Dataset Information

Causal Analysis of World Health Organization's Surgical Safety Checklist Implementation Quality and Impact on Care Processes and Patient Outcomes: Secondary Analysis From a Large Stepped Wedge Cluster Randomized Controlled Trial in Norway.

ABSTRACT: OBJECTIVE:We hypothesize that high-quality implementation of the World Health Organization's Surgical Safety Checklist (SSC) will lead to improved care processes and subsequently reduction of peri- and postoperative complications. BACKGROUND:Implementation of the SSC was associated with robust reduction in morbidity and length of in-hospital stay in a stepped wedge cluster randomized controlled trial conducted in 2 Norwegian hospitals. Further investigation of precisely how the SSC improves care processes and subsequently patient outcomes is needed to understand the causal mechanisms of improvement. METHODS:Care process metrics are reported from one of our earlier trial hospitals. Primary outcomes were in-hospital complications and care process metrics, e.g., patient warming and antibiotics. Secondary outcome was quality of SSC implementation. Analyses include Pearson's exact ? test and binary logistic regression. RESULTS:A total of 3702 procedures (1398 control vs. 2304 intervention procedures) were analyzed. High-quality SSC implementation (all 3 checklist parts) improved processes and outcomes of care. Use of forced air warming blankets increased from 35.3% to 42.4% (P < 0.001). Antibiotic administration postincision decreased from 12.5% to 9.8%, antibiotic administration preincision increased from 54.5% to 63.1%, and nonadministration of antibiotics decreased from 33.0% to 27.1%. Surgical infections decreased from 7.4% (104/1398) to 3.6% (P < 0.001). Adjusted SSC effect on surgical infections resulted in an odds ratio (OR) of 0.52 (95% confidence interval (CI): 0.38-0.72) for intervention procedures, 0.54 (95% CI: 0.37-0.79) for antibiotics provided before incision, and 0.24 (95% CI: 0.11-0.52) when using forced air warming blankets. Blood transfusion costs were reduced by 40% with the use of the SSC. CONCLUSIONS:When implemented well, the SSC improved operating room care processes; subsequently, high-quality SSC implementation and improved care processes led to better patient outcomes.

SUBMITTER: Haugen AS

PROVIDER: S-EPMC6326038 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Causal Analysis of World Health Organization's Surgical Safety Checklist Implementation Quality and Impact on Care Processes and Patient Outcomes: Secondary Analysis From a Large Stepped Wedge Cluster Randomized Controlled Trial in Norway.

Haugen Arvid Steinar AS Wæhle Hilde Valen HV Almeland Stian Kreken SK Harthug Stig S Sevdalis Nick N Eide Geir Egil GE Nortvedt Monica Wammen MW Smith Ingrid I Søfteland Eirik E

Annals of surgery 20190201 2

<h4>Objective</h4>We hypothesize that high-quality implementation of the World Health Organization's Surgical Safety Checklist (SSC) will lead to improved care processes and subsequently reduction of peri- and postoperative complications.<h4>Background</h4>Implementation of the SSC was associated with robust reduction in morbidity and length of in-hospital stay in a stepped wedge cluster randomized controlled trial conducted in 2 Norwegian hospitals. Further investigation of precisely how the SS ...[more]

PMID: 29112512

Similar Datasets

Project description:India is revising its mental health legislation with the Indian Mental Healthcare Act 2017 (IMHA). When implemented, this legislation will apply to over 1.25 billion people. In 2005, the World Health Organization (WHO) published a Resource Book (WHO-RB) on mental health, human rights and legislation, including a checklist of 175 specific items to be addressed in mental health legislation or policy in individual countries. Even following the publication of the United Nations Convention on the Rights of Persons with Disabilities (CRPD) (2006), the WHO-RB remains the most comprehensive checklist for mental health legislation available, rooted in UN and WHO documents and providing the most systematic, detailed framework for human rights analysis of mental health legislation. We sought to determine the extent to which the IMHA will bring Indian legislation in line with the WHO-RB.The IMHA and other relevant pieces of Indian legislation are compared to each of the items in the WHO-RB. We classify each item in a binary manner, as either concordant or not, and provide more nuanced detail in the text.The IMHA addresses 96/175 (55.4%) of the WHO-RB standards examined. When other relevant Indian legislation is taken into account, 118/175 (68.0%) of the standards are addressed in Indian law. Important areas of low concordance include the rights of families and carers, competence and guardianship, non-protesting patients and involuntary community treatment. The important legal constructs of advance directives, supported decision-making and nominated representatives are articulated in the Indian legislation and explored in this paper.In theory, the IMHA is a highly progressive piece of legislation, especially when compared to legislation in other jurisdictions subject to similar analysis. Along with the Indian Rights of Persons with Disabilities Act 2016, it will bring Indian law closely in line with the WHO-RB. Vague, opaque language is however, used in certain contentious areas; this may represent arrangement-focused rather than realisation-focused legislation, and lead to inadvertent limitation of certain rights. Finally, the WHO-RB checklist is an extremely useful tool for this kind of analysis; we recommend it is updated to reflect the CRPD and other relevant developments.

