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Oral anticoagulants (OACs) are critical for preventing stroke in patients with atrial fibrillation (AF), yet adherence and persistence remain suboptimal, especially in primary care settings. The COVID-19 pandemic introduced new barriers to care that may have further disrupted medication use. This study aimed to examine the impact of the COVID-19 pandemic on OAC adherence and persistence among patients with nonvalvular AF managed in primary care practices. In this retrospective cohort study, we used clinical records from the American Board of Family Medicine's (ABFM) PRIME Registry, for March 2017 through March 2023. We included 3,010 patients with documented AF and at least two OAC prescriptions prior to baseline. Persistence was assessed annually using a treatment anniversary method, and adherence was measured using the proportion of days covered (PDC), analyzed among persistent patients only. Interrupted time series and multivariable logistic regression models evaluated changes in quarterly persistence and factors associated with persistence and good adherence. Persistence declined sharply during the pandemic from 49.9% in 2018-2019 to 8.2% in the pandemic year-1. Adherence also dropped, with >95% PDC decreasing from 46.0% pre-pandemic to 17.7% in the pandemic year-2. Interrupted time series analysis showed a significant immediate drop in persistence. Compared to warfarin, NOAC use was associated with lower persistence in the pre-pandemic period, but higher persistence by the second year of the pandemic. The COVID-19 pandemic was associated with sustained declines in OAC adherence and persistence among AF patients in primary care. Targeted interventions including telemedicine, home-based care, and attention to high-risk subgroups are essential to maintain continuity of care and improve adherence during public health crises.
To evaluate the early effects of Pathways to Success implementation on utilization, as measured by quarterly price-standardized Medicare spending per beneficiary. This study was a nationwide retrospective cohort analysis of Traditional Medicare beneficiaries. The primary outcome was overall utilization, as measured by adjusted quarterly price standardized spending per beneficiary. Secondary outcomes included adjusted quarterly price standardized spending by component type (inpatient, outpatient institutional, Part B, and skilled nursing facility). The primary independent variable is Pathways to Success implementation on July 1, 2019. A 20% sample of national Medicare data from January 1, 2018, through March 31, 2020, includes Traditional Medicare beneficiaries managed in ACOs (n = 1,368,523) and outside of ACOs ("controls," n = 1,476,982) prior to Pathways implementation. Unadjusted quarterly spending among those in ACOs and controls decreased over the study period by $13.5 (from $2614.8 before Pathways implementation to $2601.3 after Pathways implementation) and $89.8 (from $2723.1 before Pathways implementation to $2633.3 after Pathways implementation), respectively. Adjusted quarterly spending per beneficiary decreased more slowly in ACOs compared to controls (differences-in-differences estimate +$46.8 (95% CI $19.2, $74.4) in ACOs vs. controls). This difference was largely driven by a more rapid decrease in the utilization of inpatient care. Adjusted quarterly spending per beneficiary for inpatient care decreased more slowly in ACOs compared to controls (differences-in-differences estimate +$43.6 [95% CI $27.2, $60.0] in ACOs vs. controls). After Pathways, reductions in utilization, as measured by price-standardized spending, by ACOs occurred less rapidly than for those managed outside of the Shared Savings Program. This effect was driven by a more rapid decrease in spending for inpatient care by nonparticipants.
Primary health care facilities offer an entry point to the health care system in Malawi. Challenges experienced by these facilities include limited resources (both material and human), poor or inadequate knowledge, skills and attitudes of health care workers in emergency management, and delay in referral from primary care level to other levels of care. These contribute to poor outcomes including children dying within the first 24 hours of hospital admission. Training of health care workers and support staff in Emergency Triage Assessment and Treatment (ETAT) at primary care levels can help improve care of children with acute and severe illnesses. Health care workers and support staff in the primary care settings were trained in pediatric ETAT. The training package for health care workers was adapted from the Ministry of Health ETAT training for district and tertiary health care. Content for support staff focused on non-technical responsibility for lifesaving in emergency situations. The primary health care facilities were provided with a minimum treatment package comprising emergency equipment, supplies and drugs. Supportive supervisory visits were conducted quarterly. The training manual for health care workers was adapted from the Ministry of Health package and the support staff training manual was developed from the adapted package. Eight hundred and seventy-seven participants were trained (336 health care workers and 541 support staff). Following the training, triaging of patients improved and patients were managed as emergency, priority or non-urgent. This reduced the number of referral cases and children were stabilized before referral. Capacity building of health care workers and support staff in pediatric ETAT and the provision of a basic health center package improved practice at the primary care level. The practice was sustained through institutional mentorship and pre-service and in-service training. The practice of triage and treatment including stabilization of children with dangerous signs at the primary health care facility improves emergency care of patients, reduces the burden of patients on referral hospitals and increases the number of successful referrals.
