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BACKGROUND: Older adults (aged ≥65 years) account for approximately 30% of inpatient procedures in the United States. After major surgery, they are at high risk of a slow return to their previous functional status, loss of independence, and complications like delirium. With the development and refinement of Enhanced Recovery After Surgery protocols, older patients often return home much earlier than historically anticipated. This put a larger burden on care partners, close family or friends who partner with the patient and guide them through recovery. Without adequate preparation, both patients and their care partners may experience poor long-term outcomes. OBJECTIVE: This study aimed to improve and streamline recovery for patients aged ≥65 years by exploring the communication needs of patients and their care partners. Information from this study will be used to inform an intervention developed to address these needs and define processes for its implementation across surgical clinics. METHODS: This qualitative research protocol has two aims. First, we will define patient and care partner needs and perspectives related to digital health innovation. To achieve this aim, we will recruit dyads of patients (aged ≥65 years) who underwent elective major surgery 30-90 days prior and their respective care partners (aged ≥18 years). Participants will complete individual interviews and surveys to obtain demographic data, characterize their perceptions of the surgical experience, identify intervention targets, and assess for the type of intervention modality that would be most useful. Next, we will explore clinician perspectives, tools, and strategies to develop a blueprint for a digital intervention. To achieve this aim, clinicians (eg, geriatricians, surgeons, and nurses) will be recruited for focus groups to identify current obstacles affecting surgical outcomes for older patients, and we will review current assessments and tools used in their clinical practice. A hybrid deductive-inductive approach will be undertaken to identify relevant themes. Insights from both clinicians and patient-care partners will guide the development of a digital intervention strategy to support older patients and their care partners after surgery. RESULTS: This study has been approved by the Massachusetts General Hospital and Harvard Institutional Review Boards. Recruitment began in December 2023 for the patient and care partner interviews. As of August 2024, over half of the interviews have been performed, deidentified, and transcribed. Clinician recruitment is ongoing, with no focus groups conducted yet. The study is expected to be completed by fall 2024. CONCLUSIONS: This study will help create a scalable digital health option for older patients undergoing major surgery and their care partners. We aim to enhance our understanding of patient recovery needs; improve communication with surgical teams; and ultimately, reduce the overall burden on patients, their care partners, and health care providers through real-time assessment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59067.
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Cuidadores , Comunicação , Pesquisa Qualitativa , Humanos , Idoso , Masculino , Feminino , Cuidadores/psicologia , Idoso de 80 Anos ou maisRESUMO
Objectives: The proposed study aims to assess users' perceptions of a surgical safety checklist (SSC) reimplementation toolkit and its impact on SSC attitudes and operating room (OR) culture, meaningful checklist use, measures of surgical safety, and OR efficiency at 3 different hospital sites. Background: The High-Performance Checklist toolkit (toolkit) assists surgical teams in modifying and implementing or reimplementing the World Health Organization's SSC. Through the explore, prepare, implement, and sustain implementation framework, the toolkit provides a process and set of tools to facilitate surgical teams' modification, implementation, training on, and evaluation of the SSC. Methods: A pre-post intervention design will be used to assess the impact of the modified SSC on surgical processes, team culture, patient experience, and safety. This mixed-methods study includes quantitative and qualitative data derived from surveys, semi-structured interviews, patient focus groups, and SSC performance observations. Additionally, patient outcome and OR efficiency data will be collected from the study sites' health surveillance systems. Data analysis: Statistical data will be analyzed using Statistical Product and Service Solutions, while qualitative data will be analyzed thematically using NVivo. Furthermore, interview data will be analyzed using the Consolidated Framework for Implementation Research and reach, effectiveness, adoption, implementation, maintenance implementation frameworks. Setting: The toolkit will be introduced at 3 diverse surgical sites in Alberta, Canada: an urban hospital, university hospital, and small regional hospital. Anticipated impact: We anticipate the results of this study will optimize SSC usage at the participating surgical sites, help shape and refine the toolkit, and improve its usability and application at future sites.
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INTRODUCTION: The WHO Surgical Safety Checklist (SSC) is a communication tool that improves teamwork and patient outcomes. SSC effectiveness is dependent on implementation fidelity. Administrative audits fail to capture most aspects of SSC implementation fidelity (ie, team communication and engagement). Existing research tools assess behaviours during checklist performance, but were not designed for routine quality assurance and improvement. We aimed to create a simple tool to assess SSC implementation fidelity, and to test its reliability using video simulations, and usability in clinical practice. METHODS: The Checklist Performance Observation for Improvement (CheckPOINT) tool underwent two rounds of face validity testing with surgical safety experts, clinicians and quality improvement specialists. Four categories were developed: checklist adherence, communication effectiveness, attitude and engagement. We created a 90 min training programme, and four trained raters independently scored 37 video simulations using the tool. We calculated intraclass correlation coefficients (ICC) to assess inter-rater reliability (ICC>0.75 indicating excellent reliability). We then trained two observers, who tested the tool in the operating room. We interviewed the observers to determine tool usability. RESULTS: The CheckPOINT tool had excellent inter-rater reliability across SSC phases. The ICC was 0.83 (95% CI 0.67 to 0.98) for the sign-in, 0.77 (95% CI 0.63 to 0.92) for the time-out and 0.79 (95% CI 0.59 to 0.99) for the sign-out. During field testing, observers reported CheckPOINT was easy to use. In 98 operating room observations, the total median (IQR) score was 25 (23-28), checklist adherence was 7 (6-7), communication effectiveness was 6 (6-7), attitude was 6 (6-7) and engagement was 6 (5-7). CONCLUSIONS: CheckPOINT is a simple and reliable tool to assess SSC implementation fidelity and identify areas of focus for improvement efforts. Although CheckPOINT would benefit from further testing, it offers a low-resource alternative to existing research tools and captures elements of adherence and team behaviours.
