Patients’ Information before invasive coronary procedures, when signing a written consent is challenging!

Patients’ Information before invasive coronary procedures, when signing a written consent is challenging!
Kallel, O. Haddar, Y. Mallek, W. Abbes, H. Denguir, H. Barhoumi, H. Ben Ahmed
Archives of Cardiovascular Diseases, January 2024
Abstract
Introduction
Despite the progress in Invasive coronary procedures, patients‘ anxiety is still of concern. This anxiety may compromise adherence to the exam and the signature of the written consent. This latter is a relatively emergent culture to the Tunisian patient. We noticed a discordance in patients attitude expressing oral consent and reticent to sign a written one.
Objective
We investigated the role of standardized oral information in reducing anxiety of patients before invasive coronary procedures, improving knowledge and signing written consent rate.
Method
We conducted an experimental randomized, prospective study including patients scheduled for coronary artery procedures over 4 weeks. The intervention consisted in a standardized oral information. We compared the level of anxiety, the level of knowledge and the rate of written consent’s signature, before and after the intervention. Information was conducted by either a doctor or a nurse according to coin tossing randomization. Anxiety was measured with Visual analogical scale (VAS), and the State Anxiety Inventory (STAI-S). Knowledge was assessed via 10 yes or No questions about coronary artery procedure (utility, access route, X rays, Contrast solution injection, stent implantation, possible outcomes). Were excluded, patients with emergent procedures and patients that refused to participate.
Results
We included 39 patients, males in 89.7% of cases, mean age was 64.5 ± 7.8 ans. Clinical presentation was a stabilized acute coronary artery syndrome in 92.3% of cases. Patients were illiterates in 23.1%, with low instructive level in 46.2% of cases. In their history, patients were asked to sign a written consent in only 2.6% of cases. Level of anxiety evaluated via VAS was significantly improved (2.91/10 before, 2.47/10 after, p = 0.041). there was no significant difference according to STAI-S score (44.44 before, 44.85 after, p = 0.39). Level of information get better (2.94/10 before, 7.71/10 after, p < 0.0001). The rate of written consent ‘signature improved significantly from 41% to 76% (p < 0.004). There was no difference between nurse and doctor in proceeding to oral information and asking for signing the written consent (73.9% with nurse versus 86.6% with doctor, p = 0.44)
Conclusion
Oral standardized information helped to improve level of knowledge of patients ongoing non emergent invasive coronary procedures, to reduce anxiety and to get a better adherence to exam attested by the signature of the written consent. Other types of information, especially with audio-visual support, may be more efficient and need to be tested.