Hospital overcrowding where patient admissions exceed capacity is associated with worse outcomes in Emergency Department. Developments in emergency stroke care have been associated with improvements in stroke outcome but are dependent on effective, organised care. We examined if overcrowding in the hospital system was associated with negative changes in stroke outcome. Data on overcrowding were obtained from the Irish Nurses and Midwives Organisation (INMO) 'Trolley Count' database recording the number of patients cared for on trolleys/chairs in all acute hospitals each midnight. These were compared with quarterly data from the Irish National Audit of Stroke from 2013 to 2021 inclusive. Variables analysed were inpatient mortality rate, thrombolysis rate for ischaemic stroke, median door to needle time and median length of stay. 579449 patient episodes were recorded by Trolley Watch over the period, (Quarterly Median 16719.5, range 3389-27015). Average Quarterly Thrombolysis rate was 11.3% (sd 1.3%) Median Quarterly Inpatient Mortality rate was 11.8% (Range 8.9-14.0%). Median Quarterly Length of stay was 9 days (8-11 days). Median quarterly door to needle was 65 min (45-80 min). Q1 was typically the worst for overcrowding with on average 19777 incidences (sd 4786). This was significantly higher than for Q2 (mean 13540 (sd 4785) p = 0.005 t-test) and for Q3 (mean 14542 (sd 4753) p = 0.03). No significant correlation was found between quarterly Trolley watch episodes and inpatient mortality (r = 0.084, p = 0.63), median length of stay r=-0.15, p = 0.37) or thrombolysis rate (r = 0.089 p = 0.61). There was an unexpected significant negative correlation between trolley watch data and median door to needle time (r=-0.36, p = 0.03). Despite increasing hospital overcrowding, stroke services still managed to preserve standard of care. We could find no association between levels of overcrowding and deterioration in selected indices of patient care.
The number of patients with advanced chronic kidney disease opting for conservative management rather than dialysis is unknown but likely to be growing as increasingly frail patients with advanced renal disease present to renal services. Conservative kidney management includes ongoing medical input and support from a multidisciplinary team. There is limited evidence concerning patient and carer experience of this choice. This study will explore quality of life, symptoms, cognition, frailty, performance decision making, costs and impact on carers in people with advanced chronic kidney disease managed without dialysis and is funded by the National Institute of Health Research in the UK. In this prospective, multicentre, longitudinal study, patients will be recruited in the UK, by renal research nurses, once they have made the decision not to embark on dialysis. Carers will be asked to 'opt-in' with consent from patients. The approach includes longitudinal quantitative surveys of quality of life, symptoms, decision making and costs for patients and quality of life and costs for carers, with questionnaires administered quarterly over 12 months. Additionally, the decision making process will be explored via qualitative interviews with renal physicians/clinical nurse specialists. The study is designed to capture patient and carer profiles when conservative kidney management is implemented, and understand trajectories of care-receiving and care-giving with the aim of optimising palliative care for this population. It will explore the interactions that lead to clinical care decisions and the impact of these decisions on informal carers with the intention of improving clinical outcomes for patients and the experiences of care givers.
