Our study began with the formulation of the checklist.The design of the checklist was based on the latest version of the 2020 Chinese Interventional Guidelines, CTO Guidelines, and related literature, combined with the current situation of the department where the work was conducted, to develop a list of nursing tasks before and after CTO interventions in line with clinical reality. The contents of the checklist were subjected to expert correspondence by the Delphi method [40] (The premise of this method is that pooled intelligence can enhance individual judgement. In practice, the researcher choses the panel of experts, and develops a series of iterative questionnaires. Panelists reply anonymously to the iterative questionnaires, where every questionnaire sent represent a round. At every round, panelists receive feedback in the form of a statistical representation of the overall group’s response. The goal of the multiple iterations is to reduce the range of responses and gain consensus based on criteria chosen a priori by the researcher. The critical issues of conducting a Delphi study are the development of the questionnaire, the definition of consensus and the interpretation of non-consensus, criteria for selection of the panel and data analysis) [40], and the final contents of the list were determined (Fig. 1). Nursesresponsible for the overall care of patients will then assist 120 CTO patients recruited from December 2020 to July 2021 to complete the checklist. The main intervention target, the nurse, can improve the quality and efficiency of work by using the checklist, and finally achieve patient satisfaction and doctor satisfaction.
Sample and settingPatients who underwent CTO intervention in the Department of Cardiology, Shengjing Hospital, China Medical University, in Shenyang, China, from December 2020 to July 2021, were selected.The inclusion criteria were as follows: [1] the clinical symptoms and coronary angiographic results were in accordance with the international diagnostic criteria for CTO [2]; age ≥ 18 years and the disease was within the scope of indications for intervention [3]; physically able to receive cardiac treatment interventions [4]; no relevant contraindications [5]; normal cognition, hearing and intelligence, and basic communication and understanding ability; and [6] complete data collection, voluntary participation, and good compliance in this study.
The exclusion criteria were as follows: [1] patients with serious chronic diseases or major organ dysfunctions such as diseases of the liver and kidney [2]; patients with unopened vessels requiring secondary surgery or bypass [3]; patients who are not undergoing PCI for the first time [4]; patients who cannot communicate effectively [5]; patients with psychiatric disorders, psychiatric history, visual and hearing impairment, or cognitive impairment [6]; patients who develop serious mental or physical illnesses during hospitalization; and [7] patients who are breastfeeding or pregnant.
InterventionsIntervention group: The checklist-based nursing care process was used to provide care and education to patients with CTO before and after PCI, and the specific contents and methods are as follows. A paper version of the checklist-based nursing process required for the study was also printed. After the patient with CTO is admitted to the hospital, the primary nurse will create a checklist for him/her, fill in the complete patient information, and manage the admitted patient according to the checklist item by item, that is, tick “√” at “yes” for completed tasks and “√” at “no” for those that are not completed. If the patient fails to complete this item during the implementation process, tick “√” at “not applicable,” and the checklist will be kept for statistical purposes after the patient is discharged from the hospital. Within 24 h of admission, the primary nurse will score the patient based on the Self-Rating Anxiety Scale (SAS) and provide nursing care to the patient following the “Preoperative Nursing Care Checklist for Patients with CTO.”
Nurses need to be trained on intervention prior to intervention.All contents of the preoperative nursing care checklist for patients with CTO should be completed 1 day before surgery to 1 h before surgery (Fig. 1). The patients only fill in demographic details at the top of the checklist. The rest is done by the nurse.The members of the quality control team should check whether all contents of the checklist and the questionnaire are completed within 1 h before surgery and inform the primary nurse in time if there are any missing items and make up for them before surgery. The primary nurse should record the time needed to complete all the contents of preoperative nursing checklist.After surgery, the primary nurse provided care to the patient following the “CTO patient postoperative nursing care list,” completed the postoperative nursing care checklist for patients with CTO within 24 h after surgery (Fig. 2), conducted doctor satisfaction survey, recorded adverse events (see Fig. 2), completed the postoperative SAS scale scoring before patient discharge, and conducted the patient satisfaction survey. Members of the quality control team checked the completion of the checklist before the patients were discharged and checked the completion of various questionnaires. In case of any omission, the primary nurse shall make up in time.And also, not all differences between groups are reflective of the use of the checklist.
