Dataset Information

Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan.

ABSTRACT:

Background

Deimplementing overused health interventions is essential to maximizing quality and value while minimizing harm, waste, and inefficiencies. Three national guidelines discourage continuous pulse oximetry (SpO₂) monitoring in children who are not receiving supplemental oxygen, but the guideline-discordant practice remains prevalent, making it a prime target for deimplementation. This paper details the statistical analysis plan for the Eliminating Monitor Overuse (EMO) SpO₂ trial, which compares the effect of two competing deimplementation strategies (unlearning only vs. unlearning plus substitution) on the sustainment of deimplementation of SpO₂ monitoring in children with bronchiolitis who are in room air.

Methods

The EMO Trial is a hybrid type 3 effectiveness-deimplementation trial with a longitudinal cluster-randomized design, conducted in Pediatric Research in Inpatient Settings Network hospitals. The primary outcome is deimplementation sustainment, analyzed as a longitudinal difference-in-differences comparison between study arms. This analysis will use generalized hierarchical mixed-effects models for longitudinal clustering outcomes. Secondary outcomes include the length of hospital stay and oxygen supplementation duration, modeled using linear mixed-effects regressions. Using the well-established counterfactual approach, we will also perform a mediation analysis of hospital-level mechanistic measures on the association between the deimplementation strategy and the sustainment outcome.

Discussion

We anticipate that the EMO Trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, and likelihood of sustained practice change using rigorously designed deimplementation strategies. This pre-specified statistical analysis plan will mitigate reporting bias and support data-driven approaches.

Trial registration

ClinicalTrials.gov NCT05132322. Registered on 24 November 2021.

SUBMITTER: Xiao R

PROVIDER: S-EPMC10568304 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Publications

Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan.

Xiao Rui R Bonafide Christopher P CP Williams Nathaniel J NJ Cidav Zuleyha Z Landrigan Christopher P CP Faerber Jennifer J Makeneni Spandana S Wolk Courtney Benjamin CB Schondelmeyer Amanda C AC Brady Patrick W PW Beidas Rinad S RS Schisterman Enrique F EF

Contemporary clinical trials communications 20231002

<h4>Background</h4>Deimplementing overused health interventions is essential to maximizing quality and value while minimizing harm, waste, and inefficiencies. Three national guidelines discourage continuous pulse oximetry (SpO<sub>2</sub>) monitoring in children who are not receiving supplemental oxygen, but the guideline-discordant practice remains prevalent, making it a prime target for deimplementation. This paper details the statistical analysis plan for the Eliminating Monitor Overuse (EMO) ...[more]

PMID: 37842322

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Project description:BackgroundMethods of sustaining the deimplementation of overused medical practices (i.e., practices not supported by evidence) are understudied. In pediatric hospital medicine, continuous pulse oximetry monitoring of children with the common viral respiratory illness bronchiolitis is recommended only under specific circumstances. Three national guidelines discourage its use for children who are not receiving supplemental oxygen, but guideline-discordant practice (i.e., overuse) remains prevalent. A 6-hospital pilot of educational outreach with audit and feedback resulted in immediate reductions in overuse; however, the best strategies to optimize sustainment of deimplementation success are unknown.MethodsThe Eliminating Monitor Overuse (EMO) trial will compare two deimplementation strategies in a hybrid type III effectiveness-deimplementation trial. This longitudinal cluster-randomized design will be conducted in Pediatric Research in Inpatient Settings (PRIS) Network hospitals and will include baseline measurement, active deimplementation, and sustainment phases. After a baseline measurement period, 16-19 hospitals will be randomized to a deimplementation strategy that targets unlearning (educational outreach with audit and feedback), and the other 16-19 will be randomized to a strategy that targets unlearning and substitution (adding an EHR-integrated clinical pathway decision support tool). The primary outcome is the sustainment of deimplementation in bronchiolitis patients who are not receiving any supplemental oxygen, analyzed as a longitudinal difference-in-differences comparison of overuse rates across study arms. Secondary outcomes include equity of deimplementation and the fidelity to, and cost of, each deimplementation strategy. To understand how the deimplementation strategies work, we will test hypothesized mechanisms of routinization (clinicians developing new routines supporting practice change) and institutionalization (embedding of practice change into existing organizational systems).DiscussionThe EMO trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, costs, and likelihood of sustained practice change using rigorously designed deimplementation strategies. The trial will also advance care for a high-incidence, costly pediatric lung disease.Trial registrationClinicalTrials.gov, NCT05132322 . Registered on November 10, 2021.