Project description:BackgroundControlled implementation trials often randomize the intervention at the site level, enrolling relatively few sites (e.g., 6-20) compared to trials that randomize by subject. Trials with few sites carry a substantial risk of an imbalance between intervened (cases) and non-intervened (control) sites in important site characteristics, thereby threatening the internal validity of the primary comparison. A stepped wedge design (SWD) staggers the intervention at sites over a sequence of times or time waves until all sites eventually receive the intervention. We propose a new randomization method, sequential balance, to control time trend in site allocation by minimizing sequential imbalance across multiple characteristics. We illustrate the new method by applying it to a SWD implementation trial.MethodsThe trial investigated the impact of blended internal-external facilitation on the establishment of evidence-based teams in general mental health clinics in nine US Department of Veterans Affairs medical centers. Prior to randomization to start time, an expert panel of implementation researchers and health system program leaders identified by consensus a series of eight facility-level characteristics judged relevant to the success of implementation. We characterized each of the nine sites according to these consensus features. Using a weighted sum of these characteristics, we calculated imbalance scores for each of 1680 possible site assignments to identify the most sequentially balanced assignment schemes.ResultsFrom 1680 possible site assignments, we identified 34 assignments with minimal imbalance scores, and then randomly selected one assignment by which to randomize start time. Initially, the mean imbalance score was 3.10, but restricted to the 34 assignments, it declined to 0.99.ConclusionsSequential balancing of site characteristics across groups of sites in the time waves of a SWD strengthens the internal validity of study conclusions by minimizing potential confounding.Trial registrationRegistered at ClinicalTrials.gov as clinical trials # NCT02543840 ; entered 9/4/2015.

Project description:BackgroundStepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs.MethodsBased on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals.ResultsSite recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3 months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6-8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled).ConclusionsFuture studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a "ramp-up" period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out.Trial registrationClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.

Project description:BackgroundPractice facilitation has been associated with meaningful improvements in disease prevention and quality of patient care. Using practice facilitation, the Improved Delivery of Cardiovascular Care (IDOCC) project aimed to improve the delivery of evidence-based cardiovascular care in primary care practices across a large health region. Our goal was to evaluate IDOCC's impact on adherence to processes of care delivery.MethodsA pragmatic stepped wedge cluster randomized trial recruiting primary care providers in practices located in Eastern Ontario, Canada (ClinicalTrials.gov: NCT00574808). Participants were randomly assigned by region to one of three steps. Practice facilitators were intended to visit practices every 3-4 (year 1-intensive) or 6-12 weeks (year 2-sustainability) to support changes in practice behavior. The primary outcome was mean adherence to indicators of evidence-based care measured at the patient level. Adherence was assessed by chart review of a randomly selected cohort of 66 patients per practice in each pre-intervention year, as well as in year 1 and year 2 post-intervention.ResultsEighty-four practices (182 physicians) participated. On average, facilitators had 6.6 (min: 2, max: 11) face-to-face visits with practices in year 1 and 2.5 (min: 0 max: 10) visits in year 2. We collected chart data from 5292 patients. After adjustment for patient and provider characteristics, there was a 1.9 % (95 % confidence interval (CI): -2.9 to -0.9 %) and 4.2 % (95 % CI: -5.7 to -2.6 %) absolute decrease in mean adherence from baseline to intensive and sustainability years, respectively.ConclusionsIDOCC did not improve adherence to best-practice guidelines. Our results showed a small statistically significant decrease in mean adherence of questionable clinical significance. Potential reasons for this result include implementation challenges, competing priorities in practices, a broad focus on multiple chronic disease indicators, and use of an overall index of adherence. These results contrast with findings from previously reported facilitation trials and highlight the complexities and challenges of translating research findings into clinical practice.Trial registrationClinicalTrials.gov NCT00574808.

Project description:Despite the established positive benefits, LMICs' adoption of the WHO Surgical Safety Checklist (SSC) is inadequate, with as little as 20% use. This study assessed the utilization and beliefs that drive the non-utilization of the WHO SSC among surgical providers at Korle Bu Teaching Hospital (KBTH) in Accra, Ghana. A cross-sectional study was conducted among 186 surgical providers at the KBTH in Ghana. Data collected included the category of personnel, awareness of the SSC, training received, previously identified barriers, and staff perceptions. Utilization and drivers associated with non-utilization of the SSC were assessed using bivariate log-binomial regression. Out of 190 surgical professionals invited, 186 gave their consent and participated in the survey, giving a response rate of 97.9%. Respondents comprised 69 (37%) surgeons, 66 (36%) anesthetists, and 51 (27%) nurses. Only 30.4% of surgical professionals always use the SSC, as advised by WHO. The majority (67.7%) of surgical professionals had received no formal training on using the WHO SSC. The proportion was highest among surgeons (81.2%) compared to anesthetists (66.7%) and nurses (51%). Surgeons were perceived by other professionals to be the least supportive of checklist use (87.6%), in contrast to nurses (96.1%) and anesthetists (93.9%). Significant drivers associated with checklist usage among surgical professionals included the SSC taking too long to complete, poor communication between anesthetist and surgeon, checklist not covering all perioperative risks, difficulty finding a coordinator, poor attitude of team members toward questions, surgical specialty/unit and training status of professionals. The checklist was always used by only a small (30%) proportion of surgical professionals at the KBTH. Improving checklist use will necessitate its careful application to all surgical operations and a cycle of periodic training that includes context-specific adjustments, checklist auditing, and feedback from local coordinators.

Project description:BackgroundPeripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes.MethodsThis single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat.ResultsBetween July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference - 8%, 95% CI - 14 to - 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred.ConclusionsThis study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes.Trial registrationTrial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415 .

Dataset Information

Causal Analysis of World Health Organization's Surgical Safety Checklist Implementation Quality and Impact on Care Processes and Patient Outcomes: Secondary Analysis From a Large Stepped Wedge Cluster Randomized Controlled Trial in Norway.

Publications

Causal Analysis of World Health Organization's Surgical Safety Checklist Implementation Quality and Impact on Care Processes and Patient Outcomes: Secondary Analysis From a Large Stepped Wedge Cluster Randomized Controlled Trial in Norway.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets