A Smartphone-Based Model of Care to Support Patients With Cardiac Disease Transitioning From Hospital to the Community (TeleClinical Care): Pilot Randomized Controlled Trial.

BACKGROUND: Patients hospitalized with acute coronary syndrome (ACS) or heart failure (HF) are frequently readmitted. This is the first randomized controlled trial of a mobile health intervention that combines telemonitoring and education for inpatients with ACS or HF to prevent readmission. OBJECTIVE: This study aims to investigate the feasibility, efficacy, and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care [TCC]) in patients discharged after ACS or HF admission. METHODS: In this pilot, 2-center randomized controlled trial, TCC was applied at discharge along with usual care to intervention arm participants. Control arm participants received usual care alone. Inclusion criteria were current admission with ACS or HF, ownership of a compatible smartphone, age ≥18 years, and provision of informed consent. The primary end point was the incidence of unplanned 30-day readmissions. Secondary end points included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness, and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure, and physical activity daily plus usual care. The devices automatically transmitted recordings to the patients' smartphones and a central server. Thresholds for blood pressure, heart rate, and weight were determined by the treating cardiologists. Readings outside these thresholds were flagged to a monitoring team, who discussed salient abnormalities with the patients' usual care providers (cardiologists, general practitioners, or HF outreach nurses), who were responsible for further management. The app also provided educational push notifications. Participants were followed up after 6 months. RESULTS: Overall, 164 inpatients were randomized (TCC: 81/164, 49.4%; control: 83/164, 50.6%; mean age 61.5, SD 12.3 years; 130/164, 79.3% men; 128/164, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P=.97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 in TCC vs 41 in the control arm; P=.02), including cardiac readmissions (11 in TCC vs 25 in the control arm; P=.03), and higher rates of cardiac rehabilitation completion (20/51, 39% vs 9/49, 18%; P=.03) and medication adherence (57/76, 75% vs 37/74, 50%; P=.002). The average usability rating for the app was 4.5/5. The intervention cost Aus $6028 (US $4342.26) per cardiac readmission saved. When modeled in a mainstream clinical setting, enrollment of 237 patients was projected to have the same expenditure compared with usual care, and enrollment of 500 patients was projected to save approximately Aus $100,000 (approximately US $70,000) annually. CONCLUSIONS: TCC was feasible and safe for inpatients with either ACS or HF. The incidence of 30-day readmissions was similar; however, long-term benefits were demonstrated, including fewer readmissions over 6 months, improved medication adherence, and improved cardiac rehabilitation completion. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001547235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375945.

Rotational Atherectomy Combined with Drug Coated-Balloons for in-Stent Restenosis.

BACKGROUND: Refractory coronary in-stent restenosis remains a clinically relevant problem in interventional cardiology despite the use of drug coated balloon angioplasty and further drug eluting stent deployment. In this study, we investigated whether the novel approach of lesion debulking with rotational atherectomy prior to drug coated balloon angioplasty for challenging coronary in-stent restenosis is safe and effective. METHODS: Procedural and registry data was retrospectively analysed for 26 patients who underwent rotational atherectomy immediately followed by drug coated balloon angioplasty to 43 coronary in-stent restenosis lesions with mean follow up of 19 months. RESULTS: Lesion success was achieved in all cases with no major procedural complications. There were no instances of death or myocardial infarction in the follow up period. Target lesion revascularisation occurred in six patients and target vessel revascularisation occurred in eight patients. All target lesion revascularisation occurred in lesions that had already failed drug coated balloon angioplasty without debulking previously while four such lesions were free of lesion failure in the follow up period. CONCLUSIONS: Lesion debulking with rotational atherectomy followed by drug coated balloon angioplasty is a feasible treatment option for selected cases of in-stent restenosis. Further study is needed to fully assess its efficacy in comparison to conventional treatment.

Simulated patient and role play methodologies for communication skills training in an undergraduate medical program: Randomized, crossover trial.

Background: Educators utilize real patients, simulated patients (SP), and student role play (RP) in communication skills training (CST) in medical curricula. The chosen modality may depend more on resource availability than educational stage and student needs. In this study, we set out to determine whether an inexpensive volunteer SP program offered an educational advantage compared to RP for CST in preclinical medical students. Methods: Students and volunteer SPs participated in interactions across two courses. Students allocated to SP interactions in one course participated in RP in the other course and vice versa. Audio recordings of interactions were made, and these were rated against criterion descriptors in a modified Calgary-Cambridge Referenced Observation Guide. Results: Independent t-test scores comparing ratings of RP and SP groups revealed no significant differences between methodologies. Discussion: This study demonstrates that volunteer SPs are not superior to RP, when used in CST targeted at preclinical students. This finding is consistent with existing literature, yet we suggest that it is imperative to consider the broader purpose of CST and the needs of stakeholders. Consequently, it may be beneficial to use mixed methods of CST in medical programs.