Factors associated with the delay in informed consent procedures of patients with ST-segment elevation myocardial infarction and its influence on door-to-balloon time: a nationwide retrospective cohort study

Abstract

Background and objectives: ST-segment elevation myocardial infarction (STEMI) is the deadliest and most time-sensitive acute cardiac event. However, failure to achieve timely informed consent is an important contributor to in-hospital delay in STEMI care in China. We investigated the factors associated with informed consent delay in patients with STEMI undergoing percutaneous coronary intervention (PCI) and the association between the delay and door-to-balloon time.

Methods: We conducted a nationally representative retrospective cohort study using patient data reported by hospital-based chest pain centers from 1 January 2016 to 31 December 2020. We applied generalized linear mixed models and negative binomial regression to estimate factors independently predicting informed consent delay time. Logistic regressions were fitted to investigate the association of the informed consent delay time and door-to-balloon time, adjusting for patient characteristics.

Results: In total, 257, 510 patients were enrolled in the analysis. Mean informed consent delay time was 22.4 min (SD = 24.0), accounting for 39.3% in door-to-balloon time. Older age (≥65 years) was significantly correlated with informed consent delay time (RR: 1.034, P = 0.001). Compared with ethnic Han patients, the minority (RR: 1.146, P < 0.001) had more likelihood to extend consent giving; compared with patients who were single, longer informed consent time was found in married patients (RR: 1.054, P = 0.006). Patients with intermittent chest pain (RR: 1.034, P = 0.011), and chest pain relief (RR: 1.085, P = 0.005) were more likely to delay informed consent. As for transfer modes, EMS (RR: 1.063, P < 0.001), transfer-in (RR: 1.820, P < 0.001), and in-hospital onset (RR: 1.099, P = 0.002) all had positive correlations with informed consent delay time compared to walk-in. Informed consent delay was significantly associated with prolonged door-to-balloon time (OR: 1.002, P < 0.001).

Conclusion: Informed consent delay is significantly associated with the door-to-balloon time which plays a crucial role in achieving better outcomes for patients with STEMI. It is essential to shorten the delay time by identifying and intervening modifiable factors that are associated with shortening the informed consent procedure in China and other countries.

Keywords: ST-segment elevation myocardial infarction; door-to-balloon time; informed consent delay; percutaneous coronary intervention.

Figure 1

Distribution of treatment time among patients with STEMI. The figure shows the key time intervals among patients in the total cohort, male and female patients, and patients aged 18–65 and >65 years. The key time intervals were calculated according to specific time points and included the onset-to-call time (only for patients who called EMS), call-to-EMS time (only for patients who called EMS), EMS-to-door time (only for patients who called EMS), door-to-PCI decision time, PCI decision-to-informed consent signature time, and informed consent signature-to-balloon time. Notably, the door-to-balloon time was the sum of the door-to-PCI decision time, PCI decision-to-informed consent signature time, and informed consent signature- to-balloon time.

Figure 2

Distribution of door-to-balloon time with informed consent delay time among patients with STEMI. The figure shows the mean (SD) door-to-balloon time in participants with informed consent delay of 0–5 min, 5–10 min, 10–15 min, 15–20 min, and >20 min.