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Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol.

ABSTRACT: BACKGROUND:Exchange transfusion is a highly complex procedure that requires high levels of expertise. Trainee paediatricians do not have adequate training in exchange transfusion because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusion that allow students to develop competencies to perform the technique in an appropriate and safe way. METHODS/DESIGN:This is a randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and non-superior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 15® software will be used. DISCUSSION:Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust. TRIAL REGISTRATION:ClinicalTrials.gov: NCT04070066. Registered on 28 August 2019. https://clinicaltrials.gov.

SUBMITTER: Maldonado MJ

PROVIDER: S-EPMC7204002 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol.

Maldonado María José MJ Agudelo Sergio Iván SI Suarez Juan David JD Gamboa Oscar O

Trials 20200507 1

<h4>Background</h4>Exchange transfusion is a highly complex procedure that requires high levels of expertise. Trainee paediatricians do not have adequate training in exchange transfusion because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusion that allow students to develop competencies to perform the technique in an appropriate and safe way.<h4>Methods/design</h4>This is a randomized parallel si ...[more]

PMID: 32381105

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Project description:Packed red blood cell (PRBC) transfusion is required in hematology patients treated with chemotherapy for acute leukemia, autologous (auto) or allogeneic (allo) hematopoietic stem cell transplantation (HSCT). In certain situations like septic shock, hip surgery, coronary disease or gastrointestinal hemorrhage, a restrictive transfusion strategy is associated with a reduction of infection and death. A transfusion strategy using a single PRBC unit has been retrospectively investigated and showed a safe reduction of PRBC consumption and costs. We therefore designed a study to prospectively demonstrate that the transfusion of a single PRBC unit is safe and not inferior to standard care.The 1versus2 trial is a randomized trial which will determine if a single-unit transfusion policy is not inferior to a double-unit transfusion policy. The primary endpoint is the incidence of severe complication (grade???3) defined as stroke, transient ischemic attack, acute coronary syndrome, heart failure, elevated troponin level, intensive care unit transfer, death, new pulmonary infiltrates, and transfusion-related infections during hospital stays. The secondary endpoint is the number of PRBC units transfused per patient per hospital stay. Two hundred and thirty patients will be randomized to receive a single unit or double unit every time the hemoglobin level is less than 8 g/dL. All patients admitted for induction remission chemotherapy, auto-HSCT or allo-HSCT in hematology intensive care units will be eligible for inclusion. Sample size calculation has determined that a patient population of 230 will be required to prove that the 1-unit PRBC strategy is non-inferior to the 2-unit PRBC strategy. Hemoglobin threshold for transfusion is below 8 g/dL. Estimated percentage of complication-free hospital stays is 93 %. In a non-inferiority hypothesis, the number of patients to include is 230 with a power of 90 % and an alpha risk of 5 %.14-128; Clinicaltrials.gov NCT02461264 (registered on 3 June 2015).

Project description:BackgroundThe levels of insecticide-treated net use among pregnant women and uptake of intermittent preventive treatment in pregnancy, have been sub-optimal in Nigeria. Previous studies have reported positive correlations between knowledge, attitude and practice of malaria preventive measures. It has also been reported that information and motivation, act through a mediator (behavioural skills), to cause a health behaviour change. The aim of this study was as such to develop, implement, and assess the effects of a health educational intervention based on the information-motivation-behavioural skills (IMB) model on the levels of knowledge, motivation, and behavioural skills for ITN use and IPTp uptake among pregnant women in a hospital in north-eastern Nigeria.MethodsThis was a randomized controlled parallel-group trial in which 372 antenatal care attendees were randomly assigned to either an intervention or control group after collecting baseline data using a structured questionnaire. The intervention group received a 4-h health education on malaria, guided by a module developed based on the IMB theory, while the control group received health education on breastfeeding for a similar duration and by the same facilitator. Follow-up data were subsequently collected at 2 months and at 4 months post-intervention using the same questionnaire. The generalized linear mixed models analysis was used to determine the between-group and within-group effects of the intervention. The intention-to-treat analysis was used after missing data had been replaced. This was followed by a sensitivity analysis, where the analyses were repeated without replacing the missing values.ResultsThe intervention was significant in achieving a 12.75% (p < 0.001), 8.55% (p < 0.001), and 6.350% (p < 0.001) higher total knowledge, motivation, and behavioural skills scores respectively, for the intervention group over the control group. The sensitivity analysis revealed no great differences in the effect sizes, even when missing data were not replaced.ConclusionThe intervention module was effective in improving knowledge, motivation and behavioural skills. It is as such recommended to be adopted and incorporated into the routine antenatal health education schedules. It is also recommended that booster doses of the module be given say 2 months after the first dose to sustain levels of motivation and behavioural skills. Trial registration Pan African Clinical Trial Registry, PACTR201610001823405. Registered 26 October 2016, http://www.pactr.org.

Project description:BackgroundWorkplace violence is an increasingly significant topic, particularly for staff working in mental health settings. The Centre for Addiction and Mental Health (CAMH), Canada's largest mental health hospital, considers workplace safety a high priority and consequently has mandated staff safety training. For clinical staff, key components of this training are self-protection and team-control skills, which are a last resort when an individual is at an imminent risk of harm to self or others and other interventions are ineffective (eg, verbal de-escalation). For the past 20 years, CAMH's training-as-usual (TAU) has been based on a 3D approach (description, demonstration, and doing), but without any competency-based assessment. Recent staff reports indicate that the acquisition and retention of these skills may be problematic and that staff are not always confident in their ability to effectively address workplace violence. The current literature lacks studies that evaluate how staff are trained to acquire these physical skills and consequently provides no recommendations or best practice guidelines. To address these gaps described by the staff and in the literature, we have used an evidence-based approach from the field of applied behavior analysis known as behavioral skills training (BST), which requires trainees to actively execute targeted skills through instruction, modeling, practice, and feedback loop. As part of this method, competency checklists of skills are used with direct observation to determine successful mastery.ObjectiveOur objectives are to evaluate the effectiveness of BST versus TAU in terms of staff confidence; their competence in self-protection and team-control physical skills; their level of mastery (predefined as 80% competence) in these skills; and their confidence, competency, and mastery at 1 month posttraining.MethodsWe are using a pragmatic randomized controlled trial design. New staff registering for their mandatory safety training are randomly assigned to sessions which are, in turn, randomly assigned to either the BST or TAU conditions. Attendees are informed and consented into the study at the beginning of training. Differences between those consenting and those not consenting in terms of role and department are tracked to flag potential biases.ResultsThis study was internally funded and commenced in January 2021 after receiving ethics approval. As of May 2022, data collection is complete; half of the baseline, posttraining, and 1-month videotapes have been rated, and three-fourths of the interrater reliability checks have been completed. The analysis is expected to begin in late summer 2022 with results submitted for publication by fall 2022.ConclusionsThe findings from this study are expected to contribute to both the medical education literature as well as to the field of applied behavioral analysis where randomized controlled trial designs are rare. More practically, the results are also expected to inform the continuing development of our institutional staff safety training program.International registered report identifier (irrid)DERR1-10.2196/39672.

Project description:BackgroundThe efficacies of fresh frozen plasma and coagulation factor transfusion have been widely evaluated in trauma-induced coagulopathy management during the acute post-injury phase. However, the efficacy of red blood cell transfusion has not been adequately investigated in patients with severe trauma, and the optimal hemoglobin target level during the acute post-injury and resuscitation phases remains unclear. Therefore, this study aimed to examine whether a restrictive transfusion strategy was clinically non-inferior to a liberal transfusion strategy during the acute post-injury phase.MethodsThis cluster-randomized, crossover, non-inferiority multicenter trial was conducted at 22 tertiary emergency medical institutions in Japan and included adult patients with severe trauma at risk of major bleeding. The institutions were allocated a restrictive or liberal transfusion strategy (target hemoglobin levels: 7-9 or 10-12 g/dL, respectively). The strategies were applied to patients immediately after arrival at the emergency department. The primary outcome was 28-day survival after arrival at the emergency department. Secondary outcomes included transfusion volume, complication rates, and event-free days. The non-inferiority margin was set at 3%.ResultsThe 28-day survival rates of patients in the restrictive (n = 216) and liberal (n = 195) strategy groups were 92.1% and 91.3%, respectively. The adjusted odds ratio for 28-day survival in the restrictive versus liberal strategy group was 1.02 (95% confidence interval: 0.49-2.13). Significant non-inferiority was not observed. Transfusion volumes and hemoglobin levels were lower in the restrictive strategy group than in the liberal strategy group. No between-group differences were noted in complication rates or event-free days.ConclusionsAlthough non-inferiority of the restrictive versus liberal transfusion strategy for 28-day survival was not statistically significant, the mortality and complication rates were similar between the groups. The restrictive transfusion strategy results in a lower transfusion volume.Trial registration numberumin.ac.jp/ctr: UMIN000034405, registration date: 8 October 2018.

Project description:IntroductionResuscitation using blood products is critical during the acute postinjury period. However, the optimal target haemoglobin (Hb) levels have not been adequately investigated. With the restrictive transfusion strategy for critically injured patients (RESTRIC) trial, we aim to compare the restrictive and liberal red blood cell (RBC) transfusion strategies.Methods and analysisThis is a cluster-randomised, crossover, non-inferiority trial of patients with severe trauma at 22 hospitals that have been randomised in a 1:1 ratio based on the use of a restrictive or liberal transfusion strategy with target Hb levels of 70-90 or 100-120 g/L, respectively, during the first year. Subsequently, after 1-month washout period, another transfusion strategy will be applied for an additional year. RBC transfusion requirements are usually unclear on arrival at the emergency department. Therefore, patients with severe bleeding, which could lead to haemorrhagic shock, will be included in the trial based on the attending physician's judgement. Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit. The outcomes measured will include the 28-day survival rate after arrival at the emergency department (primary), the cumulative amount of blood transfused, event-free days and frequency of transfusion-associated lung injury and organ failure (secondary). Demonstration of the non-inferiority of restrictive transfusion will emphasise its clinical advantages.Ethics and disseminationThe trial will be performed according to the Japanese and International Ethical guidelines. It has been approved by the Ethics Committee of each participating hospital and The Japanese Association for the Surgery of Trauma (JAST). Written informed consent will be obtained from all patients or their representatives. The results of the trial will be disseminated to the participating hospitals and board-certified educational institutions of JAST, submitted to peer-reviewed journals for publication, and presented at congresses.Trial registration numberUMIN Clinical Trials Registry; UMIN000034405. Registered 8 October 2018.

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Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol.

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Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol.

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