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions. Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD. Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities. Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs. Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices. With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications. In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs. In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings. Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system. Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented. Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians. The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices. All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience. The research directions and specific research questions for this evidence review were as follows: 1. To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices. 2. To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs. 3. To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices. 4. To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies. 5. To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada. LITERATURE SEARCH: The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices. SEARCH STRATEGY: A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. INCLUSION CRITERIA: published between 1950 and September 2010; English language full-reports and human studies; original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings; reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction; randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies. EXCLUSION CRITERIA: non-systematic reviews, letters, comments and editorials; reports not involving standardized outcome events; clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings; reports involving studies testing or validating algorithms without RM; studies with small samples (<10 subjects). OUTCOMES OF INTEREST: The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life. The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow. 1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning. In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries. The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults. Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below: The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians. In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event. Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted: – Fewer inappropriate shocks were administered in the RM group. – Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts. – No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up. Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported. Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS. – Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services. – Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission. – The majority of patients would recommend RM to other ICD patients. – Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported. Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS: – Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS. – Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely. – Both nurses and physicians reported a high level of satisfaction with the web registry system. 2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes. Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods. 3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs. Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS. 3A. RANDOMIZED CONTROLLED TRIALS OF REMOTE MONITORING SYSTEMS FOR PACEMAKERS: Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below: In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm. The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm. The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001). Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation. The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays. Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions. In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes. Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician. The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days). The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days). Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up. 3B. RANDOMIZED CONTROLLED TRIALS EVALUATING REMOTE MONITORING SYSTEMS FOR ICD OR CRT DEVICES: The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations. The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up. Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups. Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups. Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups. Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up. The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up. The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group. The in-clinic waiting time was eliminated for patients in the RM follow-up group. The physician talk time was significantly reduced in the RM follow-up group (P < 0.05). The time for the actual device interrogation did not differ in the study groups. The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality. There was a 63.2% reduction in in-office visits in the RM group. Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups. Patient-induced visits were higher in the RM group than the in-clinic follow-up group. THE TRUST TRIAL: The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events. Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001). Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups. The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months. The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days). The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days). System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group. The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively. The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174). THE CONNECT TRIAL: The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below: Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up. The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients). – The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days). Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days). Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group. Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group. The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants. The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46). There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations. The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way. Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
Medication nonadherence is a major concern for many health care stakeholders. Improving medication adherence in health plan members who have both hypertension and diabetes is essential for the successful management of these chronic diseases, with anticipated outcomes in decreased health care utilization, all-cause mortality and cost. To (a) identify patients who are potentially nonadherent to antidiabetic or antihypertensive agents within 1 managed care organization and (b) determine the relationship of rates of medication nonadherence with 2 mail intervention programs that involved quarterly medication-specific profiles of patients with potential nonadherence sent to primary care physicians (PCPs) and general medication adherence letters sent to patients with potential nonadherence. The study sample consisted of commercial members, Medicare Advantage-Prescription Drug Plan (MA-PD) members and Medicare Prescription Drug Plan (PDP) members who filled prescriptions for antihypertensive and antidiabetic medications and utilized their managed care pharmacy benefit during each measurement quarter (3 months) in the 2-year study period. Nonadherence was defined as a medication possession ratio (MPR) less than 77.0% for 1 or more antihypertensives and/or antidiabetic medications for each standalone calendar quarter. The first intervention, letters to PCPs with patient-specific medication profiles for 2008 Q2, began 6-8 weeks after 2008 Q2 and continued for each standalone calendar quarter through the end of the study period in 2010 Q1 (January 1, 2010, through March 31, 2010). We assumed that patient care was managed by PCPs for hypertension and diabetes treatment. The medication profile also included antihyperlipidemic medication claims information, but there was no adherence analysis performed for antihyperlipidemic medications. The second intervention, letters sent to potentially nonadherent patients, began 6-8 weeks after 2009 Q1 for patients with MPR less than 77% for 1 or more antidiabetic or antihypertensive medications in 2009 Q1 and continued for each standalone calendar quarter through the end of the study period in 2010 Q1. Because there were 2 different interventions, 2 baseline adherence rates were calculated, for 2008 Q2 for the PCP mailing and for 2009 Q1 for the patient mailing. Compared with the baseline nonadherence rate in 2008 Q2 (35.6%), a small increase in nonadherence was observed in 2008 Q3 (36.4%), following by 6 calendar quarters of lower rates of nonadherence with a 27.7% nonadherence rate in the last measurement period in 2010 Q1. Compared with the nonadherence rate of 30.8% in baseline 2 (2009 Q1), the patient mailings were associated with small increases in nonadherence to 31.4% in 2009 Q2 and 31.1% in 2009 Q3, respectively, followed by lower nonadherence rates in 2009 Q4 (29.2%) and 2010 Q1 (27.7%). A 2-part intervention that involved mailings to PCPs for patients with both diabetic and antihypertensive medications who were potentially nonadherent to at least 1 medication, followed 9 months later by a general mailing sent to these potentially nonadherent patients regarding medication adherence, was associated with apparent improvement. However, the effect of the 2-part intervention on medication nonadherence could not be isolated because of coincident disease management interventions in diabetes and hypertension during the 2-year study period.