Fig. 1Preoperative-PCI nursing care checklist for CTO patients
Fig. 2Postoperative-PCI nursing care checklist for CTO patients
Control group: Nursing care process for patients with CTO was carried out according to existing working methods, clinical observation, and health education. That is, nurses performed preoperative preparation and provided postoperative nursing care according to medical advice and personal work habits after patients were admitted to the hospital, placed intravenous indwelling needles one day or on the same day before surgery, performed skin preparation in the operating area, and provided preoperative diet, medication, and psychological guidance. The time required to complete all preoperative nursing tasks was recorded. The patient’s clinical observation, wound care, postoperative education, diet instruction, medication, and psychological guidance were conducted regularly according to the doctor’s postoperative advice. The preoperative and postoperativeSASscoring was performed within 24 h of admission and before discharge, respectively. The doctor satisfaction survey was conducted after surgery. The patient satisfaction survey was performed before discharge, and the occurrence of adverse events was recorded.
Quality control: [1] A checklist for quality control team was also established. The head nurse served as the team leader, and the team members were the head nurse assistant and two senior primary nurses with more than 5 years of experience. The team members were trained with the contents of the checklist, overall process of the study, and when to conduct checks to ensure the implementation of the checklist. The quality team measuring the occurrence of adverse events was blinded to the study allocation groups for the patient outcomes they were assessing [2]. Training organization. The head nurse organizes trainings for all nurses in the department to study the content of the checklist, understand the overall process of scientific research, and ensure complete data collection [3]. Implementation of supervision and inspection. Members of the quality control team strictly check whether the study content is implemented on time before and after the surgery, and in any case of omission, the primary nurse is required to further complete the tasks to ensure appropriate implementation.
MeasurementsPreoperative nursing care time. This refers to the sum of time spent by the primary nurse on all matters related to preoperative preparation, which was timed by the primary nurse herself.The less total preoperative nursing care time, the less the work time.
Occurrence of adverse events due to nurse’s omission or inadequate instruction. This includes inadequate preoperative patient preparation (failure to leave a venous access or incorrect placement of the venous access, blockage of the venous access, failure to prepare the skin in the operative area, and omission of preparations), failure to clean the contaminated operative area during surgery (such as vomitus and feces), and failure to train the patient about defecation on bed after surgery resulting in postoperative urinary difficulties, puncture site injury, bleeding, hematoma, and skin problems in patients after braking of the femoral artery puncture.
Patients’ anxiety. The SAS scale was used to compare the preoperative and postoperative anxiety of the two groups. There were 20 items in total, and the 4-level scoring methodwas adopted, with 15 positive scores and 5 negative scores.<50 points indicate no anxiety, 50–59 points indicate mildanxiety, 60–69 points indicate moderate anxiety, and > 69points indicate severe anxiety [41]. The higher the score, theworse the mental state [41].
Doctor and patient satisfaction. The “Doctors’ Satisfaction with Nursing Care Questionnaire” and the “Patients’ Satisfaction with Nursing Care Questionnaire” were used for the assessment. The higher the score, the better the satisfaction.
Validity and reliability of instrumentsCronbach’s α of SAS was 0.932.The content validity index of the nursing care checklist for CTO patients was 0.82, and internalconsensus reliability Cronbach’s α coefficient was 0.859. The content validity index of theDoctors’ Satisfaction with Nursing Care Questionnairewas 0.85, and internalconsensus reliability Cronbach’s α coefficient was 0.893. Thecontent validity index of Patients’ Satisfaction with Nursing Care Questionnairewas 0.83, and internal consensus reliability Cronbach’s α coefficient was 0.898. All the above scales have good reliability and validity.
RandomizationDoctors use random sequence software to generate 1 to 120 random serial numbers. Random serial numbers and then in the order in which the patients were treated, from front to back. Odd-numbered patients were included in the intervention group, while even-numbered patients were included in the control group. In order to avoid cross-infection during the experiment, the intervention group and the control group were arranged in wards A and B respectively. (Note: Both groups of patients were blinded, meaning they were unaware of whether they were in the experimental group or the control group; Doctors who evaluate the quality of patient care use a blind method, that is, they are unaware whether the evaluated patients are in the experimental group or the control group; The nurses in the control group used a blind method, that is, they were unaware that the ward had become the control group and still used existing working methods to care for patients; The nurses in the experimental group used a non blind method, that is, they were aware of using checklists to care for patients and received unified training.)
Sample sizeGroup sample sizes of 43 and 43 achieve 90% power to reject the null hypothesis of equal means when the population mean difference of preoperative nursing care time is 5 min and - with a standard deviation for both groups of 7 min and with a significance level (alpha) of 0.050. Assuming a 20% potential dropout rate, the final sample size was increased to 120 subjects, with 60 subjects in each intervention group.
Statistical analysisSPSS 26.0 software was used for statistical analysis. Measurement data were expressed as (‾x ± s), and the t test was used for comparison between groups. Count data were expressed as number of cases or percentage, and the χ2 test was used for comparison between groups. The difference was considered significant at P < 0.05.
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