfer to the healthcare provider (HCP) begins. The devices are worn continuously, 24 hours/day, for C1:D1–3 and C2:D1–2 only. Devices: Current Health’s Wearable Monitoring System (CHWMS) is an FDA-cleared platform for wireless wearable health monitoring at home. The CHWMS provides continuous oxygen saturation, respiratory rates, and heart rates; an axillary sensor provides continuous temperature. Patients manually measure blood pressure every 3–6 hours around the clock. Patients have an integrated tablet to contact the HCP if needed. HCP/designee has a smartphone and receives vital signs constantly. The CHWMS platform generates a loud alert based on pre-specified vital sign thresholds or for data transfer interruption. Regardless of whether there is an alert, HCP may initiate direct audio/video contact with the patient, assess the patient’s condition, and make appropriate interventions. Patients are required to have a caregiver present during monitoring. Patients have a full set of replacement devices and a 24/7 support hotline. Trial enrollment is underway. This study may generate feasibility data on the effectiveness of home monitoring during blinatumomab infusion in patients with MRD+ BCP-ALL. 1Gokbuget, Blood, 2018. © 2021 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2021 ASCO Annual Meeting. All rights reserved.

A phase 4 study to evaluate outpatient blinatumomab in patients with minimal/measurable residual disease (MRD) positivity (+) of B-cell precursor acute lymphoblastic leukemia (BCP-ALL).

TPS7051 Background: The prognosis for adults with relapsed or refractory BCP-ALL is poor. MRD+ is the strongest predictor of relapse. Blinatumomab, a CD3/CD19-directed BiTE® (bispecific T-cell engager) molecule, is an effective treatment for patients with MRD+.1 Blinatumomab is administered as a continuous intravenous infusion (cIV) 28 days per cycle. Severe adverse events (AEs) such as cytokine release syndrome (CRS) and neurologic toxicity (NT) may occur; thus, hospitalization is recommended for the first 3 days of cycle 1 and the first 2 days of cycle 2 for MRD+ patients. However, the incidence of severe AEs is low in MRD+ BCP-ALL patients (CRS: 2%, NT: 13%).1 We believe that with the use of effective digital monitoring devices, blinatumomab can be safely administered for the entire 28-day cIV cycle as an outpatient. Methods: Adult patients (n = 45) with BCP-ALL in complete remission and MRD+ (≥0.1% blasts) are being enrolled at 25 planned treatment sites, endpoint: grade ≥3 AE during monitoring (Amgen NCT04506086). Patient suitability for blinatumomab and outpatient monitoring is established. Patients will receive 2-4 cycles of blinatumomab. Cycles are initiated in the outpatient setting, digital monitoring devices activated and attached, and patients sent home. Once home, patients set up the home hub and real-time remote data transfer to the healthcare professional (HCP) begins. The devices are worn continuously, 24 hours a day for the first 3 days of cycle 1 and the first 2 days of cycle 2 only. Devices: Current Health’s Wearable Monitoring System (CHWMS) is an FDA-cleared platform for wireless and wearable health monitoring of patients at home. The CHWMS provides continuous oxygen saturation, respiratory rate, and heart rate; an axillary temperature sensor is worn and provides continuous temperature. Patients manually measure blood pressure every 3-6 hours around the clock. Patients have an integrated mobile device (tablet) to initiate contact with the HCP if needed. HCP/designee has a mobile device (smart phone) and receives vital signs as a constant live feed transmitted from the CHWMS device. The CHWMS platform generates a loud audible alert based on pre-specified vital sign alarming thresholds or if there is an interruption in data transfer. HCP may initiate direct audio and video contact with the patient, assess the patient’s condition, and make an appropriate intervention. HCP may also initiate patient contact in the absence of an alert. Patients are required to have a caregiver present during the entire period of outpatient monitoring. Patients have a full set of replacement devices as well as a 24/7 hotline for device support. Trial enrollment is underway. This study may generate feasibility data on the effectiveness of home monitoring during blinatumomab infusion in patients with MRD+ BCP-ALL. 1Gökbuget, Blood, 2018. Clinical trial information: NCT04506086.

Return Hospital Admissions Among 1419 COVID-19 Patients Discharged from Five U.S. Emergency Departments.

Although many ED patients with known or suspected Covid-19 require hospital admission, the majority are discharged home. Concern for surges in hospital occupancy compel emergency providers to preserve inpatient resources and discern which patients benefit most from admission. Even in the absence of surge conditions, patients may prefer to recover at home if safe to do so. However, some patients with Covid-19 experience delayed decompensation.

Effectiveness of interstage home monitoring on healthcare outcomes in infants with hypoplastic left heart syndrome: a systematic review protocol.

What is the effectiveness of home monitoring on interstage survival rates, weight gain, hospital admissions and cost savings in infants with hypoplastic left heart syndrome?

Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery

ImportanceIn the age of information and patient-centered care, new methods of delivering postoperative care must be developed and evaluated.ObjectiveTo determine whether follow-up care delivered via a mobile app can be used to avert in-person follow-up care visits compared with conventional, in-person follow-up care in the first 30 days following ambulatory surgery.Design, Setting, and ParticipantsA randomized clinical trial was conducted from February 1 to August 31, 2015, among ambulatory patients undergoing breast reconstruction at an academic ambulatory care hospital. Patients were randomly assigned to receive follow-up care via a mobile app or at an in-person visit during the first 30 days after the operation. Analysis was intention-to-treat.Main Outcomes and MeasuresThe primary end point was the number of in-person follow-up visits during the first 30 days after the operation. Secondary end points were the number of telephone calls and emails to health care professionals, patient-reported convenience and satisfaction scores, and rates of complications.ResultsOf the 65 women in the study (mean [SD] age, 47.7 [13.4] years), 32 (49%) were in the mobile app group, and 33 (51%) were in the in-person follow-up care group. Those in the mobile app group attended a mean of 0.66 in-person visits, vs 1.64 in-person visits in the in-person follow-up care group, for a difference of 0.40 times fewer in-person visits (95% CI, 0.24-0.66; P < .001) and sent more emails to their health care professionals during the first 30 days after the operation (mean, 0.65 vs 0.15; incidence rate ratio, 4.13; 95% CI, 1.55-10.99; P = .005) than did patients in the in-person follow-up care group. This statistically significant difference was maintained at 3 months postoperatively. The mobile app group reported higher convenience scores than the in-person follow-up care group (incidence rate ratio, 1.39; 95% CI, 1.09-1.77; P = .008). There was no difference between groups in the number of telephone communications, satisfaction scores, or complication rates.Conclusions and RelevancePatients undergoing ambulatory breast reconstruction can use follow-up care via a mobile app to avert in-person follow-up visits during the first 30 days after the operation. Mobile app follow-up care affects neither complication rates nor patient-reported satisfaction scores, but it improves patient-reported convenience scores.Trial Registrationclinicaltrials.gov Identifier: NCT02318953

A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial

AimsThe ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD).Methods and resultsThe trial's primary objective was to randomly compare the proportions of patients experiencing ≥1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ≥1 MAE (P < 0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n = 193) than in the control (n = 657) group (P < 0.05) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081).ConclusionOur observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery.Clinical trials registrationNCT00989417.

Effect of home monitoring on hypertension control

Effect of home monitoring on hypertension control

Effect of home monitoring on a high-risk population.

A large cohort of infants (8,998) at high risk for sudden and unexpected death was followed with home cardiorespiratory monitoring over a five-year period. These infants included premature infants (23-36 weeks post-conceptual age), SIDS siblings, and infants who experienced an Apparent Life-Threatening Event. The overall SIDS rate in this high-risk population was 0.55/1,000, a rate significantly less than the 0.85 deaths/1,000 reported in the "general population" of Georgia over this same time period. In addition, we report our experience with using home monitors as a diagnostic tool, as well as how monitors can actually be cost-effective. Editorial opinions, and lay press summaries of the CHIME study (JAMA, May 2, 2001) imply that home cardiorespirtory monitors are of little value. Despite the fact that the study never made this claim, many clinicians are now referring to this study as evidence that home monitoring is ineffective and not needed. This article disputes those misconceptions about home cardiorespiratory monitors based on our experience with a large high-risk population of infants.

The Effect of Home Monitoring and Telemanagement on Blood Pressure Control Among African Americans

Hypertension is disproportionately prevalent among African Americans compared with other ethnic groups. Furthermore, research demonstrating effective management strategies for this group is limited. The objectives of this study were to determine: (1) compliance with home blood pressure monitoring among hypertensive African Americans, and (2) the effectiveness of telemanagement in blood pressure control within 1-3 months. Participants used a transtelephonic home monitor that transmitted their blood pressure daily via their existing telephone lines to a university server system. A one-group, pre-post design was used. The sample included 33 African Americans (age 51.5 ± 14.3, 70% female) with uncontrolled blood pressures despite pharmacological treatment for ≥ 1 year. Interventions were conducted over the phone, including patient education and medication titration congruent with JNC-VI guidelines. Daily data were transmitted by 88% of the sample; significant decreases (p ≤ 0.001) in mean systolic (154.1 ± 16.0 to 141.4 ± 12.2 mmHg) and diastolic (89.9 ± 9.6 to 83.2 ± 9.6 mmHg) blood pressures; and 60% (p ≤ 0.001) achieved blood pressure control within 1 month. Significant blood pressure improvements (p ≤ 0.001) were maintained throughout the study. Additionally, disease knowledge was improved (p < 0.002), and some lifestyle modifications were demonstrated including mean weight loss (p ≤ 0.02); quality of life, which was rated as 'satisfying' at baseline, did not change. African American patients in this sample were compliant with the required home monitoring and blood pressure control in a relatively short time. Other beneficial psychosocial and behavioral effects were demonstrated.

Sudden Infant Death Syndrome Prevention and an Understanding of Selected Clinical Issues

The etiology and prevention of sudden infant death syndrome (SIDS) are among the more frustrating topics in pediatrics. This article addresses several clinically relevant issues, including the relationships between apnea and SIDS, the nature of the "terminal event," effectiveness of home monitoring, the role of gastroesophageal reflux in apparent life-threatening events, and the association between the prone sleeping position and SIDS. This article is intended to provide the clinician with an awareness of the issues and the scientific basis needed to understand their contribution to SIDS.