Effect of a cluster randomised team training intervention on adverse perinatal and maternal outcomes: a stepped wedge study.
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ABSTRACT: Objective
To study the effect of an intervention based on Crew Resource Management team training, including a tool for structured communication, on adverse perinatal and maternal outcomes.Design
Stepped wedge.Setting
The Netherlands.Population or sample
Registry data of 8123 women referred from primary care to a hospital during childbirth, at ? 32.0 weeks of singleton gestation and with no congenital abnormalities, in the period 2012-15.Methods
Obstetric teams of five hospitals and their surrounding primary-care midwifery practices participated in the intervention. In total, 49 team training sessions were organised for 465 care professionals (75.5% participated). Adverse perinatal and maternal outcomes before, during and after the intervention were analysed using multivariate logistic regression analyses.Main outcome measures
Adverse Outcome Index (AOI-5), a composite measure involving; intrapartum or neonatal death, admission to neonatal intensive care unit, Apgar < 7 at 5 minutes, postpartum haemorrhage and/or perineal tear.Results
In total, an AOI-5 score was reported in 11.3% of the study population. No significant difference was found in the incidence of the AOI-5 score after the intervention compared with before the intervention (OR 1.07: 95% CI 0.92-1.24).Conclusions
We found no effect of the intervention on adverse perinatal and maternal outcomes for women who were referred during childbirth. Team training is appreciated in practice, but evidence on the long-term impact is still limited. Upcoming studies should build on previous research and consider more sensitive outcome measures.Tweetable abstract
A cluster randomised team training intervention showed no effect on adverse perinatal and maternal outcomes for women referred during childbirth.
SUBMITTER: Romijn A
PROVIDER: S-EPMC6594236 | biostudies-literature | 2019 Jun
REPOSITORIES: biostudies-literature
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Project description:BackgroundAbout 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs.MethodsA cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used.ResultsSixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p < 0.001 and aOR = 11.0, CI95 [4.6-26.4], p < 0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management.ConclusionA booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status.Trial registrationTrial registry identifier NCT01610817 (2012/05/30).
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Project description:Previous reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used.This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials.Literature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design.This review identified 102 trials which employed the stepped wedge design compared to 37 from the most recent review by Beard et al. 2015. Forty six trials were cohort designs and 45 % (n = 46) had fewer than 10 clusters. Of the 42 articles discussing the design methodology 10 covered analysis and seven covered sample size. For cohort stepped wedge designs there was only one paper considering analysis and one considering sample size methods. Most trials employed either a GEE or mixed model approach to analysis (n = 77) but only 22 trials (22 %) estimated sample size in a way which accounted for the stepped wedge design that was subsequently used.Many studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power.
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Project description:ObjectivesTo examine whether primary care outreach facilitation improves the quality of care for general practice patients from refugee backgrounds.DesignPragmatic, cluster randomised controlled trial, with stepped wedge allocation to early or late intervention groups.Setting, participants31 general practices in three metropolitan areas of Sydney and Melbourne with high levels of refugee resettlement, November 2017 - August 2019.InterventionTrained facilitators made three visits to practices over six months, using structured action plans to help practice teams optimise routines of refugee care.Major outcome measureChange in proportion of patients from refugee backgrounds with documented health assessments (Medicare billing). Secondary outcomes were refugee status recording, interpreter use, and clinician-perceived difficulty in referring patients to appropriate dental, social, settlement, and mental health services.ResultsOur sample comprised 14 633 patients. The intervention was associated with an increase in the proportion of patients with Medicare-billed health assessments during the preceding six months, from 19.1% (95% CI, 18.6-19.5%) to 27.3% (95% CI, 26.7-27.9%; odds ratio, 1.88; 95% CI, 1.42-2.50). The impact of the intervention was greater in smaller practices, practices with larger proportions of patients from refugee backgrounds, recent training in refugee health care, or higher baseline provision of health assessments for such patients. There was no impact on refugee status recording, interpreter use increased modestly, and reported difficulties in refugee-specific referrals to social, settlement and dental services were reduced.ConclusionsLow intensity practice facilitation may improve some aspects of primary care for people from refugee backgrounds. Facilitators employed by local health services could support integrated approaches to enhancing the quality of primary care for this vulnerable population.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001970235 (retrospective).
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