Project description:BackgroundMajor Outcomes with Personalized Dialysate TEMPerature (MyTEMP) is a 4-year cluster-randomized clinical trial comparing the effect of using a personalized, temperature-reduced dialysate protocol versus a dialysate temperature of 36.5°C on cardiovascular-related death and hospitalization. Randomization was performed at the level of the dialysis center ("the cluster").ObjectiveThe objective is to outline the statistical analysis plan for the MyTEMP trial.DesignMyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial.SettingA total of 84 dialysis centers in Ontario, Canada.PatientsApproximately 13 500 patients will have received in-center hemodialysis at the 84 participating dialysis centers during the trial period (April 3, 2017, to March 1, 2021, with a maximum follow-up to March 31, 2021).MethodsPatient identification, baseline characteristics, and study outcomes will be obtained primarily through Ontario administrative health care databases held at ICES. Covariate-constrained randomization was used to allocate the 84 dialysis centers (1:1) to the intervention group or the control group. Centers in the intervention group used a personalized, temperature-reduced dialysate protocol, and centers in the control group used a fixed dialysate temperature of 36.5°C.OutcomesThe primary outcome is a composite of cardiovascular-related death or major cardiovascular-related hospitalization (defined as a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) recorded in administrative health care databases. The key secondary outcome is the mean drop in intradialytic systolic blood pressure, defined as the patients' predialysis systolic blood pressure minus their nadir systolic blood pressure during the dialysis treatment. Anonymized data on patients' predialysis and intradialytic systolic blood pressure were collected at monthly intervals from each dialysis center.Analysis planThe primary analysis will follow an intent-to-treat approach. The primary outcome will be analyzed at the patient level as the hazard ratio of time-to-first event, estimated from a subdistribution hazards model. Within-center correlation will be accounted for using a robust sandwich estimator. In the primary analysis, patients' observation time will end if they experience the primary outcome, emigrate from Ontario, or die of a noncardiovascular cause (which will be treated as a competing risk event). The between-group difference in the mean drop in intradialytic systolic blood pressure obtained during the dialysis sessions throughout the trial period will be analyzed at the center level using an unadjusted random-effects linear mixed model.Trial statusThe MyTEMP trial period is April 3, 2017, to March 31, 2021. We expect to analyze and report results by 2023 once the updated data are available at ICES.Trial registrationMyTEMP is registered with the US National Institutes of Health at clincaltrials.gov (NCT02628366).Statistical analytic planVersion 1.1 June 15, 2021.