Longitudinal trajectories of healthcare utilization, medication prescription, and clinical outcomes among older adults with disabilities receiving home healthcare (HHC) holds significance but remains elusive. People aged≥65 years who newly received Taiwan's National Health Insurance funded HHC program from January 2005 to December 2013 were identified. Healthcare utilization, life-sustaining treatment, medication prescriptions (polypharmacy, psychotropics, anticholinergic burden and antibiotics), health status (Charlson's comorbidity index, CCI), and mortality were assessed over a 10-year period spanning 5 years before and after initiating HHC. Overall, 187,547 patients (80.6 ± 7.7 years, 51.2 % females, CCI 3+: 51.2 %) with a high prevalence of dementia (34.0 %), stroke (38.7 %), and pneumonia (49.5 %), and usage of life-sustaining treatment (urinary catheters: 82.8 % and nasogastric feeding: 78.7 %) were obtained. A sudden peak of admission rate at 1 year (91.7 %) before HHC, followed by the 70 % and 60 % admission rate in the first and second year after receiving HHC were found. Quarterly changes of using life-sustaining treatment showed significant increases from as early as 1 year prior to HHC. Gradual increases of polypharmacy, use of psychotropics, and antibiotic (4.5-fold and 3-fold) after HHC further demonstrated the complex needs (both p < 0.01). The 5-year cumulative mortality rate was 81 % (40 % in the first year with an annual rate of 25 %). HHC recipients embody a confluence of complex care needs and high mortality risk, whereby various interventions aim to alleviate symptoms and sustain life. Engaging in proactive advanced care planning and end-of-life care should be prioritized when home healthcare is being contemplated.
This study describes the current management of patients with eating disorders (EDs) served by publicly-funded Medicaid behavioral health systems. Behavioral health leaders across nine counties in California met on a quarterly basis to share experiences, challenges, and lessons in the management of EDs within publicly-funded service systems. Detailed notes were taken, and a qualitative content analysis was undertaken to identify key themes. County leadership noted insufficient outpatient capacity and difficulty building capacity for ED treatment, in addition to extraordinary challenges when facilitating admission to out-of-network higher level of care programs, at significant expense. Several challenges were identified in building an internal ED workforce, including the fact that many providers weren't eager to treat EDs due to training burden, patient complexity, and high levels of clinician burnout. When a higher level of care was required due to lack of outpatient resources or patient symptom severity or complexity, leaders dedicated significant resources to identify and contract with an appropriate program and secure the necessary funds. Our study supports the need for specialized ED treatment and case management, as well as standardized processes and centralized resources, in Medicaid-managed care. Findings also indicate the importance of protecting against clinician burnout, possibly through reduced caseload expectations, financial incentives, or increased support. Future policy change could reduce administrative burden and clinician burnout by facilitating admission to and reimbursement for higher levels of care.
To assess how the infrastructure improvements supported by the US Centers for Disease Control and Prevention (CDC) and the United States President's Emergency Plan for AIDS Relief (PEPFAR) contributed to facility-level quarterly and annual new patient enrolment in HIV care and treatment and antiretroviral therapy (ART) uptake and retention in care. Aggregate quarterly and annual facility-based HIV care and treatment data from the CDC-managed PEPFAR Reporting Online and Management Information System database collected between 2005 and 2012 were analysed for the 11 rural and 32 urban facilities that met the eligibility criteria. Infrastructure improvements, including both renovations and new construction, occurred on different dates for the facilities; therefore, data were adjusted such that pre- and post-infrastructure improvements were aligned and date-time was ignored. The analysis calculated the mean (95% confidence interval) number of patients per facility who were (1) newly enrolled in HIV care, (2) patients initiated on ART, (3) patients retained in care, defined as alive and on ART, and (4) reasons for attrition, defined as transferred out, lost to follow-up, deceased or stopped ART. The overall mean number of adult patients newly enrolled in HIV care clinics per quarter declined from 187.7 (151.4-223.9) to 135.2 (117.4-152.9) after infrastructure improvements but was not statistically significant (p = 0.20). However, the mean number of patients who were alive and remained on ART increased from 193.2 (145.3-241.1) to 273.2 (219.0-327.3) after improvements in both rural and urban facilities, although not significantly (p = 0.59). A similar picture was observed for overall paediatric enrolment and retention in care. Health facility-specific case studies show variations in new patient enrolment and retention in care between health facilities depending on the catchment area, population HIV prevalence and coverage of ART facilities. Regarding attrition, the mean number of adult patients lost to follow-up changed from 76.6 (20.8-132.3) to 139.4 (79.6-199.1) (p = 0.65) among rural facilities, while the mean number of children lost to follow-up increased significantly from 3.4 (0.5-6.3) to 8.7 (5.0-12.3) (p = 0.02) after improvements. Patient retention in care improved in HIV care and treatment facilities with infrastructure improvements. However, the overall number of patients newly enrolled and initiated on ART declined and attrition increased in facilities after improvements.