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Lista de Checagem , Salas Cirúrgicas , Humanos , Reprodutibilidade dos Testes , Comunicação , Segurança do PacienteRESUMO
Importance: Patient safety interventions, like the World Health Organization Surgical Safety Checklist, require effective implementation strategies to achieve meaningful results. Institutions with underperforming checklists require evidence-based guidance for reimplementing these practices to maximize their impact on patient safety. Objective: To assess the ability of a comprehensive system of safety checklist reimplementation to change behavior, enhance safety culture, and improve outcomes for surgical patients. Design, Setting, and Participants: This prospective type 2 hybrid implementation-effectiveness study took place at 2 large academic referral centers in Singapore. All operations performed at either hospital were eligible for observation. Surveys were distributed to all operating room staff. Intervention: The study team developed a comprehensive surgical safety checklist reimplementation package based on the Exploration, Preparation, Implementation, Sustainment framework. Best practices from implementation science and human factors engineering were combined to redesign the checklist. The revised instrument was reimplemented in November 2021. Main Outcomes and Measures: Implementation outcomes included penetration and fidelity. The primary effectiveness outcome was team performance, assessed by trained observers using the Oxford Non-Technical Skills (NOTECH) system before and after reimplementation. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture was used to assess safety culture and observers tracked device-related interruptions (DRIs). Patient safety events, near-miss events, 30-day mortality, and serious complications were tracked for exploratory analyses. Results: Observers captured 252 cases (161 baseline and 91 end point). Penetration of the checklist was excellent at both time points, but there were significant improvements in all measures of fidelity after reimplementation. Mean NOTECHS scores increased from 37.1 to 42.4 points (4.3 point adjusted increase; 95% CI, 2.9-5.7; P < .001). DRIs decreased by 86.5% (95% CI, -22.1% to -97.8%; P = .03). Significant improvements were noted in 9 of 12 composite areas on culture of safety surveys. Exploratory analyses suggested reductions in patient safety events, mortality, and serious complications. Conclusions and Relevance: Comprehensive reimplementation of an established checklist intervention can meaningfully improve team behavior, safety culture, patient safety, and patient outcomes. Future efforts will expand the reach of this system by testing a structured guidebook coupled with light-touch implementation guidance in a variety of settings.
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Lista de Checagem , Salas Cirúrgicas , Humanos , Lista de Checagem/métodos , Estudos Prospectivos , Segurança do Paciente , Hospitais , Equipe de Assistência ao PacienteRESUMO
BACKGROUND: Interruptions in operative flow are known to increase team stress and errors in the operating room. Device-related interruptions are an increasing area of focus for surgical safety, but common safety processes such as the Surgical Safety Checklist do not adequately address surgical devices. We assessed the impact of the Device Briefing Tool, a communication instrument for surgical teams, on device-related interruptions in a large academic referral center in Singapore. METHODS: The Device Briefing Tool was implemented in 4 general surgery departments, with 4 additional departments serving as a comparator group. Trained observers evaluated device-related interruption incidence in live operations at baseline and after implementation. Changes in device-related interruption frequency were assessed in each group using Poisson regression, with and without adjustment for surgical department and device complexity. Subgroup analyses assessed the impact of the Device Briefing Tool by device type. RESULTS: A total of 210 operations were evaluated by observers. In the Device Briefing Tool group, there were 38.6 and 27.2 device-related interruptions per 100 cases at baseline and after Device Briefing Tool implementation, respectively (difference -23%, P = .0047, adjusted difference -28%, P = .0013). Device-related interruption frequency in the comparator group remained stable across study periods. Point estimates indicated reductions in device-related interruptions for all device types, reaching statistical significance for circular staplers (-26%, P = .0049). CONCLUSION: Implementation of the Device Briefing Tool was associated with a 28% reduction in device-related interruptions. Proactive approaches to improving surgical device safety are crucial in the technology-driven landscape of modern surgical care. Future efforts will assess formal integration of the Device Briefing Tool into institution-wide surgical safety processes.
