[How informed is patient consent to interventional cardiology procedures. A quality assurance survey by the nurses]. / Quanto è informato il consenso dei pazienti alle procedure di emodinamica? Una survey di quality assurance degli infermieri.

BACKGROUND: A new patient consent form has recently been adopted in our Institution, with a uniformly written text to be used for all medical procedures and interventions. It is accompanied by a separate information sheet, explaining both the details and the risk/benefit profile for each specific procedure/intervention. It should be given to the patient as early as possible after the procedure/intervention is planned. Testing the effectiveness of this new information policy has been included into the quality assurance goals by our nursing staff. METHODS: From mid April to mid June 2004 a questionnaire was administered to all patients who had undergone an elective cardiac interventional procedure. The timing, manner and perceived completeness of the information received by patients was investigated by 14 yes/no or multiple choice questions. A goal of <5% deviation from a 100% standard was set for all indicators. RESULTS: Two hundred and thirty-eight valid questionnaires were obtained out of 308 consecutive procedures. Seven patients (3%) refused the questionnaire. The response rate was >90% for each question. Seventy-eight patients (33%) had a history of cardiac interventional procedures. The information sheet had been received before the procedure in 93% of cases, and this had happened in the ward in 58% of cases; the procedure had been performed at least 1 hour after receipt of the information sheet in 83% of cases. Twenty-seven patients (13%) stated they had not read the information sheet, in most cases (92%) because they felt they already knew enough. Among patients who had read the information sheet, 99% deemed it could be easily understood. Difficulties in asking questions were reported by 6% of patients. When questions had been asked, the nursing staff was addressed in 42% of cases, and the answers were rated as clear in 98% of cases. The consent form was not read at all by 13% of patients, due to alleged lack of time, and was not read completely by another 15%; 98% of those who had read it, however, found it was fairly understandable. CONCLUSIONS: The effectiveness of our new patient information policy seems to approach our quality goals, and is liable to further improvement. The nursing staff of the cardiac catheterization unit is involved in the patient information process, and has full competence to study this issue.