Patient satisfaction is a key metric for assessing quality and equity in health systems. In Saudi Arabia, the Ministry of Health (MOH) has prioritized monitoring patient experiences to guide primary health care (PHC) improvements. Understanding seasonal variation in satisfaction is particularly important, as it can reveal fluctuations in service performance and inform workload planning, staffing, and quality improvement policies. This study examined three-year trends and seasonal variation in patient satisfaction with PHC services from 2022 to 2024. A retrospective repeated cross-sectional analysis was conducted using secondary data from the MOH Patient Experience Measurement Program. Data included responses from patients or their caregivers who visited PHC centres and completed the Press Ganey®-based patient satisfaction survey. Quarterly datasets from January 2022 to December 2024 across all PHC centres managed by 20 health clusters in Saudi Arabia were merged. The main outcome was the mean satisfaction score (scaled 0-100). Linear regression models were used to examine changes in patient satisfaction, adjusting for sociodemographic factors such as age, sex, and nationality. Interaction terms were introduced separately to assess temporal trends across different subgroups. Predicted margins were calculated and visualized to interpret subgroup patterns. A total of 2,173,518 responses were analysed. The overall mean satisfaction score was 82.2 (SD = 23.4), increasing significantly from 79.7 in 2022 to 84.3 in 2024, p < 0.001. Older adults and non-Saudis reported higher satisfaction, while younger respondents and females had lower scores. The highest adjusted gain occurred in the last quarter of 2024 (β = 4.18; 95% CI: 4.01, 4.34). All subgroups showed upward trends, although disparities by age, sex, and nationality persisted throughout the three-year period. Patient satisfaction with PHC services in Saudi Arabia improved significantly between 2022 and 2024, with evidence of seasonal patterns. These findings emphasize the importance of using national patient experience data to strengthen patient-centered reforms, promote equity, and guide evidence-based PHC quality improvement and policy design.
Cancer-related emergency department (ED) visits and hospitalizations that would have been appropriately managed in the outpatient setting are avoidable and detrimental to patients and health systems. This quality improvement (QI) project aimed to leverage patient risk-based prescriptive analytics at a community oncology practice to reduce avoidable acute care use (ACU). Using the Plan-Do-Study-Act (PDSA) methodology, we implemented the Jvion Care Optimization and Recommendation Enhancement augmented intelligence (AI) tool at an Oncology Care Model (OCM) practice, the Center for Cancer and Blood Disorders practice. We applied continuous machine learning to predict risk of preventable harm (avoidable ACU) and generated patient-specific recommendations that nurses implemented to avert it. Patient-centric interventions included medication/dosage changes, laboratory tests/imaging, physical/occupational/psychologic therapy referral, palliative care/hospice referral, and surveillance/observation. Nurses contacted patients every 1-2 weeks after initial outreach to assess and maintain adherence to recommended interventions. Per 100 unique OCM patients, monthly ED visits dropped from 13.7 to 11.5 (18%), a sustained month-over-month improvement. Quarterly admissions dropped from 19.5 to 17.1 (13%), a sustained quarter-over-quarter improvement. Overall, the practice realized potential annual savings of $2.8 million US dollars (USD) on avoidable ACU. The AI tool has enabled nurse case managers to identify and resolve critical clinical issues and reduce avoidable ACU. Effects on outcomes can be inferred from the reduction; targeting short-term interventions toward patients most at-risk translates to better long-term care and outcomes. QI projects involving predictive modeling of patient risk, prescriptive analytics, and nurse outreach may reduce ACU.
Maternal nutrition intervention research (MNIR) embedded in antenatal care (ANC) was conducted in Burkina Faso to improve reproductive services. The aim of this study was to understand and document the contributions of leadership and management at various health system levels in improving resource management and maternal nutrition service coverage. It was a qualitative case study conducted from July to December 2022 with 44 participants from the Boucle du Mouhoun and Hauts-Bassins health regions. It consisted of interviews with key managers and document reviews. This study demonstrated that strengthening maternal nutrition through ANC in Burkina Faso was feasible and significantly impacted nutrition practices within a year. Coordination involved national and regional actors, nongovernmental organizations, and the private sector, ensuring effective collaboration. Leadership was shared with the private sector, but not effectively at the central level. Inputs and databases were managed by the private executive association and were not integrated into the National Health Information System. The health system's usual organization was respected, with well-defined roles and effective communication, despite some delays in per diem payments and a lack of implementation tools. Monitoring and follow-up were systematic, involving quarterly and monthly review meetings. The project showed significant improvements in maternal nutrition knowledge, weight gain, ANC visits, anemia management, and early breastfeeding initiation, despite minimal changes in self-efficacy, beliefs, and family support. The MNIR was successfully implemented in four health districts, with private sector involvement improving communication and leadership. The project enhanced the health system's resilience against terrorism and coronavirus disease 2019, demonstrating potential for expansion to national implementation.