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Salas Cirúrgicas , Instrumentos Cirúrgicos , Humanos , Projetos Piloto , Coleta de Dados , ComunicaçãoRESUMO
BACKGROUND: Non-technical skills are critical to surgical safety. We examined the impact of the COVID-19 pandemic on non-technical skills of operating room (OR) teams in Singapore. MATERIALS AND METHODS: Observers rated live operations using the Oxford NOTECHS system. Pre- and post-COVID observations were captured from November 2019 to January 2020 and from January 2021 to February 2021, respectively. Scores were compared using Schuirmann's Two One-Sided Test procedure. Multivariable linear regression was used to adjust for case mix. A 10% margin of equivalence was set a priori. RESULTS: Observers rated 159 cases: 75 pre-COVID and 84 post-COVID. There were significant differences between groups in surgical department and surgeon-reported case complexity (both P < 0.001). Total NOTECHS scores increased post-COVID on raw analysis (36.1 vs 38.0, P < 0.001) but remained within the margin of equivalence (90% CI 1.3 to 2.6, P < 0.001). Multivariable analysis demonstrated a similar increase within the margin of equivalence (2.0, 90% CI 1.3 to 2.7). Teamwork and cooperation scores increased by 1.0 post-COVID (90% CI 0.8 to 1.3); all other subcomponent scores were equivalent. CONCLUSION: Non-technical skills before and after the peak of the COVID-19 pandemic were equivalent but not equal. A small but statistically significant improvement post-COVID was driven by an increase in teamwork and cooperation skills. These findings may reflect an improvement in team cohesion, which has been observed in teams under duress in other settings such as the military. Future work should explore the effect of the pandemic on OR culture, team cohesion, and resilience.
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COVID-19 , Competência Clínica , Humanos , Pandemias , Equipe de Assistência ao Paciente , SARS-CoV-2RESUMO
BACKGROUND: As surgical systems are forced to adapt and respond to new challenges, so should the patient safety tools within those systems. We sought to determine how the WHO SSC might best be adapted during the COVID-19 pandemic. METHODS: 18 Panelists from five continents and multiple clinical specialties participated in a three-round modified Delphi technique to identify potential recommendations, assess agreement with proposed recommendations and address items not meeting consensus. RESULTS: From an initial 29 recommendations identified in the first round, 12 were identified for inclusion in the second round. After discussion of recommendations without consensus for inclusion or exclusion, four additional recommendations were added for an eventual 16 recommendations. Nine of these recommendations were related to checklist content, while seven recommendations were related to implementation. CONCLUSIONS: This multinational panel has identified 16 recommendations for sites looking to use the surgical safety checklist during the COVID-19 pandemic. These recommendations provide an example of how the SSC can adapt to meet urgent and emerging needs of surgical systems by targeting important processes and encouraging critical discussions.
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COVID-19 , Lista de Checagem , Cirurgia Geral/organização & administração , Pandemias , Técnica Delphi , Humanos , Organização Mundial da SaúdeRESUMO
BACKGROUND: The Surgical Safety Checklist (SSC) has been shown to reduce perioperative complications across global health systems. We sought to assess perceptions of the SSC and suggestions for its improvement among medical students, trainees, and early career providers. METHODS: From July to September 2019, a survey assessing perceptions of the SSC was disseminated through InciSioN, the International Student Surgical Network comprising medical students, trainees, and early career providers pursuing surgery. Individuals with ≥2 years of independent practice after training were excluded. Respondents were categorized according to any clinical versus solely non-clinical SSC exposure. Logistic regression was used to evaluate associations between clinical/non-clinical exposure and promoting future use of the SSC, adjusting for potential confounders/mediators: training level, human development index, and first perceptions of the SSC. Thematic analysis was conducted on suggestions for SSC improvement. RESULTS: Respondent participation rate was 24%. Three hundred and eighteen respondents were included in final analyses; 215 (67%) reported clinical exposure and 190 (60%) were promoters of future SSC use. Clinical exposure was associated with greater odds of promoting future SSC use (aOR 1.81 95% CI [1.03-3.19], p = 0.039). A greater proportion of promoters reported "Improved Operating Room Communication" as a goal of the SSC (0.21 95% CI [0.15-0.27]-vs.-0.12 [0.06-0.17], p = 0.031), while non-promoters reported the SSC goals were "Not Well Understood" (0.08 95% CI [0.03-0.12]-vs.-0.03 [0.01-0.05], p = 0.032). Suggestions for SSC improvement emphasized context-specific adaptability and earlier formal training. CONCLUSIONS: Clinical exposure to the SSC was associated with promoting its future use. Earlier formal clinical training may improve perceptions and future use among medical students, trainees, and early career providers.
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Lista de Checagem , Segurança do Paciente , Estudantes de Medicina , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Procedimentos Cirúrgicos Operatórios/educação , Adulto , Escolha da Profissão , Feminino , Humanos , Modelos Logísticos , Masculino , Percepção , Inquéritos e Questionários , Adulto JovemRESUMO
In the original version of the article, Dominique Vervoort's last name was misspelled. It is correct as reflected here. The original article has been updated.