Harris Kristin, Søfteland Eirik, Moi Asgjerd Litleré, Harthug Stig, Ravnøy Mette, Storesund Anette, Jurmy Elaheh, Skeie Eli, Wæhle Hilde Valen, Sevdalis Nick, Haugen Arvid Steinar
Department of Anesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway.
Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway.
Pilot Feasibility Stud. 2023 Mar 27;9(1):52. doi: 10.1186/s40814-023-01277-3.
The World Health Organization's Global Patient Safety Action Plan 2021-2030 call for attention to patient and family involvement to reduce preventable patient harm. Existing evidence indicates that patients' involvement in their own safety has positive effects on reducing hospitalisation time and readmissions. One intervention reported in the literature is the use of checklists designed for patients' completion. Studies on such checklists are small scale, but they are linked to reduction in length of hospital stay and readmissions. We have previously developed and validated a two-part surgical patient safety checklist (PASC). This study aims to investigate the feasibility of the PASC usage and implementation prior to its use in a large-scale clinical trial.
This is a prospective cross-sectional feasibility study, set up as part of the design of a larger stepped-wedge cluster randomised controlled trial (SW-CRCT). Descriptive statistics were used to investigate patient demographics, reasons for not completing the PASC and percentage of PASC item usage. Qualitative patient interviews were used to identify barriers and drivers for implementation. Interview was analysed through content analysis.
Out of 428 recruited patients, 50.2% (215/428) used both parts of PASC. A total of 24.1% (103/428) of the patients did not use it at all due to surgical or COVID-19-related cancellations. A total of 19.9% (85/428) did not consent to participate, 5.1% (22/428) lost the checklist and 0.7% (3/428) of the patients died during the study. A total of 86.5% (186/215) patients used ≥ 80% of the checklist items. Barriers and drivers for PASC implementation were grouped into the following categories: Time frame for completing the checklist, patient safety checklist design, impetus to communicate with healthcare professionals and support throughout the surgical pathway.
Elective surgical patients were willing and able to use PASC. The study further revealed a set of barriers and drivers to the implementation. A large-scale definitive clinical-implementation hybrid trial is being launched to ascertain the clinical effectiveness and scalability of PASC in improving surgical patient safety.
Clinicaltrials.gov: NCT03105713. Registered 10.04.2017.
世界卫生组织《2021 - 2030年全球患者安全行动计划》呼吁关注患者及其家属的参与,以减少可预防的患者伤害。现有证据表明,患者参与自身安全对缩短住院时间和再入院率有积极影响。文献中报道的一种干预措施是使用供患者填写的检查表。关于此类检查表的研究规模较小,但它们与缩短住院时间和再入院率有关。我们之前开发并验证了一份两部分的手术患者安全检查表(PASC)。本研究旨在调查在大规模临床试验中使用PASC之前其使用和实施的可行性。
这是一项前瞻性横断面可行性研究,作为一项更大规模的阶梯楔形整群随机对照试验(SW - CRCT)设计的一部分。使用描述性统计来调查患者人口统计学特征、未完成PASC的原因以及PASC项目的使用百分比。通过对患者进行定性访谈来确定实施的障碍和推动因素。通过内容分析对访谈进行分析。
在428名招募的患者中,50.2%(215/428)使用了PASC的两个部分。共有24.1%(103/428)的患者由于手术或与新冠病毒相关的取消手术而根本未使用。共有19.9%(85/428)的患者不同意参与,5.1%(22/428)的患者丢失了检查表,0.7%(3/428)的患者在研究期间死亡。共有86.5%(186/215)的患者使用了≥80%的检查表项目。PASC实施的障碍和推动因素分为以下几类:检查表的完成时间框架、患者安全检查表的设计、与医护人员沟通的动力以及整个手术过程中的支持。
择期手术患者愿意且能够使用PASC。该研究进一步揭示了一组实施的障碍和推动因素。正在开展一项大规模的确定性临床实施混合试验,以确定PASC在提高手术患者安全方面的临床有效性和可扩展性。
Clinicaltrials.gov:NCT03105713。于2017年4月10日注册。