The prevalence of type 2 diabetes (T2D) is growing globally and hospital-based outpatient clinics are burdened with increasing numbers of patients. To ensure high quality treatment and care, it is necessary to structurally reorganise the management of patients with T2D. The objective of this study is to test if T2D patients (who are at intermediate risk of or are already having incipient diabetic complications) jointly managed by a hospital-based outpatient clinic and general practitioners (shared care programme) have a non-inferior outcome compared to an established programme in a specialised (hospital based) outpatient diabetes clinic. The study is designed as a randomised controlled trial. The shared care model will be tested during a period of 3 years, with data collection at baseline and at 12, 24 and 36 months. All patients will be offered four medical visits a year; the shared care intervention consists of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at the general practitioners' office. The control group will be followed with four quarterly visits at the outpatient clinic, including an annual comprehensive check-up. In the outpatient clinic, the patients will be treated by a specialised diabetes team, including an endocrinologist. On the basis of a predefined stratification model, we will recruit patients stratified to be at intermediate risk of or already having incipient diabetic complications. We plan to include 140 patients. The primary outcome is glycated haemoglobin. Other outcome measures include (1) the proportion of patients who meet the Danish standard indicators reflecting quality of care; (2) quality of life measured by Short Form 36; and (3) the functionality of the patients' families measured by Family Assessment Measure III. The experiences of the patients and families when participating in the shared care program will be explored by collecting dyadic interviews. This study will evaluate the quality of a shared care programme for patients with T2D, and provide evidence about advantages and disadvantages compared with a programme in a specialised outpatient clinic. The results may provide important information on how to organise the care for patients with T2D in the future. This trial was registered with Clinicaltrials.gov on 21 October 2015, registration number: NCT02586545 .
International evidence suggests that reducing user costs increases maternity care utilization but not necessarily care quality, underscoring the need for transparent, comparable measurement. In Japan, evidence-based maternity care for low-risk childbirth has not been systematically evaluated, and limited claims-data capture hinders assessment, benchmarking, and sustained quality improvement. We aimed to explore how determinants (facilitators and barriers) of implementing a multifaceted quality improvement intervention for low-risk childbirth emerge and evolve over time. This longitudinal qualitative study was performed at four facilities in the Kinki region of Japan using a process-evaluation approach. The intervention included quarterly performance-based audits and feedback to healthcare providers caring for low-risk women, multidisciplinary team-based quality improvement efforts, and educational sessions addressing care quality and organizational culture. Healthcare providers involved with low-risk childbirth participated in semi-structured interviews at the beginning and end of the intervention. Data were analyzed using directed content analysis, following the Consolidated Framework for Implementation Research (CFIR), to identify facilitators and barriers of the intervention, observe changes over time, and compare variations across facilities. Ethical approval was obtained from the Ethics Committee of Kyoto University (R2342 and R2344), and all interview participants provided written informed consent. Across 66 semi-structured interviews with 41 participants, four CFIR constructs-Champions, Key Stakeholders, Structural Characteristics, and Networks and Communications-transitioned from serving as facilitators to barriers during the intervention. In contrast, the Knowledge and Beliefs about the Intervention construct remained stable within each facility over time, although its valence differed across facilities. Facilities where Champions exhibited participatory leadership and effectively disseminated the intervention's positive value experienced greater stakeholder engagement and smoother implementation. In contrast, in facilities where the intervention was perceived as having low value, various context-driven factors hindered implementation. The role-related CFIR constructs, such as Champions and Key Stakeholders, exhibited more dynamic change over time, whereas perceptions of the intervention's value remained relatively constant. Consistently positive perceptions of value facilitated sustained participation despite the presence of additional barriers. These findings highlight temporal fluctuations in implementation determinants and underscore the importance of supporting key roles and offering phase-specific, contextually responsive implementation support over time.