Project description:BackgroundDeimplementation, the systematic elimination of low-value practices, has emerged as an important focus within implementation science. Bronchiolitis is the leading cause of infant hospitalization. Among stable inpatients with bronchiolitis who do not require supplemental oxygen, continuous pulse oximetry monitoring is recognized as an overused, low-value practice in pediatric hospital medicine. There is strong scientific evidence and practice guideline support for limiting pulse oximetry monitoring of stable children with bronchiolitis who do not require supplemental oxygen, yet the practice remains common. This study aims to (1) characterize the extent of this overuse in hospitals located in the USA and Canada, (2) identify barriers and facilitators of successful deimplementation of continuous pulse oximetry monitoring in bronchiolitis, and (3) develop consensus strategies for large-scale deimplementation. In addition to identifying feasible strategies for deimplementation, this study will test the feasibility of data collection approaches to be employed in a large-scale deimplementation trial.MethodsThis multicenter study will be performed in approximately 38 hospitals in the Pediatric Research in Inpatient Settings Network. In Aim 1, we will determine the rate of overuse within each hospital by performing repeated cross-sectional observational sampling of continuous pulse oximetry monitoring of stable bronchiolitis patients age 8 weeks through 23 months who do not require supplemental oxygen. In Aim 2, we will use the Consolidated Framework for Implementation Research (CFIR) as a framework for semi-structured interviews with key stakeholders (physician, nurse, respiratory therapist, administrator, and parent) at the highest- and lowest-overuse hospitals to understand barriers and facilitators of continuous pulse oximetry monitoring deimplementation. In Aim 3, we will use a theory-based causal model to match the identified barriers and facilitators to potential strategies for deimplementation. Candidate strategies will be discussed with a panel of stakeholders from hospitals with high rates of overuse to assess feasibility and acceptability. A questionnaire ranking strategies based on feasibility, acceptability, and impact will be administered to a broader group of stakeholders to arrive at consensus about promising strategies for large-scale deimplementation to be tested in a subsequent trial.DiscussionEffective strategies for deimplementing continuous pulse oximetry monitoring of stable patients with bronchiolitis have not been well characterized. The findings of this study will provide further understanding of factors that facilitate deimplementation in pediatric hospital settings and provide pilot and feasibility data to inform a trial of large-scale deimplementation of this overused practice.Trial registrationNot applicable. This study does not meet the World Health Organization definition of a clinical trial.

Project description:BackgroundA birth plan (BP) is a written document in which the pregnant woman explains her wishes and expectations about childbirth to the health professionals and aims to facilitate her decision-making. Midwives' support to women during the development of the BP is essential, but it's unknown if shared decision making (SDM) is effective in birth plan counselling. We hypothesized that women who receive counselling based on SDM during their pregnancy are more likely to present their BP to the hospital, more satisfied with the childbirth experience, and have better obstetric outcomes than women who receive standard counselling. We also aimed to identify if women who presented BP to the hospital have better obstetric outcomes and more satisfied with the childbirth experience.MethodsThis was a randomised cluster trial involving four Primary Care Units. Midwives provided BP counselling based on SDM to the women in the intervention group (IG) during their pregnancy, along with a leaflet with evidence-based recommendations. Women in the control group (CG) only received the standard birth plan counselling from midwives. The primary outcomes were birth plan presentation to the hospital, obstetrics outcomes and satisfaction with childbirth experience. The Mackey Satisfaction with Childbirth Scale (MCSRS) was used to measure childbirth satisfaction.ResultsA total of 461 (95.5%) pregnant women received BP counselling (IG n = 214 and CG n = 247). Fewer women in the intervention group presented their BP to the hospital compared to those in the control group (57.8% vs 75.1%; p <0.001). Mean satisfaction with childbirth experience was high in the IG as well as the CG: 150.2 (SD:22.6) vs. 153.4 (SD:21.8); p = 0.224). The information received about childbirth during pregnancy was high in both groups (95.1% vs 94.8%; p = 1.0). Fewer women in the IG used analgesia epidural compared to those in the CG (84.7% vs 91.7%; p = 0.034); women who combined non-pharmacological and pharmacological methods for pain relief were more in number in the IG (48.9% vs 29.5%; p = 0.001) and women who began breastfeeding in the delivery room were more in number in the IG (83.9% vs 66.3%; p = 0.001). Women who presented their BP had a greater probability of using combined non-pharmacological and pharmacological methods for pain relief aOR = 2.06 (95% CI: 1.30-4.30) and early skin-to-skin contact aOR = 2.08 (95% CI: 1.07-4.04).ConclusionThis counselling intervention was not effective to increase the presentation of the BP to the hospital and women's satisfaction with childbirth; however, it was related to a lower usage of analgesia epidural, a higher combination of pharmacological and non-pharmacological methods for pain relief and the initiation of breastfeeding in the delivery room. Presenting the BP to the hospital increased the likelihood of using pharmacological and non-pharmacological methods for pain relief, and early skin-to-skin contact.

Dataset Information

Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan.

Background

Methods

Discussion

Trial registration

Publications

Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan.

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