Valverde Bernal Jonatan, Martínez-Soler Fina, Berga Congost Gemma, Martínez Pérez José, Asmarats Lluis, Moreno Arroyo Carmen
Interventional Cardiology Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Department of Fundamental and Clinical Nursing, Faculty of Nursing, Universitat de Barcelona, Hospitalet de Llobregat, Barcelona, Spain.
Int J Gen Med. 2023 Sep 20;16:4257-4265. doi: 10.2147/IJGM.S412369. eCollection 2023.
The percutaneous treatment of heart valve diseases carried out in the hemodynamic service is constantly growing. After analyzing the mortality, readmissions, success of the procedure, and complications, several studies support this type of percutaneous procedure. The increase in these procedures has required the creation of multidisciplinary teams and new diagnostic and care circuits, such as presurgical consultations and postsurgical follow-ups. Even so, there is little evidence regarding the effect of these consultations on quality indicators.
The objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (PROCESS-VALVE) on quality indicators of the health of patients undergoing percutaneous valve procedures.
The influence of presurgical and postsurgical consultations on quality indicators will be evaluated through an ambispective quasi-experimental study. Patients will be recruited at a tertiary-level hospital in Barcelona, Spain. For the control group, data will be collected retrospectively from patients who underwent percutaneous valve procedures but did not receive pre- or postsurgical consultations. The intervention group comprises those patients agreeing to participate in the study and the hemodynamic nurse valve consultation program (PROCESS-VALVE). In addition, we will assess whether a face-to-face postsurgical consultation equally improves quality indicators compared to postsurgical telephone consultation; for this, a sub-study will be carried out comparing face-to-face or telephone postsurgical follow-up by means of a randomized controlled clinical trial with simple blinding in the intervention group.
This study will generate scientific evidence regarding the impact on quality indicators of a nursing intervention via presurgical and postsurgical consultations. In addition, it will allow us to decide the most appropriate follow-up strategy for this type of patient.
ClinicalTrials.gov NCT05179278, registration date 01/05/2022.
在血流动力学服务中开展的心脏瓣膜疾病经皮治疗正在不断增加。在分析了死亡率、再入院率、手术成功率和并发症后，多项研究支持这种经皮手术。这些手术的增加需要组建多学科团队并建立新的诊断和护理流程，如术前咨询和术后随访。即便如此，关于这些咨询对质量指标的影响，证据仍然很少。
本研究的目的是评估一项术前和术后护士干预计划（PROCESS-VALVE）对接受经皮瓣膜手术患者的健康质量指标的影响。
将通过一项双向准实验研究评估术前和术后咨询对质量指标的影响。患者将在西班牙巴塞罗那的一家三级医院招募。对于对照组，将回顾性收集接受经皮瓣膜手术但未接受术前或术后咨询的患者的数据。干预组包括同意参与研究的患者以及血流动力学护士瓣膜咨询计划（PROCESS-VALVE）。此外，我们将评估与术后电话咨询相比，面对面的术后咨询是否同样能改善质量指标；为此，将在干预组中通过一项采用简单盲法的随机对照临床试验，比较面对面或电话术后随访情况，开展一项子研究。
本研究将产生关于术前和术后咨询护理干预对质量指标影响的科学证据。此外，它将使我们能够为这类患者确定最合适的随访策略。
ClinicalTrials.gov NCT05179278，注册日期2022年5月1日。