The perception in the US is that insulin formulations prescribed for type 1 and type 2 diabetes and delivered via insulin pens are more costly to patients than the same or similar products provided in vials, and that basal insulin analogs offered either in pens or vials are likewise more costly to patients than human insulin formulations. This study compares levels of coverage and copays by private and Medicare Part D plans for insulin pens and vials containing basal insulin analogs and for NPH formulations in vials. A commercially available formulary database (Access Point, Pinsonault Associates; updated quarterly) was analyzed as of January 2010 for private insurance plans and as of March 2010 for Medicare Part D plans. Analyses were performed for Tier-level coverage and copays per prescription for basal insulin analogs in pens and vials, and NPH in vials. Basal insulin analogs in pens were covered by >91% of private and Part D plans. NPH coverage was reported by >92% of private plans and 69-95% of Part D plans, depending on brand. Irrespective of delivery mode, copays in the majority of private plans for basal insulin analogs and NPH were in the >$10-35 range. Copays were higher in Part D plans, with the majority of plans and subscribers in a >$35-50 range. Prior authorization was required by <10% of insurance plans for insulin analog pen prescriptions, and <3% of plans for insulin analog or NPH prescriptions in vials. This analysis was descriptive, copay stratification was not based on a statistical model but on copay ranges typically used by the plans, and there were no direct correlations performed on the numbers of subscribers per plan vs copay or Tier level. These results counter the widely held perception that insurance coverage is less extensive for insulin pens vs vials. Medicare Part D plans often had higher copay requirements than private plans for the same product at the same copay Tier.
Medicaid enrolls a disproportionate share of US adults with hepatitis C virus (HCV), and most receive Medicaid benefits through managed care organizations (MCOs). Medicaid MCOs often impose stricter requirements to access HCV medications than traditional fee-for-service Medicaid, which may inhibit use. Though Medicaid MCOs generally cover prescription drugs, several states have carved out direct-acting antiviral HCV medications from MCO coverage and opted to cover them under fee-for-service. Whether these carve outs were associated with changes in medication use is unknown. To examine the association between Medicaid-covered HCV medication fills and carve outs of these medications from MCO coverage. This cross-sectional study examined changes in fills of Medicaid-covered direct-acting antiviral HCV medications in 4 states (Indiana, Michigan, New Hampshire, and West Virginia) that carved out these drugs from Medicaid MCOs between 2015 and 2017. A synthetic control approach was used to compare changes in HCV prescription fills between states that did and did not carve out these medications from MCO prescription drug coverage. Data of direct-acting antiviral HCV prescription fills were obtained from the Medicaid State Drug Utilization Data files, January 2015 to June 2020. Data analysis was conducted from November 2020 to June 2021. Carve outs of direct-acting antiviral HCV medications from Medicaid MCO prescription drug coverage. Direct-acting antiviral HCV prescriptions filled per 100 000 Medicaid enrollees. In this cross-sectional study, carve outs were associated with a mean quarterly increase of 22.1 (95% CI, 12.7-34.1) HCV prescriptions per 100 000 Medicaid enrollees, a relative increase of 86.3% compared with synthetic control states. Compared with each state's respective synthetic control, HCV prescription fills were associated with an increase of 11.5 (95% CI, 5.1-19.0) HCV prescription fills per 100 000 Medicaid enrollees per quarter in Indiana, 36.6 (95% CI, 23.5-53.9) in Michigan, 20.7 (95% CI, 11.1-32.8) in West Virginia, and 43.6 (95% CI, 25.9-68.4) in New Hampshire. In this cross-sectional study of data from 39 states and the District of Columbia, carve outs of direct-acting antiviral HCV medications from Medicaid MCO prescription drug coverage were associated with significant increases in HCV medication use. Given their clinical benefits, greater uptake of HCV medication may help improve the health of Medicaid enrollees with HCV and reduce the economic burden of untreated HCV on the US health care system.
