Remote intensive management to improve antiplatelet adherence in acute myocardial infarction: a secondary analysis of the randomized controlled IMMACULATE trial.

This study aim to investigate if remote intensive coaching for the first 6 months post-AMI will improve adherence to the twice-a-day antiplatelet medication, ticagrelor. Between July 8, 2015, to March 29, 2019, AMI patients were randomly assigned to remote intensive management (RIM) or standard care (SC). RIM participants underwent 6 months of weekly then two-weekly consultations to review medication side effects and medication adherence coaching by a centralized nurse practitioner team, whereas SC participants received usual cardiologist face-to-face consultations. Adherence to ticagrelor were determined using pill counting and serial platelet reactivity measurements for 12 months. A total of 149 (49.5%) of participants were randomized to RIM and 152 (50.5%) to SC. Adherence to ticagrelor was similar between RIM and SC group at 1 month (94.4 ± 0.7% vs. 93.6±14.7%, p = 0.537), 6 months (91.0±14.6% vs. 90.6±14.8%, p = 0.832) and 12 months (87.4±17.0% vs. 89.8±12.5%, p = 0.688). There was also no significant difference in platelet reactivity between the RIM and SC groups at 1 month (251AU*min [212-328] vs. 267AU*min [208-351], p = 0.399), 6 months (239AU*min [165-308] vs. 235AU*min [171-346], p = 0.610) and 12 months (249AU*min [177-432] vs. 259AU*min [182-360], p = 0.678). Sensitivity analysis did not demonstrate any association of ticagrelor adherence with bleeding events and major adverse cardiovascular events. RIM, comprising 6 months of intensive coaching by nurse practitioners, did not improve adherence to the twice-a-day medication ticagrelor compared with SC among patients with AMI. A gradual decline in ticagrelor adherence over 12 months was observed despite 6 months of intensive coaching.

Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care: The IMMACULATE Randomized Clinical Trial.

Importance: There are few data on remote postdischarge treatment of patients with acute myocardial infarction. Objective: To compare the safety and efficacy of allied health care practitioner-led remote intensive management (RIM) with cardiologist-led standard care (SC). Design, Setting, and Participants: This intention-to-treat feasibility trial randomized patients with acute myocardial infarction undergoing early revascularization and with N-terminal-pro-B-type natriuretic peptide concentration more than 300 pg/mL to RIM or SC across 3 hospitals in Singapore from July 8, 2015, to March 29, 2019. RIM participants underwent 6 months of remote consultations that included ß-blocker and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACE-I/ARB) dose adjustment by a centralized nurse practitioner team while SC participants were treated face-to-face by their cardiologists. Main Outcomes and Measures: The primary safety end point was a composite of hypotension, bradycardia, hyperkalemia, or acute kidney injury requiring hospitalization. To assess the efficacy of RIM in dose adjustment of ß-blockers and ACE-I/ARBs compared with SC, dose intensity scores were derived by converting comparable doses of different ß-blockers and ACE-I/ARBs to a scale from 0 to 5. The primary efficacy end point was the 6-month indexed left ventricular end-systolic volume (LVESV) adjusted for baseline LVESV. Results: Of 301 participants, 149 (49.5%) were randomized to RIM and 152 (50.5%) to SC. RIM and SC participants had similar mean (SD) age (55.3 [8.5] vs 54.7 [9.1] years), median (interquartile range) N-terminal-pro-B-type natriuretic peptide concentration (807 [524-1360] vs 819 [485-1320] pg/mL), mean (SD) baseline left ventricular ejection fraction (57.4% [11.1%] vs 58.1% [10.3%]), and mean (SD) indexed LVESV (32.4 [14.1] vs 30.6 [11.7] mL/m2); 15 patients [5.9%] had a left ventricular ejection fraction <40%. The primary safety end point occurred in 0 RIM vs 2 SC participants (1.4%) (P = .50). The mean ß-blocker and ACE-I/ARB dose intensity score at 6 months was 3.03 vs 2.91 (adjusted mean difference, 0.12 [95% CI, -0.02 to 0.26; P = .10]) and 2.96 vs 2.77 (adjusted mean difference, 0.19 [95% CI, -0.02 to 0.40; P = .07]), respectively. The 6-month indexed LVESV was 28.9 vs 29.7 mL/m2 (adjusted mean difference, -0.80 mL/m2 [95% CI, -3.20 to 1.60; P = .51]). Conclusions and Relevance: Among low-risk patients with revascularization after myocardial infarction, RIM by allied health care professionals was feasible and safe. There were no differences in achieved medication doses or indices of left ventricular remodeling. Further studies of RIM in higher-risk cohorts are warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT02468349.

The development and pilot study of a nurse-led HOMe-based HEart failure self-Management Programme (the HOM-HEMP) for patients with chronic heart failure, following Medical Research Council guidelines.

BACKGROUND: Chronic heart failure (CHF) is one of the most common causes of hospital admissions and readmissions. Managing CHF requires a comprehensive treatment plan that consists of medication treatment and behavioural change. However, patients often feel unprepared for their self-management role in the community, especially during the period of transition after discharge from hospital. Therefore, an effective intervention to promote CHF self-management is needed. AIMS: This paper describes the development and pilot testing of a multicomponent nursing intervention (i.e. the HOM-HEMP) for a randomised controlled trial to assess its effectiveness in improving self-care behaviour among CHF patients in Singapore. A description of the study intervention is also delineated in detail. METHODS: The HOM-HEMP was developed based on the UK Medical Research Council framework for developing and evaluating complex interventions. After the development of the study intervention, a single group pre- and post-repeated measure pilot test was conducted to evaluate the study intervention package for its acceptability and the feasibility of the data collection procedure. Ten participants were recruited through consecutive sampling. All of the participants received the full intervention package with the supplementary mobile application. The data were collected at baseline and immediately after the study intervention (i.e. 6 weeks from baseline). The outcome measures included the Self-Care Heart Failure Index, Cardiac Self-Efficacy Scale, Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale and Short Form of the Social Support Questionnaire. RESULTS: The results from the pilot testing showed that the programme was feasible and potentially effective in improving patient's self-care management, psychological outcomes and health-related quality of life. CONCLUSION: A self-management psychosocial education approach is the preferred choice for many patients with chronic diseases. The effectiveness of the HOM-HEMP will next be tested in a full scale randomised control trial.