The rising burden of alcohol-associated liver disease (ALD) calls for effective interventions. Alcohol cessation remains the only intervention known to reduce long-term ALD morbidity and mortality. Integrating treatment for alcohol use disorder with medical and hepatology care shows significant promise. This study aims to conduct a randomized, controlled, type 1 hybrid implementation-effectiveness trial in patients with ALD to evaluate an evidence-based smartphone app for alcohol use disorder (Connections). The primary aim is to (1) compare the effectiveness of the Connections app plus usual care to the effectiveness of usual care alone on days of alcohol abstinence for patients with ALD and (2) assess the implementation of the Connections app in the ALD population using a multilevel model of system change to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels. Study procedures were approved by the Institutional Review Board on March 13, 2024. Patients are recruited from General Hepatology and Multidisciplinary Clinics in Wisconsin and Michigan. Participants are randomized to an intervention (Connections + treatment as usual) or no intervention (treatment as usual). During the 6-month enrollment period, participants complete monthly e-surveys measuring alcohol consumption and quarterly e-surveys measuring patient health indicators and behaviors. Patients earn up to US $240 for participation. This study was funded in September 2023. Recruitment began in June 2024 and is ongoing. As of February 26, 2026, 144 participants have been enrolled in the study. Of these, 65 (45.1%) have completed all the study activities. We aim to recruit 298 participants through 2027, with analysis and results publication estimated in 2028. Implementation insights highlight the importance of flexibility and strong provider relationships. Challenges include reliance on technology, which limits access for patients with low digital literacy, and the risk of loss to follow-up. This trial is the first fully powered implementation-effectiveness study of a mobile health app for alcohol cessation in ALD, testing a new care model that integrates multidisciplinary expertise. DERR1-10.2196/94231.
Adherence to antiretroviral therapy is critical to successful treatment of human immunodeficiency virus (HIV). Few interventions have been demonstrated to improve both adherence and virologic outcomes. We sought to determine whether an intervention derived from problem solving theory, Managed Problem Solving (MAPS), would improve antiretroviral outcomes. We conducted a randomized investigator blind trial of MAPS compared with usual care in HIV-1 infected individuals at 3 HIV clinics in Philadelphia, Pennsylvania. Eligible patients had plasma HIV-1 viral loads greater than 1000 copies/mL and were initiating or changing therapy. Managed Problem Solving consists of 4 in-person and 12 telephone-based meetings with a trained interventionist, then monthly follow-up calls for a year. Primary outcome was medication adherence measured using electronic monitors, summarized as fraction of doses taken quarterly over 1 year. Secondary outcome was undetectable HIV viral load over 1 year. We assessed 218 for eligibility, with 190 eligible and 180 enrolled, 91 randomized to MAPS and 89 to usual care. Fifty-six participants were lost to follow-up: 33 in the MAPS group and 23 in usual care group. In primary intention-to-treat analyses, the odds of being in a higher adherence category was 1.78 (95% CI,1.07-2.96) times greater for MAPS than usual care. In secondary analyses, the odds of an undetectable viral load was 1.48 (95% CI, 0.94-2.31) times greater for MAPS than usual care. In as-treated analyses, the effect of MAPS was stronger for both outcomes. There was neither a difference by prior treatment status nor change in effect over time. Managed Problem Solving is an effective antiretroviral adherence intervention over the first year with a new regimen. It was equally effective at improving adherence in treatment experienced and naïve patients and did not lose effect over time. Implementation of MAPS should be strongly considered where resources are available. clinicaltrials.gov Identifier: NCT00130273.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are therapies for type 2 diabetes whose use expanded sharply after semaglutide's 2021 approval for obesity. Although gastrointestinal effects are well described, national patterns of acute GLP-1 RA exposures are poorly characterized. This study evaluated trends in GLP-1 RA exposures reported to U.S. poison centers, focusing on demographic shifts, exposure circumstances, and clinical outcomes before and after the 2021 FDA approval. We analyzed human GLP-1 RA exposures reported to the National Poison Data System from 2012 to 2023, using July 1, 2021, to define pre- and post-approval periods. Demographics, exposure characteristics, therapies, and medical outcomes were compared using standardized statistical tests. Quarterly call counts were modeled with segmented Poisson regression to assess changes in reporting trajectory. A total of 10,033 exposures were identified (3,113 pre-approval; 6,920 post-approval). Semaglutide predominated post-approval (64.2%). The exposed population shifted younger and more female. Most cases were unintentional therapeutic errors with mild gastrointestinal symptoms. The proportion managed in or referred to a health care facility increased from 23.0% to 33.5% (RR = 1.46, [95% CI: 1.36, 1.57], p < 0.001). Segmented Poisson modeling demonstrated a significant inflection in call volume, with semaglutide exposures increasing an additional 9.9% per quarter after approval. GLP-1 RA exposures rose sharply following semaglutide's weight-loss approval, accompanied by increased health care utilization despite generally mild clinical effects. Although multiple factors likely contributed to these trends, improved patient counseling and clearer poison center guidance may help reduce preventable therapeutic errors and unnecessary emergency evaluation.